Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): November 15, 2011
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for George M. O'Brien Kidney Research Core Centers to support both basic and clinical research on kidney disease. Core Centers should provide shared institutional and national resources to facilitate basic and clinical research on kidney disease and improve the effectiveness of translating insights from basic biology to clinical practice. The Centers will also support pilot and feasibility studies to develop and test innovative approaches to therapy.
Much progress has been made since the initial solicitation for O'Brien Kidney Research Centers in 1987. This program not only allows for, but encourages regional, national and even international collaboration. While there is still no cure for chronic kidney disease, the number of patients progressing to kidney failure now appears to be stabilizing, (possibly even decreasing). Despite this trend in the overall population, however, the same down turn in disease incidence has not been realized in minority populations. Additionally, while there are new genetic findings that explain some of the increased risk for disease, many challenges remain in determining the pathophysiologic mechanisms of kidney disease that could potentially be targeted for therapeutic interventions. Similarly, acute kidney injury (AKI) remains an important clinical problem. Although important advances have been made in understanding AKI in animals, translating that knowledge from experimental models to humans is complicated by its heterogeneity, and has fallen short of expected goals of impacting on the morbidity and mortality of this disease.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) currently supports through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD) eight George M. O'Brien Kidney Research Centers, two Centers of Excellence in Pediatric Nephrology, and four Polycystic Kidney Disease (PKD) Research and Translation Core Centers. These Centers are part of an integrated program of kidney-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive kidney research bases.
The goal of these O'Brien Research Core Centers is to provide unique resources for communication and collaboration between basic and clinical researchers in the field of kidney disease. Research with clear translational potential, is strongly encouraged, as is clinical research. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of kidney disease research. Centers may be located in a single institution or in multiple institutions with complementary research bases.
PROJECT ORGANIZATION
Institution and Research Base
A Kidney Research Core Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Kidney Research Core Center applications must be associated with an existing program of excellence in biomedical research in kidney disease. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in kidney disease and related research areas. A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Kidney Disease Core Research Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs.
Kidney research often requires the use of specialized technologies and resources to support a cohesive research effort. The O'Brien Kidney Research Core Center program should make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.
Biomedical Resource Cores
A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants, enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Each core should provide services to multiple funded research projects. Centers may propose Institutional, Regional, National or International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A new category of research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it will be evaluated as part of the core, in order to distinguish it from the local institutional research base.
Examples of types of biomedical core resources that would be considered responsive to this Request for Applications include, but are not limited to:
Collection, analysis, storage and distribution of data and samples; Provision of specialized tools and technologies or access to specialized expertise; Development, standardization and distribution of reagents and/or protocols; Provision of technical assistance, training, and enrichment programs; Recruitment of patients and coordination of patient studies; Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level; Increase interdisciplinary interactions at the institution through cross-project/laboratory exchange; Sharing of specialized tools, technologies and expertise between collaborating investigators.
Administrative Core
In addition to biomedical cores, an Administrative Core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative Core will also be responsible for planning an Educational Enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. In addition, all O'Brien Kidney Research Core Centers will be required to maintain a Center website, with the Administrative Core taking primary responsibility for its curation and oversight.
Pilot and Feasibility Program
Each Core Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of kidney research. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. Each Core Center application must include a minimum of two up to a maximum of four pilot projects. Each pilot project may request a maximum of $60,000 direct costs per year (excluding Facility and Administrative costs) (NOT-OD-04-040) for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines, http://www2.niddk.nih.gov/NR/rdonlyres/C109078B-2886-42CA-A050-49508AC812DC/0/RFADK11008P30guidelines.pdf.
Additional Features
Applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the O'Brien Kidney Research Core Center. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the O'Brien Kidney Research Core Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of O'Brien Kidney Research Core Center activities through cooperation with other NIH-supported core facilities at the applicant institution. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the O'Brien Kidney Research Core Center.
The proposed budget should include travel for the Program Director/Principal Investigator (PD/PI) and Associate Center Director, or other key personnel, to attend an annual O'Brien Kidney Research Core Centers meeting. The application should include a statement of willingness to attend this annual meeting.
Core Access and Cost Recovery: Core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in core services (e.g., comparative costs of other sources of proposed core services) and policies for cost recovery from investigators for use of services should also be included.
Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.
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 (other than institutions of higher education); 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); for-profit organizations; 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. Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration: See instructional documents in the NIH Guide Publishing System for the text to insert. 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution is allowed.
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.
Research Base: Successful O'Brien Kidney Research Core Center applications require an existing program of excellence in biomedical research in kidney disease and its complications. To justify Center support, the O'Brien Kidney Research Core Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as kidney disease investigators with other sources of peer-reviewed support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK O'Brien Kidney Research Core Centers (http://www2.niddk.nih.gov/NR/rdonlyres/C109078B-2886-42CA-A050-49508AC812DC/0/RFADK11008P30guidelines.pdf).
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-008.html.
EFFECTS OF SECOND-HAND SMOKE ON CARDIOVASCULAR AND PULMONARY DISEASE MECHANISMS (R01): PA-11-244
Components of Participating Organizations
National Heart, Lung, and Blood Institute
National Institute of Environmental Health Sciences
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The purpose of this FOA is to encourage research to better characterize the dose-response relationship between secondhand smoke (SHS) exposure and the cardiovascular and pulmonary diseases by improving our understanding of the mechanisms by which SHS contributes to these diseases. Case-control and cohort epidemiologic studies indicate that secondhand smoke increases the risk of coronary artery disease by 25-30%. Even small amounts of SHS exposure increase cardiovascular disease risk. Recent studies have shown robust and rapid reductions of myocardial infarction (MI) deaths and hospitalizations following the initiation of public smoking bans. Although these epidemiologic and naturalistic studies provide considerable support for the relationship of SHS exposure and cardiovascular and pulmonary diseases, the nature and extent of a causal relationship between SHS exposure and cardiovascular and pulmonary diseases is inadequately understood due to a) methodological limitations of these epidemiologic and naturalistic studies, and b) a relative paucity of data on the pathophysiologic mechanisms of SHS exposure on cardiovascular and pulmonary disease processes compared to carcinogenicity and reproductive toxicity of SHS exposure. These research needs were recently highlighted by an Institute of Medicine (IOM) report on "Secondhand Smoke Exposure and Cardiovascular Effects" (http://www.iom.edu/Reports/2009/Secondhand-Smoke-Exposure-and-Cardiovascular-Effects-Making-Sense-of-the-Evidence.aspx).
The IOM report noted a number of methodological limitations of the population-based studies, particularly studies of MI risk following smoking ban implementation. Although some of these limitations are inherent in population research of uncontrolled policy changes, methodological improvements such as obtaining individual-level data on smoking status, accounting for potential confounders such as other cardiovascular risk factors, assessing biomarkers or environmental sensor levels of SHS exposure, evaluating potential disease process biomarkers, and sensitivity analyses of models and assumptions would allow for better estimation of magnitude of the dose-response relationship. Prospective population-based studies may be needed to address these methodological concerns, but the IOM committee noted that a number of existing cohort studies could be leveraged to better characterize the dose-relationship of SHS exposure and cardiovascular disease and pathophysiology. These cohort studies include, but are not limited to Multi-Ethnic Study of Atherosclerosis (MESA), American Cancer Society's CPS-3, European Prospective Investigation of Cancer (EPIC), Framingham Heart Study, and Jackson Heart Study. Links to NHLBI-sponsored epidemiology studies that could be utilized for this purpose can be found at: http://www.nhlbi.nih.gov/resources/epidemiology.htm, and from the BioLINCC repository (https://biolincc.nhlbi.nih.gov/home/). Therefore, research in response to this FOA may propose a prospective cohort study or utilize existing databases to address the cardiovascular and pulmonary mechanisms affected by secondhand smoke exposure and the dose-response characteristics of these relationships.
The IOM report also documented the paucity of research on the pathophysiologic mechanisms of SHS exposure on cardiovascular disease processes. Evidence is building on the effects of SHS on various cardiovascular mechanisms (e.g. oxidative stress, heart rate variability, inflammation, platelet aggregation, endothelial function, arterial stiffness, atherosclerosis), but more research is needed to better characterize the dose response relationship of SHS exposure patterns on these mechanisms. Plaque stability/rupture from SHS was specifically cited by the IOM report as a research need. A number of animal and human laboratory procedures have been developed for studying the effects of smoking, particulate matter, and other inhalable toxins on a range of pulmonary and cardiovascular disease mechanisms including oxidative stress, endothelial dysfunction, inflammation, thrombosis, pulmonary thrombo-embolism, pulmonary hypertension, and plaque stability. Applying these laboratory procedures to SHS exposure would substantially increase our understanding of the mechanisms by which SHS exposure leads to cardiovascular and pulmonary diseases and the dose-response relationship of SHS exposure and these mechanisms.
Whether through population- or laboratory-based studies, research that addresses acute vs. chronic SHS exposure and how various patterns of exposure (duration and intensity over time) influence the dose response relationship of SHS and cardiovascular and pulmonary mechanisms is particularly encouraged. The rapid reductions in MI events following smoking bans implicates potential effects of acute SHS exposures on more downstream pathophysiological mechanisms such as plaque stability, but little is known about SHS exposure and plaque stability. Since most research to date has been cross-sectional or short-term longitudinal, the effects of chronic intermittent exposure on cardiovascular and pulmonary disease mechanisms are also poorly understood. These dose-response relationships also are likely moderated by genetic, medical history, and other predisposing factors that are important to consider. For example, recent research has shown that glutathione S-transferase deficiency interacts with SHS exposure to reduce heart rate variability. Age of exposure also may be an important moderator, especially since children, due to smaller airways and higher respiration rates, may have greater levels of SHS inhalation exposure per unit of body weight than adults. More research is needed on how SHS exposure interacts with these predisposing factors.
Examples of research in response to this FOA include but are not limited to those listed below:
Use biorepositories or existing cotinine data from cohort studies to assess the effects of both recent SHS exposure and the duration of pattern of SHS exposure over time on cardiovascular disease risk and mechanisms.
Use natural experiments as states and localities impose public smoking bans to determine how these bans impact SHS exposure and cardiovascular and pulmonary disease processes.
Conduct animal studies on the effects of SHS on atherogenesis, plaque stability, lung remodeling, and/or obstructive disease.
Conduct human studies of either manipulated or natural SHS exposure over time and their cardiopulmonary effects.
Evaluate the effects of SHS dose and duration on a variety of cardiovascular markers and mechanisms including intima-media thickness (IMT), flow-mediated dilation (FMD), c-reactive protein, homocysteine, and fibrogen.
Evaluate the effects of SHS dose and duration on a variety of pulmonary markers and mechanisms including cilia damage, mucous production, endothelial injury/inflammation, inhibited chloride secretion.
Evaluate how chronic SHS exposure interacts with other CVD risk factors such as obesity and hypertension to contribute to cardiovascular disease processes.
Assess how SHS impacts hyperlipidemia and reduces HDLs; and how SHS alone and in combination with hyperlipidemia and hypercholesterolemia contributes to CVD disease processes.
Evaluate the effect of pre-existing medical conditions such as coronary or peripheral artery disease, COPD, or asthma on the effects of SHS on disease mechanisms and exacerbations.
Explore the role of hormonal supplementation (e.g., birth control medications) on the amplification of the risk of MI from SHS exposure in women.
Assess SHS exposure in non-smoking children and adults living with smokers, and the effects of varying exposure (e.g., number of cigarettes smoked in the home, proximity to smoker, built environment factors [e.g., space, ventilation system] and exposure to "third hand smoke" constituents deposited on home and car surfaces) on lung function and cardiovascular disease processes.
Evaluate SHS exposures in high density, multi-unit housing from neighbors who smoke and effects of these potentially low SHS doses on disease mechanisms.
Conduct studies of various intermittent SHS exposure patterns in children (e.g., exposure when home in summer or during holidays vs. during school year, two parent homes in which only one parent smokes) and the effects on cardiovascular and respiratory mechanisms.
Assess potential predisposing factors that may moderate the effects of SHS exposure on cardiovascular and pulmonary disease processes (e.g., genetics, medical status, former smoker, age).
Evaluate the effects of specific SHS exposure constituents (e.g., carbonyls, benzene, butadiene, metals, polycyclic aromatic hydrocarbons, particulate matter) and their contribution to SHS exposure effects on cardiovascular and pulmonary disease processes, particularly as these findings may be relevant to FDA regulation of tobacco products and constituents.
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 organizations). Foreign (non-U.S.) components of U.S. Organizations 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/PIs) 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 four (4) 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/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 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-11-244.html.
