Also note: Dissemination and Implementation Research in Health (R01): PAR-13-055
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-055.html.
Also note: Dissemination and Implementation Research in Health (R03): PAR-13-056
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-056.html.
Components of Participating Organizations
National Institute of Mental Health
National Center for Complementary and Alternative Medicine
National Cancer Institute
National Human Genome Research Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute on Drug Abuse
National Institute on Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on service delivery and community health programs. However, relatively little is spent on, or known about, how best to ensure that the lessons learned from research are relevant to, and, inform and improve the quality of health, delivery of services and the utilization and sustainability of evidence-based tools and approaches. In the context of increased interest and investment in comparative effectiveness research that will help to determine the optimal interventions to be used in clinical and community healthcare practice, it is essential that health care providers, patients, families, caregivers, communities and healthcare settings are equipped with empirically-supported strategies to integrate scientific knowledge and effective interventions into everyday use. The National Institutes of Health has recognized that closing the gap between research discovery and clinical and community practice is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in scientific discoveries.
The National Institute of Mental Health (NIMH), National Cancer Institute (NCI), National Center on Complementary and Alternative Medicine (NCCAM), National Human Genome Research Institute (NHGRI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Nursing Research (NINR), and the Office of Behavioral and Social Science Research (OBSSR), invite exploratory and developmental grant applications for research that will identify, develop, and refine effective and efficient methods, systems, infrastructures, and strategies to disseminate and implement research-tested health behavior change interventions, evidence-based prevention, early detection, diagnostic, treatment, symptom management, and quality of life improvement interventions, and data monitoring and surveillance reporting tools into public health and clinical practice settings.
The purpose of this dissemination and implementation research funding opportunity announcement (FOA) is to support innovative approaches to identifying, understanding, and overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Conversely, there may be a benefit in understanding circumstances that create a need to “de-implement” or reduce the use of strategies and procedures that are not evidence-based, have been prematurely widely adopted, or are harmful or wasteful.
Many researchers who propose to develop and test informational materials, diagnostic tools, and/or prevention or disease control interventions either explicitly or implicitly intend to promote evidence-based interventions to the broader population from which the study sample was drawn or the public health or clinical practice settings in which the intervention was originally tested. Thus, for many years, health researchers may have assumed that tools and interventions deemed efficacious within clinical or community-based trials would be readily transmitted to the field; however, compelling evidence suggests that this has not been the case. Even when information, tools, and interventions have been tested within real-world effectiveness studies, the development of knowledge to support their broader dissemination and implementation (e.g. cost and financing of the intervention, provider training, availability of resources, monitoring the quality of intervention delivery) has often remained outside the scope of these large-scale clinical trials.
This FOA also encourages research on the dissemination and implementation of policies and guidelines, such as from the US Preventive Services Task Force, or the Community Guide to Preventive Services. Study of strategies to most effectively, equitably, and efficiently implement health policies and guidelines are encouraged, as are studies that evaluate policy and other contextual factors that influence the success of implementation or dissemination efforts.
In the past few years, both empirically-supported models (e.g., CFIR, RE-AIM, PRECEDE/PROCEED, ISF, KTA) and authoritative research syntheses have been developed to guide dissemination and implementation of evidence-based interventions both in the U.S. and abroad, but there is still limited understanding of the generalizability of these approaches to the variety of evidence-based interventions and settings that can benefit health.
Recent literature has underscored the importance of understanding the many factors that affect whether the public health or clinical practice communities will adopt, successfully implement and/or sustain a given intervention. Research on dissemination will address how information about health promotion, treatment, preventive and services interventions is packaged, transmitted, and interpreted among a variety of important stakeholder groups. Research on implementation will improve the knowledge base to guide efforts to fit health interventions within real-world public health, clinical and community service systems.
The goals of this FOA are to encourage trans-disciplinary teams of scientists and practice stakeholders to work together to develop and/or test conceptual models of dissemination and implementation that may be applicable across diverse community and practice settings and patient populations, and design studies that will accurately and transparently assess the outcomes of dissemination and implementation efforts.
Key characteristics of high-priority dissemination and implementation (D&I) research applications may include but are not limited to:
Use and testing or refinement of intervention and evaluation models appropriate for D&I
Understanding of the complexity of health interventions, including those with multiple components and those for low resource settings and for populations traditionally underrepresented in research, for which D&I may not be a simple process
Understanding the incentives and/or barriers to the D&I of novel tools and practices to improve public health
Consideration and characterization of the multi-level context and environment in which the proposed research will be conducted
Development and/or use of applicable outcomes, measures and analyses related to the models used and the project specific aims
Attention to issues of resources expended, programs’ costs, cost-effectiveness or other economic outcomes
Incorporation of stakeholder relevant outcomes of research (including relevant outcomes for patients, families, providers, administrators, policymakers).
This FOA addresses priorities laid out in a number of reports including the: NIMH Strategic Plan; NHGRI Strategic Plan; NINR Strategic Plan; National Institute on Drug Abuse Blue Ribbon Task Force Report on Services Research; NIDCR Strategic Plan, and the NIDCD Strategic Plan.
For additional resources on dissemination and implementation research, including information on D&I training opportunities, funded studies, key references, past workshops and conferences, visit: http://cancercontrol.cancer.gov/is/ and http://obssr.od.nih.gov/scientific_areas/translation/index.aspx.
For D&I research in oral health, note that the NIDCR does not accept applications that include clinical trials in response to trans-NIH FOAs. Applicants proposing a clinical trial should refer to the following NIDCR websites: http://www.nidcr.nih.gov/clinicaltrials/ and http://grants.nih.gov/grants/guide/pa-files/PAR-11-338.html.
For specific information about NCCAM priorities for dissemination and implementation research refer to the NCCAM website: http://nccam.nih.gov/grants/disseminationPAR.
In addition to the resources of individual Institutes and Centers, NIH encourages applications that build on existing networks and infrastructures that could facilitate D&I research projects, the study of key system-level variables, and eventual scale-up. Such platforms include Clinical Translational Science Award (CTSA) sites; the NIH Health Care Systems Research Collaboratory; networks funded by the Health Resources and Services Administration (HRSA) including federally-qualified health centers and Ryan White HIV/AIDS programs; Practice-Based Research Networks supported by the Agency for Healthcare Research and Quality (AHRQ); VA healthcare facilities; and other research and practice networks. International investigators are also eligible to be primary or co-investigators on D&I applications.
Research Terms
D&I research intends to bridge the gap between public health, clinical research, and everyday practice by building a knowledge base about how health information, interventions, and new clinical practices and policies are transmitted and translated for public health and health care service use in specific settings. Unfortunately, there continues to be great variation in how these terms are used. Dissemination and implementation have both been used to represent the complete process of bringing “evidence” into practice. While using these and other terms to cover such a wide area can be helpful in facilitating discussion, it does not allow for the division of this very complex process into smaller, more easily addressed research questions that can develop a robust knowledge base. We encourage applications that will continue to address the complexity of bridging research, policy and practice using both established and innovative approaches to theory, measurement, research design, and analyses.
For the purpose of this FOA, we make a distinction between “dissemination” and “implementation.”
Dissemination is the targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to spread (“scale up”) and sustain knowledge and the associated evidence-based interventions.
Implementation is the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings.
This distinction needs to be made because interventions developed in the context of efficacy and effectiveness trials are rarely transferable without adaptations to specific settings and additional tools and guidance to support uptake and implementation. Therefore, research is needed to examine the process of transferring interventions into local settings, settings that may be similar to but also somewhat different from the ones in which the intervention was developed and tested.
Dissemination Research
We are currently missing critical information about how, when, by whom, and under what circumstances research evidence spreads throughout the agencies, organizations, and front line workers providing public health and clinical services. As a necessary prerequisite for unpacking how information can lead to intervention or service changes, we need to understand how and why information on physical and behavioral health, preventive services, disease management, decision making, and other interventions may or may not reach many different stakeholders. We need to understand what underlies the creation, transmission, and reception of information on evidence-based pharmacological, behavioral, psychosocial, genomic, policy and systems interventions. Successful dissemination of health information (including information about underutilized interventions) may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other or multiple stakeholder groups. Moving the field forward will require studies identifying mechanisms and approaches to package and convey the evidence-based information necessary to improve public health and clinical care services in ways relevant to local settings and that balance fidelity and adaptation.
