Components of Participating Organizations
National Institute of Mental Health
Application Receipt/Submission Date(s): January 7, 2013; January 7, 2014; and January 7, 2015
The purpose of the NIH Research Education Programs (R25) is to support research education activities in the mission areas of the NIH. The goal of the NIMH R25 Program is to augment the education and training of the scientific workforce to meet the nation’s biomedical, behavioral, and clinical research needs in the mission areas of the NIMH. The NIMH R25 Program currently provides four thematic funding opportunities: 1) short courses for mental health-related research education (PAR-12-262), 2) research education programs supporting psychiatric residents (PAR-12-263), 3) mentoring networks for mental health-related research education (PAR-12-264), and 4) research education mentoring programs for HIV/AIDS researchers (PAR-12-273). Note that NIMH R25 applications in the area of HIV/AIDS research education will only be accepted in response to this Funding Opportunity Announcement (FOA).
This FOA issued by the National Institute of Mental Health (NIMH) encourages Research Education Grant (R25) applications from Institutions/Organizations that propose to develop, implement, and evaluate creative and innovative research education mentoring programs that will facilitate the development of a cadre of investigators in requisite scientific research areas to advance the mental health-related objectives of the Office of AIDS Research (OAR) Annual Strategic Plan. Applications are expected to support the development of innovative mentoring programs, relevant to the mission of the NIMH AIDS research program (see Program Scope, below), and that fulfill one or more of the objectives below:
Continue and/or expand current R25 programs, originally funded under PAS-06-447 and PAR-07-386, to develop educational/research experiences that enhance public health, interdisciplinary and translational approaches to the mental health-related aspects of HIV/AIDS research;
Expand the pool of investigators who participate in a program of didactic/academic and research-based components to increase critical mass for sustained and full participation in HIV/AIDS-related mental health research;
Recruit faculty members from across the country for the proposed mentoring programs to attract undergraduates, graduate/medical students, medical residents, postdoctoral fellows or junior faculty to the field of mental health-related aspects of HIV/AIDS. A multidisciplinary mentoring program (in domestic or international settings) should be proposed in an HIV/AIDS-related mental health field that has a thematic concentration (for all programs) such as disparities, prevention, implementation, neuropsychiatry, therapeutics or NeuroAIDS.
Support innovative specialized, intensive mentoring institutes or national mentoring networks (see below for details), either in areas of critical importance or in underserved HIV/AIDS-vulnerable populations. A valuable approach would be to build upon existing HIV/AIDS clinical trial networks. Research education programs other than an institute or a network (as further described below) will be accepted as long as mentoring activities to promote research career development are the cornerstone of the program and the program fulfills one or more of the stated objectives.
Preparing the next generation of basic and clinical research scientists requires research education and career development experiences in highly interdisciplinary and collaborative HIV/AIDS research settings. These experiences will require access to multiple scientific disciplines and methodologies, the involvement of mentors from more than one discipline, and the opportunity for individually tailored research education programs. Due to the likely breadth of the science involved, these experiences will frequently require facilitation and coordination across departments, schools, centers, and institutions; and dedicated time of interdisciplinary faculty. In today’s research climate, having junior and senior faculty with different, but complementary expertise (crossing basic, clinical and services disciplines) serve as co-mentors would be potentially advantageous. Such co-mentoring could provide guidance on cutting-edge as well as established research to help ensure research success. Such co-mentoring would also be likely to facilitate interdisciplinary and translational approaches to HIV/AIDS research.
Just as there is no universally accepted definition of scientific mentoring, there is no single model for successful mentoring. Therefore, applicants should propose a program/network that includes mentoring, resources, and interactive opportunities in a specific scientific content area as the framework for the proposed mentoring program/network. The rationale for the mentoring model and the scientific content area chosen, as well as the relationship of the scientific content area to the mission of the OAR Annual Strategic Plan and to the research programs of the NIMH Division of AIDS Research (DAR) should be described in the application. Recent NIMH/DAR FOAs in the behavioral (PA-11-271; PA-11-275) and biological (PA-11-014) arenas highlight scientific priorities relevant to proposed mentoring networks/programs.
The scope of a mentoring program should be broad enough to accomplish a set of goals rather than a single goal. For example, the program could advance the broad career goals of participants; facilitate scholarly writing and grantsmanship; provide access to a group of skilled mentors who are outstanding researchers but not otherwise available at the home institution of the participant; promote successful transitions from one career stage to another; provide leadership development; facilitate potential collaborations; and help establish interdisciplinary or translational research approaches. The content area should be of sufficient breadth to provide reasonable assurance of the ability to recruit a high-quality pool of potential participants annually and to ensure that a critical mass of mentors and participants in the mentoring program. It is expected that an over-arching goal of any mentoring program is to facilitate the professional success of participants as independent researchers and members of the research community.
Successful mentoring and capacity development require a sustained commitment and ongoing effort and must be done in the context of infrastructure development and partnering between institutions/organizations and the communities served. It will be important for proposed programs to identify and link to existing institutional infrastructure and resources to carry out mentoring effectively.
It is recommended that applicants propose innovative mentoring programs including one of the below options.
Research Mentoring Institutes: Institute-based research education programs that combine didactics and research opportunities. These opportunities should be integrated through research mentoring.
National Research Mentoring Networks: National network-based research education programs that provide a resource of mentors who will enhance the professional development of the participants, sustain their career trajectory through research independence, and lead to scientific advances addressing the mental health of those affected by HIV/AIDS. An applicant organization may wish to partner with other organizations to develop a national mentoring network.
Research education programs other than an institute or a network will be accepted as long as mentoring activities are the cornerstone and the program fulfills one or more of the stated objectives. For all proposed programs, consultation with the scientific program officer is strongly advised.
The major intent of this type of Research Education Program (R25) is to establish long-term mentoring that will enable participants to develop a research program and obtain NIH funding. A multidisciplinary mentoring program should be developed in an HIV/AIDS field that has thematic concentration such as NeuroAIDS, neuropsychiatry, disparities, therapeutics, prevention, dissemination/implementation (see NIMH Division of AIDS Research (DAR) programs). Mentoring activities should be the cornerstone of this program and these mentoring activities should be embedded in both academic and research educational activities that include the components listed below.
(1) Academic program component. The academic program component might include seminars or didactic instruction to provide an introduction to a particular field of research relevant to HIV/AIDS. This should include information relevant to state of the art research methods, recent developments and research findings, particularly those relevant to underrepresented groups (as defined in Section IV.2, Diversity Recruitment and Retention Plan). Didactic instruction should provide the background and basis of individual tutorials and/or small group seminars on research planning to help elaborate and clarify new research questions and develop a preliminary research plan. Regardless of the scientific theme selected, cross-cutting topic areas such as networking/career development and grantsmanship should be addressed.
(2) Research program component. The research program component should involve research career development-related activities and mentoring (in-person, telephonic or virtual) in the context of the participant’s original research studies (including preliminary pilot work). Research should involve preliminary pilot studies and conduct of the research itself as well as the subsequent development of research grant applications for NIH submission. Pilot research projects are for new participants and are limited to $20,000 for up to two years, as detailed in Section II. Other Program-Related Expenses. An application may request up to $20,000, for up to two years, for pilot research projects. Applications that request funds for pilot research projects must clearly describe the process by which the proposed projects will be reviewed and monitored to ensure effective use of pilot project funds.
(3) Local mentoring network. A critical mass of faculty/research mentors with ongoing funded research projects is necessary to implement the proposed specialized, intensive institute academic and research program components. This local network should oversee the following three tasks: (i) the process for matching mentor with participant; (ii) the education proposed, as well as the standardization of mentoring activities; and (iii) the regularly occurring workshops/meetings whose purpose is to pair mentor(s) with participants so that they may work together on the design of research projects and development of research applications for NIMH grant submission.
(4) Institute Administrative Coordination. When there are multiple sites and/or collaborative partnerships for the research mentoring institute, one site should be identified as primary for the purpose of logistical and administrative coordination. This site should provide a resource for overall management, coordination and supervision of the institute mentoring program. This should ensure satisfactory ongoing management of an integrated set of sites with fiscal accountability and evidence of a strong collaborative environment for the institute mentoring program.
(5) Institute Workshops/Meetings. Since a major aspect of the research mentoring institute is participants’ pilot research projects, every attempt should be made for these workshops/meetings to serve as a forum for participants’ research presentations and critiques. During these workshops, concept papers could be reviewed, major trends in HIV/AIDS research discussed, and opportunities provided to interact with mentors, experts and federal program officials. These workshops should also provide a forum for appropriate didactic instruction and plenaries by senior investigators.
(6) Optional Short Courses. Innovative and interactive short courses (their development, implementation, evaluation) may be included as a component of the proposed mentoring institute. These courses are for scientists interested in learning state-of-the-art tools, methods, knowledge and skills needed to conduct research on topics that are well aligned with the mission of the NIMH. They are expected to reflect one or more aspects of the mental health research priorities of the Office of AIDS Research (OAR) Annual Strategic Plan and the program priorities of the NIMH Division of AIDS Research (DAR). Since this FOA is intended to target the national level, the short courses (or workshops) should benefit the entire research community, not primarily the host institution. As such, a selection process should be put in place that allows for participation from both within and outside the host institution while maintaining the focus on research mentoring.
The major intent of a national research mentoring network is to build a qualified pool of HIV/AIDS research scientists who will serve as a central resource of mentors to facilitate the transition of participants to the next level of career development. A multidisciplinary mentoring network should be developed in an HIV/AIDS field that has thematic concentration such as NeuroAIDS, neuropsychiatry, disparities, therapeutics, prevention, dissemination/implementation (see DAR programs). Mentoring networks may propose to mentor only participants from a single career stage or may propose a mentoring network to bridge several career stages (i.e., post baccalaureate through the transition to research independence). Applicants should provide a rationale for the proposed career stage(s) of the participants to be mentored within the network. An applicant organization may wish to partner with scientific professional organizations or other partnering organizations to develop a national mentoring network. The national mentoring network should include the components listed below.
(1) Mentor-Participant matching process. Applicants must clearly define and justify the mentoring approach that is proposed for the levels of participants who will be targeted. This would require matching and tailoring mentors to participants based on interests, needs, personality, and other relevant characteristics.
(2) Mentor training and standardization of mentoring activities. Since applicant institutions are free to choose different delivery modes (e.g., online, peer-based, team-based) for the proposed mentoring activities, it will be important to ensure a process for specific mentorship training, both in general and program-specific activities. After training of mentors is established, standardized participant outcomes should be used to assess the success of mentoring activities.
(3) Participant research activity. While we do not propose a specific research activity for the participant as part of the network, the research activity is expected to encompass issues related to research design, execution and analysis and/or grantsmanship itself ranging from concept development to grant application submission. The proposed national mentoring network should provide a framework for an integrated, high-quality research infrastructure addressing any of these research aspects through innovative mentoring networks that cover research topics, didactic content and mentoring expertise that reflects research interests of NIMH/DAR. While any of a number of methods might be used (e.g., recurring webinars, one-on-one, small group discussions), the ultimate goal should be to promote the participant career development working towards research excellence and successful grant competition.
(4) Network Administrative Coordination. One coordinating center should be identified as a clearinghouse for logistical, administrative and infrastructure support. A process for administrative coordination should be described to provide a resource for overall management, coordination and supervision of the national mentoring network. This should ensure satisfactory ongoing management of an integrated network across several sites with fiscal accountability and evidence of a strong, collaborative environment for the network.
(5) Network Connecting Workshops/Meetings. During these network workshops/meetings, there should be attempts to integrate and bring together aspects of the national network since such a broad network has the potential of being diffuse and spread out over the country. For example, bidirectional exchange might occur where participants learn more about the research university environment and staff learns more about the needs and perceptions of participants. These meetings might also serve as a forum for contextual mentoring where participants communicate with mentors in the network other than their primary mentor as well as with the community and stakeholders.
(6) Optional Short Courses. Innovative and interactive short courses (their development, implementation, evaluation) may be included as a component of the proposed mentoring network. These courses are for scientists interested in learning state-of-the-art tools, methods, knowledge and skills needed to conduct research on topics that are well aligned with the mission of the NIMH. They are expected to reflect one or more aspects of the mental health research priorities of the Office of AIDS Research (OAR) Annual Strategic Plan and the program priorities of the NIMH Division of AIDS Research (DAR). Since this FOA is intended to target the national level, the short courses (or workshops) should benefit the entire research community, not primarily the host institution. As such, a selection process should be put in place that allows for participation from both within and outside the host institution while maintaining the focus on research mentoring.
All programs are expected to incorporate training opportunities that will help individuals move a step forward towards productive careers as HIV/AIDS research scientists. These opportunities might include individualized long-term mentoring; networking interactions; experience in grant writing, preparing presentations, and writing research papers for publication; reviewing manuscripts; participating in mock grant application reviews; having access to state of the art methodology; and traveling to scientific meetings.
This FOA is intended to support new mentoring networks or renewals of currently funded NIMH mentoring networks. The proposed research education program may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
Applicants are strongly encouraged to contact NIMH program staff for current information about priorities and policies before preparing an application (see Section VII).
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments), and faith-based or community-based organizations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Justification for a foreign component: If the research education project includes a foreign component, the application must provide a justification including the special resources or characteristics of the project necessitating a foreign component, the availability (or lack thereof) of this resource in the United States, and the need for additional research education projects in this area. For a definition of a substantial foreign component, see Part III: Policies, Assurances, Definitions, and Other Information in the SF424(R&R) Application Guide.
If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. The need for and use of multiple sites must be justified.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
The PD/PI should have a strong track record as a mentor in an area relevant to the scientific focus of the mentoring institute/network.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
The application must have a strong research program in the area(s) proposed for research education and should include a letter explaining the institutional commitment to the proposed research education program.
The application should describe the anticipated number of mentors who will participate in the mentoring network and their desired qualifications. Describe the planned recruitment process for mentors as well as eligibility, selection, evaluation, and removal criteria. Describe the responsibilities of mentors. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program, a track record of mentoring individuals at the career stage(s) proposed in the application, and a record of leadership related to training and career development programs or activities. Mentors must be committed to continue their involvement throughout the total period of the participation by participant(s) assigned to them during the course of this award, and for a period of no less than one year.
Applications must describe the intended participants, and the eligibility and/or specific education background characteristics that are essential for participation in the proposed research education program. Noting that this FOA can support the development and implementation of educational activities targeting individuals at the career stage of undergraduates, graduate/medical students, medical residents, postdoctoral fellows, and/or early-career faculty, identify the career levels of participants in the planned program and the rationale for the selected career levels. Describe the pool from which participants will be selected regionally and/or nationally (including the anticipated size of the pool and qualifications of the applicants) and criteria for participant eligibility and selection. Describe planned methods for reviewing the progress of participants and for identifying and addressing any problems. Describe strategies that will be used to advertise the mentoring institute/network to this pool, recruitment strategies, and retention strategies.
Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-273.html.
Potential Effects of Metformin on Aging and Age-Related Conditions: Small-Scale Clinical Studies and Secondary Analysis of Controlled Clinical Studies (R01): PA-12-271
Components of Participating Organizations
National Institute on Aging
Application Receipt/Submission Date(s): Multiple dates, see announcement.