NUTRITION OBESITY RESEARCH CENTERS (P30): RFA-DK-11-012
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): November 16, 2011
The objective of the Nutrition Obesity Research Centers program is to bring together basic science and clinical investigators from relevant disciplines to enhance and extend the effectiveness of research related to nutritional sciences and/or obesity, and related disorders, with clinical and/or translational applications in these areas. The NIDDK-supported Nutrition and Obesity Research Centers (NORC) are part of an integrated program of nutritional sciences and obesity research. The NORC program combines the previously supported NIDDK Clinical Nutrition Research Units (CNRUs) and the Obesity Nutrition Research Centers (ONRCs) into one centers program.
A Center must be an identifiable unit within a university or medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical basic and clinical research in the areas of nutritional sciences and/or obesity, and related disorders, is required. The research must be in the form of research project grants (R01), program project grants (P01), Resource-Related Research Project Grant (R24), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non-federal groups at the time of submission of the Center grant application. It is required that at least fifty percent of the nutritional sciences and obesity or other related disorders research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives.
NORC applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, all Nutrition Obesity Research Centers will be required to maintain a Center website, with the administrative core taking primary responsibility for its creation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website.
The NORC Director, who is the Program Director/Principal Investigator (PD/PI) on the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrate proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the NORC and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend Center Director's meetings to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget of the Administrative Core of the Center. The Core Center Director should provide at least 1.2 person months (calendar year) effort on the Administrative Core and a total of 2.4 person months (calendar year) effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.
The NORCs are based on the core concept. Four to six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in nutritional sciences and/or obesity and related disorders research to accomplish the stated goals of the Center. Examples of such resources include biostatistics, imaging, biotechnology, and instrumentation facilities. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused.
Centers are encouraged to foster clinical and/or translational research. This clinical component can exist in multiple formats, as a stand-alone core, a 'clinical component' as part of the administrative core, a combination of the two, or some other format that supports clinical research. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support; enhance clinical study design; enhance collaboration among researchers and recruitment of subjects for clinical studies; provide for epidemiological studies; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of children, women, and ethnic minority participation in clinical studies.
In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institutions. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Nutrition Obesity Research Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.
Proposed NORC research cores may be an institutional shared research core. In such cases, the research core support provided by the NORC should be proportional to the use of the institutional research core by NORC members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the NORC will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.
The need for core support from the NORC must be well-justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as nutrition and/or obesity researchers with other sources of peer-reviewed support. Participants in the NORC program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://www.ctsaweb.org/) and other NIH Common Fund activities, and any related NIDDK-funded Center programs: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/. Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the NORC and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.
Two other types of activities should also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program.
The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity or nutritional sciences research, and at established investigators who wish to make a substantial change in the direction of their nutritional sciences or obesity-related research. It is expected that the majority of P/F project investigators will fall into the first category and only in exceptional circumstances will investigators in the third category be supported. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK.
The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. The NORC enrichment program should be designed to advance translational research in nutrition and obesity and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition and obesity researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops.
Applicants should describe any training opportunities afforded by the NORC for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on any related NIDDK T32 training programs at the Center institution(s), and describe how the NORC will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PI of the T32 intends to promote cohesive interactions between the two programs. Training postdoctoral fellows to conduct research in nutrition and obesity is an associated activity of a NORC. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training.
NORCs are encouraged to support clinical and translational research. A NORC may support clinical research through a 'clinical component' housed in the Administrative Core, through one or more stand-alone research cores, or through some other mechanism. Services should be budgeted through the core in which they would be performed. For a description of the expectations related to clinical research, please see the NORC Administrative Guidelines available at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf.
The NORC must have a central focus or theme(s) that is related to nutritional sciences or obesity. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application.
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 (other than institutions of higher education); 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 organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution is allowed.
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.
Only institutions at which there is an ongoing, strong base of nutrition and/or obesity-related research are eligible. At least 50 percent of the already funded research base in a new application must be Federally-funded. In renewal applications, the NIH-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering nutrition and/or obesity research from other fields.
Applications for NORC grants must propose themes for the center that is relevant to nutrition and/or obesity and is supported by the research projects which comprise the research base for the NORC. The research base grants should be summarized in accordance with the NORC guidelines found at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf.
Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to supporting the center. Such commitment may be provided as dedicated space, staff recruitment, salary-support for investigators, dedicated or shared equipment, or other financial support for the proposed center.
Each proposed core must be utilized by a minimum of two federally-funded investigators. A detailed description of each core proposed must be provided, including a detailed budget and budget justification. A well-qualified core director must be named for each core. The description of each core should include a rationale indicating how it will support the center's research effort in a cost-effective manner. Facilities must be available for the primary needs of the NORC because funds for new construction are not available from the P30 grant.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-012.html.
TRANSLATIONAL RESEARCH IN PEDIATRIC AND OBSTETRIC PHARMACOLOGY (R01): PAR-11-246
Also note: Translational Research in Pediatric and Obstetric Pharmacology (R03): PAR-11-247
http://grants.nih.gov/grants/guide/pa-files/PAR-11-247.html
Also note: Translational Research in Pediatric and Obstetric Pharmacology (R21): PAR-11-248
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-248.html
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Application Receipt/Submission Date(s): October 4, 2011, January 10, 2012, May 15, 2012, September 12, 2012, January 10, 2013, May 15, 2013
The purpose of this funding opportunity announcement (FOA) is to encourage applications for translational and clinical research as well as clinical trials that will advance our knowledge about the underlying mechanisms of drug action, response and safety in children at various developmental stages, and/or in pregnant women and the developing fetus. The overall goals of the FOA are to improve the safety and effectiveness of current drugs for pediatric or obstetric patients, and to enhance the development of new drugs or a safer usage of the existing drugs for tailored therapies to meet emerging clinical needs for these special populations.
Children and pregnant women are two special populations with special dynamic physiology and pharmacology, and are vulnerable to drug toxicities and to ineffective treatments. They are generally excluded from drug research and new drug development due to factors including technical difficulties, ethical and legal concerns, as well as potential drug toxicities for the pregnant women, the fetus and children. Thus, most drugs were developed in men, non-pregnant women and non-pediatric populations. Information guiding clinical drug therapy for pediatric and obstetric patients is largely extrapolated from studies and clinical trials conducted in adult and non-pregnant populations. In addition, the majority of drugs used in children or in pregnant women are used off label leading to possible ineffective and costly therapies, as well as potentially unpredictable adverse events and other clinical consequences. Inappropriate and ineffective drug therapy for these special populations is still a major concern of the patients, their families and health care professionals.
Advances in understanding of molecular and genetic bases of diseases, and identification and validation of biomarkers, together with the development of powerful, high-throughput technologies (deep sequencing, microarrays, proteomics, and bioinformatics), have led to molecular profiling for many disease conditions in children as well as in pregnant women, leading to the identification of many new molecular targets and pathways. These discoveries have created new frontiers for clinical investigators to conduct translational research and novel drug development among children and pregnant women. Although some progress has been made in research by providing valuable therapeutic information for pediatric and obstetric patients in recent years, information guiding appropriate drug therapy for pediatric and obstetric patients remains incomplete. There is still a great need for pharmacological research in children and pregnant women to advance our knowledge and understanding of the mechanisms of drug actions and responses in children at different developmental stages, and in women during pregnancy, to develop effective and safe therapeutic approaches for these special populations.
In 2009, the Obstetric and Pediatric Pharmacology Branch (OPPB) within the Center for Research for Mothers and Children of NICHD launched a translational pharmacologic research program covering a broad area of research activities focusing on children and pregnant women. The long-term goals of this program are: (1) to provide a mechanism to support investigator-initiated research to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations; and (2) to improve the safety and efficacy of pharmaceuticals for these special populations. This program complements the OPPB's ongoing activities supported by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Trials Network (PTN), the Specialized Centers in Research in Pediatric Developmental Pharmacology (RPDP), and the Obstetric-Fetal Pharmacology Research Units (OPRU) network within the OPP Branch of NICHD (http://www.nichd.nih.gov/about/org/crmc/opp/index.cfm).
This funding opportunity announcement (FOA) is intended to encourage applications for translational and clinical research as well as clinical trials that will advance our knowledge about the underlying mechanisms of drug action, response and safety in children at various developmental stages, and/or in pregnant women and the developing fetus. The overall goals of the FOA are to improve the safety and effectiveness of current drugs for pediatric or obstetric patients, and to enhance the development of new drugs or a safer usage of existing drugs for tailored therapies to meet emerging clinical needs for these special populations.
Studies from a variety of scientific fields that investigate drug metabolism and disposition, new drug development, and mechanism of drug action, toxicity and safety in children at different developmental stages or in women during pregnancy and lactation are of particular interest.
Studies applying scientific discoveries generated from the basic science laboratory, preclinical and clinical studies, to the development of pharmacotherapeutics and clinical trials in pediatric or obstetric populations are appropriate to this FOA.
Studies encompassing innovative approaches and multidisciplinary collaborations, and using genome-wide as well as epigenomic, transcriptomic, proteomic, or metabolomic approaches to advance the knowledge base in pediatric or obstetric pharmacology are highly encouraged.
Examples of research topic areas of interest include but are not limited to:
Develop/apply pharmacogenomic strategies to pediatric or obstetric clinical trials to improve drug safety and efficacy;
Study genetic variations that affect drug metabolism and disposition, and alter treatment responses in pediatric or obstetric patients;
Study microRNAs (miRNAs) that affect transcription and/or translation of the target transcripts for drug transporters, receptors, metabolizing signaling pathways in children at different developmental stages or in women during pregnancy;
Study genomic, proteomic and epigenomic changes that are associated with variability in pharmacokinetics and pharmacodynamics in pediatric or obstetric patients;
Develop novel mathematical, statistical and computational methods for modeling and simulating PK/PD, and evaluate existing methods in children and pregnant women;
Identify and validate biomarkers for monitoring disease progression and treatment responses, and predicting clinical outcomes of pediatric or obstetric patients;
Identify small molecules and compounds or develop biologics for new targets for pharmacological intervention;
Develop in vivo and animal models for preclinical testing of new therapeutic agents;
Study placental drug transfer and fetal disposition of maternally administered drugs using in vitro and animal models;
Study the effects of in-utero exposure to therapeutic drugs during pregnancy;
Conduct pharmacoepidemiological studies to determine the frequency and pattern of medication use in children or pregnant women, and to develop novel methodologies for drug safety surveillance for these special populations;
Identify imaging markers for the development of new drugs, and apply imaging tools to assess drug effects, toxicity, safety as well as clinical outcomes.
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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 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-11-246.html.
PEDIATRIC CENTERS OF EXCELLENCE IN NEPHROLOGY (P50): RFA-DK-11-009
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): November 03, 2011
Kidney disease is a major cause of illness and death in infants, children and adolescents. The incidence of end-stage renal disease (ESRD) in patients age 0 - 19 years in the United States is about 15 per million population, according to the 2010 USRDS Annual Data Report. The primary etiologies vary with age, but structural anomalies predominate. Data in the most recent report from the Chronic Kidney Disease arm of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) indicate that overall, more than 50% of the patients in the registry had some type of structural anomaly. This diagnosis approaches 75% in infants. Approximately one third of adolescents in the study have some type of glomerular disease; >50% of African-American adolescents and 35% of Hispanic adolescents.
There are also several causes of acute kidney injury (AKI) particularly pertinent to the pediatric population, which are in need of translational research. These include hemolytic uremic syndrome (HUS), postinfectious glomerulonephritis, and post cardiac surgery AKI.
Progress is being made in molecular and genetic analyses to link specific gene products to normal or abnormal kidney growth and development and some human kidney diseases. For example the nephrin mutation in congenital nephrotic syndrome, a glomerular disease characterized by massive amounts of proteinuria and progressive renal failure in infants. Similarly specific podocin mutations have been linked to some forms of familial FSGS. However, the basic cellular and molecular mechanisms of the majority of pediatric kidney disorders are poorly understood. Progression often occurs even when the primary disease process has been thought to be adequately treated and the disorder appears to have become inactive. Several diseases that lead to chronic kidney disease and end-stage renal disease (ESRD) in adults likely have their origin in childhood; notable examples are diabetes and hypertension. Up to one third of children who develop Type 1 diabetes will develop ESRD in their twenties or thirties. Therefore strategies to prevent kidney disease should begin in childhood, ideally. A great need exists to better understand the pathogenesis of these conditions. In addition, the child's special growth and developmental needs present particular challenges.
The NIDDK has funded three pediatric multicenter studies in recent years: (1) Clinical trial in children and young adults with FSGS (FSGS-CT); (2) Prospective Study of Chronic Kidney Disease in Children (CKiD); (3) Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR). Preliminary findings from these studies will inform the designs of additional clinical trials in pediatric kidney disease patients in the future.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) currently supports through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD) eight George M. O'Brien Kidney Research Centers, two Centers of Excellence in Pediatric Nephrology, and four Centers for Polycystic Kidney Disease Research. These Centers are part of an integrated program of kidney-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive kidney research bases.