Implementation Research
Implementation Research is the scientific study of methods to promote the integration of research findings and evidence-based interventions into healthcare practice and policy. It seeks to understand the behavior of healthcare professionals and support staff, healthcare organizations, healthcare consumers and family members, and policymakers in context as key variables in the adoption, implementation and sustainability of evidence-based interventions and guidelines such as those from the Institute of Medicine, Community Guide to Preventive Services, U. S. Preventive Services Task Force, and clinical and professional societies. Implementation research studies should not assume that empirically-supported interventions can be transferred into any service setting without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change. Relevant studies should develop a knowledge base about “how” interventions are transported to real-world practice settings, which will likely require more than the distribution of information about the interventions. This research announcement encourages theory-driven studies to test conceptual frameworks of the implementation process that move away from an exclusively “top-down” approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders, including approaches such as team science, community based participatory research, action research and related frameworks that engage stakeholders and end users throughout the process.
Dissemination and Implementation research studies typically involve both interdisciplinary cooperation and trans-disciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields not traditionally associated with health research. Relevant fields include but are not limited to: information science, clinical decision-making, organizational and management theory, economics, individual and systems-level behavioral change, public health, business and public administration, statistics, anthropology, learning theory, engineering, and marketing. D&I research will include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks. This FOA will support a variety of sound methodological approaches that address the above issues including observational, experimental and simulation modeling approaches capable of producing relevant evidence on outcomes, costs, and/or unanticipated consequences. The goal is to conduct studies utilizing designs that are both rigorous and relevant.
Research Topics
Listed below are examples of topics supported by this program announcement for dissemination and implementation research. The list is illustrative, not exhaustive. Additionally, it is expected that investigators responding to this FOA will identify other important research areas.
Studies of efforts to scaffold multiple evidence-based practices within care settings, to meet the needs of complex patients, systems of care, and service integration.
Longitudinal and follow-up studies on the factors that contribute to the sustainability of research-based improvements in public health and clinical practice.
Studies testing the effectiveness and cost-effectiveness of dissemination or implementation strategies to reduce health disparities and improve quality of care among rural, minority, low literacy and numeracy, and other underserved populations.
Studies using simulation modeling, evaluability assessments, and other estimation approaches to evaluate proposed D&I actions, policies and practices.
Studies that address context in descriptive and innovative ways and investigate the relationship of context to adoption, implementation and maintenance.
Comparative effectiveness research that addresses D&I issues and approaches, and that evaluate the cost, resource requirements and other economic and policy outcomes.
Studies of the adoption, implementation and sustainability of health policies and their interaction with programs and contextual factors.
Studies of complex health problems, co-morbid patients and complex interventions using innovative methods, models and analyses that fit these needs.
Analysis of factors influencing the creation, packaging, transmission and reception of valid health research knowledge, ranging from psychological and socio-cultural factors affecting individual practitioners, consumers, primary caregivers and other stakeholder groups to investigations addressing large service delivery systems and funding sources.
Studies on the fidelity/adaptation of implementation efforts, including the identification of components of implementation that will enable fidelity to be assessed meaningfully.
Studies of systems interventions to impact organizational structure, climate, culture, and processes to enable dissemination and implementation of clinical/public health information and effective clinical/public health interventions.
Studies of efforts to implement health promotion, prevention, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures or guidelines into existing care systems across the lifespan to measure the extent to which such procedures are utilized, adhered to and sustained, by patients, providers and consumers.
Studies of the capacity of specific care delivery settings (primary care, schools, worksites, community health settings, health departments, etc.) to incorporate dissemination or implementation efforts within current organizational forms.
Studies that focus on the development and testing of theoretical and evaluation models for D&I processes, or use such models to conduct reviews of the D&I literature.
Studies that develop D&I relevant outcome and process measures and suitable methodologies for dissemination and implementation approaches that accurately assess the success of an approach to move evidence into practice (i.e., not just clinical outcomes). Applicants are encouraged to review available resources where possible and use more harmonized and standard measures, rather than developing their own measures for each study.
Studies testing D&I strategies of symptom management interventions that reduce the symptom burden in patients with chronic conditions, including multiple chronic conditions.
Studies of the dissemination of palliative care and end of life research into practice that enhances quality of life for patients and families.
Studies of the dissemination of different strategies to promote effective patient and caregiver communication, leading to improved healthcare delivery and outcomes.
Studies of how approaches to shared decision-making may be implemented and sustained among practitioners.
Studies of how successful screening promotion approaches and policies are implemented in healthcare and community practice, and especially in international or low-resource settings.
Studies of the adoption, implementation and sustainability of data and surveillance reporting tools and techniques.
Studies of the dissemination and implementation of effective and cost-effective strategies for incorporating genomic medicine, sequence-based diagnostics and therapeutics in clinical care.
Studies testing the incorporation and use of genomic information, family history risk information, and/or pharmacogenetic information for improved diagnosis and treatment.
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; Asian American Native American Pacific Islander 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 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 SF424 (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.
System for Award Management (SAM)– must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-054.html.
Small Grants for New Investigators to Promote Diversity in Health-Related Research (R03): PAR-13-074
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Mental Health
Office of Dietary Supplements
Application Receipt/Submission Date(s): June 16, 2013; June 16, 2014; June 16, 2015 AIDS: September 7, 2013; September 7, 2014; September 7, 2015
This FOA is intended to provide support for New Investigators from diverse backgrounds underrepresented nationally in biomedical research who are interested in conducting research projects in the scientific mission areas of the NIDDK, the NIMH and the ODS, with the purpose of providing the preliminary data to support a R01-equivalent application.
NIDDK Mission
The mission of the NIDDK is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.
NIMH Mission
The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For the Institute to continue fulfilling this vital public health mission, it must foster innovative thinking and ensure that a full array of novel scientific perspectives are used to further discovery in the evolving science of brain, behavior, and experience. In this way, breakthroughs in science can become breakthroughs for all people with mental illnesses. In support of this mission, NIMH will generate research and promote research training to fulfill the following four objectives:
Promote discovery in the brain and behavioral sciences to fuel research on the causes of mental disorders.
Chart mental illness trajectories to determine when, where, and how to intervene.
Develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses.
Strengthen the public health impact of NIMH-supported research.
ODS Mission
The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.
In addition to their respective missions, these institutes and offices recognize that the entry of New Investigators into the ranks of independent, NIH-funded researchers is essential to improve the overall health of this country’s biomedical research enterprise. As a result, NIH and the participating components of the organization are deeply committed to the research support of New Investigators. This program will enable New Investigators to successfully gain additional research experience while transitioning to independence, and obtain preliminary data on which to base a subsequent research grant application (i.e., R01-equivalent) within the scientific mission areas of the NIDDK, NIMH and ODS.
In 2003, the NIDDK collaborated with the National Center for Research Resources (NCRR) in a FOA entitled “Clinical Research Education and Career Development (CRECD) in Minority Institutions (RFA-RR-03-007, available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-007.html). The purpose of this FOA was to support the development and implementation of curriculum-dependent programs to train selected doctoral and postdoctoral candidates in clinical research in minority serving institutions with professional schools offering doctoral degrees. The goal was to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards.
In 2006, the Office of Minority Health Research Coordination (OMHRC) at the NIDDK released the funding opportunity announcement RFA-DK-06-015, “NIDDK Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research (K08)” (available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-06-015.html). This RFA gave special consideration for funding to those candidates who graduated from the CRECD program with a Master’s Degree in Clinical Research. Once again, the goal was to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards. Unfortunately, this request for applications (RFA) did not gain much attention within the target audience of clinical scientists from diverse backgrounds.
Following the Office’s review of the K08 program’s achievement of the stated objectives, the Office determined that the K08 failed to achieve its goals of promoting “diversity in the health-related workforce by increasing the number of highly trained clinical researchers from diverse backgrounds with the cultural competence and sensitivity to conduct laboratory or clinical research in health disparities and who possess the ability to successfully recruit and retain a diversity of subjects into clinical research.” After consultation with the NIDDK Advisory Council, the Office identified that less than three percent (3%) of all PD/PIs, and less than one percent of New Investigators (1%) on R01 and R01-equivalent awards in the NIDDK were individuals from underrepresented (i.e., racial or ethnic minorities) backgrounds. As a result of these data, a new program was developed in order to address the program objective to “strengthen the capacity for clinical research focused on eliminating health disparities by increasing the number of clinician scientists from ethnically diverse and disadvantaged backgrounds in the health-related research workforce.”
Subsequently, the OMHRC released the FOA PAR-09-223, “NIDDK Small Grants for Clinical Scientists to Promote Diversity in Health-Related Research (R03)” (available at: http://grants.nih.gov/grants/guide/pa-files/PAR-09-223.html). Given the data presented to the NIDDK Advisory Council which found that less than one percent (1%) of PD/PIs with R01 or R01-equivalent awards met the eligibility criteria for New Investigators, the Office concluded that the Institute needed an FOA that supported the transition of post-doctoral and early career investigators to become New Investigators. Similar to the earlier K08 FOA, this FOA sought to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards with the preliminary data generated by the R03 award.