An important goal of translational research in aging is the development of new therapeutic options to prevent or delay the onset of deleterious aging changes that contribute to morbidity and mortality among older adults. New opportunities in clinical translation could arise from the discovery of potential new therapeutic effects of already-approved drugs. The current scientific literature suggests that metformin may have additional, previously unrecognized therapeutic effects against age-related conditions and warrants further attention in translational aging research. Initially approved for treatment of Type 2 diabetes, it has now been shown to be effective in Type 2 diabetes prevention. Emerging data from clinical studies of metformin in a variety of patient populations suggest that it may have other effects, besides being an antihyperglycemic agent. For example, there is some clinical evidence that metformin may have cardioprotective effects (e.g., reduce proinflammatory factors, improve lipid profiles, improve endothelial cell function, slow progression of coronary artery calcification). There is also evidence that it may contribute to prevention of some forms of human cancer (e.g., breast, prostate, colon). However, additional studies are necessary to determine if the potential cardioprotective and antineoplastic effects of metformin are direct (glucose or insulin-independent) or secondary effects through restoration of glucose and insulin levels.
Evidence from animal models and in vitro studies suggest that metformin may also influence metabolic and cellular processes associated with the development of chronic conditions of old age, including inflammation, oxidative damage, increased glycation of proteins, diminished autophagy, cell senescence and apoptosis. However, many of these effects of metformin have been observed in pre-clinical studies using doses/concentrations of metformin which far exceed therapeutic levels in humans. Further investigations of metformin at clinically relevant doses/levels will be needed to better understand the translational potential of metformin for the prevention or treatment of chronic conditions of old age.
Though not fully understood, the pleiotropic effects of metformin are thought to be mediated primarily through inhibition of mitochondrial complex 1 (i.e., effects on mitochondrial oxidative phosphorylation and cellular energy charge) and in part, through regulation of the activity of 5’adenosine monophosphate (AMP)-activated protein kinase (AMPK) and the mammalian target of rapamycin (mTOR). Thus metformin has been of interest in experimental aging research because these pathways have been implicated in the modulation of life span and health span in animal models, as well as risk or progression of specific age-related conditions in animal models. Furthermore, metformin has been noted to have some effects similar to those of caloric restriction, which extends life span and health span in many, but not all, experimental animal models. Thus drugs that affect several processes or outcomes are of particular interest in clinical translational research in aging since they may exert their effects by influencing fundamental aging factors that underlie multiple age-related conditions. Information on this range of effects of metformin could have translational value either by directly suggesting alternative, new clinical uses for preventing or ameliorating age-related diseases, or leading to the identification of potential new therapeutic targets for which new compounds could be developed.
Insight into alternative, clinical effects of metformin on a broader range of age-related changes in disease risk factors and incidence of clinical outcomes can be gained through the conduct of small-scale physiological studies (including ancillary projects to ongoing clinical trials) and/or through secondary analyses of data and biospecimens generated from existing controlled clinical studies of metformin. Numerous controlled clinical trials and other controlled human studies of metformin monotherapy (i.e., placebo-controlled versus metformin-only treatment) have been completed or are in progress to examine effects on specific outcomes in a variety of patient populations. Data and stored samples from these studies could be leveraged to address factors contributing to heterogeneity of responses to metformin treatment within a given patient population, as well as questions regarding the effects of metformin and their mechanisms of action(s) under various conditions (e.g., hyperglycemia, hyperinsulinemia, proinflammatory conditions). Moreover, some of the existing clinical studies are prevention or risk factor studies, rather than treatment studies, thus providing an opportunity to assess such effects in persons free of potential complicating effects of conditions that are themselves potential targets of metformin. It is also worth noting that clinical trials of metformin have included individuals of varying age ranges, including children. This allows analyses to explore possible age-related differences in the effects of metformin on aging changes and risk factors at different stages of the life span.
The objective of this FOA is to support research projects (R01) that include small-scale physiologic studies in humans or utilize secondary analyses to increase our understanding about the clinical translational potential of metformin to delay deleterious aging changes or to extend healthy human life span. This includes identification of specific populations particularly likely to benefit (i.e., in diabetic, as well non-diabetic populations), and/or to obtain information on metformin’s human physiologic and cellular effects that would be useful in identifying novel molecular targets.
For those proposing projects utilizing secondary analyses, the principal focus of this FOA is on analyses of data sets and/or stored samples from controlled clinical studies of metformin monotherapy (i.e., placebo-controlled versus metformin-only treatment). Potential applicants may wish to review the following links to identify controlled human intervention studies/trials from which valuable data and/or biospecimens may be analyzed to better understand the effects of metformin on aging and age-related conditions:
NIH Research Portfolio Online Reporting Tools (RePORT): http://projectreporter.nih.gov/reporter.cfm
NIH Clinical Trials.gov: http://clinicaltrials.gov/
Central NIDDK Repository for Biosamples and Data: http://www.niddkrepository.org
The NCI Cooperative Group Banks Associated with Large Clinical Trials: http://cgb.cancer.gov/
Applicants are responsible for adhering to the individual study policies governing ancillary projects and access to clinical trials data and/or biorepository samples. The application should include a letter of support from the relevant study committee indicating approval of proposed ancillary study or granting access to data sets and/or repository (if proposal involves analysis of stored samples) and study approval for the proposed analyses.
This FOA invites small-scale physiological studies in humans or secondary analyses of data and/or stored samples from controlled clinical trials or other controlled human intervention studies of metformin. These studies may: 1) involve small-scale physiologic studies in humans (including ancillary studies to ongoing trials), 2) employ data mining techniques (e.g., data from a single trial or pooled analyses) and/or 2) utilize in vitro experimental models such as cells or tissues from intervention and control groups and/or 3) measure and compare factors in blood/plasma samples from intervention and controlled groups. For proposed projects employing secondary analyses, this FOA will allow limited collection of new data (including collection of samples) if necessary to fully address the specific aims.
As appropriate, proposed studies of mechanism of action of metformin should consider a range of doses, especially the testing of metformin concentrations which are clinically relevant. Experiments to distinguish between direct effects of metformin (glucose or insulin-independent) from those effects mediated via reductions in hepatic gluconeogenesis and improvements in insulin sensitivity are especially encouraged.
Examples of potential research topics relevant to this FOA include but are not limited to:
Comparisons of treatment and control groups in single or merged multiple clinical trials data sets to investigate the effects of metformin on multiple risk factors for multiple age-related conditions (e.g., blood pressure, lipids, proinflammatory factors, prothrombotic factors, visceral obesity). Analyses of both beneficial and potential adverse effects are of interest.
Analyses of data from individual or pooled trials to identify potential populations who may be particularly likely to benefit (or be harmed) by broader uses of metformin. It is suggested that relationships of covariates such as age (e.g., children vs. adults, middle-age vs. old age), genotype, gender, or presence of specific conditions or risk factors be considered in the proposed analyses.
Analyses of data and stored biospecimens to identify factors, including genetic factors, which contribute to heterogeneity of responses to metformin treatment.
Small-scale physiological studies or secondary analyses of data sets and/or assays of stored samples to probe metformin effects on physiologic processes that may influence aging (e.g., oxidative damage, inflammation, protein glycation, autophagy). Approaches to distinguish direct effects of metformin on these processes versus effects which are secondary to and mediated via improvements in glucose metabolism are of interest.
Small-scale physiological studies to further elucidate effect(s) of metformin on mitochondrial function and its impact on aging processes (e.g., ROS production, oxidative damage). Such studies may employ non-invasive methods to assess mitochondrial function in vivo, as well as in vitro studies of isolated mitochondria from biopsy samples. In vitro studies of metformin effects on mitochondrial function are encouraged to evaluate concentrations of metformin within therapeutic levels.
In vitro studies comparing cells, cell lines, tissue samples, serum, or plasma from metformin-treated and control-group individuals, to determine effects of metformin treatment on cellular or circulating factors that may influence protective or deleterious cellular or physiologic processes (e.g., responses to stressors and other stimuli, stress resistance, autophagy, apoptosis) and mechanism(s) of action by which metformin exerts such effects. Analyses of dose-effect relationships are of particular interest.
Gene expression studies (e.g., comparisons of peripheral blood cells from metformin-treated and control group individuals) to identify possible mediators of effects of metformin.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-12-271.html.
SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics Toward Commercialization (R44): RFA-CA-12-023
Components of Participating Organizations
National Cancer Institute
Application Receipt Date(s): November 6, 2012; March 6, 2013, by 5:00 PM local time of applicant organization.
The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) helps bring innovative solutions to public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA) solicits SBIR grant applications from SBCs to support later stage research and development (referred to as Phase IIB) for projects that were previously funded by NIH SBIR Phase II awards. The goal of this FOA and Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product or service along a promising commercialization pathway.
To be responsive to this FOA, proposed projects MUST be applicable to at least one of the following technical/scientific areas:
(1) Cancer Therapeutics;
(2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; and/or
(3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics.
SBIR Phase IIB Bridge Awards are designed to facilitate the continuation of promising SBIR Phase II projects in order to pursue the next appropriate milestone(s) toward ultimate commercialization. To achieve this goal, this FOA is designed to promote partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners.
In particular, competitive preference and funding priority will be given to applications deemed likely to result in a commercial product or service as indicated by the applicant’s ability to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NCI funds). NCI support is thus intended to benefit cancer patients by accelerating the development of novel cancer-relevant products and services toward commercialization.
This FOA is specifically intended to provide additional support for products and services that require ultimate approval by a Federal regulatory agency; therefore, proposed projects may address preclinical and/or clinical stages of development (including clinical trials).
Since its inception in 1982, the NIH SBIR program has provided the small business community with critical seed funding to support the development of a broad array of commercial products and services for the detection, diagnosis, treatment, and prevention of disease. The SBIR Program is structured in three phases. The main objective in Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. The objective in Phase III is for the small business to fully commercialize their product or service using non-SBIR funds. However, many of the early-stage projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to achieve commercialization. In particular, the development of therapeutics and medical devices often requires several years and substantial capital investments, due in large part to the costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process.
Among the areas of R&D supported by the NCI’s SBIR Program, cancer therapeutics, imaging technologies, interventional devices, diagnostics and prognostics typically require substantial levels of additional financing beyond the SBIR Phase I and Phase II funding. Moreover, a number of emerging products in these areas are becoming increasingly complex due to the technological advances in multi-disciplinary fields. For example, new products may involve measurements of both physical and molecular signatures, combine device(s) and molecular probe(s), or perform dual functions of diagnosis and therapy. These products are referred to as “combined technologies” by the Food and Drug Administration (FDA), and examples in oncology include those related to genomics, proteomics, certain approaches to imaging, image-guided diagnosis and therapy, and other therapeutics. Importantly, the developers of such technologies often face additional challenges during the regulatory approval process, requiring even more time and effort to commercialize such technologies.
Large pharmaceutical and biotechnology companies, as well as venture capital firms, have traditionally provided the resources needed to fully develop and commercialize biomedical products and services initiated with NIH SBIR funding. More recently, however, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses. Consequently, a number of NIH-funded SBIR awardees are successfully completing their Phase II activities, yet they are still unable to attract sufficient investment (by the end of the Phase II award) to continue the development of their product or service, thus exhausting their financial resources at a critical stage. The purpose of this FOA is to address this funding gap between the end of the SBIR Phase II award and the point at which non-NIH financing can be secured for the subsequent stages of product development – a phase often referred to as the “Valley of Death.”
A number of public and private organizations have begun to recognize the challenges associated with the “Valley of Death” and are taking steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the pre-clinical stages of development, and some of these firms have established technology incubators to provide regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. Taken together, these programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.
Specific Objectives for SBIR Phase IIB Bridge Award Applications
A. Independent Third-Party Investor Funds
This FOA is specifically intended to encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and services initiated with NIH SBIR funding. In particular, applicants are expected to leverage their previous NIH SBIR support, as well as the opportunity to compete for additional NCI funding under this FOA, to negotiate and attract third-party financing needed to advance a product or service toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NCI funds being requested over the entire Bridge Award project period will provide a measure of the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered by the NCI in respective funding decisions. It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NCI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies.
B. Scientific/Technical Scope
The technical and commercial objectives described in the SBIR Phase IIB Bridge Award application MUST represent an extension of the development efforts that were pursued in a previously funded NIH SBIR Phase II award. It is essential that significant progress has been accomplished during the current/preceding NIH SBIR Phase II project and also that the proposed product or service has significant commercial potential. Applicants should also demonstrate that the proposed product/service has a clear advantage over existing and/or competing products/services and should clearly define an appropriate path toward ultimate commercialization.
In particular, this FOA is specifically designed to provide additional support for products and services that require ultimate approval by a Federal regulatory agency.
Applications received under this FOA must fall within at least one of three technical/scientific areas: (1) Cancer Therapeutics; (2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; or (3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics. The following descriptions provide additional details on each of these areas, as well as appropriate development activities to be proposed under this FOA.
Area 1: Cancer Therapeutics
Projects proposed under Area 1 may include (but are not necessarily limited to) the development of the following categories of cancer therapeutics:
Small molecule anticancer agents;
Anticancer biologics, including antibodies and therapeutic vaccines;
Multifunctional cancer therapeutics based on nanotechnology; and/or
Anticancer drug delivery systems.
Therapeutic modalities other than those listed above may also be considered.
Applicants proposing projects under Area 1 are generally expected to have completed most of the following steps in the development process (as appropriate for the specific project):
Target validation;
Screening of candidates and identification of active entities (small molecules, biologicals, etc.);
Confirmation of hits based on repeat assay/concentration response curve (CRC);
Structure-Activity Relationship (SAR) studies;
Identification of lead compound(s) or biological(s) suitable for further development;
Process development to support clinical manufacturing (e.g., scale-up feasibility);
In vivo pharmacokinetics and toxicity studies;
In vivo preclinical efficacy studies; and/or
Other activities leading to the selection of a development candidate.
For projects pertaining to Area 1, applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application, as well as clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).
Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 1 include (but are not necessarily limited to) the following examples:
Demonstration of acceptable pharmacokinetics and pharmacodynamics;
Completion of in vivo preclinical efficacy studies (properly powered);
Demonstration of acceptable safety (toxicity in rodents and large animals);
Manufacturing of acceptable clinical dosage form [i.e., meeting the Good Manufacturing Practices (GMP) quality];
Other R&D activities that might be needed to complete an IND application;
Human Proof of Concept (Phase I clinical trial); and/or
Clinical Proof of Concept (Phase II clinical trial).
Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization.
Area 2: Cancer Imaging Technologies, Interventional Devices & In Vivo Diagnostics.
Projects proposed under Area 2 may include (but are not necessarily limited to) the development of the following categories of cancer imaging technologies, interventional devices and in vivo diagnostics:
Medical devices for in vivo cancer imaging and/or image-guided interventions (e.g., systems for image-guided surgery);
Radiation therapy devices and other ablative techniques;
Cancer imaging agents, including imaging radiopharmaceuticals and nanotechnology-based contrast agents; and/or
Devices and technologies for in vivo cancer diagnostics.