The purpose of the Pediatric Centers of Excellence in Nephrology is to attract a partnership of interdisciplinary research among investigators with scientific expertise who will use complementary and integrated approaches to study kidney diseases endemic to the pediatric population. In approaching the study of these disease processes it is anticipated that extensive collaboration will be required among individuals in the clinical and basic sciences, including cell biology, molecular biology, immunology, virology, genetics, epidemiology, biochemistry, physiology and pathology. Studies designed to foster and extend the development of new approaches into the causes, early diagnoses, improved treatment, and where possible, prevention of these diseases and disorders are appropriate.
A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants, enabling them to conduct their individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Each core should provide services to multiple research projects. Centers may propose either Institutional, Regional, National or International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level.
In addition to biomedical cores, an Administrative Core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative Core will also be responsible for planning an Educational Enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. In addition, the Pediatric Centers of Excellence in Nephrology should maintain a Center website, with the Administrative Core taking primary responsibility for its curation and oversight.
Each Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of kidney research. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. Each Core Center application must include a minimum of two up to a maximum of four pilot projects. Each pilot project may request a maximum of $50,000 direct costs per year (excluding Facility and Administrative costs) (NOT-OD-04-040) for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines (http://www2.niddk.nih.gov/NR/rdonlyres/6C7FDEDE-62ED-4196-8CBA-935B79252CED/17891/P50guidelinesPedsCenters.pdf).
Applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Pediatric Centers of Excellence in Nephrology. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Pediatric Centers of Excellence in Nephrology and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of Pediatric Centers of Excellence in Nephrology activities through cooperation with other NIH-supported core facilities at the applicant institution. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the Pediatric Centers of Excellence in Nephrology.
Core access and Cost Recovery: core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in core services (e.g. comparative costs of other sources of proposed core services) and policies for cost recovery from investigators for use of services should also be included.
Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.
Representative, but not all-inclusive areas of research appropriate for investigation include:
(1) studies of renal disorders of genetic and congenital origin that may lead to progressive loss of renal function or cause severe metabolic imbalances in children;
(2) further identification and study of genes and gene mutations and molecular events involved in renal and urogenital morphogenesis and differentiation;
(3) studies of events involved in cellular signaling in renal morphogenesis in health and disease, including the definition of events involved in cellular communication and mechanisms by which growing cells influence and are influenced by extracellular matrix;
(4) immune-mediated disorders, including such diseases as post-infectious glomerulonephritis, human immunodeficiency virus (HIV), immunoglobulin A (IgA) nephropathy, and Wegner's granulomatosis;
(5) studies to understand the molecular mechanisms underlying the renal hypertension in infants and children;
(6) studies addressing the short and long-term effects of anti-hypertensive agents in infants and children;
(7) identification of risk factors and predisposing factors contributing to renal disease progression in infants and children;
(8) studies addressing the etiology, pathophysiology, and treatment strategies for end-stage renal disease in infants and young children, including determinants of abnormal growth and development, the development of animal models to quantitate the contribution of selective variables in growth retardation in chronic renal failure, the effects of exogenous recombinant hormones, and the role of uremia in protein synthesis in young growing infants;
9) cellular and molecular studies underlying the development and progression of glomerulonephritis in children, including the molecular changes affecting the glomeruli, alterations of the basement membrane, mechanisms leading to proteinuria, and the biochemistry of the nephron during pathological states.
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 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution is allowed.
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-11-009.html.
ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS (ELSI) OF GENOMIC RESEARCH SMALL RESEARCH GRANT PROGRAM (R03): PA-11-249
Components of Participating Organizations
National Human Genome Research Institute
National Institute on Aging
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute of Environmental Health Sciences
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The rapid evolution of genomic technologies and the increasing availability and use of genomic information has the potential to transform how research and medicine are practiced and how a wide range of social practices and norms are understood and shaped. This FOA is intended to encourage small research grant applications that identify, examine and address the ethical, legal and social implications (ELSI) of advances in genomic research and technology for individuals, families, communities and society more broadly. These applications should be for small, self-contained research projects. Of particular interest are projects that propose focused legal, economic, philosophical or historical analyses of new or emerging issues.
On February 10, 2011, Nature magazine published NHGRI's strategic plan for the future of human genome research, called "Charting a Course for Genomic Medicine from Base Pairs to Bedside." This plan includes a section on Genomics and Society that outlines four areas that will need to be addressed as genomic science and medicine move forward. Based on these areas, the NHGRI has identified the following broad research priorities.
Genomic Research. Projects in this area may examine and address the issues that arise in the design and conduct of genomic research, particularly as it increasingly involves the production, analysis and broad sharing of individual genomic information that is frequently coupled with detailed health information.
Genomic Health Care. Projects in this area may explore how rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided and how it affects the health of individuals, families and communities.
Broader Societal Issues. Projects in this area may examine the normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as the implications of genomics for how we conceptualize and understand such issues as health, disease, and individual responsibility.
Legal, Regulatory and Public Policy Issues. Projects in this area may explore the effects of existing genomic research, health and public policies and regulations and provide data to inform the development of new policies and regulatory approaches.
A more detailed discussion of each of these areas and a list of examples of possible research topics is provided below.
Genomic Research:
Genomic research studies frequently involve human participants who provide samples-and frequently detailed, personal health information-with the understanding that: (1) the study of their samples (and, where relevant, their personal health information) may generate an enormous amount of data-including information relevant to their genetic risk for a broad range of traits or disorders; (2) those data (and, where relevant, the health information) will, in many cases, be broadly shared-including with as-yet-unknown secondary data users in unspecified places; and (3) the samples and data may continue to be used for many years into the future-perhaps even indefinitely.
In the context of earlier, more traditional, and more circumscribed genetics studies, the benefits and risks of the research could for the most part be framed and handled through a relatively routine informed consent process accompanied by discrete policy reforms (such as changes in guidelines published by the Office of Human Research Protections (OHRP) or the recent enactment of a law prohibiting genetic discrimination in a particular setting). Such approaches to participant protection, however, have not always been adequate for genomic studies, which can be significantly more complex. Thus, it is necessary to develop, implement, evaluate, and continuously refine innovative mechanisms and policies that continue to recognize participants' interests in the privacy, disposition and use of the data, while simultaneously obtaining the scientific advantages that come from broad access to genomic research data.
Some specific examples of topics related to genomic research in which further ELSI research is needed include, but are not limited to:
recruitment issues (including diversity in research participation);
perceptions of risks and benefits by the public, research participants, researchers, and IRBs;
issues in informed consent in genomic research (including unexpected results or results in which there are no interventions to offer)
return of individual research findings (including incidental findings);
privacy and identifiability of genomic information;
data sharing and data security;
governance structures for genomic repositories (including treatment of archived samples, such as newborn bloodspots);
compensation to sample and data providers;
fair distribution of benefits from research;
third-party benefits and risks of genomic research (including effects on family members and broader communities);
use of tissue and health data from deceased individuals in genomic research;
role of community consultation and engagement;
relationship between ancestral biomarkers and self-identified race and ethnicity and incorporation of these variables in genomic research.
Genomic Health Care: The availability of personalized genomic information, coupled with rapid changes in how health information is collected, stored, accessed, transferred, and used, promises to revolutionize health care. In order to fully realize this potential, genome-based health interventions that take advantage of advances in information and knowledge, as well as advances in communication technologies, must be developed. To ensure that these new interventions are safe and effective, their impact on individuals, their families, their communities and society more generally must be addressed and understood.
Some specific examples of topics related to genomic health care in which further ELSI research is needed include, but are not limited to:
fairness in the distribution of genomic and genetic services (access and reimbursement issues, including issues relating to insurance and other third party payers);
assessment and evaluation of personalized genomic-based health care in terms of general effectiveness and comparative cost-effectiveness;
issues in informed consent as related to genomically-based health care (including unexpected results or results in which there are no interventions to offer);
issues surrounding the potential inclusion of genomic information in Electronic Health Records and Personal Health Records;
communication of genomic information and test results in clinical settings;
issues surrounding the use of pharmacogenomics and other genomics-based therapies, including reimbursement;
issues in preimplantation and prenatal genomic diagnosis and other genomically-based reproductive technologies;
understanding the contribution of genomic, psychosocial and cultural factors that may have a role in health disparities;
communication of the relationship between ancestral biomarkers and self-identified race and ethnicity to individuals and families receiving genomically-based clinical test results.
Broader Societal Issues: The ongoing evolution of genomic research and health care requires a continuing analysis of the normative underpinnings of beliefs, practices and policies regarding research, health and disease. In addition, as personal genomic information permeates many aspects of society, it will have profound implications for how we understand ourselves as individuals and as members of families, communities, and society-and even for how we understand what it means to be human. Long-held beliefs about the continuum between health and disease may be transformed, as will concepts of free will and responsibility. These conceptual shifts may have implications for current approaches to research, health and social policies, and will require both careful study and the development of practical mechanisms to translate the findings of these studies into language and formats that are relevant and useful to those involved in the development and implementation of these policies.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
normative factors underlying concepts of risk and benefit in genomic research and health care;
ethical implications of the blurring of the distinction between genomic research and genomics-based health care;
ethical issues relevant to genomic research and genomic health care involving special populations (e.g., newborns and children, people with disabilities, pregnant women, deceased individuals);
implications of increasing genomic knowledge for how health and disease are conceptualized by individuals, health care providers and the health care industry;
implications of genomic variation research (and of genetic ancestry testing) for understanding identity, race and ethnicity, and relationships within and among human populations;
implications of learning more about epigenomics and the human microbiome for concepts of human identity, personhood, health and disease;
implications of comparative genomic research and evidence of natural selection among human populations for understanding the relationships among humans, and between humans and non-humans, and the intersection of genomic knowledge with existing beliefs about evolution and human origins;
implications of manifestations of genetic determinism, reductionism, essentialism, and exceptionalism in public attitudes and in public policy;
implications of genomic information for understandings of free will and individual responsibility.
Legal, Regulatory, and Public Policy Issues: New legal and regulatory approaches need to be crafted in anticipation of or in response to rapid developments in genomic research and genomic health care. These approaches will need to be sensitive to the ways in which new genomic technologies and information are integrated into society. They also will have to adapt to the challenges inherent in attempts to maintain confidentiality and privacy in a new era of genomic information coupled with revolutionary changes in information technology. In addition, policy-makers will need to revisit the issues of autonomy and ownership that are evolving as society changes. Research will be needed to explore the effects of existing policies and regulations and to provide data to inform the development of new policies and regulatory approaches.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
intellectual property issues (status of patents and patenting covering genomic sequences, associations, and tests; effects of gene patenting and licensing on the development of genomic medicine);
appropriate regulation of genetic testing (including direct-to-consumer genetic test marketing), pharmacogenomics and genomics-based therapies;
ownership and liability issues surrounding the secondary use of biobanked samples;
genetic discrimination and stigmatization (including the impact of GINA);
non-medical uses of genomics in non-health care settings (e.g., criminal and civil courts; employment; schools; the military).
More information on the NHGRI ELSI Research Program and its evolving research priorities is available on the ELSI homepage: http://www.genome.gov/ELSI/.
In addition, the following high priority issues have been identified by the participating institutes.
The NIA is particularly interested in specific issues (ethical, legal, social, and economic) that researchers face and the unique safeguards that are needed to protect participant privacy when genetic data are linked with a rich array of data that may include longitudinal information, behavioral, social and health measures and/or information derived from linked administrative records. These issues may include those faced by researchers, those posed by data sharing and access committees to protect privacy, and those related to concerns of individual study participants and their families. Specifically of interest is the issue of likelihood and prevention of re-identifiability in behavioral and social research. Even when data is de-identified, the re-identification of research subjects is feasible with very few data points. Behavioral and social datasets have large amounts of individual level data; when combined with biomarker and genetic data, the chance of re-identification increases substantially.
The NICHD has specific interests in research with implications for children, adults, and families in the following areas: assisted reproductive technologies; race, ethnicity, and kinship; child development; obesity; developmental disabilities; and medical rehabilitation. For example, the NICHD supports studies of the genetics of learning disabilities (reading, math, co-morbidities of these such as ADHD), and the need to consider the social and ethical implications of how this information will be used to inform parents and to guide educational interventions is extremely important to the continuation of such research. The NICHD also has specific interests in newborn screening; for example, we support studies on the genetic basis of rare disease.
The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, and genetic susceptibility to environmental exposures. In particular, NIEHS has an interest in supporting an ongoing dialogue between scientists and the public for accurate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of educational interventions used.