Diversity
The 2010 U.S. Census data shows that while White non-Hispanics are still numerically and proportionally the largest major race and ethnic group in the United States, significant changes in the demographics of the U.S. are underway. More than one-half of the growth in the U.S. total population between the 2000 and 2010 Census was due to the increase in the Hispanic ethnic population. Similarly, the Asian alone racial population grew faster than any other major race group between the 2000 and 2010 Census, a staggering 43 percent. Finally, California, Hawaii, New Mexico, Texas and the District of Columbia now have more than 50 percent of their total population being members of a minority (e.g., non-White) group.
As the population of the U.S. continues to diversify, the members of non-White racial and Hispanic ethnic groups continue to be disproportionately underrepresented in the research workforce of the U.S. The business sector of the U.S. economy have long-embraced the advantages of diversity in their organizations, reporting benefits ranging from improved flexibility, creativity, competitiveness, higher levels of critical analysis, better problem solving, and improved reputation of the business as an employer of choice.
The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.
There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is limited evidence that individuals who have participated in the NIH administrative supplement program preferentially conduct research in areas related to health disparities or minority health. There is no question that the need for a diverse workforce permeates all aspects of the nation’s health-related research effort.
New Investigators
For many individuals interested in pursuing biomedical, behavioral or clinical research careers, the long hours, low pay, and the decades of work before achieving independent research funding often proves too formidable for them to pursue a research career. As noted by the National Research Council (NRC) in their recent publication, “Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research,” (National Academies Press, 2005; available at: http://www.nap.edu/catalog.php?record_id=11249), the creative spirit and high-risk high-reward research proposals by new investigators is being sacrificed in favor of more conservative research with a better probability of being funded.
The NRC also recommended several policies for the NIH to enact in order to support New Investigators, including the following:
5.1. “NIH should establish a program to promote the conduct of innovative research by scientists transitioning into their first independent positions. These research grants … would provide sufficient funding and resources for promising scientists to initiate an independent research program and allow for increased risk-taking….”
Since 2006, coincident with the introduction of the “Pathway to Independence” awards, the percentage of NIH first-time PD/PIs (e.g., “New Investigators”) increased from approximately 10% to 15% in 2011. In comparison, the percentage of established investigators on competing R01 awards during the same period remained relatively constant at approximately 32% (http://report.nih.gov/FileLink.aspx?rid=826).
The introduction of NIH awards targeting the New Investigator has increased the percentage of New Investigators successfully becoming PD/PIs on research program grants. Thus, there is evidence that providing transitional support for New Investigators does directly translate into improved success in becoming PD/PIs on subsequent R01-equivalent awards.
As such, the Office, Institute and the NIDDK Advisory Council concluded that an FOA New Investigators would be the most efficient means of increasing the representation of PD/PIs from underrepresented backgrounds, and thereby increase the diversity of the NIDDK PD/PIs of R01 and R01-equivalent awards.
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; Asian American Native American Pacific Islander 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 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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Applicants must fit the following four criteria:
New Investigators
Eligible Health Professional or Doctoral Degree
Underrepresented PD(s)/PI(s)
US Citizenship, Noncitizen National, or Permanent Resident
A. New Investigators
For definitions of New Investigators, as well as conditions applying, please see: http://grants.nih.gov/grants/new_investigators/.
B. Eligible Health Professional or Doctoral Degrees:
Eligible doctoral degrees include the MD, DO, DDS, DVM, PsyD, DrPH, OD and PhD. Applicants must have completed a minimum of 2 to 4 years of postdoctoral research experience at the time of application.
C. Underrepresented PD(s)/PI(s):
The eligible PD/PI must meet one of the following eligibility criteria in order to demonstrate that she/he is from a group identified as nationally underrepresented in the biomedical and behavioral research workforce on a national level:
Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2011). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.
Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
D. Citizenship Requirements:
The demonstration of underrepresented in science and engineering is based upon data from the National Center for Education Statistics (NCES) survey of Integrated Postsecondary Education Data System. The NCES and graduate enrollment data refers only to US Citizens, US Noncitizen Nationals and US Permanent Residents. Therefore, 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. Individuals on temporary or student visas are not eligible.
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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. However, due to the once a year submission due dates corresponding to Cycle III, all resubmissions will be accepted one year following the original submission.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-074.html.
NIDA Research Education Program for Clinical Researchers and Clinicians (R25): PAR-13-084
Components of Participating Organizations
National Institute on Drug Abuse
Application Receipt/Submission Date(s): May 22, 2013, May 22, 2014, May 22, 2015 AIDS: September 9, 2013, September 8, 2014, September 7, 2015
There is a shortage of well-qualified researchers prepared to conduct clinical, translational, prevention, health services, and treatment research with drug users/abusers and those affected by drug use/abuse, including underserved populations such as children, adolescents, women, elderly, and those from diverse sexual, racial, or ethnic backgrounds. A related need is for increased numbers of clinicians/service providers who are sufficiently sophisticated consumers of research to evaluate and apply research-based findings. Despite recent progress in providing opportunities for clinicians, such as specialty research training programs, and certification in addiction medicine, there remains a need for coordinated research education in this area. This is especially true for medical residents and fellows, as well as other health services providers.
This FOA encourages applications from organizations that propose creative and innovative research education programs in the mission area(s) of the NIH. The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers, or for public education and outreach on health-related research to a variety of audiences. Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. As such, each application must include a plan to evaluate the activities proposed (see Section IV, Evaluation Plan). For some types of projects, a plan for disseminating results may also be appropriate and may be required as well (see Section IV, Dissemination Plan).
The overall objective of this funding opportunity announcement (FOA) is to ensure that highly trained clinical scientists will be available in adequate numbers and in appropriate scientific areas to reduce the burden of substance abuse, addiction, and their related health consequences. To accomplish this goal, the NIDA Research Education Program will support research education in the mission areas of the NIDA, for those in clinically focused careers. Participants (those receiving the research education) should be training for careers as clinical researchers, clinicians/service providers, or optimally a combination of the two. Participants may be working toward or have obtained either a research or clinical degree. This mechanism may not be used for support of non-research related clinical training. In addition, applicant organizations may only propose educational research experiences at the following levels of professional career development: medical/graduate student, postdoctoral fellow, medical resident, and/or independent scientist. Those in clinically focused career paths at the undergraduate level are eligible to participate, as long as certain conditions are met (see Section III, Eligibility Information).
NIDA has a strong interest in supporting the development of clinical research expertise and infrastructure internationally. Applicants are encouraged to proactively include efforts to recruit foreign trainees for this program, particularly from low and middle-income countries as well as from countries and regions experiencing new and/or serious drug use epidemics.
Depending on the different strengths of the applicant institutions, it is expected that research education activities will vary in how they are formalized and integrated, and various strategies may be utilized. These approaches may include, but are not limited to: core coursework appropriate to the participants’ experience levels and needs; development of interdisciplinary, translational, or other specialized courses; short courses; a series of seminars and workshops; short-term laboratory rotations; project-based research participation; and other career development and mentored activities. Commitment of sufficient investigator/faculty time is critical for these educational programs. Applications that include curriculum development must include plans for implementation and evaluation. Research education activities may be in any topic area related to substance use/abuse/addiction; however, the following are examples of particular relevance to this FOA: etiology; clinical assessment and diagnostics; treatment; prevention; health services; clinical neuroscience; medical consequences of drug abuse; and pre-clinical research as it pertains to translational research. In addition, interdisciplinary research education is encouraged and may include co-morbid conditions and consequences of drug use such as HIV/AIDS.
Although NIDA expects applicants to propose their own research education programs, some examples of programs that would be of interest to NIDA include, but are not limited to:
Research education experiences provided to patient-oriented clinicians, including those from International settings (e.g., MD, PhD, MD/PhD, DO, DSW, DSN, DDS), designed to enhance their commitment to and participation in the substance use/abuse field.
Creation of a research track within a residency or medical fellowship program, and development or enhancement of the research curricula and training provided within it.
Experiences relevant to the conduct of clinical, prevention, treatment, or services research that will prepare students or junior investigators for an independent career in substance use/abuse research. The program cannot substitute for an institutional research training program (T32) and thus must have innovative components that would provide research experiences and/or mentoring not available through formal NIH training mechanisms.
Provide medical students with mentored summer or semester-long research experiences in drug abuse and addiction science. See Section IV for allowable costs.
Curricula and/or research experiences that involve patient-oriented clinicians in interdisciplinary research or research that translates approaches from basic behavioral, social science, neuroscience, and biomedical fields, to prevention, treatment, or services research. Examples of interdisciplinary and translational approaches include:
○ Use of cognitive, affective, and social neuroscience to develop and evaluate behavioral and pharmacological treatment interventions for drug abuse and addiction.
○ Interdisciplinary approaches that facilitate the translation of prevention or treatment interventions with evidence of efficacy into novel settings or populations.