Cancer imaging modalities and interventional devices/technologies other than those listed above may also be considered.
Applicants proposing projects under Area 2 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):
Development of a prototype system with desired functionality;
Measurements and/or phantom studies to characterize system parameters;
Initiated efficacy studies in an animal model; and
Initiated transfer of the technology/device to manufacturing.
For projects pertaining to Area 2, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, Investigational Device Exemption (IDE) application, and/or the successful approval of a study protocol by the Radioactive Drug Research Committee (RDRC).
Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 2 include (but are not necessarily limited to) the following examples:
Efficacy studies in an animal model;
Process development for manufacturing;
GMP/QS manufacturing;
Verification of the classification;
Non-clinical safety studies (e.g., toxicology, biocompatibility); and/or
Clinical trials.
Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization of the technology.
Area 3: In Vitro and Ex Vivo Cancer Diagnostics and Prognostics
Projects proposed under Area 3 may include (but are not necessarily limited to) the development of the following categories of in vitro and ex vivo cancer diagnostics and prognostics:
Molecular diagnostics and prognostics, including in vitro diagnostic multivariate index assays (IVDMIA);
Image analysis tools for diagnosis; and/or
Spectroscopic techniques for in vitro and ex vivo tissue analysis.
In vitro and ex vivo cancer diagnostic and prognostic technologies other than those listed above may also be considered. Prognostic technologies may be focused on (predicting) disease progression, response to therapy, or both.
Applicants proposing projects under Area 3 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):
Identification and development of a selective biomarker(s) for the detection of cancer;
Design and development of a prototype system/assay;
Characterization of the system/assay in terms of reproducibility, variability, and accuracy;
Development of a qualified assay for the biomarker that is applicable in the clinical setting; and
Initiated validation studies in a relevant patient population(s).
For projects pertaining to scientific Area 3, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay. Thus, activities to be pursued under this FOA should address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology.
C. Plan for Full Commercialization (all applications)
The goal of the SBIR Phase IIB Bridge Award is to advance SBIR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Bridge Award project period), which outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization of the product or service should be carried out with non-SBIR funds.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD(s)/PI(s must be with the SBC at the time of award and during the conduct of the proposed project. For projects with multiple PD(s)/PI(s), at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide. Consistent with this policy, resubmission applications will be accepted for SBIR Bridge Award Phase IIB applications that were originally submitted in response to the previous SBIR Phase IIB Bridge Award FOAs (RFA-CA-11-002 or RFA-CA-12-001).
The SBIR Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previously funded NIH SBIR Phase II award. Applications may be predicated on a previously funded SBIR Phase II grant or contract award. NOTE: Applicants who intend to submit a Phase IIB Bridge Award application that is predicated on an SBIR Phase II contract MUST contact the SBIR Development Center prior to submission, so that the NCI can properly arrange for such applications to be accepted. Applicants should demonstrate in their application that significant progress has been accomplished during the ”parent” NIH SBIR Phase II project, and also that the product or service has significant commercial potential. Applicants should also demonstrate that the proposed product/service has a clear advantage over existing and/or competing products/services and should clearly define an appropriate path toward ultimate commercialization. The qualifying “parent” NIH SBIR Phase II project may be renewed only once through the Phase IIB Bridge Award under this FOA. Following the Phase II Bridge Award period (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.
To qualify for renewal under the Phase IIB Bridge Award, the prior Phase II award could have been funded in response to any NIH SBIR solicitation and could have been funded by the NCI or by another NIH Institute/Center. However, the proposed objectives must fall within the technical scope required for this FOA as defined in Section I (under “Specific Objectives for SBIR Phase IIB Bridge Award Applications”). In addition, the development activities completed under the previous Phase II award MUST provide the appropriate technical foundation to justify continued development of the technology for a cancer-relevant indication/use. Platform technologies that were initially developed for a non-cancer indication/use (i.e., certain Phase II projects funded by another NIH Institute/Center) may be eligible for continued support under this FOA, only if the earlier data demonstrates technical proof-of-concept that is scientifically relevant to the cancer indication/use. For all projects supported under this FOA, the aims of the project should focus on a cancer-relevant indication/use as the primary product or service. SBIR Phase IIB awards are non-renewable.
This FOA is only open to NIH SBIR Phase II projects nearing completion and those that have recently ended. To be eligible under the current FOA, current Phase II projects MUST end on or before August 31, 2013. In general, past Phase II projects should have ended within 24 months of the application receipt date. The NCI will consider longer periods of hiatus on a case-by-case basis. In all cases, the Phase II project period must end before a Phase IIB Bridge Award can be issued.
In Phase II (including Phase IIB), normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the SBC. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-12-023.html.
Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01): PAR-12-265
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt/Submission Date(s): Multiple receipt dates, see announcement.
This Funding Opportunity Announcement issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) invites investigator initiated research project applications (R01) for ancillary studies to major ongoing clinical trials, epidemiological studies and disease databases (described as parent studies) supported by the Institute, other Institutes and Centers of the National Institutes of Health, other government agencies and the private sector to capitalize on the already established infrastructure of the parent study to enhance the breadth and depth of its scientific output. Major studies include multi-center clinical research investigations, national databases and Phase 3 clinical trials. An ongoing study is one that is currently following and assessing study participants. In some cases grant applications may be submitted prior to implementation of a study (before the study is ongoing) with the anticipation by the applicant that funding will coincide with the beginning of recruitment.
Ancillary studies proposed under this FOA must be of scientific interest and within the mission of the NIDDK. Such studies may be proposed from both NIDDK supported parent studies and parent studies funded from other sources as described above. Typically, but not exclusively, ancillary studies are proposed for NIDDK supported parent studies. The NIDDK-supported parent studies are focused on a wide range of diseases and conditions including diabetes, obesity, acute and chronic liver disease, chronic kidney disease, acute kidney injury, benign prostatic hyperplasia and other lower urinary disorders, among others. Examples of NIDDK-supported parent studies for which ancillary studies may be conducted may be found at the following website: http://www2.niddk.nih.gov/Research/ClinicalResearch/AncillaryStudies/. These studies are typically supported by cooperative agreements or contracts. This FOA also invites applications from investigators who plan to conduct ancillary studies utilizing major ongoing clinical research studies (multi-center clinical research investigations, national databases and Phase 3 clinical trials) supported by other Institutes and Centers of the NIH, other government agencies and the private sector. However, to be eligible for this FOA the ancillary study proposed must be clearly within the scientific mission of the NIDDK and focused on diseases and conditions of direct interest to the Institute. The scientific areas funded by the NIDDK may be found at http://www2.niddk.nih.gov/Research/. Irrespective of the original goals of the parent study, the diseases or conditions of interest to NIDDK must have been rigorously defined and present in a sufficient number of study participants. It is strongly recommended that the applicant contact NIDDK program staff prior to submission of their grant application to verify that the proposed ancillary study addresses research goals within the mission and interest of the Institute. While it is recognized that ongoing studies funded by NIDDK may be useful for studying diseases outside the mission of the NIDDK, this FOA may not be used to support such studies. Applications addressing the research goals of other NIH Institutes may be submitted using the NIH parent R01 FOA (PA-11-260), or relevant FOAs from other Institutes.
The NIDDK supports a large number of major multi-center clinical trials to determine the beneficial effect of therapies and interventions. In addition, the Institute supports a number of large-scale multi-institution epidemiological studies and disease databases to better characterize the natural history and response to treatment of a wide range of diseases and conditions. Each of these studies represents a substantial financial commitment from the NIDDK to establish an infrastructure for participant recruitment, examination, data collection and follow-up. These studies offer unique opportunities to conduct additional investigations to fully exploit the research potential of these established cohorts to study the diseases for which these studies were originally designed. These studies may also provide the opportunity to learn more about diseases and conditions outside the original scope of the study protocol but within the mission and interest of the NIDDK. It is also recognized that studies supported by other Institutes and Centers of the NIH, other government agencies and the private sector may also lend themselves to ancillary studies which will advance the research mission of the NIDDK.
The goal of this FOA is to obtain additional scientific information for the diseases and conditions of interest and within the mission of the NIDDK. It is recognized that there is considerable potential for obtaining new knowledge beyond the core activities of the parent study by means of ancillary studies. For this FOA, core activities are considered the measures described in the parent study protocol and are being carried out; having been previously approved by the group responsible for conducting the study-e.g., the Steering Committee-and/or the study’s oversight body-e.g., the Data and Safety Monitoring Board. This knowledge may include identification of additional risk factors for disease or genetic factors related to the development, diagnosis, or progression of disease or to the response to therapy. This FOA may also be used to extend the scope of participant data collection and assessment to identify co-morbidities and their impact on the primary disease/condition under study. It is also recognized that a parent study not originally designed to address diseases and scientific areas of responsibility of the NIDDK may yield important insights and additional information of interest to the Institute through ancillary studies. Generally, this FOA is not applicable to small and/or single center studies. For studies supported by Research Project Grants (R01) ancillary study grant applications may be submitted under the Funding Opportunity for Research Project Grants (Parent R01, PA-11-260). However, to determine eligibility of a parent study it is recommended that interested investigators contact NIDDK staff prior to submission of their grant application. Applications to this FOA must include a letter from the appropriate committee (e.g., Ancillary Study Committee) or person (e.g., Chairman of the Steering Committee) indicating that the parent study investigators have approved the ancillary study. In order to take advantage of new data and/or sample collection at the beginning of recruitment of study participants (at baseline) grant applications may be submitted prior to study implementation (before the study is considered ongoing). In those instances the applicant must include a letter from the parent study sponsoring organization/Project Scientist indicating the timetable for its implementation.
Areas of Research Interest: It is anticipated that grant applications may include but are not limited to identification of additional and/or unique/emerging risk factors, pathogenic mechanisms, genetic factors, predictors of drug response (pharmacogenetics, pharmacogenomics), proteomics, metabolomics, biomarker discovery and/or validation as well as better characterization of the co-morbid illnesses suffered by the subjects enrolled in the parent studies. The natural history, risk factors and effect of clinical trial interventions of diseases and conditions for which the parent study was not originally designed may also be studied by means of additional data collection and/or assay of already collected or newly obtained biological samples as long as new questions being addressed are within the scientific mission of NIDDK.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-265.html.
New Technologies for the Study of Lymphatics in the Digestive and Urinary Systems (R43/R44): PA-12-258
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Despite the fact that lymphatic vessels are a major component of the organs of the digestive system and the urinary tract, perform critical roles in organ function, and are altered in digestive system and urinary tract diseases and inflammation, their roles in digestive system and urinary tract health and disease are poorly understood and rarely studied. This announcement is to encourage applications for development of reagents, tools and technologies that will accelerate research into aspects of lymphatic vessel physiology and pathophysiology related to health and disease of digestive system and urinary tract organs. The announcement does not focus on immune mechanisms; however tools that will aid studies to understand the factors that direct local lymphatic vessel functional anatomy and physiology during health, inflammation and disease in digestive and urinary tract organs, and the mechanisms by which alterations of lymphatic vessel function affect organ function, are of interest.
The lymphatic system is a crucial component of nutrient and hormone absorption, fluid homeostasis and immunity. However, the current description of the lymphatics of the kidney and bladder is restricted to gross morphology and virtually nothing is known about the specific function of the lymphatic system in the organs of the urinary tract. In the digestive system, lymphatic vessel function is interwoven with organ function, both anatomically and physiologically and these vessels lie at the nexus of critical hormonal, digestive and immune functions. For example, each villus in the small intestine has a lymphatic vessel, the lacteal, associated with it, that is instrumental in absorption of digested fats. Lymphatic vessels selectively transport certain hormones from enteroendocrine cells, provide a major absorption pathway for some drugs, and are the route of uptake of some nutrients in addition to fats. Lymphatic endothelium mediates passage of immune cells through an array of adhesion molecules and chemokines. Thus, lymphatic vessels potentially play active roles in the relationship of gut health to the microbiome and in inflammatory disease, however the factors that affect these roles, and the resultant effects on the local tissue, are underexplored. Even less is understood about lymphatics in other organs of the digestive system, such as liver. Research in some organs demonstrates that lymphatic vessels have altered numbers and morphologies under conditions of inflammation. Yet we know very little about the normal micro-anatomy, regulation, and interactions of lymphatics in the digestive system or urinary tract in the context of health and even less in the context of digestive and urinary diseases and inflammation. Similarly, little is understood regarding lymphangiogenesis in digestive system and urinary tract organs. Altered function of the lymphatic vessels has the potential for far-reaching consequences to digestive system and urinary tract function and overall health. For example, loss of lymphatic fluid and plasma protein into the gastrointestinal lumen is associated with inflammatory bowel disease and leads to edema and hypoproteinemia. Edema associated with insufficient lymphatic drainage has been associated with fat deposition in localized areas of the body, yet mechanisms for this effect are unclear. Whether and how lymphatic drainage affects transplant of digestive and urinary tract organs is also unclear. Furthermore, as a transportation system that intersects with the blood circulatory system, the lymphatic vessels and lymph from the gut and the urinary tract have the potential to affect distant organs. Research on lymphatic vessels of digestive and urinary tract organs holds the potential for greater understanding of not only lymphatic system function and local organ function, but whole body health, as well.
On November 3–4, 2009, the NIDDK sponsored an exploratory workshop on Lymphatics and the Digestive System: Physiology, Health and Disease. In addition to reviewing current relevant research, major questions for future research were also identified through participant discussions. However, research on lymphatics would be aided by development and standardization of research reagents, development of techniques for quantitative assessment of lymphatic anatomy and function, generation of model systems for investigation of the function of lymphatic vessels within the context of organ function, and generation of biomarkers to assess changes in lymphatics in organ health and disease. This announcement is to stimulate development of these reagents, tools and technologies in order to facilitate research on lymphatic function in the digestive system and urinary system.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD(s)/PI(s), at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).
In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-12-258.html.
AHRQ Individual Awards for Postdoctoral Fellows (F32) National Research Service Awards (NRSA): PA-12-261
Components of Participating Organizations
Agency for Healthcare Research and Quality
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The purpose of the postdoctoral fellowship (F32) award is to provide support to promising postdoctoral applicants who have the potential to become productive and successful independent research investigators. The proposed postdoctoral training must offer an opportunity to enhance the applicant’s understanding of health services research and must be responsive to AHRQ’s mission, which is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 42 U.SC. 299a(b) authorizes AHRQ to provide training programs in the field of health services research.
The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of health care in the United States. It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost. It evaluates both clinical services and the system in which these services are provided. These scientific results improve the evidence base to enable better decisions about health care, including such areas as: disease prevention; appropriate use of medical technologies; care coordination, care management, enhancing access to care, patient self-management; palliative care; improving diagnosis, treatment, patient access, and work flow while reducing costs or holding them constant; long-term care; reducing disparities in health care outcomes and quality among racial, ethnic, and underserved populations; enhancing the transparency and accountability of care delivery practices and outcomes; and contributing to evidence-based decision making by patients, providers, regulators, and payers. AHRQ is especially interested in applications that propose to train researchers to address healthcare disparities and quality measurement and improvement. Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality. Results should be directly relevant to stakeholders, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers. The strategic research goals are:
Safety/quality – Reduce the risk of harm from health care services by promoting the delivery of appropriate care that achieves the best quality outcomes
Efficiency – Achieve wider access to effective health care services and reduce health care costs
Effectiveness – Assure that providers and consumers/patients use beneficial and timely health care information to make informed decision choices.