The research areas and possible research questions described above should be seen as a general guide to areas of interest, but should not be seen as a comprehensive list of all possible research topics. As genomic research advances and the interpretation and use of genomic information continues to evolve, applicants are encouraged to identify additional topics and issues ripe for research. In addition, many of the listed topics are relevant to the design and implementation of genomic research studies and may be appropriately examined in conjunction with a variety of planned or ongoing genomic research projects. Potential applicants are encouraged to explore possible collaborations with genomic and other biological researchers who are integrating genomics into their research and also to explore other relevant funding opportunities developed by NHGRI or by other NIH institutes.
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; regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). Foreign (non-U.S.) components of U.S. Organizations 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/PIs) 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 four (4) 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/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 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-11-249.html.
ETHICAL LEGAL AND SOCIAL IMPLICATIONS (ELSI) OF GENOMIC RESEARCH REGULAR RESEARCH PROGRAM (R01): PA-11-250
Components of Participating Organizations
National Human Genome Research Institute
National Cancer Institute
National Institute on Aging
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Deafness and Other Communication Disorders
National Institute of Environmental Health Sciences
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The rapid evolution of genomic technologies and the increasing availability and use of genomic information has the potential to transform how research and medicine are practiced and how a wide range of social practices and norms are understood and shaped. This FOA is intended to encourage multi-disciplinary research applications that identify, examine and address the ethical, legal and social implications (ELSI) of advances in genomic research and technology for individuals, families, communities and society more broadly.
On February 10, 2011, Nature magazine published NHGRI's strategic plan for the future of human genome research, called "Charting a Course for Genomic Medicine from Base Pairs to Bedside." This plan includes a section on Genomics and Society that outlines four areas that will need to be addressed as genomic science and medicine move forward. Based on these areas, the NHGRI has identified the following broad research priorities.
Genomic Research. Projects in this area may examine and address the issues that arise in the design and conduct of genomic research, particularly as it increasingly involves the production, analysis and broad sharing of individual genomic information that is frequently coupled with detailed health information.
Genomic Health Care. Projects in this area may explore how rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided and how it affects the health of individuals, families and communities.
Broader Societal Issues. Projects in this area may examine the normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as the implications of genomics for how we conceptualize and understand such issues as health, disease, and individual responsibility.
Legal, Regulatory and Public Policy Issues. Projects in this area may explore the effects of existing genomic research, health and public policies and regulations and provide data to inform the development of new policies and regulatory approaches.
A more detailed discussion of each of these areas and a list of examples of possible research topics is provided below.
Genomic Research:
Genomic research studies frequently involve human participants who provide samples-and frequently detailed, personal health information-with the understanding that: (1) the study of their samples (and, where relevant, their personal health information) may generate an enormous amount of data-including information relevant to their genetic risk for a broad range of traits or disorders; (2) those data (and, where relevant, the health information) will, in many cases, be broadly shared-including with as-yet-unknown secondary data users in unspecified places; and (3) the samples and data may continue to be used for many years into the future-perhaps even indefinitely.
In the context of earlier, more traditional, and more circumscribed genetics studies, the benefits and risks of the research could for the most part be framed and handled through a relatively routine informed consent process accompanied by discrete policy reforms (such as changes in guidelines published by the Office of Human Research Protections (OHRP) or the recent enactment of a law prohibiting genetic discrimination in a particular setting). Such approaches to participant protection, however, have not always been adequate for genomic studies, which can be significantly more complex. Thus, it is necessary to develop, implement, evaluate, and continuously refine innovative mechanisms and policies that continue to recognize participants' interests in the privacy, disposition and use of the data, while simultaneously obtaining the scientific advantages that come from broad access to genomic research data.
Some specific examples of topics related to genomic research in which further ELSI research is needed include, but are not limited to:
recruitment issues (including diversity in research participation);
perceptions of risks and benefits by the public, research participants, researchers, and IRBs;
issues in informed consent in genomic research (including unexpected results or results in which there are no interventions to offer)
return of individual research findings (including incidental findings);
privacy and identifiability of genomic information;
data sharing and data security;
governance structures for genomic repositories (including treatment of archived samples, such as newborn bloodspots);
compensation to sample and data providers;
fair distribution of benefits from research;
third-party benefits and risks of genomic research (including effects on family members and broader communities);
use of tissue and health data from deceased individuals in genomic research;
role of community consultation and engagement;
relationship between ancestral biomarkers and self-identified race and ethnicity and incorporation of these variables in genomic research.
Genomic Health Care: The availability of personalized genomic information, coupled with rapid changes in how health information is collected, stored, accessed, transferred, and used, promises to revolutionize health care. In order to fully realize this potential, genome-based health interventions that take advantage of advances in information and knowledge, as well as advances in communication technologies, must be developed. To ensure that these new interventions are safe and effective, their impact on individuals, their families, their communities and society more generally must be addressed and understood.
Some specific examples of topics related to genomic health care in which further ELSI research is needed include, but are not limited to:
fairness in the distribution of genomic and genetic services (access and reimbursement issues, including issues relating to insurance and other third party payers);
assessment and evaluation of personalized genomic-based health care in terms of general effectiveness and comparative cost-effectiveness;
issues in informed consent as related to genomically-based health care (including unexpected results or results in which there are no interventions to offer);
issues surrounding the potential inclusion of genomic information in Electronic Health Records and Personal Health Records;
communication of genomic information and test results in clinical settings;
issues surrounding the use of pharmacogenomics and other genomics-based therapies, including reimbursement;
issues in preimplantation and prenatal genomic diagnosis and other genomically-based reproductive technologies;
understanding the contribution of genomic, psychosocial and cultural factors that may have a role in health disparities;
communication of the relationship between ancestral biomarkers and self-identified race and ethnicity to individuals and families receiving genomically-based clinical test results.
Broader Societal Issues: The ongoing evolution of genomic research and health care requires a continuing analysis of the normative underpinnings of beliefs, practices and policies regarding research, health and disease. In addition, as personal genomic information permeates many aspects of society, it will have profound implications for how we understand ourselves as individuals and as members of families, communities, and society-and even for how we understand what it means to be human. Long-held beliefs about the continuum between health and disease may be transformed, as will concepts of free will and responsibility. These conceptual shifts may have implications for current approaches to research, health and social policies, and will require both careful study and the development of practical mechanisms to translate the findings of these studies into language and formats that are relevant and useful to those involved in the development and implementation of these policies.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
normative factors underlying concepts of risk and benefit in genomic research and health care;
ethical implications of the blurring of the distinction between genomic research and genomics-based health care;
ethical issues relevant to genomic research and genomic health care involving special populations (e.g., newborns and children, people with disabilities, pregnant women, deceased individuals);
implications of increasing genomic knowledge for how health and disease are conceptualized by individuals, health care providers and the health care industry;
implications of genomic variation research (and of genetic ancestry testing) for understanding identity, race and ethnicity, and relationships within and among human populations;
implications of learning more about epigenomics and the human microbiome for concepts of human identity, personhood, health and disease;
implications of comparative genomic research and evidence of natural selection among human populations for understanding the relationships among humans, and between humans and non-humans, and the intersection of genomic knowledge with existing beliefs about evolution and human origins;
implications of manifestations of genetic determinism, reductionism, essentialism, and exceptionalism in public attitudes and in public policy;
implications of genomic information for understandings of free will and individual responsibility.
Legal, Regulatory, and Public Policy Issues: New legal and regulatory approaches need to be crafted in anticipation of or in response to rapid developments in genomic research and genomic health care. These approaches will need to be sensitive to the ways in which new genomic technologies and information are integrated into society. They also will have to adapt to the challenges inherent in attempts to maintain confidentiality and privacy in a new era of genomic information coupled with revolutionary changes in information technology. In addition, policy-makers will need to revisit the issues of autonomy and ownership that are evolving as society changes. Research will be needed to explore the effects of existing policies and regulations and to provide data to inform the development of new policies and regulatory approaches.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
intellectual property issues (status of patents and patenting covering genomic sequences, associations, and tests; effects of gene patenting and licensing on the development of genomic medicine);
appropriate regulation of genetic testing (including direct-to-consumer genetic test marketing), pharmacogenomics and genomics-based therapies;
ownership and liability issues surrounding the secondary use of biobanked samples;
genetic discrimination and stigmatization (including the impact of GINA);
non-medical uses of genomics in non-health care settings (e.g., criminal and civil courts; employment; schools; the military).
More information on the NHGRI ELSI Research Program and its evolving research priorities is available on the ELSI homepage: http://www.genome.gov/ELSI/.
In addition, the following high priority issues have been identified by the participating institutes.
The NIA is particularly interested in specific issues (ethical, legal, social, and economic) that researchers face and the unique safeguards that are needed to protect participant privacy when genetic data are linked with a rich array of data that may include longitudinal information, behavioral, social and health measures and/or information derived from linked administrative records. These issues may include those faced by researchers; those posed by data sharing and access committees to protect privacy, and those related to concerns of individual study participants and their families. Specifically of interest is the issue of likelihood and prevention of re-identifiability in behavioral and social research. Even when data is de-identified, the re-identification of research subjects is feasible with very few data points. Behavioral and social datasets have large amounts of individual level data; when combined with biomarker and genetic data, the chance of re-identification increases substantially.
The NCI is interested in empirical research that focuses on the ethical, legal and social issues related to heritable cancer syndromes. Study of the psycho-social and behavioral impact on affected individuals, their families and populations and research that takes into consideration the perspectives of diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities is highly desirable. The ultimate goal of this research will be to improve outcomes related to the diagnosis of heritable cancer syndromes.
The NICHD has specific interests in research with implications for children, adults, and families in the following areas: assisted reproductive technologies; race, ethnicity, and kinship; child development; obesity; developmental disabilities; and medical rehabilitation. For example, the NICHD supports studies of the genetics of learning disabilities (reading, math, co-morbidities of these such as ADHD), and the need to consider the social and ethical implications of how this information will be used to inform parents and to guide educational interventions is extremely important to the continuation of such research. The NICHD also has specific interests in newborn screening; for example, we support studies on the genetic basis of rare disease.
The NIDCD is interested in addressing social, ethical and legal issues related to deafness and other communication disorders (hearing, balance, smell, taste, voice, speech and language). The NIDCD is especially interested in the impact of genomic research and genetic testing on the behaviors and attitudes of individuals with hearing impairment and their families.
The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, and genetic susceptibility to environmental exposures. In particular, NIEHS has an interest in supporting an ongoing dialogue between scientists and the public for accurate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of educational interventions used.
The NINDS is particularly interested in applications which address subjects relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH, see http://www.ninds.nih.gov/about_ninds/mission.htm.
The research areas and possible research questions described above should be seen as a general guide to areas of interest, but should not be seen as a comprehensive list of all possible research topics. As genomic research advances and the interpretation and use of genomic information continues to evolve, applicants are encouraged to identify additional topics and issues ripe for research. In addition, many of the listed topics are relevant to the design and implementation of genomic research studies and may be appropriately examined in conjunction with a variety of planned or ongoing genomic research projects. Potential applicants are encouraged to explore possible collaborations with genomic and other biological researchers who are integrating genomics into their research and also to explore other relevant funding opportunities developed by NHGRI or by other NIH institutes.
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; regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). Foreign (non-U.S.) components of U.S. organizations 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/PIs) 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 four (4) 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/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 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-11-250.html.
ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS (ELSI) OF GENOMIC RESEARCH EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21): PA-11-251
Components of Participating Organizations
National Human Genome Research Institute
National Institute on Aging
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Deafness and Other Communication Disorders
National Institute of Environmental Health Sciences
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The rapid evolution of genomic technologies and the increasing availability and use of genomic information has the potential to transform how research and medicine are practiced and how a wide range of social practices and norms are understood and shaped. This FOA is intended to encourage exploratory or developmental research applications that identify, examine and address the ethical, legal and social implications (ELSI) of advances in genomic research and technology for individuals, families, communities and society more broadly. These applications should propose studies that break new ground or extend previous discoveries toward new directions or applications. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.
On February 10, 2011, Nature magazine published NHGRI's strategic plan for the future of human genome research, called "Charting a Course for Genomic Medicine from Base Pairs to Bedside." This plan includes a section on Genomics and Society that outlines four areas that will need to be addressed as genomic science and medicine move forward. Based on these areas, the NHGRI has identified the following broad research priorities.
Genomic Research. Projects in this area may examine and address the issues that arise in the design and conduct of genomic research, particularly as it increasingly involves the production, analysis and broad sharing of individual genomic information that is frequently coupled with detailed health information.
Genomic Health Care. Projects in this area may explore how rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided and how it affects the health of individuals, families and communities.
Broader Societal Issues. Projects in this area may examine the normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as the implications of genomics for how we conceptualize and understand such issues as health, disease, and individual responsibility.