Research education programs to increase the number of researchers who are able to address health disparities in racial/ethnic minorities and other vulnerable or underserved populations.
Research education experiences provided to infectious-disease trained clinicians designed to enhance their commitment to and participation in the substance use/abuse field.
Educational partnerships to facilitate translational and interdisciplinary research, and/or collaborations between multiple institutions of the same type are highly encouraged. The following are examples of organizations/institutions that may comprise an educational partnership: basic and applied research institutions, drug abuse treatment organizations, and primary care organizations. For any educational partnership or collaboration, research education activities must be integrated across partnering/collaborating institutions and the applicant institution must act as the lead or coordinating organization.
A multidisciplinary advisory committee for the overall administration of the proposed program is recommended. Primary responsibilities of this committee would include the recruitment and selection of participants, procedures for the selection of research activities and mentors for participants, and evaluation of participant progress. The committee should consist of experts representing basic, behavioral, and clinical disciplines concerned with drug abuse and its treatment and prevention. Organizations, departments, and clinical sites participating in the proposed program should be represented on the committee.
Applicants should also describe planned processes for: (a) conducting and monitoring recruitment and selection of participants, (b) planning research and educational activities and selecting mentors for participants, (c) evaluating participant progress, (d) coordinating among existing training or research activities available at the site, and (e) assessing the quality and effectiveness of the overall research education program. Organizations participating in the joint applications should demonstrably be involved in the planning, implementation, and assessment processes listed above.
The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
Applicants are strongly encouraged to contact NIDA program staff for current information about targeted priorities before preparing an application (see Section VII).
Special Considerations
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
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; regional organizations, and non-domestic (non-U.S.) entities (foreign institutions).
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) entities (foreign institutions) are 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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple 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.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
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. However, an individual may be named as a PD/PI on only one application.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Preceptors/Mentors
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Participants
Those in clinically focused careers at the following levels of professional career development may participate: medical/graduate student, postdoctoral fellow, medical resident, and/or independent scientist. Participants can be from international institutions, provided they are at comparable levels of career development. Participants should be training for careers as clinical researchers, clinicians/service providers, or optimally a combination of the two. Participants may be working toward or have obtained either a research or clinical degree. Non-research related clinical training will not be supported.
Those in clinically focused career paths at the undergraduate level are eligible to participate, as long as the following two conditions are met:
The undergraduate students must be matriculated in a program leading to a baccalaureate degree, or be preparing for an early admission graduate program or dual degree research/clinical doctorate program (some of these programs may not require a baccalaureate degree for admission). Premedical students constitute an example of eligible undergraduates.
The undergraduate research education and training must be a complementary component of the overall proposed program and not the sole or primary component. The undergraduate program component should be well integrated with the overall program, and further the goals/objectives stated in this FOA.
Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-084.html.
Delivering Therapeutics to Residual Active HIV Reservoirs (R01): RFA-AI-12-042
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
National Institute of Mental Health
Application Receipt Date(s): July 24, 2013
The purpose of this FOA is to solicit new ideas for eliminating residual reservoirs of HIV that persist in individuals despite long-term suppression of plasma viremia by traditional antiretroviral therapy. Specifically, the research objective is to develop innovative strategies for improved delivery of antiretroviral drugs and other anti-HIV agents to specific cell types or tissue compartments that serve as persistent HIV-producing reservoirs. The majority of research on HIV persistence to date has focused on studies of latently infected resting CD4 T cells that do not actively produce virus. Indeed, most drug intensification and single-genome analysis studies of residual virus have not demonstrated evidence of ongoing viral replication or evolution in the plasma of individuals on optimally suppressive antiretroviral therapy. Nonetheless, emerging evidence suggests that it may be possible for cells in tissues such as the gut and lymph nodes to continue to produce low levels of HIV and, perhaps, to transmit virus from cell-to-cell at a low rate. This could potentially serve to re-seed the reservoir of persistent HIV. Continued virus production and infection could also lead to inflammation, which may play a role in maintaining the persistent reservoir of HIV. This lack of control of virus production and infection could, in part, be due to reduced concentrations of antiretrovirals in cells within specific tissue compartments.
Specific Areas of Research Interest
Applications in response to this FOA should propose research to better understand the nature of the persistently active reservoir of HIV and to test innovative approaches to eliminate this reservoir. In addition to studies involving human subjects, investigators may also employ an animal model, such as humanized mice or non-human primates, to assess the effect of their proposed strategy on residual reservoirs of persistent HIV/SIV production in the context of optimized antiretroviral therapy. Therapeutics to be employed may include traditional small molecule inhibitors, as well as new classes of experimental therapeutics. Strategies may include the use of novel formulations or delivery methods, the use of therapeutics that concentrate in specific tissues or cell types associated with HIV reservoirs, or the rational design of new drug regimens based on pharmacology in specific tissues or cell types that serve as HIV reservoirs.
Specific areas of research interest include, but are not limited to:
Studies of intracellular drug concentrations in vivo to identify drugs particularly well suited for inhibiting virus production and cell-cell transmission in tissues
Testing of new combinations of existing antiretrovirals to identify regimens with optimal tissue penetration
Designing “rational intensification” studies using antiretrovirals predicted to penetrate persistent reservoirs more efficiently
Delivery of antiretrovirals directly to sanctuary sites in the gut or other tissues and testing of the effect on the persistent viral reservoir in the context of suppressive antiretroviral therapy
Development of new approaches to target antiretrovirals to specific cell types or tissues (e.g. using nanoparticles)
Testing of new antiretrovirals that concentrate intracellularly in specific cell types or tissues or that penetrate the blood-brain barrier more efficiently
Development of efficient methods to deliver new classes of inhibitors to reservoir sites or specific cell types to facilitate the testing of novel HIV eradication strategies in vivo
Identification and testing of new strategies for killing or limiting the survival of cells that constitute the active reservoir
Use of animal models to demonstrate proof-of-concept for the strategies outlined above
Development of new assays to facilitate the studies of active tissue reservoirs outlined above.
Note: the areas below are NOT areas NIAID is seeking through this FOA. Applications in these areas will be considered non-responsive and will not be reviewed.
Studies performed in the absence of fully suppressive antiretroviral drug therapy or without a fully suppressive standard regimen control arm.
Studies of new classes of inhibitors without a specific delivery strategy that targets active reservoirs.
Testing of new combinations or intensification of traditional drugs without a clearly defined rationale or strategy for an enhanced effect on active tissue reservoirs.
Studies focused on latent reservoirs that are not actively producing virus.
Clinical Trials will not be supported.
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; Asian American Native American Pacific Islander 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 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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov &OV0556;œManage Entity &OV0556;• function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-042.html.
Autoimmunity Centers of Excellence, Clinical Research Program (UM1): RFA-AI-12-059
Also note: Autoimmunity Centers of Excellence, Basic Research Program (U19)
RFA-AI-12-060
Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-060.html.
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
Application Receipt Date(s): June 13, 2013
The ACE was founded in 1999, re-competed and expanded in 2004, and revised and re-competed in 2009. The ACE fosters collaborations among basic and clinical scientists with the goal of advancing our understanding of autoimmunity and accelerating the development of improved therapies for autoimmune diseases. Such collaborations have been productive but they are also difficult to create. This reissued FOA divides the ACE program into 2 components – Basic and Clinical – to better align grant awards with responsibilities. The Basic research program will provide a solid scientific foundation and will conduct advanced investigations into human immunology. The Clinical research program will develop and conduct Clinical Projects: clinical trials with integrated mechanistic studies. The members of the Basic and Clinical programs will work closely together to fully develop and conduct Clinical Projects.
Clinical trials with integrated mechanistic studies that are designed to “utilize materials and data from clinical trials to elucidate underlying mechanisms of drug activity and immune response” were advocated in the 2005 Autoimmune Diseases Research Plan by the Trans-NIH Autoimmune Diseases Coordinating Committee. The Plan also acknowledged that clinical trials are lengthy, risky, and expensive, conceding “many agents that show promising results in preclinical studies do not advance to clinical trials” and noting that new treatments are sometimes discovered ”when practitioners identify new uses for medications originally approved for other conditions”. The importance of informative clinical trials in developing new therapies and evaluating existing therapies was also emphasized by expert panels convened by the Institute of Medicine, most recently by a panel convened in November 2011 (“Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020” pre- publication Clinical Trials Workshop Summary). Well-designed clinical studies of immune modulating agents can be fundamentally informative whether or not an investigational agent ultimately advances to licensure and clinical practice.