AHRQ also has specific research portfolio areas of interest which include comparative effectiveness/patient-centered outcomes, health information technology (health IT), value, patient safety, prevention and care management, and healthcare innovations. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm
Applicants are required to address training in research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.
Trainees must focus their research development and projects on health care delivery in the United States.
Applicant fellows with a health professional doctoral degree may use the proposed postdoctoral training to satisfy a portion of the degree requirements for a master’s degree, a research doctoral degree or any other advanced research degree program.
Individuals from diverse racial and ethnic groups and individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Eligible institutions and organizations include: public or non-profit private institutions, such as universities, colleges, or faith-based or community-based organizations; units of local or state government; eligible agencies of the Federal Government; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized), and Indian/Native American tribally designated organizations.
Awards for fellowship training may only be made to domestic institutions.
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training as the PD/PI is invited to work with his/her sponsor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
Citizenship: On or before the issue date of the award, the individual must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F32 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.
Degree Requirements: Before a NRSA postdoctoral fellowship award can be activated, the individual must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. A NRSA fellowship may not be used to support studies leading to the MD, DO, DDS, DVM, or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training. However, these awards are appropriate for the research fellowship years of a research-track residency program. Research clinicians must devote full-time to their proposed research training and confine clinical duties to those activities that are part of the research training program.
This program does not require cost sharing for applications in response to this FOA.
An individual may not have more than one competing NIH or AHRQ fellowship application pending review concurrently.
Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Awards are not renewable and are not transferable from one PD/PI to another.
Individuals may receive up to 3 years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F32). It is not allowable to have concurrent NRSA support from two different sources (e.g., F32 and T32). Applicants must consider any prior NRSA postdoctoral research training in determining the duration of fellowship support requested. Accurate information regarding previous NRSA support must be included in the application and will be considered at the time of award. Applications not providing this information or showing a combined prior and proposed duration of NRSA postdoctoral support exceeding 3 years by the time of an award are not eligible for this FOA.
Training beyond the 3-year aggregate limit may be possible under certain exceptional circumstances, but a waiver from AHRQ is required. Individuals seeking additional NRSA support beyond the third year are strongly advised to consult with relevant AHRQ staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. A waiver request should be made to the program official at AHRQ at least six months prior to the termination date of the fellowship award. A request for a waiver cannot be made prior to the issuance of the initial award.
Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in the postdoctoral research training program which is determined by the AHRQ Program staff review of information documented in the progress report.
Sponsor: Before submitting a fellowship application, the applicant fellow must identify a sponsor (also called mentor or supervisor) who will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research training and be committed both to the research training of the Fellowship Applicant and to the direct supervision the applicant’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant’s research training program. The applicant must work with his/her sponsor(s) in preparing the application.
The sponsor must describe the research training plan for the applicant fellow (coordinated with the applicant’s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged.
Sponsoring Institution: Before submitting a fellowship application, the applicant fellow must also identify a sponsoring institution. The sponsoring institution must have appropriate staff and facilities available on site to provide a suitable environment for performing high-quality research training and be demonstrably committed to research training in the particular program proposed by the applicant.
The fellowship is designed to support research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. In most cases, therefore, the sponsoring institution should be a site other than where the applicant fellow has trained as a graduate student. However, if the applicant fellow is proposing postdoctoral training at his/her doctoral institution, the application must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background. In addition, the application should propose research experiences that will allow the fellow to acquire new knowledge and/or technical skills that will enhance the candidate’s potential to become a productive, independent investigator.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-12-261.html.
Time-Sensitive Obesity Policy and Program Evaluation (R01): PAR-12-257
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
National Institute on Aging
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): October 10, 2012; November 14, 2012; December 11, 2012; January 10, 2013; February 11, 2013; March 11, 2013; April 11, 2013; May 10, 2013; June 10, 2013; July 10, 2013; August 14, 2013; September 10, 2013; October 10, 2013; November 14, 2013; December 11, 2013; January 10, 2014; February 11, 2014; March 11, 2014; April 11, 2014; May 12, 2014; June 10, 2014; July 10, 2014; August 14, 2014; September 10, 2014; October 10, 2014; November 10, 2014; December 10, 2014; January 12, 2015; February 10, 2015; March 10, 2015; April 14, 2015; May 11, 2015; June 10, 2015; July 10, 2015; August 12, 2015; September 10, 2015.
Obesity is a major contributor to many serious health conditions that increase morbidity and mortality and reduce quality of life. The prevalence of obesity in children and adults in the United States has dramatically increased in the past four decades. While helping people achieve and maintain a healthy weight is a critical public health goal, little is known about the effectiveness of large scale policies and programs that could help achieve this goal. Nationally and internationally there is an imperative to take action at local, state and federal levels, especially related to obesity in children. Some of the policies or programs being implemented offer investigators the opportunity to perform “natural experiments”. A natural experiment is not a randomized controlled experiment as the allocation of intervention is not within the researcher’s control. As noted in the 2010 IOM report, Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making, rigorous scientific evaluation of these policies and programs can help build an evidence base to measure advances toward preventing excess weight gain or improving weight management and to ensure that future resources are directed towards those interventions shown to be effective.
This FOA is intended to encourage and support research in which a unique and time sensitive opportunity has arisen to collect baseline data and then prospectively assess effectiveness of an imminent policy or program designed to prevent or reduce obesity in a given population (e.g. designed to reduce energy intake, increase activity, or decrease sedentary behavior).
For the purposes of this FOA:
Policy is broadly defined to include both formal public policies at local, state and federal levels of government, as well as organizational level policies, such as those implemented by organizations, schools or worksites. Examples include but are not limited to the development of supermarkets in underserved areas, calorie labeling requirements, added tax on food or beverage, school-based BMI measurement and reporting, modification of transportation pathways to facilitate more walking or bicycle riding, or the implementation of multi-use trail/s.
Program is defined as a set of activities initiated by governmental or other organizational bodies to enhance obesity prevention and control. Examples might include programs implemented in schools, worksites, or communities designed to improve obesity related behaviors such as energy intake and activity level. This FOA is not intended to support the initiation and delivery of new programs; rather, it is intended to support time sensitive evaluations of the effectiveness of programs and/or policies that will be implemented imminently and regardless of the outcome of a research application in response to this FOA.
Several distinguishing features of the obesity program and/or policy research evaluation must be articulated in the grant application:
It must be clear that the research question offers an uncommon and scientifically compelling research opportunity that will only be available if the evaluation research component is initiated with minimum delay.
Expedited review and funding are required in order for the scientific question to be addressed and for the research design to be carried out. It should be clear that the knowledge gained from the study could not be obtained through the traditional NIH cycle of application submission, review and award. Therefore, as noted above, applications in response to this time-sensitive mechanism are eligible for only one submission. Resubmission applications are not permitted under this FOA.
The plan for collection of baseline and follow-up data is feasible.
The obesity program or policy to be evaluated should reasonably be expected to affect behaviors relevant to obesity such as reduced energy intake, reduced sedentary behavior, or increased physical activity in the target population. Further, research proposed in response to this FOA should demonstrate that measures collected and evaluated will allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on the target behaviors or weight.
Examples of appropriate studies include, but are not limited to, the following:
Examine the effect of imminent policy or programs intended to improve dietary intake or activity levels such as:
○ Introduction of new taxes/subsidies/price changes/other incentives;
○ Infrastructure Initiatives such as the introduction of new aspects of the built environment such as retailers offering healthier food options in underserved areas;
○ Changes to school or workplace food and/or physical activity environment;
○ Polices designed to influence available options and purchasing, such as calorie labeling in restaurants, menu or food product reformulation, and supermarket layout or pricing strategies;
○ Introduction of active transportation options such as the implementation of bike lanes in urban areas, multi-use trails, or subsidies for public transit on activity of citizens; and community-level changes, e.g., upgrades of sidewalks, modification of transportation pathways to facilitate more walking or bicycle riding, implementation of multi-use trail/s, or traffic calming measures.
Primary outcomes under study must be assessed using objective measures, or in the case of dietary intake, by using standardized and comprehensive 24hr recall methods. Examples of acceptable primary outcomes include objective measures of behavior change (purchasing behavior, use of resources intended for physical activity, energy intake with a focus on lowered calories or lower calorie substitutions, activity changes such as reduced sedentary behavior or increased physical activity) and/or weight related variables (e.g. BMI, body composition). Other self-reported measures of dietary intake and physical activity can be included but should not be the primary outcome measure/s.
Where possible or relevant, grant applications should include secondary outcomes that evaluate potential unintended consequences of a policy or program, degree of implementation, and an assessment of barriers and facilitators associated with implementation. This includes measures that will help identify why the policy or program succeeds or does not succeed.
This funding opportunity announcement encourages innovative scientific partnerships between researchers and public partners (e.g., community based organizations, local governments, school districts, employers). Where relevant, applicants must provide letters of support from those who hold ownership or management of the program and/or policy that indicate their full cooperation with the research team. This must include support for access to the data required for the evaluation. Where appropriate, agreements must also be in place that allow for unrestricted publication of findings regardless of study outcomes. Research applications that include comparison group/s must include letters of support/agreement for access to the comparison group. The Program Director/Principal Investigator of the evaluation study should not be the initiator of the policy or director of the program to be evaluated.
Applicants are strongly encouraged to contact the program staff listed on this FOA to discuss their planned research prior to submission to this announcement.
Applications requesting research support for the evaluation or retrospective analysis of existing obesity policies or programs that are not time sensitive should not be submitted under this FOA. Rather, such applications should be submitted under PA-10-027, Obesity Policy Research: Evaluation and Measures (R01) or PA-10-052, School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R01).
Given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-257.html.
Lymphatics in Health and Disease in the Digestive, Urinary, Cardiovascular and Pulmonary Systems (R01): PAR-12-259
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Heart, Lung, and Blood Institute
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Lymphatic vessels, a major component of most organs in the body, perform critical roles in organ functions. Their role in disease is poorly understood and rarely studied. This announcement encourages applications for research on lymphatic vessel physiology and pathophysiology related to the health and disease of the digestive system and urinary tract organs, and cardiovascular and pulmonary systems; in resolution of thromboembolic events; and inflammation and immune responses as they relate to these diseases. However, studies with the major focus on immune mechanisms will not be considered responsive. Studies to understand the factors that control lymphatic vessel functional anatomy and physiology during health or disease, and the mechanisms by which alterations of normal lymphatic vessel structure and function affect the systems and processes enumerated above are of interest.
The lymphatic system is a crucial component of nutrient and hormone absorption, fluid homeostasis and immunity. However, the current description of the lymphatics of the kidney and bladder is restricted to gross morphology and virtually nothing is known about the specific function of the lymphatic system in the organs of the urinary tract. In the digestive system, lymphatic vessel function is interwoven with organ function, both anatomically and physiologically and these vessels lie at the nexus of critical hormonal, digestive and immune functions. For example, each villus in the small intestine has a lymphatic vessel, the lacteal, associated with it, that is instrumental in absorption of digested fats. Lymphatic vessels selectively transport certain hormones from enteroendocrine cells, provide a major absorption pathway for some drugs, and are the route of uptake of some nutrients in addition to fats. Lymphatic endothelium mediates passage of immune cells through an array of adhesion molecules and chemokines. Thus, lymphatic vessels potentially play active roles in the relationship of gut health to the microbiome and in inflammatory disease, however the factors that affect these roles, and the resultant effects on the local tissue, are underexplored. Even less is understood about lymphatics in other organs of the digestive system, such as liver. Research in some organs demonstrates that lymphatic vessels have altered numbers and morphologies under conditions of inflammation. Yet, we know very little about the normal micro-anatomy, regulation, and interactions of lymphatics in the digestive system or urinary tract in the context of health and even less in the context of digestive and urinary diseases and inflammation. Similarly, little is understood regarding lymphangiogenesis in digestive system and urinary tract organs. Altered function of the lymphatic vessels has the potential for far-reaching consequences to digestive system and urinary tract function and overall health. For example, loss of lymphatic fluid and plasma protein into the gastrointestinal lumen is associated with inflammatory bowel disease and leads to edema and hypoproteinemia. Edema associated with insufficient lymphatic drainage has been associated with fat deposition in localized areas of the body, yet mechanisms for this effect are unclear.
Whether and how lymphatic drainage affects transplant of digestive and urinary tract organs is also unclear. Furthermore, as a transportation system that intersects with the blood circulatory system, the lymphatic vessels and lymph from the gut and the urinary tract have the potential to affect distant organs (e.g., cardiopulmonary function). Research on lymphatic vessels of digestive and urinary tract organs holds the potential for greater understanding of not only lymphatic system function and local organ function, but whole body health, as well.
On November 3–4, 2009, the NIDDK sponsored an exploratory workshop on Lymphatics and the Digestive System: Physiology, Health and Disease. In addition to reviewing current relevant research, major questions for future research were also identified through participant discussions. This announcement is to stimulate research in response to these needed research areas and important questions in the digestive system and urinary system. Studies on the role of lymphatic vessels in the function of organs of interest to the NIDDK are encouraged.
Specific areas of interests for the National Heart, Lung, and Blood Institute (NHLBI) include approaches that will identify the genetic, molecular, and cellular defects that contribute to congenital malformation of the lymphatic system; congenital-lymphatic-malformation-induced pulmonary dysfunction; whether and how lymphangiogenesis affects cardiovascular and pulmonary diseases; whether and how lymphatic drainage affects transplant of heart or lungs; whether and how the lymphatic vessel hyperplasia in the dermal interstitium is involved in salt-sensitive hypertension; and whether and how the manipulation of platelet-lymphatic endothelial cell interaction may provide clinical benefit during thromboembolic events.
Studies that focus on mechanisms of immunity are not appropriate to this announcement. Clinical research and clinical trials are not intended to be supported under this Funding Opportunity Announcement.
Examples of research areas of interest under this program announcement include, but are not limited to the following:
What are the mechanisms whereby altered lymphatic vessel structure and function affect organ health and function? Do lymphatic vessels have a role in disease initiation and propagation?
Is lymphatic vessel structure and function altered in the presence of inflammation in organs of the digestive system, urinary tract, heart or lungs, and what are the mechanisms involved?
Is lymphangiogenesis affected in disease conditions affecting the digestive system, urinary tract organs, the cardiovascular system or the pulmonary system, and what mechanisms are involved?
Is lymph composition from digestive and urinary tract organs actively modulated and how?
Does lymph composition originating from diseased digestive tract impact cardiopulmonary health?
What are the roles of lymph vessel anatomy and cell junctions in sampling of the environment of the mucosa? How does this relate to the microbiome and maintenance of mucosal homeostasis?