Legal, Regulatory and Public Policy Issues. Projects in this area may explore the effects of existing genomic research, health and public policies and regulations and provide data to inform the development of new policies and regulatory approaches.
A more detailed discussion of each of these areas and a list of examples of possible research topics is provided below.
Genomic Research:
Genomic research studies frequently involve human participants who provide samples-and frequently detailed, personal health information-with the understanding that: (1) the study of their samples (and, where relevant, their personal health information) may generate an enormous amount of data-including information relevant to their genetic risk for a broad range of traits or disorders; (2) those data (and, where relevant, the health information) will, in many cases, be broadly shared-including with as-yet-unknown secondary data users in unspecified places; and (3) the samples and data may continue to be used for many years into the future-perhaps even indefinitely.
In the context of earlier, more traditional, and more circumscribed genetics studies, the benefits and risks of the research could for the most part be framed and handled through a relatively routine informed consent process accompanied by discrete policy reforms (such as changes in guidelines published by the Office of Human Research Protections (OHRP) or the recent enactment of a law prohibiting genetic discrimination in a particular setting). Such approaches to participant protection, however, have not always been adequate for genomic studies, which can be significantly more complex. Thus, it is necessary to develop, implement, evaluate, and continuously refine innovative mechanisms and policies that continue to recognize participants' interests in the privacy, disposition and use of the data, while simultaneously obtaining the scientific advantages that come from broad access to genomic research data.
Some specific examples of topics related to genomic research in which further ELSI research is needed include, but are not limited to:
recruitment issues (including diversity in research participation);
perceptions of risks and benefits by the public, research participants, researchers, and IRBs;
issues in informed consent in genomic research (including unexpected results or results in which there are no interventions to offer)
return of individual research findings (including incidental findings);
privacy and identifiability of genomic information;
data sharing and data security;
governance structures for genomic repositories (including treatment of archived samples, such as newborn bloodspots);
compensation to sample and data providers;
fair distribution of benefits from research;
third-party benefits and risks of genomic research (including effects on family members and broader communities);
use of tissue and health data from deceased individuals in genomic research;
role of community consultation and engagement;
relationship between ancestral biomarkers and self-identified race and ethnicity and incorporation of these variables in genomic research.
Genomic Health Care: The availability of personalized genomic information, coupled with rapid changes in how health information is collected, stored, accessed, transferred, and used, promises to revolutionize health care. In order to fully realize this potential, genome-based health interventions that take advantage of advances in information and knowledge, as well as advances in communication technologies, must be developed. To ensure that these new interventions are safe and effective, their impact on individuals, their families, their communities and society more generally must be addressed and understood.
Some specific examples of topics related to genomic health care in which further ELSI research is needed include, but are not limited to:
fairness in the distribution of genomic and genetic services (access and reimbursement issues, including issues relating to insurance and other third party payers);
assessment and evaluation of personalized genomic-based health care in terms of general effectiveness and comparative cost-effectiveness;
issues in informed consent as related to genomically-based health care (including unexpected results or results in which there are no interventions to offer);
issues surrounding the potential inclusion of genomic information in Electronic Health Records and Personal Health Records;
communication of genomic information and test results in clinical settings;
issues surrounding the use of pharmacogenomics and other genomics-based therapies, including reimbursement;
issues in preimplantation and prenatal genomic diagnosis and other genomically-based reproductive technologies;
understanding the contribution of genomic, psychosocial and cultural factors that may have a role in health disparities;
communication of the relationship between ancestral biomarkers and self-identified race and ethnicity to individuals and families receiving genomically-based clinical test results.
Broader Societal Issues: The ongoing evolution of genomic research and health care requires a continuing analysis of the normative underpinnings of beliefs, practices and policies regarding research, health and disease. In addition, as personal genomic information permeates many aspects of society, it will have profound implications for how we understand ourselves as individuals and as members of families, communities, and society-and even for how we understand what it means to be human. Long-held beliefs about the continuum between health and disease may be transformed, as will concepts of free will and responsibility. These conceptual shifts may have implications for current approaches to research, health and social policies, and will require both careful study and the development of practical mechanisms to translate the findings of these studies into language and formats that are relevant and useful to those involved in the development and implementation of these policies.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
normative factors underlying concepts of risk and benefit in genomic research and health care;
ethical implications of the blurring of the distinction between genomic research and genomics-based health care;
ethical issues relevant to genomic research and genomic health care involving special populations (e.g., newborns and children, people with disabilities, pregnant women, deceased individuals);
implications of increasing genomic knowledge for how health and disease are conceptualized by individuals, health care providers and the health care industry;
implications of genomic variation research (and of genetic ancestry testing) for understanding identity, race and ethnicity, and relationships within and among human populations;
implications of learning more about epigenomics and the human microbiome for concepts of human identity, personhood, health and disease;
implications of comparative genomic research and evidence of natural selection among human populations for understanding the relationships among humans, and between humans and non-humans, and the intersection of genomic knowledge with existing beliefs about evolution and human origins;
implications of manifestations of genetic determinism, reductionism, essentialism, and exceptionalism in public attitudes and in public policy;
implications of genomic information for understandings of free will and individual responsibility.
Legal, Regulatory, and Public Policy Issues: New legal and regulatory approaches need to be crafted in anticipation of or in response to rapid developments in genomic research and genomic health care. These approaches will need to be sensitive to the ways in which new genomic technologies and information are integrated into society. They also will have to adapt to the challenges inherent in attempts to maintain confidentiality and privacy in a new era of genomic information coupled with revolutionary changes in information technology. In addition, policy-makers will need to revisit the issues of autonomy and ownership that are evolving as society changes. Research will be needed to explore the effects of existing policies and regulations and to provide data to inform the development of new policies and regulatory approaches.
Some specific examples of topics in this area in which further ELSI research is needed include, but are not limited to:
intellectual property issues (status of patents and patenting covering genomic sequences, associations, and tests; effects of gene patenting and licensing on the development of genomic medicine);
appropriate regulation of genetic testing (including direct-to-consumer genetic test marketing), pharmacogenomics and genomics-based therapies;
ownership and liability issues surrounding the secondary use of biobanked samples;
genetic discrimination and stigmatization (including the impact of GINA);
non-medical uses of genomics in non-health care settings (e.g., criminal and civil courts; employment; schools; the military).
More information on the NHGRI ELSI Research Program and its evolving research priorities is available on the ELSI homepage: http://www.genome.gov/ELSI/.
In addition, the following high priority issues have been identified by the participating institutes.
The NIA is particularly interested in specific issues (ethical, legal, social, and economic) that researchers face and the unique safeguards that are needed to protect participant privacy when genetic data are linked with a rich array of data that may include longitudinal information, behavioral, social and health measures and/or information derived from linked administrative records. These issues may include those faced by researchers, those posed by data sharing and access committees to protect privacy, and those related to concerns of individual study participants and their families. Specifically of interest is the issue of likelihood and prevention of re-identifiability in behavioral and social research. Even when data is de-identified, the re-identification of research subjects is feasible with very few data points. Behavioral and social datasets have large amounts of individual level data; when combined with biomarker and genetic data, the chance of re-identification increases substantially.
The NICHD has specific interests in research with implications for children, adults, and families in the following areas: assisted reproductive technologies; race, ethnicity, and kinship; child development; obesity; developmental disabilities; and medical rehabilitation. For example, the NICHD supports studies of the genetics of learning disabilities (reading, math, co-morbidities of these such as ADHD), and the need to consider the social and ethical implications of how this information will be used to inform parents and to guide educational interventions is extremely important to the continuation of such research. The NICHD also has specific interests in newborn screening; for example, we support studies on the genetic basis of rare disease.
The NIDCD is interested in addressing social, ethical and legal issues related to deafness and other communication disorders (hearing, balance, smell, taste, voice, speech and language). The NIDCD is especially interested in the impact of genomic research and genetic testing on the behaviors and attitudes of individuals with hearing impairment and their families.
The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, and genetic susceptibility to environmental exposures. In particular, NIEHS has an interest in supporting an ongoing dialogue between scientists and the public for accurate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of educational interventions used.
The NINDS is particularly interested in applications which address subjects relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH, see http://www.ninds.nih.gov/about_ninds/mission.htm.
The research areas and possible research questions described above should be seen as a general guide to areas of interest, but should not be seen as a comprehensive list of all possible research topics. As genomic research advances and the interpretation and use of genomic information continues to evolve, applicants are encouraged to identify additional topics and issues ripe for research. In addition, many of the listed topics are relevant to the design and implementation of genomic research studies and may be appropriately examined in conjunction with a variety of planned or ongoing genomic research projects. Potential applicants are encouraged to explore possible collaborations with genomic and other biological researchers who are integrating genomics into their research and also to explore other relevant funding opportunities developed by NHGRI or by other NIH institutes.
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; regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). Foreign (non-U.S.) components of U.S. organizations 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/PIs) 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 four (4) 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/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 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-11-251.html.
PAUL B. BEESON CLINICAL SCIENTIST DEVELOPMENT AWARD IN AGING (K08): (RFA-AG-12-003)
Also note: Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23): RFA-AG-12-004
Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-12-004.html
Components of Participating Organizations
National Institute on Aging
National Institute of Neurological Disorders and Stroke
Application Receipt Date(s): October 27, 2011
The National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS), working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/), and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to sustain and promote the research careers of clinically trained individuals who are pursuing research careers in aging. The numbers of physicians and other clinically trained individuals who are committing to and sustaining independent research careers in the biomedical sciences remain inadequate to address the opportunities for translational research, interdisciplinary collaboration, and groundbreaking basic research being generated by advances in genetics, biomedical engineering, and other life sciences. Within the field of aging research the small numbers of individuals receiving training in geriatrics, and the smaller numbers pursuing research on aging remain inadequate to address the burgeoning needs of the rapidly growing older population. These needs require a substantial investment in current and future faculty who will devote their careers to advancing knowledge of effective prevention and management of illness and disabilities, and to inspire successive generations to do the same.
The program is named after Dr. Paul B. Beeson who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society. Dr. Beeson died in August 2006 at the age of 97.
The aims of the Paul B. Beeson Career Development Awards in Aging (BCDA) program are:
To encourage and assist the development of future leaders in the field of aging by supporting clinically trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research.
To deepen the commitment of research institutions to academic research in aging and to translating research outcomes to geriatric medicine by involving mentor and recipient in establishing and advancing the recipient's career in aging research.
The broad fields of research appropriate for this K08 announcement include work in the basic sciences including animal models of aging or the use of secondary data analyses where there is apparent clinical relevance. Other examples include but are not limited to:
The elucidation of basic biochemical, genetic, and physiological mechanisms underlying aging and age-related changes in humans and in appropriate animal models;
Investigations focused on basic social and behavioral influences on the aging process, both at the individual and societal levels; models of transplantation in older patients; the utility and challenges of Medicare;
Research on the neural and behavioral processes associated with the aging brain, including brain-behavior biomarkers and behavior in models of Alzheimer's disease (some topics may also be appropriate for the companion K23 announcement).
Additional information on research programs supported by the NIA can be found at http://www.nia.nih.gov/ResearchInformation/. The BCDA program particularly includes additional support for clinically trained scientists who wish to pursue careers dedicated to basic research on Alzheimer's disease and other neurodegenerative diseases, formerly supported by the Alzheimer's Disease Clinical Scientist Development Award announcement. Up to three additional awards each year will be dedicated to investigators planning careers in neuroscience related to aging and neurodegenerative disease. Overall the program will foster the independent research careers of clinically trained investigators whose research will enhance overall health and quality of life of Americans, particularly older people.
The objective of the NIH Mentored Clinical Scientist Research Career Development Award (K08) program is to provide salary and research support for a sustained period of "protected time" (3-5 years) to support didactic study and/or mentored research for individuals with clinical doctoral degrees (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines). The K08 provides support for an intensive, mentored research career development experience in biomedical or behavioral research, including translational research. For the purpose of this award, translational research is defined as application of basic research discoveries toward the diagnosis, management, and prevention of human disease. Individuals with a clinical doctoral degree interested in pursuing a career in patient-oriented research should refer to the companion RFA AG-004 the Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23).
The K08 award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in a given field of research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.
K08 Candidates must hold a doctoral degree, and must commit a minimum of 9 person-months (75% of full-time professional effort) conducting research and relevant career development activities during the period of the award. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development.
The BCDA provides support to clinically trained faculty members in strong research environments to enable them to gain skills and experience in clinically relevant aging research and to establish an independent program of research in these fields. If you are such a faculty member and wish to apply for this program you must identify a mentor or mentors. These individuals should be senior researchers in aging, and/or geriatrics who agree to commit time to supervising and guiding you during the period of the award.