The purpose of this FOA is to solicit applications for the reissuance of the Autoimmunity Centers of Excellence (ACE) program. The goal of the ACE is to conduct insightful analyses of human immunology within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. For this reissuance, the formerly integrated Centers are divided into Basic and Clinical research programs. This FOA solicits applications for the Clinical research program; a companion FOA (RFA-AI-12-060) solicits applications for the Basic research Program. The members of the Basic and Clinical ACE will work together after award to design, fully develop, and conduct studies of mechanisms of action of the immune-modulating agents being tested in clinical trials with integrated mechanistic studies.
Clinical ACE Structure
A Clinical ACE possesses the following Components:
Center Research Agenda (Program Overview): Applicants must set forth their perspectives on the fields of autoimmune disease research and therapy in a Center Research Agenda. This should include the theme and goals of the Center, the most important questions to be answered, and a description of how the work of the Center will answer these questions. Also the applicants should discuss how the Projects proposed within this application relate to the Center’s Research Agenda, how they would receive benefit from the ACE collaboration, and how they would benefit the ACE.
Clinical Projects: Each applicant must propose two Clinical Projects (clinical trials with integrated mechanistic studies) designed to advance our understanding of autoimmune disease in humans. “Clinical trial” is defined for this FOA as a medical research study in humans to evaluate the effects of one or more interventions for treatment of an autoimmune disease. “Mechanistic studies” are supplements to clinical trials and are designed to improve the understanding of the mechanism of action of the intervention. In addition to assessing practical questions about the intervention, such as whether the targeted cell or molecule has been affected, these studies should also be designed to address fundamental questions about human immunology. These Projects should not be fully developed in the application but must be ready to be fully developed by the entire ACE after award. The Clinical Projects will consist of:
Primary Clinical Project: The Primary Clinical Project must be ready to enter into full development soon after award.
Alternate Clinical Project: The Alternate Clinical Project must be ready to enter into full development within a year of award.
Collaborative Project (optional): An applicant to the Clinical program may propose a single Collaborative Project to test at least one specific hypothesis on the nature of human autoimmunity, exploit particular strengths of the applicant, and be designed to engage other members of the ACE after award. The Aims should exceed the reach of a single investigator and produce a greater-than-additive return. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the ACE will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build some flexibility into their research plans. The Collaborative Project must include a 5 year research plan with scope and Specific Aims consistent with the goals of the ACE and annual benchmarks for evaluating progress. The ACE will fully develop the Collaborative Projects after award and they will become part of the ACE Research Agenda (see below).
Administrative Core: The Administrative Core should include the following information: a Staffing and Administrative Plan to facilitate the objectives of the proposed Center; the managaement experience, level of commitment, and availability of the PD(s)/PI(s), and Project and Core Leaders; the plans for coordination, problem identification and resolution and the establishment of a strong collaborative environment; timelines, milestones and performance objectives for the overall Center; and a management plan for fiscal accountability and communication within the Program.
Applicants must request funds and justify their use to coordinate the Center activities.
ACE Funds Management Core (optional): The ACE program will be awarded a Clinical Project Fund (CPF) for support of the Clinical Projects, and an Opportunity Fund (OF) for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. Applicants may propose an ACE Funds Management Core to administer the CPF and OF on behalf of the entire group.
The ACE will coordinate its activities through a Steering Committee, which will formulate an ACE Research Agenda and manage resources to complete the Agenda. These elements are described below.
ACE Program: The ACE Clinical and Basic programs will interact through the following elements:
Steering Committee: The work of the ACE will be coordinated by a Steering Committee formed with the PDs/PIs of the Basic and Clinical programs. The Steering Committee will, within 6 months of award, collaboratively formulate the ACE Research Agenda and post it on the public website (www.autoimmunitycenters.org). The Steering Committee will execute the Agenda by fully developing and conducting Clinical Projects and Collaborative Projects and managing resources, including reviewing applications to the Clinical Projects Fund and Opportunity Fund. The Steering Committee will monitor work and post on the public website an annual report on the progress toward the goals of the Agenda.
ACE Research Agenda: The Steering Committee will formulate an ACE Research Agenda that includes overarching themes, goals, and approaches for the period of award. The Agenda should incorporate the best ideas from the individual Centers’ Research Agendas as well as the Collaborative Projects and the Clinical Projects.
Plenary Meeting: The ACE will convene an annual plenary meeting to develop collaborations among the investigators. The aims and status and highlights of all projects from all Centers will be presented in brief talks. All key personnel, including project leaders, are expected to attend and participate. The initial plenary meeting will be held in Bethesda, Maryland soon after award.
These elements will help enable, coordinate, and direct collaborations among the Centers and Projects.
Objectives and Scope
The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies, fostering intellectual and material collaborations among basic and clinical scientists, and facilitating the study of clinical samples by basic research scientists. These approaches are expected to identify common and distinct mechanisms in the pathogenesis of autoimmune diseases.
Research Scope: All projects must investigate autoimmune disease in humans.
Clinical Projects: Clinical Projects developed by the ACE must be innovative and propose clear, testable hypotheses on underlying mechanisms. Mechanisms of interest include the intervention, the disease, and immunity in general. The proposed Clinical Projects may aim to generate initial evidence of efficacy and mechanism, using resources appropriate to the scope of the ACE network.
Types of trials that may be proposed include but are not limited to the following:
Combinations of approved drugs;
Comparative effectiveness research using approved drugs;
Repurposing drugs approved for other indications, based on biological mechanisms;
Use of unapproved drugs with evidence of strong collaboration and endorsement from pharmaceutical partners;
Stratification of patients into groups that benefit or not from particular therapies, accompanied by mechanistic studies to determine why this is so.
Clinical Projects of particular interest to the ACE include but are not limited to the following:
Pathogenesis of human autoimmune disease;
Mechanisms responsible for the initiation, maintenance, or loss of tolerance;
Clinical trials of new tolerogenic and immunomodulatory approaches using individual or combined therapies to treat autoimmune disease;
Studies to improve understanding of existing therapies, including mechanism of action and why they may work better in subsets of patients;
Understanding sex-based differences in autoimmune disease;
Identification and evaluation of biomarkers for autoimmune disease status, including diagnosis, prediction or confirmation of remission or relapse, and measurement of therapeutic response or disease progression; and
Novel approaches to therapy applying new advances in fundamental immunity and biology, such as regulating gene transcription (methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), Natural Killer (NK) inhibitor receptors (KIR), and proteins mediating signal transduction (immune synapse, intracellular pathways).
The ACE Clinical Projects will NOT support:
Large scale epidemiology studies;
A clinical trial whose major goal is to enable licensing;
Research using animal models of human disease.
Note: Applications that propose research in these areas are nonresponsive and will not be reviewed.
Collaborative Project (optional): The Collaborative Project may use samples from previously completed clinical trials but they may not support a clinical trial. For these Projects, specific areas of interest include, but are not limited to:
Pathogenesis of human autoimmune disease;
Mechanism(s) of action of existing therapies;
Biomarkers for autoimmune disease status, including diagnosis, disease progression, prediction of remission or relapse, therapeutic response, or stratification;
Sex-based differences in autoimmune disease;
Mechanisms responsible for the initiation, maintenance, or loss of tolerance;
Cellular analysis for diagnosis or therapy, including adult stem cells, regulatory B or T cells, antigen-presenting cells;
Single-cell or clonal analysis of genetic variation (including epigenetic) contributing to autoimmunity;
Influence of histocompatibility genes (e.g., HLA) on autoimmunity; and
Novel approaches to therapy through advances in fundamental immunity and biology, such as regulating gene transcription (methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), Natural Killer (NK) inhibitor receptors (KIR), and proteins mediating signal transduction (immune synapse, intracellular pathways).
The ACE Collaborative Projects will NOT support:
Large scale epidemiology studies;
Research using animal models of human disease;
Clinical trials.
Note: Applications that propose research in these areas are nonresponsive and will not be reviewed.
Statistical, Data Management, Pharmacy, and Operations Support
NIAID will provide statistical, data collection and management, pharmacy, and clinical trial operations support through a separately funded Statistical and Clinical Coordinating Center for Autoimmune Diseases Clinical Trials (SACCC-ADCT) contract. Each participating institution will be responsible for providing primary study data to the SACCC-ADCT. Timeliness and accuracy of submitted data will be monitored by the SACCC-ADCT and evaluated by the Steering Committee. SACCC-ADCT responsibilities are further described under Section VI Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”
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; Asian American Native American Pacific Islander 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 not allowed.
Applicant organizations must complete the following registrations as described in the PHS 398 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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.
Each individual Project and Core must be led by a single Project or Core Leader. Multiple PDs/PIs for projects and cores are NOT allowed.
An individual may serve as PD/PI on an application to either this ACE Clinical program FOA or the companion Basic program FOA but not both. PD(s)/PI(s) should commit at least 2.4 person months effort (total for multiple PDs/PIs). A PD/PI may lead no more than one of the proposed Projects. The PD/PI (or one of the PDs/PIs if multiple PDs/PIs) should also lead the Administrative Core.