Is there a relationship between regional drainage of lymph and local accumulation of fat in organs? What are the mechanisms involved and how does this relate to organ function?
What are the mechanisms by which impaired lymph pumping or transport affect nutrient transport, hormonal transport and water transport from digestive organs?
Are there organ-specific characteristics of vessels of the lymphatic system?
What is the interplay of gut microbiome and dietary constituents on the structure and function of lymphatic vessels?
How do environmental factors such as diet and dietary constituents change the structure and function of local lymphatic vessels as they relate to the health and disease of digestive system and urinary tract organs?
Normal lymphatic vascular development is regulated through the interactions of platelets and lymphatic endothelial cells. Can platelet/endothelial cell interaction be manipulated to regulate lymphangiogenesis, reduce localized swelling, and prevent thromboembolic events?
What are lymphatic remodeling pathways in airway inflammatory diseases?
Does lymphangiogenesis have a role in atherosclerosis and, if so, through what mechanism(s)?
What is the role of the lymphatic system in reverse cholesterol transport?
What is the role of lymphatic vessels in the dermal interstitium in salt balance and in salt-sensitive hypertension?
What is the role of lymphatic drainage in normal cardiac function and recovery after cardiac injury, such as myocardial infarction?
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-259.html.
Lymphatics in Health and Disease in the Digestive, Cardiovascular and Pulmonary Systems (R21): PAR-12-260
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Heart, Lung, and Blood Institute
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Lymphatic vessels, a major component of most organs in the body, perform critical roles in organ functions. Their role in disease is poorly understood and rarely studied. This announcement encourages applications for research on lymphatic vessel physiology and pathophysiology related to health and disease of the digestive, cardiovascular and pulmonary systems, resolution of thromboembolic events, and inflammation and immune responses as they relate to these diseases. However, studies with the major focus on immune mechanisms are not applicable. Studies to understand the factors that control lymphatic vessel functional anatomy and physiology during health or disease, and the mechanisms by which alterations of normal lymphatic vessel structure and function affect the systems and processes enumerated above are of interest.
The lymphatic system is a crucial component of nutrient and hormone absorption, fluid homeostasis and immunity. In the digestive system, lymphatic vessel function is interwoven with organ function, both anatomically and physiologically and these vessels lie at the nexus of critical hormonal, digestive and immune functions. For example, each villus in the small intestine has a lymphatic vessel, the lacteal, associated with it, that is instrumental in absorption of digested fats. Lymphatic vessels selectively transport certain hormones from enteroendocrine cells, provide a major absorption pathway for some drugs, and are the route of uptake of some nutrients, in addition to fats. Lymphatic endothelium mediates passage of immune cells through an array of adhesion molecules and chemokines. Thus, lymphatic vessels potentially play active roles in the relationship of gut health to the microbiome and in inflammatory disease, however the factors that affect these roles, and the resultant effects on the local tissue, are underexplored. Even less is understood about lymphatics in other organs of the digestive system, such as liver. Research in some organs demonstrates that lymphatic vessels have altered numbers and morphologies under conditions of inflammation. Yet, we know very little about the normal micro-anatomy, regulation, and interactions of lymphatics in the digestive system in the context of health and even less in the context of digestive diseases and inflammation. Similarly, little is understood regarding lymphangiogenesis in digestive system organs. Altered function of the lymphatic vessels has the potential for far-reaching consequences to digestive system function and overall health. For example, loss of lymphatic fluid and plasma protein into the gastrointestinal lumen is associated with inflammatory bowel disease and leads to edema and hypoproteinemia. Edema associated with insufficient lymphatic drainage has been associated with fat deposition in localized areas of the body, yet mechanisms for this effect are unclear.
Whether and how lymphatic drainage affects transplant of digestive organs is also unclear. Furthermore, as a transportation system that intersects with the blood circulatory system, the lymphatic vessels and lymph from the gut have the potential to affect distant organs (e.g., cardiopulmonary function). Research on lymphatic vessels of digestive organs holds the potential for greater understanding of not only lymphatic system function, and local organ function, but whole body health, as well.
On November 3–4, 2009, the NIDDK sponsored an exploratory workshop on Lymphatics and the Digestive System: Physiology, Health and Disease. In addition to reviewing current relevant research, major questions for future research were also identified through participant discussions. This announcement for R21 applications is to stimulate research in response to these needed, important questions in the digestive system. It is recognized that research on lymphatics in the digestive system may require novel scientific ideas or new model systems, tools or technologies for which there is little preliminary information but which will have a significant impact on future research. This announcement for R21 applications is intended to support such novel research. Studies on the role of lymphatic vessels in the function of organs of interest to the NIDDK are encouraged.
Specific areas of interests for the National Heart, Lung, and Blood Institute (NHLBI) include approaches that will identify the genetic, molecular, and cellular defects that contribute to congenital malformation of the lymphatic system; congenital-lymphatic-malformation-induced pulmonary dysfunction; whether and how lymphangiogenesis affects cardiovascular and pulmonary diseases; whether and how lymphatic drainage affects transplant of heart or lungs; whether and how lymphatic vessel hyperplasia in the dermal interstitium is involved in salt-sensitive hypertension; and whether and how the manipulation of platelet-lymphatic endothelial cell interaction may provide clinical benefit during thromboembolic events.
Studies that focus on mechanisms of immunity are not appropriate to this announcement. Clinical research and clinical trials are not intended to be supported under this Funding Opportunity Announcement.
Examples of research areas of interest under this program announcement include, but are not limited to the following:
What are the mechanisms whereby altered lymphatic vessel structure and function affect organ health and function? Do lymphatic vessels have a role in disease initiation and propagation?
Is lymphatic vessel structure and function altered in the presence of inflammation in organs of the digestive system, heart or lungs, and what are the mechanisms involved?
Is lymphangiogenesis affected in disease conditions affecting the digestive system, cardiovascular system or pulmonary system, and what mechanisms are involved?
Is lymph composition from digestive organs actively modulated and how?
Does lymph composition originating from diseased digestive tract impact cardiopulmonary health?
What are the roles of lymph vessel anatomy and cell junctions in sampling of the environment of the mucosa? How does this relate to the microbiome and maintenance of mucosal homeostasis?
Is there a relationship between regional drainage of lymph and local accumulation of fat in organs? What are the mechanisms involved and how does this relate to organ function?
What are the mechanisms by which impaired lymph pumping or transport affect nutrient transport, hormonal transport and water transport from digestive organs?
Are there organ-specific characteristics of vessels of the lymphatic system?
What is the interplay of gut microbiome and dietary constituents on the structure and function of lymphatic vessels?
How do environmental factors such as diet and dietary constituents change the structure and function of local lymphatic vessels as they relate to the health and disease of digestive system organs?
Normal lymphatic vascular development is regulated through the interactions of platelets and lymphatic endothelial cells. Can platelet/endothelial cell interaction be manipulated to regulate lymphangiogenesis, reduce localized swelling, and prevent thromboembolic events?
What are lymphatic remodeling pathways in airway inflammatory diseases?
Does lymphangiogenesis have a role in atherosclerosis and, if so, through what mechanism(s)?
What is the role of the lymphatic system in reverse cholesterol transport?
What is the role of lymphatic vessels in the dermal interstitium in salt balance and in salt-sensitive hypertension?
What is the role of lymphatic drainage in normal cardiac function and recovery after cardiac injury, such as myocardial infarction?
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-260.html.
Advancing Clinical Research in Primary Glomerular Diseases (UM1): RFA-DK-12-014
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): February 27, 2013
A. Background: The disease focus of this solicitation is primary glomerular disease resulting specifically from minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IGAN), and idiopathic membranous nephropathy (IMN). These chronic disorders often produce symptoms of edema and signs of nephrotic range proteinuria and/or hematuria in both adults and children. Progressive loss of kidney function occurs over many years, and these diseases are responsible for approximately 10% of incident end stage renal disease (ESRD) patients per year.
There have been recent knowledge advances in the mechanistic aspects of these diseases that provide hope for new methods of diagnosis and treatment. Genetic mutations within the Podicin and Nephrin genes result in some forms of childhood nephrotic syndrome of MCD or FSGS, and adult FSGS in people of African descent is now linked to the APOL1 gene. A hyposialylated Angiopoietin-like 4 protein has been shown to result in MCD with severe proteinuria, which is treatable in rodent models. Increased levels of soluble urokinase-type plasminogen activator receptor (suPAR) have been associated with FSGS; inhibition of suPAR may be a therapy for this disease. Recent studies have identified antibodies to the M-type phospholipase A2 receptor (PLA2R) as the cause of a large percentage of IMN in humans. Other studies have demonstrated a multi-hit mechanism for IGAN involving the increase in an aberrant IgA1 antibody followed by antibody formation to the o-glycan portion of the IgA, formation of circulating immune complexes with subsequent deposition in the mesangium and glomerular injury. These mechanisms provide potential targets and biomarkers for these diseases.
Major challenges to development of clinical therapies for these diseases are their relative rarity in comparison with the more common diabetic nephropathy and the slow progression that is often measured in decades rather than months to years. This translates into significant difficulties in participant recruitment for sufficient numbers for the study of mechanisms, identification of disease targets and biomarkers, and diagnostic development in translational and clinical studies. Subsequent trials of specific new therapies are difficult for the same reasons. In addition, the hard endpoints of mortality and ESRD are not appropriate in these diseases for trials of only a few years duration. Alternative outcomes (e.g., biomarkers or patient reported outcomes) are typically required to be validated and acceptable to the FDA prior to the launch of a phase III trial.
B. Overall Goals: The NIDDK seeks to form a collaboration of academia, industry (e.g., pharmaceutical companies), government (e.g., FDA, NIH), and advocacy groups in order to establish and follow a longitudinal, observational cohort of patients using a common protocol. The overall goals of this consortium include:
Importance of the scientific question(s) that will form the basis of the longitudinal cohort data collection
Development of a common protocol (with specific elements for each disease, if necessary)
Recruitment of participants for a natural history cohort study
Longitudinal collection of phenotypic, genetic, biochemical, and tissue data
Analysis of these data including Systems biology approaches to the dataset
Applications for subsequent ancillary studies to identify disease targets, develop biomarker-therapy combinations, and establish and validate Patient Reported Outcomes (PROs) and surrogate outcomes for disease progression and remission
The common protocol will be developed in the first two months after award, after which recruitment will take place over the next 3 years or until the number is sufficient for the study goals. NIDDK estimates that approximately 2400 participants or 600 per disease entity will be required for the future requirements in this research area, as well as 2400 controls. Follow-up of these patients is anticipated to be ongoing until significant progression (e.g., doubling of creatinine) or ESRD or death occurs. In the present economic environment, no one agency or entity will be able to fully fund all the research that is required to address these diseases, and therefore the NIDDK is open to collaborations set up as public-private partnerships (http://ppp.od.nih.gov). Proposed collaborations must include close interaction with the FDA on biomarker and surrogate outcome development. Collaborations with industry on pre-competitive items are encouraged. Partnerships with advocacy groups may accelerate and strengthen patient recruitment.
C. Important elements of applications are:
Discussion of scientific questions that need to be addressed within the longitudinal cohort.
Diseases to be studied are restricted to chronic forms of MCD, FSGS, IGAN, and IMN. Chronicity is defined by a disease progression of months to years versus acute kidney injury with progression of days to weeks. All sites should recruit for all diseases, and NIDDK recognizes that sites may have to subcontract to other sites to attain their goals. Diagnosis will be established by renal biopsy either prior to or on entry into the cohort. Diagnosis with diabetes, diabetic nephropathy or another renal disease will preclude participants from the study.
Definition of inclusion and exclusion criteria as well as a separate control cohort of normal participants without apparent kidney disease. Recruitment should include adult and/or pediatric participants. Efficient use of electronic health records or other on-line databases (e.g., advocacy groups) for recruitment and follow-up is encouraged.
Definition of the number of participants with each disease entity to be recruited along with realistic strategies, including back-up plans, for recruitment of adults and children. It is recognized that there may not be adequate numbers of pediatric patients with all four diseases, particularly IGAN and IMN; this should be discussed in the application with explanation of the value of their longitudinal follow-up despite low numbers. Existing cohorts can be used, but the steering committees of existing cohorts would have to agree to all aspects of a common protocol designed by the steering committee of this collaboration.
Proposed protocol for collection of longitudinal data, including timing of visits and specimen collection, phenotypic data (including symptoms to facilitate development of patient reported outcomes, [PRO]), genomic data, biochemical data, and tissues. These data should support future R01-funded ancillary studies (to be funded separately with PAR-12-NNN), which likely include the following among many research topics:
a. Establish, validate, and qualify alternative outcomes for disease flare or relapse in conjunction with the FDA. These might include PROs as well as physician- or other medical practitioner- reported outcomes. These should include short-term goals, i.e., testing of known biomarkers as well as long-term goals of potential alternative outcomes.
b. Identify biomarkers (diagnostic, prognostic, progression) from pathophysiologic, molecular, and genetic studies of patients and of controls or from the application of Systems biology to the combined data sets that will be collected.
c. Develop biomarker - therapy combinations that halt or retard disease progression and test these in Phase 0 Studies (FDA qualification).
d. Develop technological solutions for real-time measurements in a.-c.: new techniques to improve the efficiency of data collection (e.g, use of smart phones to report ongoing symptoms (PROs) or vital signs or devices for measuring proteinuria and transmitting to a study site)
e. Facilitate Phase I pilot studies of potential therapies
The successful applicants will meet at NIH on September 11–12, 2013 to draw up the common protocol.
It is envisioned that the Consortium will be composed of four Participating Clinical Centers (PCCs) which will recruit study participants and conduct studies, collecting data which will be submitted electronically to a single Data Coordinating Center (DCC).
D. Successful DCC applications will have addressed all of the following:
How the DCC will coordinate data collection, perform analyses and prepare study reports for the PCCs or other entities performing ancillary studies, in addition to preparing the final protocol(s) for review and approval.
The DCC will be responsible for the conduct of Steering Committee meetings and conference calls. 3. It is envisioned that a DCC will require at a minimum a senior Biostatistician, a Master’s level Biostatistician/Epidemiologist and a Database Manager and other key staff.
It is envisioned that ancillary studies performed by the consortium or other entities will include multi-center studies. All data collected by PCCs in single and multi-center studies will be sent to the DCC for quality control and analysis.
All data collection and analyses (i.e., questionnaires, biochemical measurements, pathological specimens, clinical data) will adhere to the standards of the Clinical Data Interchange Standards Consortium (CDISC) in order to facilitate biomarker, surrogate outcome, and therapy development in accordance with the FDA guidelines.
The DCC should include a description of the operating plan for the study (with characteristics as described in C.4 above) to illustrate how it will operate.
E. Successful PCC applications will have addressed all of the following:
1. Discussion of one or more scientific questions that the PCC will emphasize in its cohort follow-up.
2. The trial population with specific inclusion and exclusion criteria, data collection, proposed endpoints, and proposed manner of patient longitudinal follow-up in accordance with C. “Important Items 1–6” above. If a PCC applicant is made up of solely pediatric researchers, the entity should provide evidence of how they will carry out this longitudinal follow-up after the participant ages out of an acceptable range at the pediatric institution.