The BCDA is intended to provide individual candidates with the resources and time to establish themselves as independent and funded investigators whose research focuses on clinically relevant topics in aging. It is targeted primarily at individuals who have had some prior training in research coursework, methods, and resources related to aging and who have received initial funding for research such as through Small Grant support from NIH, through similar support from other federal agencies, or through foundation funding. As a career development award it will allow the candidate time to expand his/her research training as well as pursue activities consistent with the expectation of future leadership in the candidate's chosen field. These activities may include symposia, workshops or other activities in which the candidate has played a leading role in enhancing her/his fields' academic medical/health and research accomplishments and visibility. The candidates' career development plan should reflect a detailed strategy to advance both the research training and leadership goals of the BCDA. All principal investigators and their primary mentors should commit to attending one of the annual Beeson meetings as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (You should budget funds for your individual travel to and from the meeting, the location of which will vary from year to year.)
Relatively junior candidates (who have not yet received initial research support) may apply if they have shown clear evidence of early leadership potential through academic honors and awards and early research accomplishment. The career development plan should be tailored to the candidate's particular career goals, current level of experience, and the environment (including mentors) in which the candidate's career development will take place. Junior candidates with limited prior research training and research experience and more advanced candidates who are changing or expanding research areas will more likely need longer periods of support on the BCDA, and more didactic coursework and guided research experiences than those with more research training and experience in their proposed field of study. More advanced candidates who are now expanding their prior research efforts within their chosen field of study and transitioning to full independence should clearly state their specific career goals and how these goals will be realized through the proposed program of career development under this award. For all candidates, it is particularly important to show those career development activities that are essential to advance to independence, that complement the research planned, and that could not be accomplished through research support alone. Similarly it is important to show that the mentoring available through this award will clearly benefit the candidate's emergence as a leading researcher in his/her chosen field.
To accommodate these differences in prior experience or intended direction the initial BCDA award may be from three to five years. In addition, clinically trained candidates with limited research experience are eligible for an up to two year renewal (formerly competing continuation) of the BCDA as described under Funds Available (Section II). Candidates who have a research doctorate earned prior to receiving the BCDA are not eligible for this renewal. The candidate's program must be tailored to his/her individual needs and ensure that the candidate will gain the experience, knowledge and skills necessary to carry out high quality clinically relevant aging research. The candidate and the selected mentor(s) are jointly responsible for the preparation of the plan for this program.
The candidate may devote the remainder of his/her effort to activities that are consistent with the purpose of the award and which allow him/her to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically relevant field of aging. The BCDA program allows support for the candidate's salary, fringe benefits, and research/research development expenses to be used for research and training.
The proposed training and research must focus on research on aging, or the aged. The candidate's research project may be in the basic sciences, use animal models, or employ primary or secondary data analysis. The full range of research methods appropriate to completing the proposed investigation is encouraged provided that the application makes clear the clinical relevance of the proposed work. The BCDA program also now includes funding for up to three additional positions formerly allocated to the NIA Alzheimer's Disease Clinical Scientist Development Award program and therefore encourages additional applications addressing innovative approaches to neuroscience research that would have relevance to brain aging, Alzheimer's disease and other neurodegenerative diseases.
Mentor(s): The candidate must name a primary mentor, who together with the candidate is responsible for the planning, direction, and execution of the program. Mentor(s) will also be responsible for providing an annual evaluation of the candidate's progress (as required) in the awardees' annual progress report. The mentor should be an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The candidate may also nominate co-mentors as appropriate to the goals of the program. It is important that research expertise in the fields of aging and an appropriate funding history of support for aging research be well-represented among the mentors. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.
Primary mentors should commit to attending one of the annual Beeson meetings with the awardee as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (You should budget funds for your individual travel to and from the meeting, the location of which will vary from year to year.). The sponsoring applicant institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics, or other topical areas within aging research. It must have faculty qualified in aging research to serve as mentors. The institution must demonstrate a commitment to the candidate's development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources (for example, an independent laboratory) as the candidate progresses through the BCDA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
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 other than institutions of higher education; 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 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/PIs) 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 four (4) weeks prior to the application due date.
Any candidate 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 mentor and 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. Multiple Principal Investigators are not allowed.
By the time of award, the individual must be a citizen or a non-citizen 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), or for non-U.S. citizen/permanent residents, requirements are described below.
Former PD/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K-awards), or the equivalent are not eligible. Former PD/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.
Candidates for this award must have a clinical doctoral degree. Such degrees include but are not limited to the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), DVM Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the NIA or NINDS concerning their eligibility for a K08 award.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-12-003.html.
DIABETES RESEARCH CENTERS (P30): (RFA-DK-11-015)
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): February 29, 2012
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes Research Center grants to support research in diabetes mellitus and its complications, and related areas of endocrinology and metabolism.
The prevalence of diabetes mellitus in the United States is reaching epidemic proportions and accounts for a huge national burden of morbidity, mortality, and health care expenditures. The mission of the Diabetes Centers is to serve as a key component of the NIDDK-supported research effort to develop new therapies and improve the health of Americans with, or at risk for, diabetes and related endocrine and metabolic disorders. The Centers promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research related to the etiology and complications of diabetes, with the goal of rapidly translating research findings into novel strategies for the prevention, treatment and cure of diabetes and related conditions.
To accomplish this mission, the Diabetes Research Centers:
Create an environment that supports important and innovative research;
Raise awareness and interest in fundamental and clinical diabetes research at their institutions as well as locally, regionally, and nationally;
Enhance diabetes research education and training opportunities for patients, students, scientists, and clinicians;
Attract and retain early stage investigators and investigators new to diabetes research;
Provide core services that leverage funding and unique expertise;
Foster interdisciplinary collaborations, especially in the emerging areas of research, to catalyze new ideas and scientific approaches;
Promote the translation of scientific discoveries from bench to bedside to community to improve public health.
The NIDDK Diabetes Research Centers are part of an integrated program of research support designed to enhance multidisciplinary cutting-edge research in diabetes and in related areas of endocrinology and metabolism. Diabetes Research Centers are intended to improve the efficiency and collaborative nature of diabetes research by providing shared access to specialized technical resources and expertise. In addition, Centers enhance translational research by providing a framework for fostering synergy between basic scientists and clinical investigators, with the goal of promoting rapid progress toward a treatment or cure for diabetes and its complications. Diabetes Research Centers support three primary research-related activities: (1) Research Core Services that provide resources to enhance the efficiency, productivity, and multidisciplinary nature of research in designated topic areas; (2) a Pilot and Feasibility Program designed to foster the development of new investigators and to provide seed-support for innovative high-risk projects; and (3) an Enrichment Program to promote interdisciplinary interaction and training of investigators in areas of NIDDK interest.
A Diabetes Research Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Diabetes Center applications must be associated with an existing program of excellence in biomedical research in diabetes and in related areas of metabolism and endocrinology. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in diabetes and related research areas. A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Diabetes Research Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs.
Diabetes research often requires the use of specialized technologies and resources to support a cohesive research effort. The goal of the Diabetes Research Center program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.
Diabetes Research Center applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, all Diabetes Research Centers will be required to maintain a Center website, with the administrative core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website. The Core Center Director should provide at least 1.2 person months (calendar year) effort on the Administrative Core and a total of 2.4 person months (calendar year) effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.
Diabetes Research Centers are designed around research cores that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators. In a Diabetes Research Center, cores are intended to facilitate basic, clinical and translational research in diabetes, endocrinology and metabolic diseases in order to accomplish the stated goals of the individual Center and of the NIDDK Centers program.
Each research core should provide state-of-the art services to multiple funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core. In addition, Diabetes Center applicants may propose to share core services or functions with other Centers in the Diabetes Center program in order to expand, enhance, or increase the cost-effectiveness of research activities at the Center institution. Examples of biomedical cores that would be considered responsive to this Request for Applications include, but are not limited to:
Genetics/genomics (including epigenetics)
Proteomics
Metabolomics
Islet isolation and function
Transgenic and ES-cell technology
Protein chemistry and macromolecular structure
Analytical biochemistry
Integrative physiology
Imaging
Translational research (bench to bedside; bedside to community/practice)
Clinical research
Bioinformatics
Biostatistics
These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institutions. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Diabetes Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure. Proposed Diabetes Center research cores may be an institutional shared research core. In such cases, the research core support provided by the Diabetes Center should be proportional to the use of the institutional research core by Diabetes Research Center members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the Diabetes Center will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.
The need for core support from the Diabetes Research Center must be well justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Participants in the Diabetes Center program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://ctsaweb.org/) and other related NIH roadmap activities, and any related NIDDK-funded Center programs such as the Nutrition Obesity Research Center (NORC) Program http://www3.niddk.nih.gov/centers/norc.shtml) and the Centers for Diabetes Translation Research (CDTR; http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-10-009.html). Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the Diabetes Research Center and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.
The Diabetes Research Center Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical, clinical and translational research questions relevant to diabetes and its complications. Typically at least 20-25% of the Center direct costs, exclusive of equipment, should be for support of P&F projects.
Funding and Duration of Support: It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P&F projects. However, a limited number of applications may be selected for support as enhanced P&F awards with prior NIDDK approval. Enhanced P&F awards require prior approval from NIDDK and will be selected from worthy proposals in the following three project categories: clinical and translational research awards, clinical and basic research innovative partnership awards, or technology research and development awards. These enhanced awards may be funded at up to $100,000 direct costs per year and for up to 2 years. Efforts to increase the number of P&F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.
Eligibility: The P&F program is particularly directed at new investigators and established investigators new to diabetes research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the Diabetes Research Center P&F program. P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers. While the distribution of P&F funds to be used in each award category is ultimately at the discretion of the Center P&F committee, it is expected that the Center P&F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects.
Each Diabetes Research Center may provide salary support for a P&F project recipient whom they designate a Named New Investigator. Support for this individual is generally for 2 years, and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.0 to 12.0 calendar months effort. These funds are included in the Administrative Core budget, and the initial Named New Investigator should be clearly identified in the application. The individual selected should be a New Investigator who meets the P&F project eligibility criteria and is a permanent resident or US citizen. Individuals are eligible only once for this support. Subsequent candidates for this position are nominated by the Center and reviewed by its External Advisory Board. Appointment of the Named New Investigator is contingent upon the concurrence of the External Advisory Board and the NIDDK program director.
The Diabetes Research Center enrichment program should be designed to advance translational research in diabetes, endocrinology and metabolism and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Applicants should describe any training opportunities afforded by the Diabetes Research Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on related NIDDK T32 training programs at the Center institution(s), and describe how the Diabetes Center will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PD/PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PD/PI of the T32 intends to promote cohesive interactions between the two programs.
Training postdoctoral fellows to conduct research in diabetes is an associated activity of a Diabetes Research Center. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training. Just as in the case of funding for individual research projects, funding for fellowships should be sought from NIH NRSA institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.
The principal goal of the opportunities listed below is to provide NIDDK Diabetes Center research core services (and pilot and feasibility grant opportunities) to diabetes researchers at institutions that are not currently served by an NIDDK Diabetes Research Center.
1) To broaden the scope and reach of current research core services, a Center may propose to serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at a different institution. Such a Regional/National Core may not be established with an affiliated hospital of the applicant organization; such an arrangement would be considered an institutional, rather than a regional/national, core for the purposes of this FOA. If the Center is primarily located at an affiliated hospital, core(s) based at another affiliated hospital of the same academic institution will not be considered Regional/National Shared Resource Cores. With a regional or national core located at a different institution, the Center will service a specific research base that is expanded beyond investigators at the academic institution and/or affiliated hospitals where the Center is primarily located. Support for the expansion of the Center P&F program to investigators at the institution where the Regional/National Shared Resource Core is located may also be requested (see below).
2) A Diabetes Research Center Core may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital. Such a Regional/National Shared Resource Core should provide a plan for expanding core services to investigators outside of the parent academic institution and its affiliated hospitals. Applicants should document that there is sufficient demand by the wider scientific community for the expansion (or establishment) of the proposed core services. The research base in diabetes at the institution(s) that would use the regional core(s) should also be documented. Plans for prioritization of research core services, as well as training to the broader research community, should be provided. Support for the expansion of the Center P&F program to the partnering institution(s) may also be requested (see below).
3) To broaden the scope and reach of the Diabetes Research Center P&F program, a Center may propose to serve a wider scientific community by expanding the Diabetes Center P&F program to a different institution(s). Expansion of the P&F program to an affiliated institution/hospital is encouraged, but will not be considered a Regional/National program for purposes of expanding the allowable requested funds. In general, NIDDK currently expects Diabetes Research Centers to allow investigators at affiliated hospitals or institutions to participate in the Center P&F program. Applicants may request funds to expand their P&F program to researchers at non-Diabetes Research Center institutions, and the applicant should provide details on how F&A costs for P&F grants will be handled with the partnering institution(s).