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) is allowed. The same institution may also apply to the companion FOA. A single PD/PI, and PDs/PIs on a multiple-PD/PI application, may NOT also serve as PDs/PIs on an application to the companion FOA.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-059.html.
Innovation for HIV Vaccine Discovery (R01): RFA-AI-13-007
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
Application Receipt Date(s): July 24, 2013
The purpose of this Funding Opportunity Announcement (FOA) is to foster original, high risk, and unconventional research that, if successful, may have a substantial impact on approaches to HIV/AIDS vaccine discovery and development. Applicants must clearly state how their proposed new idea, approach and rationale:
(1) offer a potential solution for preventing acquisition of infection,
(2) could be stringently tested (e.g., in a vaccine animal challenge model) and potentially implemented,
(3) differ from current or previously failed approaches, and
(4) will contribute, inform, or provide more than incremental knowledge to the field regardless of the outcome of the proposed work.
Recent advances in biomedical technologies, such as molecular and structural imaging, deep sequencing, and new ways of probing the antibody repertoire, have generated insight into the virology and immunology of HIV. Clearly, a more intense effort focused on the application of these evolving research tools poses an exciting potential for vaccine discovery. Projects proposed will be expected to explore and test novel hypotheses that, if successful, would significantly impact the design of immunogens or immunization strategies leading to an effective HIV vaccine.
Identifying safe and effective preventive vaccines against HIV transmission and infection is a major research priority of NIAID. The limited immunogenicity and breadth of multiple vaccine candidates tested in phase I and phase II studies and the modest success in efficacy trials, highlight the fact that identifying highly effective vaccination approaches may prove more elusive than anticipated. Previous research has led to a better understanding of the transmission process and of the complexities of the virus’ structure, diversity and biology, all of which demonstrate the need for clever new approaches in designing a successful prophylactic vaccine. Major gaps still exist in our basic understanding of how to convert antigenicity of a promising candidate into effective immunogenicity, and the type(s) of immune responses that correlate with protection. NIAID held a Vaccine Summit in early 2008 to solicit ideas from investigators/attendees about the status of the field and the research approaches that should be pursued to reinvigorate the effort. One of the strongest recommendations was to invest substantially in fostering new discoveries that improve understanding of the immune responses most relevant for preventing HIV infection, and novel approaches for generating those responses. This need continues, and through this FOA, NIAID intends to continue the support of innovative ideas, new investigators and new interdisciplinary collaborations.
The current AIDS vaccine candidate pipeline is limited and the eventual effectiveness of many candidate vaccines remains uncertain unless strong in vitro or in vivo correlates of protective responses in animal models and/or in humans are defined. Multiple recent attempts have led to clinical testing of candidates expected to produce both T cell- and antibody-mediated protective effects. However, there has only been modest success in the effort to identify an effective vaccine. Because of the urgent need for highly effective AIDS vaccine candidates, more effort must be devoted to exploring and exploiting relevant findings from basic mechanistic research that can be translated into, and tested as, effective strategies.
The broad scientific objective of this FOA is to fill knowledge gaps in the basic understanding of the immunity required to block acquisition of viral infection. The expectation is to stimulate novel areas of research with the goal of discovering new AIDS vaccine strategies and/or measures that require a single or limited number of steps to prevent HIV acquisition and/or dissemination from the portal of entry. Cross-disciplinary collaboration among virologists, immunologists, biochemists, molecular biologists, cell biologists, microbiologists, clinical scientists and other relevant specialists is strongly encouraged. Research conducted under this FOA is expected to clarify the critical cellular and molecular events involved in HIV acquisition and contribute significantly to the knowledge base needed to identify, evaluate and develop novel vaccines to prevent acquisition of infection.
Innovation for HIV Vaccine Discovery Research Initiative
The effort to stem the AIDS epidemic is confronted with unique challenges. New discoveries in HIV pathogenesis and virus adaptation in the host continue to provide useful information and fresh opportunities that guide development of effective strategies to prevent acquisition of infection or curb the spread from initial entry to distant sites. For example, findings on how host genetics influence HIV infection, while adding another layer of complexity to the problem, may provide new leads for identifying effective prevention targets. Such hypothesis-generating leads are needed to invigorate the field and stimulate novel vaccine design and testing. There is continuing need to probe fundamental aspects of HIV immunity at mucosal surfaces to gain insights for the future development of vaccines. In the HIV vaccine field, multiple gaps exist in understanding basic mechanisms that induce broad mucosal immunity, priming, protection, and tolerance. This lack of information hampers the design of effective vaccines that provide adequate mucosal protection. The types of early immune responses that will be effective are unclear; for instance, the need to elicit local IgA responses (largely undetected during infection) through mucosal immunization is still debated. Functional genomics studies with licensed vaccines have suggested some leads to designing effective vaccination strategies by modulating dendritic cells with appropriate Toll-Like or other Pattern Recognition Receptors. While other similar leads are being explored, the HIV vaccine field must improve its fundamental understanding of viral immunity at mucosal surfaces and must expedite discovery of ways to achieve robust innate immunity, especially in preventing acquisition and establishment of latent HIV infection.
Several key features of this FOA are designed to emphasize that applications should be very different from conventional investigator-initiated R01s. The information to be included in the research plan should describe explicitly and should focus primarily on the importance of the scientific problem being addressed, the novelty of the hypothesis and proposed methodology, and the magnitude of the potential impact on vaccine design. At the Program level, unavoidable risk is considered acceptable if the probability for a successful outcome is reasonable. The PD’s/PI’s record of overcoming difficult scientific hurdles, appropriately gauged to their career stage, also will be evaluated for likelihood of success. These features are intended to emphasize the goal of the initiative, which is to support bold and potentially transformative research. Further, unlike standard R01 applications, this FOA does not require preliminary data because the principal aim is to attract and support new ideas.
Scope of the Solicited Research
Preventing acquisition of HIV infection encompasses events associated with infecting initially susceptible cells, local propagation, and initial dissemination of virus from the first infected cells. For the purpose of this FOA, HIV acquisition is defined to encompass the initial infection of susceptible target cells at sites of entry, as well as the early dissemination of HIV from a local infection to nearby or distant tissues before latency of infection is established. Under this definition, initial infection involves the process of a target cell acquiring the virus from an infected source. Then the target cell replicates virus and subsequently transmits infectious virus to new target cells. An infectious source could be secretions (fluid or blood) carrying free virus or infected cells. This process can be halted by preventing the initial infection of target cells, or by preventing the active or passive spread of virus from the initial infection foci to new target cells. Therefore, blocking the initial entry of the virus into a host and/or preventing/inhibiting/reducing its subsequent replication such that initial spread of infection is aborted may result in protection of the host from HIV acquisition and infection. These processes could include innate and adaptive immunological processes that may promote, inhibit and/or delay infection of target cells and spread of HIV.
Although research involving human subjects (clinical research) is permitted, this FOA will not support clinical trials. Applications proposing clinical trials are considered nonresponsive and will not be reviewed. For the NIH definition of clinical research versus clinical trials, please see: http://funding.niaid.nih.gov/researchfunding/sci/human/pages/default.aspx.
Animal model evaluation of a proposed hypothesis using HIV, SIV or pathogenic SHIV challenge is strongly encouraged during the award period (see Section II. Award Information).
Because of the complexity in the research areas being solicited, potential applicants are strongly encouraged to communicate with the Scientific/Research Contact, listed in Section VII. Agency Contacts of this FOA, to discuss the responsiveness of their proposed work scope.