3. The target population should be carefully defined with respect to such variables as: disease entity including pathological (biopsy-proven) diagnosis, duration of disease, renal function, age, co-morbidities (e.g., hypertension, autoimmune and other diseases), gender, race, generalizability for ancillary studies, and other factors deemed important.
4. Plans for selection and recruitment of study subjects, and backup plans, as appropriate. Details of collaborations with advocacy groups or other longitudinal cohorts or other subcontracted sites should be given.
5. Plans for data collection of potential renal and non-renal biomarkers and alternative outcomes, if appropriate for the scientific question(s) from E.1. This might include applications for known as well as potential future biomarkers. Alternative outcomes should be acceptable to the FDA or should be qualified within future ancillary studies. All proposed measurements should be justified by the proposed scientific question(s).
6. Statistical considerations, including power calculations for possible studies as outlined in C.5.
7. Demonstration of ability to work with industry or advocacy partners, who will submit letters of support or collaboration stipulating agreement to a) provide drug(s)/biologic(s)/device(s)/assay to be used in future ancillary studies, b) the use of provided interventions in combination studies within the consortial structure, c) allowing access to recruited participants to all consortial members, and d) working collaboratively with the PCC and other members of the consortium on conference calls and during Steering Committee meetings, and in the dissemination of research findings through presentations at scientific meetings and in publication in the scientific literature.
7. Applicants for PCCs should demonstrate the importance of the proposed data collection for ancillary studies. Applicants should demonstrate their experience in and ability to recruit a diverse and appropriate population for the longitudinal studies.
F. Common study issues for DCC and PCC:
Ability to establish Consortium Agreements (or policies/procedures) that address: (1) data sharing amongst members for data generated not only by the consortium but also data received by a PCC from industry or other collaborators; and (2) procedures for protecting any confidential information, including without limitation, data generated from the consortium or from industry partners or other external collaborators. These procedures will address appropriate administrative, physical and technical safeguards that protect confidential information and prevent its inadvertent disclosure. Each industry collaboration will be governed by an appropriate Research Collaboration Agreement with terms that ensure collaboration is conducted in accordance with the terms of the Cooperative Agreement and all applicable NIH policies and procedures. Each industry/PCC agreement will address ownership of intellectual property discovered from multi-party data generated by the consortium, and the Consortium will develop intellectual property policies and procedures with terms that ensure collaboration and dissemination of research findings are conducted in accordance with the terms of the Cooperative Agreement and all applicable NIH policies and procedures. Consortium policies will require continued submission of data centrally to the DCC and consortium policies/procedures will address protection of medical and genetic records of individuals.
Awardees will meet to finalize the consortial study protocol(s). Both PCC and DCC applicants should be prepared to participate in conference calls immediately after funding, and should reserve September 11 and 12, 2013 for the first Steering Committee meeting in Bethesda, Maryland. Applicants should indicate their availabilities on these dates in their applications.
A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote. Membership on the Steering Committee will include a Steering Committee Chair (chosen by the NIDDK), the Participating Clinical Centers (PCC) and Data Coordinating Center (DCC)PD(s)/PI(s), and a NIDDK Project Scientist.
The responsibilities of the Steering Committee include: Development of the common protocol that will address points E.1–7 above; Providing input on and approval of all studies developed by the Consortium members prior to or after study implementation; Review and approval of all data analyses, public presentations and publications of research conducted within the consortium; Development of policies and procedures for submission and approval of ancillary research applications using Consortium resources.
NIDDK will appoint an External Expert Group (EEG) who will have oversight over the conduct of the study and provide advice and guidance to the investigators and to the NIDDK during the study. The steering committee will meet with the EEG at least once per year.
A pre-submission, informational phone conference will be held at 3 pm (EDT), October 11, 2012. Contact Dr. Flessner for call-in details, flessnermf@niddk.nih.gov.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-014.html.
Collaborative R01s for Clinical and Services Studies of Mental Disorders and AIDS (Collaborative R01): PAR-12-278
Components of Participating Organizations
National Institute of Mental Health
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The National Institute of Mental Health (NIMH) seeks to support collaborative intervention trials in the treatment, prevention or rehabilitation of those with mental disorders and comorbid mental disorders. Support is also provided for other collaborative clinical studies, including but not limited to mental health services research, AIDS, genetics, and psychopathology.
This Funding Opportunity Announcement (FOA) should be used when two or more sites are needed to complete the study. The collaborating studies share a specific protocol across the sites and are organized as such in order to increase sample size, accelerate recruitment, or increase sample diversity and representation. In studies with a large number of sites, it is expected that one site may be submitted as a coordinating site for data management and/or other centralized administration. (For additional considerations for multi-site trials research, see the NIMH NAMHC report, specifically Appendix C, on “Treatment Research in Mental Illness: Improving the Nation’s Public Mental Health Care through NIMH Funded Interventions Research.” For a linked set of collaborative R01s, each site has its own Program Director/Principal Investigator (PD/PI) and the program provides a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting.
Collaborative studies are appropriate to address research questions that are beyond the capacity of any single-site investigation. Considerations such as increased sample size, representation, and diversity may all support the need for multi-site studies, as do considerations of the need for collaboration between sites with diverse expertise and/or perspectives.
Across all mental health research areas, clinical studies that address research objectives outlined in the NIMH Strategic Plan are encouraged. Additional priorities for mental health research that is specifically focused on intervention research are detailed in the NAMHC Workgroup Report “From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses.” Potential applicants are encouraged to contact program staff as far in advance as possible to discuss the match between potential research applications and current NIMH priorities. The following are examples of the types of studies that can be supported under this mechanism—these are meant to be illustrative only and are not intended to be exclusive or exhaustive.
Large scale, public health oriented intervention studies (treatment, prevention, or rehabilitation) using pharmacologic, psychosocial, or somatic approaches individually or in combination, including studies that examine the balance between efficacy and safety, studies that compare cost-effectiveness of alternate intervention approaches, and studies that employ novel designs to test personalized intervention strategies.
Studies within the context of clinical trials that assess population pharmacokinetics or identify other candidate biomarkers that, in combination with sociodemographic and clinical information, enhance prediction of treatment response
Large-scale human genetic studies, in which pedigree recruitment and ascertainment must occur in parallel fashion across multiple sites
Smaller scale studies of unique clinical populations or low base rate outcomes that would be difficult to recruit from a single clinical setting
Large scale studies of risk factors/psychopathology (including genetic, neurobiological, behavioral, environmental, and experiential factors), particularly studies which elucidate potential mechanisms of disorders and are consistent with the Research Domain Criteria (RDoC) initiative and the RDoC emphasis on classification of psychopathology on the basis of underlying dimensions of observable behavior and neurobiological measures
Studies to develop and test strategies to reduce modifiable risk factors and improve the management of common chronic medical conditions in persons with severe mental illness.
Services research to identify mutable factors that impact access, utilization, quality, and outcomes of mental health services to inform or test patient-, provider-, organizational-, systems- or policy- level services interventions
Studies of diffusion strategies (i.e., dissemination and implementation) to improve adoption of evidence-based treatments in practice settings (These can include patient-, provider-, organizational-, or systems- level targets and may also consider the role and impact of differential incentives and resources to achieve adoption.)
For applications relevant to pediatric mental health, studies that will aid in the development of novel therapies for serious mental disorders of childhood and adolescence; identify mechanisms and processes (genetic, biological, behavioral, and/or environmental) that confer risk for or protection from childhood psychopathology; improve the phenotypic characterization of pediatric mental disorders and refine standardized behavioral assessment tools that are sensitive to developmental change, cultural diversity, and variation in functioning; develop, test, and validate biologically based markers for diagnosing or detecting risk/vulnerability, onset, progress, and/or severity of pediatric mental disorders; identify psychosocial and neurobiological mechanisms underlying sex differences in, and gender influences on, pediatric mental disorders; and delineate mechanisms and processes of neurobehavioral development relevant to understanding pediatric mental disorders with a focus on periods of rapid neurobiological change during which the brain is particularly sensitive to contextual influence.
For HIV/AIDS relevant applications, studies of the development, testing, and implementation of integrated behavioral biomedical prevention strategies to reduce the further spread of the epidemic; interventions to increase linkage-to-care, retention in care, and adherence to HIV treatment regimens; central nervous system (CNS) effects of HIV infection and associated neurobehavioral outcomes; mental health factors relevant to HIV prevention and treatment; the development of CNS-specific therapeutic agents; behavioral issues in biomedical prevention trials; the role of socioeconomic factors, including personal networks in preventing and adapting to HIV/AIDS.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations; regional organizations, and non-domestic (non-U.S.) Entities (Foreign Institutions). Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA requires the use of the linked NIH Collaborative Research Project Grant (R01) award mechanism and there has been some confusion with regard to the applicability to the NIH multiple PD/PI policy. Multiple PDs/PIs are allowed on any single application and the policy for doing so is included in this FOA. Because the collaborative R01 mechanism already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should NOT be designated as multiple PIs on each application of a collaborative set.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-278.html.
Pilot Intervention and Services Research Grants (R34): PAR-12-279
Components of Participating Organizations
National Institute of Mental Health
National Institute on Alcohol Abuse and Alcoholism
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage research on 1) the development and/or pilot testing of novel or adapted interventions, 2) the adaptation and/or pilot testing of interventions with demonstrated efficacy for use in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development, as detailed in the sub-headed sections that follow. The R34 award mechanism provides resources for evaluating the feasibility, tolerability, acceptability, and safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale intervention (efficacy or effectiveness) or services study.
For the purpose of intervention pilot research, “intervention” is broadly defined to include psychosocial, pharmacologic, somatic or combination approaches to prevent the onset of disorder; efforts to treat disorder in the acute and later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; and rehabilitative efforts to reduce residual symptoms and/or enhance functioning. This mechanism is also intended to support innovative pilot services research to identify mutable factors that impact access, utilization, quality, and outcomes of mental health services and to inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery.
Pilot intervention studies submitted in response to this FOA do not necessarily need to be scaled down randomized controlled trials (RCTs) that propose formal tests of intervention outcomes. Indeed, as described below, depending on the stage of intervention development, the R34 project might not involve randomization, but rather might focus on earlier stages such as the operationalization of an intervention protocol and corresponding manual and/or pilot testing of the experimental intervention in a case series with a sample drawn from the target population. Most importantly, the R34 should propose the developmental work to be performed that would enhance the probability of success in a larger trial. This is best done by working out the details of the experimental protocols, including the assessment protocol, the experimental intervention protocol, as well as the comparison intervention protocol and randomization procedures (if appropriate); examining the feasibility of recruiting and retaining participants into the study conditions (including the experimental condition and the comparison condition, if relevant); and developing supportive materials and resources.
Accordingly, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate. However, given the intended pilot nature of the R34 mechanism, conducting formal tests of outcomes or attempting to obtain an estimate of an effect size is often not justified. Given the limited sample sizes typically supportable under this pilot study mechanism, the variability in the effect sizes obtained is often so large as to be unreliable. Thus, using these potentially unstable effect size estimates in power calculations for larger studies, without regard to clinical meaningfulness, is not advisable.
Likewise, pilot services studies that propose non-RCT designs do not need to be a reduced scope version of the anticipated larger study, but should instead attempt to develop and refine the research strategies to be utilized in the subsequent definitive study.
NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span. Across all mental health intervention/services research areas, intervention and services research that addresses research objectives outlined in the NIMH Strategic Plan are encouraged. Additional priorities for mental health research that is specifically focused on intervention research are detailed in the NAMHC Workgroup Report “From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses.” Priorities for services research are addressed in the NAMHC Workgroup Report “The Road Ahead: Partnerships to Transform Services.”
NIAAA prevention, treatment, and services research is aimed at preventing or ameliorating alcohol use disorders, related emotional or behavioral problems, and the co-occurrence of other mental, physical, and substance abuse problems, HIV/AIDS, and the functional consequences of these problems across the life span.
Potential applicants are encouraged to contact program staff as far in advance as possible to discuss the match between potential research applications and current NIMH and NIAAA priorities.
1. Development and Pilot Testing of Novel or Adapted Interventions
For the purpose of intervention development or pilot testing, “intervention” is broadly defined to include pharmacologic agents (including novel mechanism drug candidates and promising investigational new drugs, IND), medical devices, psychosocial approaches, or combination of the aforementioned approaches to treat or prevent mental disorders. Treatment or prevention efforts may include treating disorders in the acute or later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; and rehabilitative efforts to reduce residual symptoms and/or enhance functioning.
Adaptation or extension of proven interventions should only be undertaken if there is a compelling rationale, supported by empirical evidence, that can be justified in terms of: (a) theoretical and empirical support for the adaptation target (e.g., the target has been associated with non-response, partial response, patient non-engagement, or relapse); (b) clear explication of the mechanism by which that moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/or biological data that support the mechanism hypothesis); and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to existing intervention approaches (see the NMHAC Workgroup Report, "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses, Recommendation 2.4.1, page 19, for additional guidance regarding the empirical justification for intervention adaptations and augmentations).
Intervention development can be considered to have three stages: 1) conceptualizing an intervention based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing.
Stage 1. When proposing a novel or adapted intervention, the application should explicate a clear conceptual link between relevant psychological or behavioral factors, various intervention components being proposed (including a description of the purported mechanisms of action by which these components are hypothesized to have an effect), and their relationship to the particular aspects of outcome that are being targeted. The need for a new or adapted intervention should be strongly justified in terms of the base-rate and public health significance of the target problem, the limitations of existing intervention approaches, and the expected increment in effect sizes in comparison to currently available intervention approaches. The justification for a new or adapted intervention might in part be based on data from prior research describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, or relapse. Accordingly, interventions might be designed or adapted to address conditions for which efficacious interventions are lacking or to target factors that have previously been identified with poor responses to existing approaches. High priority will be given to applications that demonstrate the systematic translation of basic behavioral and neurobiological processes (e.g., cognition, memory, attention, emotion, personality) into applied interventions. Attention should also be given to the effects of these interventions with underserved populations in disparate social, economic, cultural and environmental contexts. Applications that propose adaptations or augmentations of currently available treatments for new subpopulations without strong empirical justification will be considered low priority.
Stage 2. Standardization of an intervention primarily involves development or adaptation of the intervention protocol (e.g., psychotherapy manual, medication dosing schedule), including iterative refinements based on feedback from patients, care providers, and other investigators. This stage might also involve refinements to assessment strategies (e.g., measures to determine inclusion/exclusion; measures to assess psychiatric and other outcomes, such as indices of functioning and cost; and measures to assess acceptability of the intervention protocol, fidelity of provider implementation, and client/patient adherence).