Diabetes Research Centers may propose partnerships that establish research cores and/or P&F programs at institutions of higher education (i.e., rural institutions, historically black colleges and universities (HBCUs), Tribally Controlled Colleges and Universities and Hispanic-serving institutions (HSIs) and Alaska Native and Native Hawaiian Serving Institutions), or other agencies that focus on underserved or health disparity populations. The primary goal of such partnerships is to foster scientific collaborations and to provide access to the Diabetes Research Center infrastructure to investigators at these institutions or organizations in order to foster health disparities research in populations disproportionately affected by diabetes. All funds exceeding the cap proposed for this purpose must be awarded to the institution that serves underserved or health disparity populations. Funding for activities supporting the collaboration at the Diabetes Center institution must be included with the Diabetes Research Center cap.
Cooperation, Coordination and Integration: applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Diabetes Research Center. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Diabetes Research Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of Diabetes Research Center activities through cooperation with other NIH-supported core facilities at the applicant institution. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the Diabetes Research Center.
The Diabetes Research Center must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research. While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers. The application should include a statement regarding willingness to participate in such activities.
The proposed budget should include travel for the Program Director/Principal Investigator (PD/PI) and Associate Center Director, or other key personnel, to attend an annual Diabetes Research Centers meeting. The application should include a statement of willingness to attend this annual meeting of Diabetes Research Center Directors.
Core access and Cost Recovery: core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in core services (e.g. comparative costs of other sources of proposed core services) and policies for cost recovery from investigators for use of services should also be included.
Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.
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 other than institutions of higher education; 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. Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration: See instructional documents in the NIH Guide Publishing System for the text to insert. 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 PHS398 Application Guide.
Because a Diabetes Research Center has a large and complex administrative structure, the Project Director/Principal Investigator (PD/PI) must have strong leadership abilities and demonstrated proficiency in managing large, multi-component projects.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution is allowed. 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.
Research Base: Successful Diabetes Research Center applications require an existing program of excellence in biomedical research in the area of diabetes, its complications, and in related research in endocrine and metabolic diseases. To justify Center support, the Diabetes Research Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK Diabetes Research Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/).
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-015.html.
2012 NIH DIRECTOR'S PIONEER AWARD PROGRAM (DP1): (RFA-RM-11-004)
Components of Participating Organizations
NIH Roadmap Initiatives
Application Receipt Date(s): October 07, 2011
Pioneer Awards are designed to support individual scientists of exceptional creativity who propose pioneering - and possibly transforming - approaches to major challenges in biomedical and behavioral research. The term "pioneering" is used to describe highly innovative approaches that have the potential to produce an unusually high impact on a broad area of biomedical or behavioral research, and the term "award" is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences that have the potential to improve the public health.
To be considered pioneering, the proposed research must reflect ideas substantially different from those being pursued in the investigator's laboratory or being pursued elsewhere. The program is not intended to expand a laboratory's funding in the area of the proposed project. While the research direction may have as its foundation the applicant's prior work and expertise, it cannot be an obvious extension or scale up of a current research enterprise which could be anticipated to be competitive as a new or competitive renewal R01 application. Rather, the proposed project must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses. Applications for projects that are extensions of ongoing research should not be submitted.
Pioneer awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award program. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. Applicants with current research commitments exceeding 49% must provide a detailed explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project. Applicants who will not be able to meet this requirement should not submit applications.
The NIH's success depends on the creativity of investigator-initiated research, much of it supported by the R01 grant mechanism. Many scientists who participated in the development of the NIH Roadmap, now the NIH Common Fund, however, expressed the view that additional means might be necessary to identify scientists with ideas that have the potential for high impact, but may be too novel, span too diverse a range of disciplines, or be at a stage too early to fare well in the traditional peer review process. A group of distinguished outside consultants proposed that NIH implement a completely new program to encourage highly innovative biomedical research with the great potential to lead to significant advances in human health. This program would complement NIH's traditional, investigator-initiated grant programs.
The NIH Director's Pioneer Award Program is an initiative of the Common Fund (http://nihcommonfund.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 other than institutions of higher education; 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 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/PIs) 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 four (4) 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/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.
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. PD/PIs may submit only one application in response to this FOA.
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-RM-11-004.html.
CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) (P20): (PAR-11-286)
Components of Participating Organizations
National Center for Research Resources
Application Receipt/Submission Date(s): February 21, 2012, February 21, 2013, and February 21, 2014
The COBRE program seeks to promote the initiation and development or expansion of unique, innovative state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states. Research supported by this program spans the full spectrum of basic and clinical sciences and encompasses all areas of health-related investigation. The NIH recognizes that contributions from institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this FOA is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art research.
The objectives of this program are (1) to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and (2) to enhance the ability of investigators to compete independently for complementary NIH individual research grant or other external peer-reviewed support. The application must have a thematic scientific focus in a specific research area and may use basic, clinical, and/or translational research approaches, including community engagement and outreach research, to attain the goals of the proposed center. The center is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area that accelerates the rate at which those investigators compete for other complementary NIH, Federal or non-Federal external peer-reviewed research grant support. It is also anticipated that, in some instances, the support through this FOA will facilitate the development of new disease-specific research centers or augment the capability of existing centers.
Although the individual career development of the junior investigators is an important part of this program, the primary objective of the COBRE initiative is to build and develop thematic multi-disciplinary research centers. This is accomplished through the leadership of a peer-reviewed, funded investigator with expertise central to the research theme of the proposal. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this FOA, especially for the mentoring of promising junior investigators.
Collaboration with other non-doctoral degree-granting and research-performing institutes or institutions is encouraged. Funds for research activities cannot be used at collaborative institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service type of activities that include activities associated with collaborative projects, attending instructional activities and learning new techniques, sample and data analysis, and workshops etc. It is the responsibility of the PD/PI to define an effective partnership and collaboration. These centers are expected to engage in future growth through the promotion of collaborative interactive efforts among researchers with complementary backgrounds, skills and expertise and to compete independently for external peer-reviewed center or program project grant support. This goal is accomplished through the direction provided by a PD/PI, who provides leadership to junior investigators (defined below) and has the primary responsibility for administering the program and for overseeing the development of the center and its associated core facilities.
The PD/PI must be an established biomedical or behavioral research scientist, who has an active research laboratory, peer-reviewed funding (NIH, NSF or other Federal or non-Federal investigator-initiated support) that is relevant to the scientific theme of the proposed COBRE, and administrative leadership and mentoring experience to effectively carry out the objectives of the COBRE program and to meet its goals. A minimum time commitment of 3 person months is required for the PD/PI. However, up to 6 person months will be supported for mentoring and administrative oversight of the COBRE. Multiple PD/PIs are not allowed.
If the PD/PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application that will result in having that individual on the full-time faculty within one year of the peer-review of the institution's application. An award will not be made until the institution has appointed a permanent COBRE PD/PI.
Each application must describe an overall center organization and management plan to justify support of a thematic multi-disciplinary COBRE program for five years. The plan should describe the unique research opportunities that will be provided to the junior investigators and to the institution. If the proposed COBRE research is closely related to ongoing research or to an existing center, an explanation of how the research activities of the COBRE will complement but not overlap with existing research should be included. In addition, the application should describe how the efforts of each junior investigator will contribute to the establishment of a multi-disciplinary research center.
For applications that propose community engagement and outreach research, clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond, for developing a coalition of community and academic stakeholders, and for implementing evaluation strategies for the proposed projects must be included. Pilot project(s) may be proposed, but they will not be subject to peer review.
Although no non-Federal matching funds are required for these applications, clear evidence of institutional commitment must be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) must outline the commitment of resources and facilities to sustain and support the COBRE throughout the period of funding and to maintain these resources beyond the period of grant support.
The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. If core facilities are included for support, the relationship of each component research project to the core(s) should be described.
Utilizing existing core facilities and sharing research resources among IDeA programs are strongly encouraged. Applicants should describe plans (if applicable) for utilizing equipment and instrumentation supported by institution, existing COBRE or IDeA Networks of Biomedical Research Excellence (INBRE) awards.
An administrative core must be included in the application. A clear plan addressing the development of junior investigators and for their transition to and attainment of independent investigator status must be included. This plan should detail the long-term goals as to how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. Each junior investigator must submit an investigator-initiated Research Project Grant (RPG) application by the end of two years of COBRE support in order to be eligible to receive continued funding through the COBRE award.
The faculty development plan must include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent status by the junior investigators, competition for complementary NIH, Federal or non-Federal external peer-reviewed research grant support, and publication in peer-reviewed journals. Plans for faculty development should include the mentoring plan that identifies established senior faculty members who will provide mentoring and oversight to the junior investigator; constructive evaluations by members of the External Advisory Committee (EAC, see details below); and how the COBRE PD/PI will coordinate the management of all of these individuals. An internal advisory committee may provide additional oversight and input, but this committee may not act as a substitute for the EAC.
Each junior investigator should have at least one mentor. The mentor must be an established investigator who has demonstrated the ability to advise others through the acquisition of external support and the maintenance of an independent research laboratory. In some instances a suitable mentor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate mentors from outside institutions. Mentors may receive up to 1.8 person months of salary support, which should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. Mentored junior investigators should clearly designate in the text of their individual research plans the identity of their mentors and describe the mentor's qualifications, both scientific and advisory, to assist in the oversight of the project.
The award of a RPG to a junior investigator should be viewed as a milestone and a criterion for changing the status of an investigator from mentored support via the COBRE to independent investigator. A junior investigator also may be considered for a status change if independence is indicated by the acquisition of sufficient skills and knowledge. However, it is stressed that the goal of the COBRE program is to promote the development of an independent and sustainable center. Investigators who have acquired independent status or completed a research project should not be excluded from center activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent status may direct a COBRE core facility or serve as a mentor. It is emphasized that COBRE support cannot be provided in instances where a junior investigator's new award overlaps or is significantly similar to that described in the COBRE program. However, if the specific aims of the junior investigator's RPG are significantly different from the project described in the COBRE, then the junior investigator has an obligation to remain in the program to complete his/her COBRE project. In this latter case, continued support for personnel (e.g., postdoctoral associates, graduate students, technicians, etc.) associated with the COBRE project but also listed on the other award can be provided. However, the percent efforts of these individuals must be appropriately adjusted. Under this FOA, IDeA Networks of Biomedical Research Excellence (INBRE) investigators are not eligible to receive simultaneous research funding as COBRE project investigators. Similarly, COBRE investigators may not receive simultaneous research project support from an INBRE award.
A junior investigator who has achieved independent status and no longer leads a research project may be replaced by a new junior investigator. Replacement junior investigators and new research projects may be substituted following review by the PD/PI and the EAC. In some instances, a junior investigator may be placed on probation or considered for removal from the COBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, to submit an investigator-initiated RPG application by the end of two years of COBRE support. The PD/PI must communicate the EAC's recommendation for adding or removing junior investigators to the NCRR for Programmatic and Administrative Review.
Each COBRE application must include an External Advisory Committee (EAC) comprised of 3-5 scientists with national scientific reputations in their fields. Their expertise must be directly relevant to the scientific theme of the COBRE. The EAC critiques the scientific progress of the COBRE and also offers advice on scientific matters to the COBRE PD/PI. The EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and mentoring, identifying resources, evaluating the development of the center, evaluating the progress of the individual research projects, and evaluating the junior investigators' progress toward acquiring independent status. The PD/PI will share the advice and critiques provided by the EAC with other COBRE investigators at the center. The EAC also will review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NCRR for Programmatic Review. The EAC must meet at least twice per year. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NCRR. The applicant should not contact potential EAC members or provide the names of potential EAC members during the preparation or review of the application.
The COBRE PD/PI should budget for a biannual two-day meeting in Bethesda, Maryland, with NCRR staff.
Funds may be requested to establish core facilities. The applicant must demonstrate that each proposed core will impact the development of the center and how it will serve the scientific needs of the individual research projects. Although the COBRE award is not intended to replace support for ongoing, investigator-initiated research projects of established investigators, mentors and other investigators at the institution may use these facilities. Additional justification may be offered by showing how a core facility will benefit these individuals and improve the research infrastructure of the institution. Each core description should indicate the qualifications of personnel selected to manage the facility and/or plans to recruit personnel to operate the core, if needed, and the proposed business plan for operation of the core including prioritization of the service requests, charge back fees for non-COBRE users. Furthermore, the PD/PI should indicate any institutional commitment to support and maintain the proposed facilities.
NCRR strongly encourages adding equipment/personnel to existing core facilities rather than creating new core facilities. As much as practicable, applicants should seek to utilize existing equipment and instrumentation supported by institution, other COBRE or INBRE awards.