The list is not intended to emphasize or limit applications to any specific areas of research, but only to serve as a set of examples of high risk, high impact and novel research projects. Research projects and studies may include, but are not limited to, the following topics listed below:
the potential of host proteins to act as immunogens alone or together with HIV immunogens
previously unexplored HIV- (or SIV-) encoded targets as immunogens
agents generated in vivo by vaccination that may directly or indirectly lead to inhibition of processes required for, or that contribute to, susceptibility to HIV infection
novel vaccination approaches to produce or release infection-blocking processes or agents in vivo, including at relevant mucosal sites
in vivo-generated immune mediators that modulate adaptive and innate immune responses at mucosal sites alone or together with HIV immunogens
HIV/SIV immunogens that stimulate potentially helpful CD4+T cell or other immune cell activation without resulting in enhancement of HIV infection
novel approaches that modulate B cell responses to HIV immunogens to facilitate the induction of broadly neutralizing antibodies
clinical research that answers key questions on systemic and/or mucosal immune response to HIV infection in humans that could lead to testing a plausible intervention
memory cell homing to and retention in mucosal sites
relationships between the susceptible target cell pool and the recruitment of activated immune cells
roles for and induction of mucosal IgA and/or IgG in protection at mucosal sites
need for local antibody vs. transudation of serum antibodies in the mucosa
need for mucosal delivery of vaccines to induce protective responses at mucosal sites
role for mucosal adjuvants, including the use of innate immune factors as adjuvants and induction of innate defense factors
cross talk between innate and adaptive immunity at mucosal sites in response to HIV/SIV vaccine
vaccine induced/imprinted innate immune responses that can be recalled in response to subsequent infection
systems biology approaches to dissect effective innate and/or adaptive mucosal immune responses to vaccines
Applications proposing any of the following research topics will be considered non-responsive and will not be reviewed.
human clinical trials
use of an oral antiretroviral therapeutic agent as part of a vaccination strategy
incorporation of a behavioral research component within a vaccination strategy
vaccines targeted to individuals with established HIV infection, e.g., for reduction of viral load; as therapeutic vaccines
incremental improvements of approaches already under development such as combination strategies incorporating multiple candidate vaccines or vaccines with microbicides or ART agents
research concepts currently being conducted in the applicant’s laboratory that are supported by NIH or other funding entities
purely descriptive basic research or structural studies not addressing a clear hypothesis for prevention of HIV infection through vaccination approaches
product development
iterative studies that propose the next step(s) in the development of a vaccination approach currently under development or in clinical studies
studies that are not linked to a novel intervention strategy for prevention of acquisition of HIV infection, including:
○ development of new animal models
○ assay development and validation
○ vector development
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; Asian American Native American Pacific Islander 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 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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-007.html.
Skin Diseases Research Core Centers (P30): RFA-AR-14-001
Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Application Receipt Date(s): September 20, 2013
Research in skin biology and diseases is at a stage where rapid advances frequently require access to sophisticated technologies and specialized areas of expertise that can be shared by multiple laboratories and are best provided by research core centers. Areas of skin research of interest to NIAMS that could benefit from shared core facilities include, but are not limited to:
Regulation of keratinocyte proliferation and differentiation, including signal transduction pathways, micro RNAs and other noncoding RNAs, and epigenetics
Developmental biology of the epidermis and skin appendages
Epithelial-mesenchymal interaction (e.g., dermal fibroblast’s role in hair follicle development)
Biology of skin stem cells
Melanocyte biology, melanosome structure and biogenesis, inherited disorders of pigmentation
Regenerative medicine, including therapeutic applications of skin stem cells and the development of artificial skin
Structural integrity of the epidermis, barrier formation and delivery of therapeutics through the skin barrier
Identification of the genetic basis of both rare and common skin diseases, including follow-up studies on pathogenesis and the generation of animal models of disease
Mechanistic studies focused on the induction and regulation of adaptive and innate immunity of the skin
Mechanistic studies focused on the induction and regulation of inflammation in the skin
Basic and clinical research focused on immune and inflammatory diseases of skin
Interactions of the skin microbiome with the host cutaneous immune system and role of the skin microbiome as a trigger for diseases in the NIAMS mission
The molecular basis and clinical treatment of pruritis
Prevention of skin diseases and research focused on the mechanisms of skin aging
Identification and development of biomarkers for diagnosis, disease severity and progression of disease, and for monitoring the response to treatment
Comparative effectiveness research studies focused on skin diseases
The structure of ECM components (e.g., collagens, fibrillins), their normal assembly, interaction, function and their diseases (e.g., Marfan Syndrome, Ehlers-Danlos Syndrome)
Fibroblast biology and diseases (e.g., fibroblast diversity, their role in sclerosis and fibrosis)
Cutaneous vasculature normal development and diseases (e.g., endothelial cell biology, hemangioma, Port Wine Stain birthmarks)
Wound healing, normal ECM remodeling and diseases (e.g., matrix metalloproteases, chronic wounds, keloids)
Signal transduction in ECM (e.g., TGF-beta)
Ectopic mineralization in ECM (e.g., pseudoxanthoma elasticum)
Cutaneous sensory organ and innervation function (e.g., temperature and touch) and diseases.
The choice of a research area(s) upon which the Skin Diseases Research Core Center (SDRC) would focus is made by the investigators. However, research focused on advanced skin cancers, including metastasis and treatment, is not in the NIAMS research mission and should not be the research base for a Core Center. Any questions with regard to cancer relatedness should be directed for clarification to the Scientific/Research Contact listed in Section VII. Agency Contacts.
In addition to providing services and resources to facilitate independently funded research projects, the Core Centers are encouraged to enhance the research environment and promote synergistic collaborations among the Center Investigators (the investigators of the research base). Scientific core personnel should help to educate the Center Investigators in the capabilities and limitations of the technologies employed by the scientific cores. Core personnel should be involved with the investigators in designing the experiments and interpreting the results. The technologies of the cores should not only evolve with the science conducted by the Center Investigators, but the cores should help to drive the science with increasingly sophisticated and powerful technologies.
The SDRCs will provide support for:
An Administrative Core, that includes a Center Enrichment Program
Two or more Research Cores
Administrative Core: An Administrative Core, including a Director, Associate Director, and an Advisory Committee, should be proposed to coordinate the Core Center activities, to evaluate and improve the Center and to administer an Enrichment Program. The Advisory Committee should include users of the scientific cores and experts outside the Core Center Institution with expertise in the management of scientific core facilities. This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research base over the course of the grant award.
Enrichment Program: An Enrichment Program must be proposed and should be designed to expand the research base in the area of skin biology and disease research. Within the award budget guidelines, each SDRC can decide what type of activities to include as part of the Program, based on what best suits the needs of the SDRC. Through this Enrichment Program, the Administrative Core can utilize the Research Cores to foster the development of new investigators, new technologies, and/or new collaborations with those who have not previously participated in skin biology and disease research. Enrichment Program activities should occur within the context and/or with the involvement of the Research Cores. Innovative approaches to the Enrichment Programs are encouraged.
Research Cores: Two or more research cores must also be proposed. A research core is a facility and/or resource shared by two or more Center investigators that enables them to conduct their independently-funded individual research projects more efficiently and/or more effectively. Cores generally fall into one of four categories: (1) provision of a technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, cell biology, biostatistics, systems biology, bioinformatics, clinical). Research Core support may include personnel, equipment, supplies, services, and facilities.
Core Center Directors are encouraged to leverage existing resources, such as registries, tissue banks and cohorts, and to coordinate with NIAMS-funded Core Centers at the same and/or other institutions, particularly if they provide similar or overlapping technologies and services. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research. Leveraging of existing resources that provides a range of services or efficiency that would not otherwise be available is also encouraged. However, applicants should demonstrate that support for the existing resource through the Core Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service.
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; Asian American Native American Pacific Islander 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 PHS 398 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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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) is allowed.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-001.html.
Core Centers for Musculoskeletal Biology and Medicine (P30): RFA-AR-14-002
Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Application Receipt Date(s): July 01, 2013
The CCMBM are intended to enhance the research productivity and provide cost effective, and sometimes specialized services and resources to existing grants (the research base), funded by the NIAMS and other organizations. Research Core Centers could potentially facilitate projects in many areas of musculoskeletal biology and medicine: the skeleton, muscles, connective tissues such as tendon, ligament, and cartilage. The Division of Musculoskeletal Diseases of the NIAMS supports research aimed at improving the diagnosis, treatment and prevention of diseases and injuries of the musculoskeletal system and its component tissues. Key public health problems addressed by this research include, but are not limited to, osteoporosis, osteoarthritis, and muscular dystrophies. CCMBM are intended to combine and provide additional resources for research into these areas of human health.
For more information, research areas, and program contacts, please visit the Musculoskeletal Diseases webpage: http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/Musculoskeletal_Diseases/default.asp
The choice of a research area(s) upon which the CCMBM would focus is made by the investigators. Any questions with regard to the research area(s) should be directed to the appropriate Program Director.
In addition to providing services and resources to facilitate independently funded research projects, the Core Centers are encouraged to enhance the research environment and promote synergistic collaborations among the Center Investigators (the investigators of the research base). Scientific core personnel should help to educate the Center Investigators in the capabilities and limitations of the technologies employed by the scientific cores. Core personnel should be involved with the investigators in designing the experiments and interpreting the results. The technologies of the cores should not only evolve with the science conducted by the Center Investigators, but the cores should help to drive the science with increasingly sophisticated and powerful technologies.
The CCMBM will provide support for:
An Administrative Core, that includes a Center Enrichment Program
Two or more Research Cores
Administrative Core: An Administrative Core, including a Director, Associate Director, and an Advisory Committee, should be proposed to coordinate the Core Center activities, to evaluate and improve the Center and to administer an Enrichment Program. The Advisory Committee should include users of the scientific cores and experts outside the Core Center Institution with expertise in the management of scientific core facilities. This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research base over the course of the grant award.