Stage 3. Pilot and feasibility studies involve testing and further refining the intervention manual and measures developed in earlier stages of intervention development/refinement. Typically, data are gathered to examine the feasibility of: identifying, enrolling, and retaining participants; implementing the experimental intervention (and comparison condition, if relevant); and implementing the assessment protocols, including examining feasibility of measures for assessing inclusion/exclusion, fidelity of intervention delivery, mediators/moderators of response, and outcomes. Depending on the characteristics of the disorder or target population, the nature of the intervention, and the stage of research program, pilot testing may take various forms. Pilot testing might involve systematic study of an uncontrolled case series or use of a small randomized pilot trial to explore feasibility of both the experimental intervention and the control condition that will be used in the subsequent definitive trial. Under other circumstances, alternative designs might be appropriate (e.g., quasi-experimental designs). The application should provide a clear justification for the type of experimental design chosen. In summary, the goal of this phase of research is to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will inform a larger, more definitive test of the intervention in the future.
Given that boundaries between these three stages are not discrete, investigators may propose research activities or methods from one or more of the above-noted stages. However, investigators are not expected to necessarily complete all stages of development during the 3-year duration of the award. Rather, the goals of the study should be clearly outlined and related to specific aims. Importantly, applications should propose feasible goals that can be accomplished within the time and funding constraints of this award while considering the aim of accomplishing the prerequisites for conducting a larger (e.g., R01) study.
Examples of possible NIMH-relevant intervention development or adaptation studies include, but are not limited to:
Development of novel behavior change strategies to target specific risk/etiological/maintaining factors for psychopathology, co-morbid mental and other physical disorders, or vulnerability to HIV infection, as identified through basic behavioral, epidemiological or neuroscience research.
Development of novel treatments that target domains which cut across multiple disorders (e.g., working memory, attention, reward response; see the Research Domain Criteria (RDoC) webpage http://www.nimh.nih.gov/research-funding/rdoc/nimh-research-domain-criteria-rdoc.shtml for more details).
Human proof-of-concept studies of novel-mechanism IND-ready pharmacological agents targeting mental disorders (e.g., mood disorders, schizophrenia, anxiety disorders, eating disorders, autism spectrum disorders).
Exploration and validation of novel clinical endpoints, biomarkers, or measures of mediators/mechanisms of response for potential use in larger-scale prospective studies
Evaluation of currently used medications (i.e., off-label uses), somatic interventions, or psychosocial approaches that show promise but lack preliminary data on safety and efficacy
Adaptation of specific interventions already established as efficacious in one target population to be applied to a different group or target behavior (i.e., pilot testing and adaptation for a new indication).
Adaptation or development of combined or sequenced interventions to address refractory groups or those with comorbid disorders.
In addition to the above, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in intervention development or adaptation studies including, but not limited to:
Development of novel behavior change strategies to target specific risk/etiological/maintaining factors for alcohol use disorders, including those co-morbid with other mental and physical disorders and HIV infection or vulnerability, based on preliminary basic behavioral, epidemiological, or neuroscience research.
Adaptation of specific interventions already established as efficacious in one target population or domain to be applied to patients with co-occurring alcohol and other substance use disorders; patients with developmental disorders, including but not limited to those with Fetal Alcohol Spectrum Disorders; and military personnel.
Development of community-based interventions (e.g., peer-led interventions; school-based interventions; community service agency-based interventions; bar-server training, etc.) to strengthen the linkage between mental health and alcohol and other substance abuse prevention and treatment services, and to alter alcohol and other substance availability.
2. Adaptation and Pilot Testing for Effectiveness
The principal aim of effectiveness (or public health-oriented) research is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings. Typically, these studies have broader inclusion (i.e., relatively few exclusion criteria) and outcomes often include variables such as functioning (school, work, interpersonal, etc.), quality of life, mortality, institutionalization, costs, and health care resource use, in addition to measures of psychiatric morbidity.
When conducting effectiveness research on an intervention with previously demonstrated efficacy, information regarding its initial degree of “fit” within an applied setting (e.g., specialty or primary care, school or work site) and the iterative process that is expected to occur when altering the intervention for successful implementation within this setting should be articulated. Accordingly, pilot effectiveness research can be considered to have stages of research that parallel the stages of novel intervention development noted above, including: (stage 1) an initial stage where characteristics of typical patients, provider, and the community/practice setting in which the intervention will be transported are systematically considered; (stage 2) a phase in which adaptations to improve the fit of the intervention are operationalized and incorporated in intervention manuals and materials; and (stage 3) a stage in which the intervention is pilot tested. As with studies proposing novel intervention development, effectiveness pilot studies using the R34 mechanism are not necessarily expected to include all of these stages, but rather, the particular stages of intervention adaptation and pilot testing should be clearly outlined and justified, and the application should include a well-articulated plan for collecting feasibility data that will inform a subsequent definite effectiveness study.
Examples of possible NIMH-relevant effectiveness research questions include, but are not limited to:
Feasibility studies to explore the degree to which efficacious preventive, therapeutic, or services interventions generalize to typical community/practice settings.
Studies to pilot test research instruments, data-management procedures, and training/supervision protocols in preparation for a larger scale effectiveness trial.
Studies to systematically adapt efficacious interventions to improve their utility for use in community/practice settings (e.g., in vivo intervention refinement to address common patterns of comorbidity).
Studies to examine/adapt parameters of evidence-informed interventions (e.g., dose, duration, method of administration) that impact generalization of efficacious interventions to practice settings.
Research examining patient-, provider-, and organizational- level factors that impact the transportability of interventions (i.e., the degree to which the evidence-informed intervention can be implemented with fidelity, the degree to which effects observed in efficacy studies generalize).
Studies to adapt and pilot test interventions that were developed and tested in mental health specialty settings for use in non-specialty community/practice settings (e.g., primary care, schools, criminal justice settings).
In addition to the above, NIAAA is interested in effectiveness research questions including, but not limited to:
Feasibility studies to explore the degree to which efficacious preventive, therapeutic, services, policy, screening, and brief counseling interventions generalize to typical community/practice settings, including obstetric care, secondary education, colleges, universities, and military environments.
Studies to examine pharmacogenetic profiles as possible important moderators of alcohol pharmacotherapy effects.
Research examining community-level factors that impact the transportability of interventions (i.e., the degree to which the evidence-informed interventions can be implemented with fidelity; the degree to which effects observed in efficacy studies generalize).
Studies to adapt and pilot test interventions that were developed and tested in alcohol and other substance specialty settings for use in non-specialty community/practice settings (e.g., primary care, schools, criminal justice settings).
3. Innovative Services Research
This funding opportunity is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development. Such pilot studies might include research on mutable factors that impact access, utilization/engagement, quality, and outcomes of mental health services, or inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery.
Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches. Studies designed to develop and/or pilot test novel service interventions or service delivery models might reflect one or more of the three stages of intervention development described in the “Development and Pilot Testing of New or Adapted Interventions” section of this Program Announcement. The feasibility of proposed service interventions and their potential for widespread uptake and sustainability should be carefully considered at the outset to maximize public health impact. Likewise, observation of factors influencing implementation and dissemination should be addressed in the pilot work, wherever possible.
Examples of NIMH-relevant services research applications in this area include, but are not limited to:
Research on factors that impact mental health services organization, delivery (process and receipt of care), and financing in specialty mental health, primary care, and other delivery settings (e.g., schools, workplaces, the criminal justice system, child welfare).
Studies to develop novel service delivery models (e.g., aftercare services and rehabilitation), which may capitalize on novel features of the service delivery setting, (e.g. social settings that foster connection with the target population, schools or other community-based settings, and online/virtual communities).
Research to identify effective dissemination and implementation processes and mechanisms to increase the uptake and sustained use of evidence-based mental health treatments.
Pilot studies to facilitate understanding of “real world” care delivery system characteristics that facilitate or impede the integration of novel or adapted intervention techniques (e.g., reimbursing physicians for HIV risk reduction counseling during routine visits).
Studies to develop, refine, or apply new methodological approaches for the analysis of complex and dynamic systems.
Studies to design or validate instruments to measure dissemination, implementation, or sustainability processes, changes in consumer functioning, or organizational environments.
Pilot studies that test the effectiveness of services for people with autism spectrum disorder (ASD) in improving outcomes for consumers across the life span.
Pilot studies of system-level interventions to reduce morbidity and mortality and improve the general health of persons with serious mental illnesses.
Research on integration of mental health services across service sectors (e.g., specialty care clinics, primary care, education, criminal justice, welfare.
Studies using technologies (e.g. mobile devices, information systems) to demonstrably improve access to, engagement in, and efficiency and quality of mental health services.
In addition to the above, NIAAA is interested in services research applications in the areas of:
Research on factors that impact services organization, delivery (process and receipt of care), and financing in specialty alcohol and other substance abuse treatment.
Research to identify the most important organizational characteristics affecting the adoption of effective interventions for comorbid mental health, alcohol and other substance use, and other chronic disorders.
Studies that develop, test, and compare different models for transferring effective, research-based interventions for comorbid mental health, substance use, and other chronic disorders into relatively resource poor communities.
Research that identifies and evaluates novel outcome measures and data collection systems appropriate to the evaluation of evidence-based interventions for comorbid mental health, alcohol and other substance use, and other chronic disorders in racial/ethnic minority and immigrant communities.
Research on the relationship between mental health disorders, alcohol and other substance use and abuse, access to care, and delivery and cost of services for individuals with co-occurring mental health and substance use disorders.
Multi-level collaborative research to identify and examine content, mechanisms, and effectiveness of communication between Federal, state, local government, community-based, and commercial stakeholders, and the impact of this communication on the delivery of treatment services to individuals with co-occurring mental health and alcohol and other substance use disorders.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-279.html.
Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21]: PA-12-284
Components of Participating Organizations
National Institute of Biomedical Imaging and Bioengineering
National Cancer Institute
National Heart, Lung, and Blood Institute
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute of Environmental Health Sciences
National Institute of Neurological Disorders and Stroke
Office of Research on Women’s Health
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The goal for exploratory/developmental bioengineering research grants (EBRG) is to foster the exploration and development of innovative technologies, models, techniques, designs, and methods that have the potential to substantially advance biomedical research by infusing principles and concepts from the quantitative sciences to transform our understanding of biological, clinical or translational science.
The purpose of this FOA is to encourage EBRG applications which establish the feasibility of technologies, techniques or methods that: 1) explore a unique multidisciplinary approach to a biomedical challenge; 2) are high-risk but have a considerable pay-off; and 3) develop data which can lead to significant future research. An EBRG application may propose hypothesis-driven, discovery-driven, developmental, or design-directed research and is appropriate for evaluating unproven approaches for which there is minimal or no preliminary data.
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. This FOA seeks to foster the introduction of innovative scientific ideas, model systems, tools, agents, targets, and technologies from the physical and computational sciences that have the potential to substantially advance biomedical research.
Many major biomedical research problems are best addressed using a multi-disciplinary approach which bridges the life and physical sciences. Principles and techniques in allied quantitative sciences such as physics, mathematics, chemistry, computer sciences, and engineering are increasingly being applied to good effect in biomedical research. Bioengineering integrates principles from a diversity of technical and biomedical fields, and the resulting multi-disciplinary research is providing new basic understandings, novel products, and innovative technologies that improve basic knowledge, human health, and quality of life. This FOA seeks to stimulate quantitative and physical scientists to work with biomedical researchers to catalyze the development of these innovative bioengineering approaches which may open entirely new areas of biomedical investigation.
While applications should involve considerable risk, they should also clearly explain the significance of the proposed work and why the potential impact outweighs these risks. Significant projects may include, but are not limited to, assessing the feasibility of a novel tool for clinical intervention, exploring new approaches to characterizing and modeling complex biological systems, improving and integrating existing technologies to provide a breakthrough in unsolved biomedical problems, or establishing preliminary evidence for a transformative bioengineering approach which challenges accepted paradigms. Innovation includes the development of new methods, ideas, or tools, as well as the integration of existing components in an unproven format which will meet the unmet needs of the biomedical research. High impact projects will have the potential to transform our understanding or practice by applying an innovative approach to an appropriate biomedical challenge and developing data to establish feasibility towards significant future research.
The use of the R21 mechanism is intended to support short-term exploratory research projects. Long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Projects should clearly serve the mission of one or more of the NIH institutes or centers participating in this FOA.
The National Heart, Lung and Blood Institute (NHLBI) is interested in the development of diagnostics, therapeutics, surgical technologies, computational and systems biology, biomaterials and nanotechnology, as applied to the cardiovascular, pulmonary, and non-malignant hematologic mission areas of the Institute. Topic areas include, but are not limited to, the development of: i) noninvasive and nondestructive 3D imaging methods for in vivo monitoring, ii) techniques for metabolic imaging of disease progression, iii) research tools such as molecular imaging probes, microfluidics, and nanotechnologies, and iv) novel diagnostic and medical devices. Of special interest are new bioengineering approaches to improve cardiovascular repair and regeneration, artificial lungs as a bridge to transplant or for treatment of lung failure, and new additive solutions, storage bags and/or new processes to enhance blood cell function and survival after storage and transfusion. Additionally, the interests of NHLBI include research tools, methods and technologies that facilitate therapeutic advances and behavioral changes to address problems in energy balance, weight control, and obesity (see: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-07-007.html)
In addition to its mission-relevant R21 projects, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) would also like to use the R21 mechanism to stimulate and promote research in building complex 3-dimensional in vitro human musculoskeletal and skin tissue models to study developmental biology, physiology, and disease pathogenesis as well as for drug discovery and toxicity studies. NIAMS is not interested in applications are developing 3D tissues for transplantation, or engineering non-human tissue models, or developing simple 3-D models that do not go significantly beyond those currently in use, such as human skin equivalents composed of only normal keratinocytes and fibroblasts.
The Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/) serves as a focal point for women’s health research at the NIH. The NIH Strategic Plan for Women’s Health and Sex Differences Research outlines six goals that guide research that will improve the health of women and men by reflecting on the differences and similarities between men and women in all areas of biomedical research. For this FOA, the ORWH would be interested in biomedical research that specifically addresses the purpose of the FOA within the context of sex differences research and diseases that disproportionately affect women and girls.
The National Institute of Environmental Health Sciences (NIEHS) is focused on understanding the effects of environmental exposures on human health with the ultimate goal of using that understanding to improve public health. Our specific interests within the Exploratory/Developmental Bioengineering Research Grants program include but are not limited to:
1) The development of technologies and integrated devices for improved personal exposure assessment. A particular emphasis is on the development of technologies that will enable untargeted, agnostic, associations between exposures and disease in support of the exposome concept.
2) The development of technologies to enable research into the mechanisms of response to environmental exposures. This includes the development of ‘omics technologies and systems modeling techniques to assess the differential response of biological networks to environmental perturbations.
3) The development of moderate to high throughput screens for the assessment of potential toxicants. A particular emphasis is on the development of model systems that more closely reflect the response of humans including engineered 3D tissue systems originating from human tissues and induced pluripotent cells and the development of humanized animal models such as mouse models with enhanced genetic diversity similar to human populations.