The COBRE center must contain at least three and up to five individual research projects. The individual research projects should stand alone, but share the COBRE's common thematic scientific focus. Each research project should be led by a single junior investigator who is responsible for ensuring that the Specific Aims of that project are met. An initial minimum commitment of 6 person months is required for this individual. It is recognized that during the development of a junior investigator's career (for example, the acquisition of other research support) it may be necessary to reduce this effort. Each individual research project should describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for projects in a COBRE application, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should have a strong research plan that includes a description of the rationale and scientific basis for the proposed research. Furthermore, each research project should describe its relationship to the thematic area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. In addition, how the Specific Aims relate to the importance and health relevance of the proposed research should be concisely stated.
Pilot project(s) may be proposed, but they will not be subject to peer review.
For the purpose of eligibility, a junior investigator is defined either as (1) an individual who does not have or has not previously had an external, peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) from either a Federal or non-Federal source that names that investigator as the PD/PI or (2) an established investigator who is making a significant change to his/her career. Senior, funded investigators who are not making a significant career change must not be proposed as leaders for individual research projects; if such a project is included, it will not be reviewed or counted in the minimum required 3 projects.
With respect to item (1), grants that name an individual as a co-investigator, collaborator, consultant, or to a position other than PD/PI or PD/PI on research grants that allow multiple PD/PIs, do not disqualify that investigator. Academic Research Enhancement Award grants (AREA, R15), exploratory/pilot project grants (such as NIH R03 and R21 awards), mentored career development awards (such as NIH K01 and K08 awards), or other Federal or non-Federal funding whose purpose is to provide preliminary support in anticipation of a RPG or PPG also do not disqualify the investigator. The intent of this FOA is to support and develop promising investigators whose early career support consists of awards geared toward initiating their intended area of research. However, investigators who have managed to obtain significant support in the form of a RPG or PPG (e.g., NIH R01 or P01, NSF, or other Federal or non-Federal agency awards) are not eligible. Each project Investigator should indicate in his/her Biographical Sketch their current and previous history of peer-reviewed research support.
A junior investigator must hold a faculty appointment (or equivalent at a research institute) at the time that the award is made. Moreover, a clear commitment to support this appointment independent of the outcome of this application must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status at the applicant institution will disqualify that individual and his/her research project from further consideration and will not be reviewed or counted towards the minimum required 3 projects.
With respect to item (2) above, support may be provided to an established investigator who is making a significant change to his/her career goals by initiating a new line of research that is distinctly and significantly different from his/her current investigative program. The current or previous history of independent peer-reviewed research support, which should be indicated in the Biographical Sketch, in a different investigative area than that proposed in this application does not disqualify the investigator. Furthermore, this individual can be of any faculty rank. Note that the intent of this initiative is to allow established investigators the opportunity to initiate and develop a new line of research. However, investigators whose current research is already supported by a RPG or PPG and who are not changing their current research program are not eligible. Investigators who propose to develop a new or alternate line of research, but whose intention is to maintain support of an active RPG or PPG in a different area of research are also not eligible.
This FOA is not intended to replace support for ongoing investigator-initiated research programs of established investigators. Instead, established investigators should serve as mentors to advance the junior investigators' careers.
Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed. This FOA will provide up to $300,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). This amount will be provided only in year one. It is expected that the funds be expended within 3 years of award. Alteration and Renovation projects must be relevant to the scope of the proposed research. Sufficient detail must be provided to estimate the cost and suitability of the project. Failure to adequately justify an A&R request will likely result in its deletion from the requested budget. Funds designated for A&R under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment/instrumentation or equipment intended for teaching or other non-research related purposes. Please note that A&R costs will be approved only for facilities improvements at the applicant organization. Proposed improvements at consortia sites are not allowed.
For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested:
Narrative Summary
(1) Relate the proposed renovations to the research projects that will use the facility. If renovations to animal facilities are proposed, they should be related to the projected animal populations (by species) in the proposed projects. If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
(2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, or cubicle) that will be directly affected by the renovation project.
(3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
(4) List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
(5) List and justify all fixed equipment items requested for the renovated area. A list of allowable equipment can be found at http://ncrr.nih.gov/research_funding/instruments/.
Line Drawings
(1) Submit line drawings on "8-1/2 × 11" paper only. (DO NOT SUBMIT BLUEPRINTS.) These drawings will not be counted against the page limit. All floor plans must be legible, with the scale clearly indicated.
(2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
(3) The plan should indicate the location of the proposed renovation area in the building.
(4) Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.
(5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.
(6) Indicate the type(s) of new finishes to be applied to room surfaces.
Detailed cost estimates must be included. Provide vendor quotes when available.
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 other than institutions of higher education; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education), and nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education). In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 2001-2005 or received less than an average of $120 million per year during that time period. Under these criteria, the following states/commonwealth are the IDeA states eligible to respond to this FOA: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming. An eligible institution must be within an IDeA state. Applications will be accepted from eligible institutions that hold two or less active COBRE awards at the time of submission. Eligible institutions that do not hold a current COBRE award are encouraged to apply. Please note that applications will NOT be accepted from institutions that hold three or more active COBRE awards (excluding COBRE Phase 3: Transition Center awards); these institutions cannot submit new applications. 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) per fiscal year is allowed.
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-11-286.html.
PLANNING GRANTS FOR CLINICAL TRIALS OF HIGH RELEVANCE TO THE NIGMS MISSION (R34): (PAR-11-287)
Components of Participating Organizations
National Institute of General Medical Sciences
Application Receipt/Submission Date(s): October 24, 2011, October 24, 2012, October 24, 2013
The purpose of this funding opportunity announcement is to permit early peer review of the scientific rationale for a proposed clinical trial and to specifically facilitate the process by which NIGMS handles applications for multi-site and/or large-scale clinical trials (>$500,000 direct costs in any one year). The planning grant is intended to provide time and support for an applicant to prepare, organize, and make oversight arrangements prior to consideration of an investigator-initiated application for a full clinical trial.
NIGMS supports a limited number of clinical trials in areas of high significance to its mission, which encompasses the clinical fields of trauma and burn, peri-operative injury, sepsis, wound healing, anesthesiology, and peri-operative pain. A clinical trial for which future funding is anticipated should address a mechanistic question of relevance to these NIGMS-supported clinical research programs and should not solely be a comparison of outcome measures. The trial should test a proposed scientific hypothesis and have the potential to make a significant impact upon a clinical field that NIGMS supports. Any clinical trial must fall within an area of explicit programmatic interest to NIGMS; the institute does not intend to accept applications in areas that are most appropriate for the mission of other institutes and centers at NIH.
An R34 planning grant should enable assembly of the necessary documentation and organizational elements prior to making an R01 grant application requesting support for the full clinical trial. The activities supported by a planning grant could include, but are not limited to:
Finalizing the most appropriate clinical trial design and corresponding study protocol(s), with definitions of all of the study objectives
Developing the Manual of Procedures (standardized elements including identification of the study population, inclusion and exclusion criteria, plans for randomization, patient recruitment and retention, experimental protocols, data collection methods, quality control procedures, etc.)
Assembling required documentation, including informed consents, case report forms, training materials, interviewer scripts, questionnaires, study logs, schedules, etc.
Establishing data safety and trial oversight plans, including a charter for a Data and Safety Monitoring Board, and adverse event reporting plans
Developing plans for sample size projections, data collection tools, data management, and statistical analysis of the data
Identifying a coordinating center, if needed, with plans for transfer of specimens, test results, and work flow
Establishing collaborative arrangements with participating sites, setting timelines and recruitment goals, and preparing plans for evaluating/remediating recruitment progress
Developing the complete trial budget, including all subcontracts
Submitting documents for regulatory approvals, including acquisition of the study agent(s)
It is expected that a planning grant will lead to the timely submission of a competitive application for a full clinical trial. Partial support for the salary of a planner or coordinator, or to enable consultation with a statistician, may be needed. Some salary support for the principal investigator may be requested. Limited travel that is clearly essential to establishing the trial could be justified; however, collection of preliminary data, either pre-clinical or clinical, to support the rationale for a clinical trial is not allowed. Support may be requested for:
Up to $100,000 direct costs for salary, specialized supplies, software, consultant, or travel funds
Up to one year in duration
This planning grant program is intended to support preparation for a limited number of trials highly relevant to the institute's mission. Applicants are urged to carefully consider which activities are essential to submitting a well-planned trial application and to utilize the funds that a planning grant can provide in support of tasks related to their own needs. Following successful completion of a planning grant, a clinical trial may be submitted to NIGMS as a regular research grant application.
Single site trials and those with budgets <$500,000 per year are also permitted but not required to apply for this award. All applicants for any size trial (single- or multi-site, smaller or larger scale) are expected to have the essential documentation and organizational elements in place before funding will be considered by the institute, with or without support from a planning grant. Prospective applicants should also be aware that completion of a planning grant does not guarantee funding for a subsequent clinical trial grant application.
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 other than institutions of higher education; 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 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/PIs) 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 four (4) 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/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 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 at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-287.html.
SECONDARY ANALYSES AND ARCHIVING OF SOCIAL AND BEHAVIORAL DATASETS IN AGING (R03): (RFA-AG-12-005)
Components of Participating Organizations
National Institute on Aging
Application Receipt Date(s): November 03, 2011
The NIA supports collection of data and biological samples including a broad array of measures that are relevant to: the dynamics of health and disability, cognition, psychosocial and sociodemographic factors, genetics and biomarkers, long-term care, caregiving, behavioral medicine, retirement, economic status and well-being over the lifecourse (see the Resources Section below for links to NIA sponsored data sources). The purpose of this FOA is to solicit one-year R03 applications for (1) secondary analysis of data on aging in the areas of psychology, behavioral genetics, economics, demography or (2) archiving and dissemination of data sets to enable secondary analyses in order to further advance research.
1. Examples of secondary analysis include, but are not limited to:
A. Psychological and Social Processes in Aging
• Studies examining how personality, motivation, and related affective or cognitive phenotypes impact physical health and socioeconomic outcomes in older ages
• Studies of gene by environment interaction where social environments may modify genetic risk, or genetic factors may modify responses to the social environment
• Studies examining the impact of social relationships, social or cognitive engagement, and psychosocial stress on cognition
• Studies of early life determinants of late-life health, well-being, cognition, morbidity, and mortality
B. Behavioral Genetics of Aging
• Analysis of genome-wide SNP data with the intention of addressing any of the research questions outlined in the bullets above.
• Hypothesis-driven studies examining genetic influences on behaviors that affect healthy aging.
• Analysis of genetic and phenotypic data from direct-to-consumer genetic testing companies for the purposes of better understanding gene-behavior associations.
• Analysis of data to better understand who opts to see their genetic status for degenerative (e.g. Alzheimer disease, Huntington disease) or health-threatening (e.g. high blood pressure, obesity) conditions and behavior changes subsequent to this new knowledge.
C. Economics and Demography of Aging
• Labor force participation and time-use of older population
• Demography of aging, including family demography and trends in chronic disease, disability and life expectancy
• The relationship between healthcare spending and health status
• Effects of the recession on retirement savings, family relationships, and health
• The economic impact of population aging, including effects on both microeconomic decision-making and the macroeconomy
• Intergenerational transfers of time and money
• Relationship between age and productivity in labor market, including productivity of researchers in academic environments
• Causes of geographic differences in health and longevity for men and women within United States and around the world
2. Examples of data archiving include, but are not limited to:
• Archiving and development of sociobehavioral datasets that can be user friendly and easily accessible for public use
• Harmonization of measures across studies to enable secondary analysis where multiple data sets are needed (such studies should then make public and archive the algorithms used to generate the harmonized measures)
• Creation of data extraction web tools for public use databases, such as the Health and Retirement Study (HRS), the Survey of Health, Ageing and Retirement in Europe (SHARE), the Study on Global AGEing and Adult Health (SAGE), or the National Survey of Midlife Development in the United States (MIDUS)
• Creation of synthetic datasets that facilitate the use of data that would otherwise not be available for public use in original form, because they include geographic information or sensitive administrative records.
Applicants are encouraged to archive data from studies with rich phenotypic, environmental or biomarkers data and make them available through the National Archive of Computerized Data on Aging (NACDA) [http://www.icpsr.umich.edu/NACDA/] or another archive for public use. Archiving may pertain to any type of data useful for secondary analysis including results of assays conducted on biospecimens, and the addition of geo-coded and community level variables for database expansion.
Priority will be given to applications undertaking secondary analysis or archiving of publicly available datasets that NIA has supported. Such datasets are located in the following document: http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/publicdatasets.htm.
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 institutions other than institutions of higher education; 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); for-profit organizations; 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 Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 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-AG-12-005.html.