Within the goals of this FOA, the National Institute of Dental and Craniofacial Research (NIDCR) is particularly interested in translational research applications that take advantage of multidisciplinary and interdisciplinary biological and bioengineering approaches to advance the regeneration of biocompatible composite tissues that can maintain long-term tissue architecture, anatomical structure, viability and functional inter-tissue interfaces as well as can integrate with native tissues of the host. The composite tissues of interest include, but are not limited to vascularized bone-skeletal muscle, periodontal complex, and osteochondral complex. NIDCR will not accept clinical trial applications through this FOA.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations; regional organizations, and non-domestic (non-U.S.) Entities (Foreign Institutions). Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-12-284.html.
Advanced Development of Informatics Technology (U24): PAR-12-287
Components of Participating Organizations
National Cancer Institute
Application Receipt/Submission Date(s): January 22, 2013; June 18, 2013; November 18, 2013; June 18, 2014, November 18, 2014; June 18, 2015
The purpose of this Funding Opportunity Announcement (FOA) is to invite Cooperative Agreement (U24) applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge in cancer research. An emerging informatics technology is defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. If successful, these technologies would accelerate research in cancer biology, cancer treatment and diagnosis, cancer prevention, cancer control and epidemiology, and/or cancer health disparities. This FOA is one component of the NCI’s Informatics Technology for Cancer Research (ITCR) Initiative whose central mission is to promote research-driven informatics technology development. Potential applicants who are interested in early-stage development should consult companion FOAs listed at the end of the current section of the FOA. Applications that focus on informatics data processing and analysis or mathematical/statistical modeling alone without informatics technology development are not appropriate for this FOA.
Over the last decade, major advances in biology coupled with innovations in information technology led to an explosive growth of biological and biomedical information. From the genomic revolution and many of its manifestations to recent development in high-throughput high-content screening, biomedical scientists have never before been exposed to research data that are so rich and comprehensive, and yet so massive and complex. This situation provides unprecedented opportunities for rapid discovery. At the same time, it confronts researchers, especially bench biologists and clinicians, with significant challenges to access data, analyze data, and ultimately transform discovery into new knowledge and clinical practice. These challenges are even more prominent in the field of cancer research where complexity and heterogeneity of the disease translate to complex data generation conditions and high data management and analysis overhead, a condition that creates significant barriers to knowledge discovery and dissemination.
The fast growing field of biomedical informatics offers potential solutions to the “big data” problem. At the intersection of biology, medicine, mathematics, statistics, computer science, and information technology, biomedical informatics involves the development and application of computational tools to the organization and understanding of biomedical information, so that new insight and knowledge can be discerned. There is now general consensus that biomedical research is transforming into an information science, and biomedical informatics is no longer an option but an integral component of all biomedical research. However, there are many challenges to the realization of broad acceptance and sophisticated adoption of information technology in everyday research. Some of the challenges are associated with tools, some are with people. For example, there continues to be the need of user-friendly software tools and informatics support for bench biologists and clinical researchers, especially in association with data generated by emerging high-throughput technologies. In some areas, tool development is disengaged from potential users, resulting in over-building and lack of usage. Another significant challenge is in data sharing and data integration. On top of philosophical and cultural barriers, there are significant technical hurdles. These include lack of common standards for data collection and data exchange, lack of common data elements for data harmonization, high overhead for data storage and dissemination, inadequate tools for annotation, and shortage of computational expertise in biomedical research in general.
Recently, informatics needs and challenges have become a frequent topic of discussion at a number of venues both within and outside of NIH. Some common themes and recommendations emerged from these discussions. These include 1) enhanced support of community-based research-driven informatics technology development; 2) improved mechanism to support software development throughout the development lifecycle (prototyping, hardening, enhancement, and maintenance); 3) sustained effort to promote data sharing and to improve software interoperability; 4) coordinated effort to establish data exchange standards and common data elements; and 5) enhanced training in bio-computing. These critical needs identified by the research community are recognized by NCI and formed the basis in developing the NCI Informatics Technology for Cancer Research (ITCR) Initiative, of which the current FOA is a component that aims at supporting more advanced research-driven informatics technology development.
This FOA encourages applications that involve the development of innovative and user friendly informatics technologies of significant value to the whole spectrum of cancer research from bench to bedside. The emphasis will be on novelty, uniqueness, and potential impact to the cancer research field. Potential applicants are advised to consult with the scientific contact listed under Section VII of this document for appropriateness of submission to this FOA.
The scope of this FOA is limited to informatics technology development. Some examples of the utility of informatics technologies that may be addressed in response to this FOA include, but are not limited to, the following:
Software for automation in experiment design and execution
Software for automation in data collection
Software for data processing and analysis
Software for data quality assessment
Software for data integration
Software for data presentation and visualization
Software for text mining and natural language processing
Archiving, organization, retrieval, and dissemination of data and knowledge
Establishing data exchange formats and/or common data elements
Improving software interoperability and compatibility
Adapting computational tools for translational, epidemiological, and clinical applications
Patient-centric laboratory and clinical data coalescence
Computer-assisted interpretation of experimental results
Environment for interactive modeling and simulation
Computational platform for research collaboration
Technology for performance evaluation of software tools, algorithms, and data collection methods
Computational tools for interdisciplinary research training
Examples of research projects that are not appropriate for this FOA:
Projects that are research centric or focus on data collection, data processing, data analysis, and computational modeling and simulation without informatics technology development; and
Development of technologies that are not computation or informatics based.
Wet-lab based technology development is supported by the NCI IMAT Program. Potential applicants who are interested in the development of molecular technologies are advised to consult with scientific staff of the IMAT Program for suitability of submission.
As the goal of this FOA is to support research-driven informatics technology development to serve the mission of NCI, program priorities will be given to applications that are exceptional in the following aspects: 1) potential impact to cancer research, 2) the level of interaction with collaborators in the cancer research field, 3) the level of innovation, and 4) proposed technology dissemination plan. Funds requested must be used to support informatics technology development instead of research.
A. Software Dissemination Plan.
A software dissemination plan, with appropriate timelines, is expected to be included in the Resource Sharing Plan(s) in the PHS398 Specific Research Plan Component to meet the goals of this initiative. Grantees are entitled to limited software copyright protections and institutional software licensing agreements.
There is no prescribed single license for software produced under this FOA; however reviewers will be instructed to evaluate dissemination plans which should be consistent with the following guidelines:
The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
Applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.
The adequacy of software sharing plans will be considered by Program staff when making funding recommendations. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the applicant. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting”.
One of the goals of this ITCR funding program is to establish a repository of software developed under this program. Once implemented, funded individual projects are expected to deposit their software including the source codes and documentations at the repository, allowing centralized access and dissemination, consistent with achieving the goals of this program.
B. Annual Meeting
Awardees of this FOA are required to attend annual meetings of the ITCR to present progress of their projects. To maximize the impact and utility of products developed under the ITCR Initiative, awardees are encouraged to interact and collaborate with each other in the effort to develop interoperable software tools. Periodically, the ITCR may organize special workshops to discuss emerging topics and issues in cancer informatics that require community engagement and input. Awardees will be expected to participate in these activities as needed. In the application, a travel budget of one to two trips per year to go to these meetings should be included.
C. Reference Letters
Applicants must include reference letters from collaborators and/or potential users in the cancer research community. These reference letters should provide details on the nature of the proposed interaction/collaboration and describe how the proposed new development will benefit their research.
This FOA versus Alternative Opportunities
As listed below, there are four additional FOAs issued under the ITCR Initiative that cover additional types of project and support technology development at different stages. Investigators are allowed to submit multiple applications in response to these FOAs given that they are scientifically distinct from each other.
PAR-12-286, “Revisions for Early-Stage Development of Informatics Technology (R01)”;
PAR-12-289, “Revisions for Early-Stage Development of Informatics Technology (U01)”;
PAR-12-290, “Revisions for Early-Stage Development of Informatics Technology (P01)”; and,
PAR-12-288, “Early-Stage Development of Informatics Technology (U01)”
Eligible institutions and organizations include:public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, regional organizations, and Non-domestic (non-U.S.) Entities (Foreign Institutions). Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-287.html.
Early-Stage Development of Informatics Technology (U01): PAR-12-288
Components of Participating Organizations
National Cancer Institute
Application Receipt/Submission Date(s): January 22, 2013; June 18, 2013; November 18, 2013; June 18, 2014; November 18, 2014; June 18, 2015, by 5:00 PM local time of applicant organization.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage Cooperative Agreement applications for the development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge in cancer research. As a component of the NCI’s Informatics Technology for Cancer Research (ITCR) Initiative, this FOA focuses on early-stage development from prototyping to hardening and adaptation. Early-stage development is defined for the purpose of this FOA as the initial development or the significant modification of existing tools for new applications. The central mission of the ITCR is to promote research-driven informatics technology development. In order to be successful, proposed development plans must have a clear rationale on why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from users and collaborators throughout the development process should be included. Applications that focus on data processing and analysis or mathematical/statistical modeling alone without new technology development are not appropriate for this FOA.
Over the last decade, major advances in biology coupled with innovations in information technology led to an explosive growth of biological and biomedical information. From the genomic revolution and many of its manifestations to recent development in high-throughput high-content screening, biomedical scientists have never before been exposed to research data that are so rich and comprehensive, and yet so massive and complex. This situation provides unprecedented opportunities for rapid discovery. At the same time, it confronts researchers, especially bench biologists and clinicians, with significant challenges to access data, analyze data, and ultimately transform discovery into new knowledge and clinical practice. These challenges are even more prominent in the field of cancer research where complexity and heterogeneity of the disease translate to complex data generation conditions and high data management and analysis overhead, a condition that creates significant barriers to knowledge discovery and dissemination.
The fast growing field of biomedical informatics offers potential solutions to the “big data” problem. At the intersection of biology, medicine, mathematics, statistics, computer science, and information technology, biomedical informatics involves the development and application of computational tools to the organization and understanding of biomedical information, so that new insight and knowledge can be discerned. There is now general consensus that biomedical research is transforming into an information science, and biomedical informatics is no longer an option but an integral component of all biomedical research. However, there are many challenges to the realization of broad acceptance and sophisticated adoption of information technology in everyday research. Some of the challenges are associated with tools, some are with people. For example, there continues to be the need of user-friendly software tools and informatics support for bench biologists and clinical researchers, especially in association with data generated by emerging high-throughput technologies. In some areas, tool development is disengaged from potential users, resulting in over-building and lack of usage. Another significant challenge is in data sharing and data integration. On top of philosophical and cultural barriers, there are significant technical hurdles. These include lack of common standards for data collection and data exchange, lack of common data elements for data harmonization, high overhead for data storage and dissemination, inadequate tools for annotation, and shortage of computational expertise in biomedical research in general. All these issues are more acute and significant in dealing with the big “data” where innovative and comprehensive responses are called for.
Recently, informatics needs and challenges have become a frequent topic of discussion at a number of venues both within and outside of NIH. Some common themes and recommendations emerged from these discussions. These include 1) enhanced support of community-based research-driven informatics technology development; 2) improved mechanism to support software development throughout the development lifecycle (prototyping, hardening, enhancement, and maintenance); 3) sustained effort to promote data sharing and to improve software interoperability; 4) coordinated effort to establish data exchange standards and common data elements; and 5) enhanced training in bio-computing. These critical needs identified by the research community are recognized by NCI and formed the basis in developing the NCI Informatics Technology for Cancer Research (ITCR) Initiative, of which the current FOA is a component that aims at supporting early-stage research-driven informatics technology development.
This FOA encourages applications that involve the development of innovative informatics tools, with a demonstration of utility and usability by the targeted group of cancer researchers or clinicians that could benefit from its development. The emphasis will be on novelty, uniqueness, and potential impact to the cancer research field. Potential applicants are advised to consult with the scientific contact listed under Section VII of this document for appropriateness of submission to this FOA.
The scope of this FOA is limited to informatics technology development. Some examples of the utility of informatics technologies that may be addressed in response to this FOA include:
Technology for automation in experiment design and execution
Technology for automation in data collection
Technology for data processing and analysis
Technology for data quality assessment
Technology for data integration
Technology for data presentation and visualization
Technology for text mining and natural language processing
Technology to advance data compression, storage, organization, and transmission
Establishing data exchange formats and/or common data elements
Improving software interoperability and compatibility
Adapting computational tools for translational, epidemiological, and clinical applications
Patient-centric laboratory and clinical data coalescence
Computer-assisted interpretation of experimental results
Environment for interactive modeling and simulation
Computational platform for research collaboration
Technology for performance evaluation of software tools, algorithms, and data collection methods
Computational tools for interdisciplinary research training
Examples of research projects that are not appropriate for this FOA:
Applications that are research centric or focus on data collection, data processing, data analysis, and computational modeling and simulation without informatics technology development.
Development of technologies that are not computation or informatics based.
Wet-lab based technology development is supported by the NCI IMAT Program. Potential applicants who are interested in the development of molecular technologies are advised to consult with scientific staff of the IMAT Program for suitability of submission.
As the goal of this FOA is to support research-driven informatics technology development to serve the mission of NCI, program priorities will be given to applications that are exceptional in the following aspects: 1) potential impact to cancer research, 2) the level of interaction with collaborators in the cancer research field, 3) the level of innovation, and 4) proposed technology dissemination plan. Funds requested must be used to support informatics technology development instead of research.
A. Software Dissemination Plan
A software dissemination plan, with appropriate timelines, is expected to be included in the Resource Sharing Plan(s) in the PHS398 Specific Research Plan Component to meet the goals of this initiative. Grantees are entitled to limited software copyright protections and institutional software licensing agreements.
There is no prescribed single license for software produced under this FOA; however reviewers will be instructed to evaluate dissemination plans which should be consistent with the following guidelines:
The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
Applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This plan may address ways to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.
The adequacy of software sharing plans will be considered by Program staff when making funding recommendations. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the applicant. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting”.
One of the goals of this ITCR funding program is to establish a repository of software developed under this program. Once implemented, funded individual projects are expected to deposit their software including the source codes and documentations at the repository, allowing centralized access and dissemination, consistent with achieving the goals of this program.
B. Annual Meeting
Awardees of this FOA are required to attend annual meetings of the ITCR to present progress of their projects. To maximize the impact and utility of products developed under the ITCR Initiative, awardees are encouraged to interact and collaborate with each other in the effort to develop interoperable software tools. Periodically, the ITCR may organize special workshops to discuss emerging topics and issues in cancer informatics that require community engagement and input. Awardees will be expected to participate in these activities as needed. In the application, a travel budget of one to two trips per year to go to these meetings should be included.
C. Reference Letters
Applicants must include at least two reference letters from collaborators in the cancer research community. These reference letters should provide details on the nature of the proposed collaboration and how the new technology will benefit their research.
This FOA versus Alternative Opportunities
As listed below, there are four additional FOAs issued under the ITCR Initiative that cover additional types of project and support technology development at different stages. Investigators are allowed to submit multiple applications in response to these FOAs given that they are scientifically distinct from each other.
PAR-12-286, “Revisions for Early-Stage Development of Informatics Technology (R01)”;
PAR-12-289, “Revisions for Early-Stage Development of Informatics Technology (U01)”;
PAR-12-290, “Revisions for Early-Stage Development of Informatics Technology (P01)”; and
PAR-12-287, “Advanced Development of Informatics Technology (U24)”.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-288.html.