Enrichment Program: An Enrichment Program must be proposed and should be designed to expand the research base in the area of musculoskeletal biology and medicine research. Within the award budget guidelines, each CCMBM can decide what type of activities to include as part of the Program, based on what best suits the needs of the CCMBM. Through this Enrichment Program, the Administrative Core can utilize the Research Cores to foster the development of new investigators, new technologies, and/or new collaborations with those who have not previously participated in musculoskeletal biology and medicine research. Enrichment Program activities should occur within the context and/or with the involvement of the Research Cores. Innovative approaches to the Enrichment Program are encouraged.
Research Cores: Two or more research cores must also be proposed. A research core is a facility and/or resource shared by two or more Center investigators to enable them to conduct their independently-funded individual research projects more efficiently and/or more effectively. Cores generally fall into one of four categories: (1) provision of a technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, cell biology, biostatistics, systems biology, bioinformatics, clinical). Research Core support may include personnel, equipment, supplies, services, and facilities.
Core Center Directors are encouraged to leverage existing resources, such as registries, tissue banks and cohorts, and to coordinate with NIAMS-funded Core Centers at the same and/or other institutions, particularly if they provide similar or overlapping technologies and services. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research. Leveraging of existing resources that provide a range of services or efficiency that would not otherwise be available is also encouraged. However, applicants should demonstrate that support for the existing resource through the Core Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service.
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; Asian American Native American Pacific Islander 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 PHS 398 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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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) is allowed.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-002.html.
Safe and Effective Instruments and Devices for use in Neonatal and Pediatric Care Settings (R43/R44): PAR-13-090
Also note: Safe and Effective Instruments and Devices for Use in Neonatal and Pediatric Care Settings
(R41/R42): PAR-13-091
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-091.html.
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) to propose research to develop new devices and instruments, and/or improve existing devices and instruments, to monitor and treat newborn infants and small children safely and efficaciously.
There are many unmet needs concerning device development in neonatal and pediatric care. A workshop held in May 2012 at NICHD highlighted the need for continued support. Devices and instruments developed for use in infants and children should be based on sound bioengineering principles. They also need to be tested for safety, efficacy, and accuracy of functioning. Despite major advances in biotechnology, research and development (R&D) efforts directed at introducing new and innovative pediatric devices and instruments (or improving the existing ones) for use in newborn infants and small children have been limited.
One objective of this FOA is to foster collaboration between clinical and bioengineering research communities in the field of pediatric device development. It is anticipated that through rigorous collaborative R&D efforts, safe and effective instruments and devices can be developed for use in newborn infants and children of all ages. This FOA invites SBCs to propose innovative research that can lead to development of non-invasive, or minimally invasive, instruments, devices, and monitors that improve assessment, monitoring, and treatment of neonates, infants, and children of all ages who require routine as well as intensive care treatments. In addition, this FOA aims to stimulate improvement in existing devices and instruments being used in pediatric care. There is an urgent need for R&D in improving existing devices and instruments and introducing new devices and instruments while optimizing their utility and safety in the neonatal and pediatric intensive care, and out-patient settings. The new and improved instruments and devices developed as a result will reduce the burden of morbidity and mortality associated with such devices, as well as providing a means for the clinical community to monitor key physiological and pathological processes while treating complex disorders in children.
Scope/Work to be Performed
The proposed studies need to establish the accuracy and safety of the device under varied clinical conditions. Studies may range from concept to developmental phases, with the goal of developing accurate devices that can be marketed, and used in regular clinical settings in newborn infants and pediatric patients of all ages. The major topic areas for the R&D efforts to be supported under this FOA include, but are not limited to:
Cardiovascular: Non-invasive or minimally invasive devices, instruments, or methods for assessing and supporting a variety of cardiovascular functions, including improved methods for measuring and monitoring systemic blood pressure such as advanced mathematical computations for analyzing cardiac pulse wave forms; devices to measure and monitor cardiac output and global tissue oxygen delivery; improved methods of assessing blood volume and tissue perfusion; devices for use in cardiac surgery; interventional catheterization; and electrophysiology technologies for neonates and children.
Pulmonary: Improved or non-invasive devices and instruments to measure pulmonary function (e.g., pulmonary arterial pressures, gas exchange, airway pressure, lung volume, ventilation/perfusion ratios, PCO2 and PO2); improved systems for respiratory support with reduced air-leaks; non-invasive ventilation; interfaces for nasal continuous positive airway pressure (CPAP) that do not affect musculoskeletal development; synchronized ventilation; improved methods of patient-triggered ventilation and pulmonary perfusion; automated inspired oxygen control; airway secretion clearance devices (including but not limited to applications for cystic fibrosis children); improved aerosol delivery systems targeting small airways for use in newborn infants and small children on and off of ventilatory support; improved oxygen cannula tubing for infants during transportation; and diaphragm pacers for use in rapidly growing infants, children and pediatric patients.
Hematologic: Non-invasive or minimally invasive methods: for testing hemostasis that provide results in a timely manner using small quantities of blood; for evaluating global hemostasis in very small infants, and in those requiring extra-corporeal membrane oxygenation (ECMO); for monitoring the efficiency of either continuous or discontinuous dialysis treatments (e.g., for optimizing management of retained fluids); and improved age and size-specific blood pumps to deliver small volumes of blood products.
Neurological: Non-invasive or minimally invasive devices, instruments, and methods for assessing a variety of cerebrovascular functions, including methods for assessing global and regional cerebral blood and cerebrospinal flow, oxygen extraction, utilization of nutritional substrates, and autoregulation of cerebral blood flow; non-invasive or minimally invasive devices, instruments, and methods for evaluating central nervous system and peripheral nervous system function; neonatal seizure detection systems; devices and technologies to objectively assess pain in neonates, infants and children, and to evaluate the adequacy of analgesic therapies; devices for measuring the wavelengths and irradiance from commercial neonatal phototherapy units; devices and technologies to measure free components of indirect-bilirubin concentrations in the serum, to enable more accurate prediction of neurological injury from severe neonatal hyperbilirubinemia; and optical imaging of the developing brain for assessing cerebrovascular structural and functional status.
Projects to conduct Phase I and Phase II clinical trials that fall under the mission of NINDS are not included in this FOA and should submit to PAR-12-072. NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions.
Metabolic: Devices, instruments, and methods for assessing a variety of metabolic substrates, including sensors for non-invasive or minimally invasive measurement of blood metabolic chemicals, such as glucose, ketone bodies, and lactate/pyruvate, that are sensitive at the low plasma concentrations seen in the neonatal period; micro-infusion pumps to optimize insulin administration and glucose control in neonates, infants, and small children; technologies to monitor kidney function or injury, or to improve indwelling urinary or dialysis catheters used in neonates, infants, children; and sensors for the assessment of other blood chemical parameters (e.g., serum sodium, potassium, and chloride) in pediatric patients of all ages.
Kidney/Genitourinary: Non-invasive, or minimally invasive approaches to develop devices, instruments, chemical molecules, and biomarkers to help study the mechanisms of normal and abnormal development of the kidney and genitourinary systems; to make early diagnosis of malformations, infections, and other renal-genitourinary disorders, and to prevent or treat renal and genitourinary diseases in fetal/neonatal and other pediatric patients.
Infections: Devices, instruments, and methods for preventing, assessing and treating neonatal/pediatric infections, including innovative technologies for improving the quality of invasive catheters and tubes used during the evaluation and care of critically ill newborn infants, small children, and pediatric patients in ICU setting. The catheters and their component systems may include IV tubes, indwelling catheters (venous, arterial, umbilical, percutaneous), connector-hubs, and syringes, and may include novel materials that prevent microbial adherence. Examples of other tubes include endotracheal tubes, oral or naso-gastric tubes, suction catheters, and chest-tubes or other catheters used for drainage purposes. The applications need to focus on methods to improve the performance quality of such tubes, catheters, and accessories that ultimately lead to reduced microbial colonization and reduced incidence of health-care and device-associated sepsis, reduced thrombogenic properties, and/or prevention of other device-associated complications. Applications may also include studies to improve the accuracy and speed of bacterial and fungal septicemia diagnoses, rapid identification of pathogenic microbial organisms, and assessment of antimicrobial resistance/susceptibility characteristics utilizing small volumes of blood and/or other biological fluids.
Hearing, speech, and swallowing functions: Devices and instruments for assessment and preservation of hearing (e.g., improved auditory brainstem response technologies to provide continuous monitoring and effective noise cancellation to reduce incubator noise) and speech/swallowing functions (e.g., improved oro-cutaneous stimulation devices and improved therapeutic devices to facilitate oral motor development and sucking capacity in premature infants and in infants with developmental/intellectual disabilities).
Radiological Devices: Device development to reduce the harm from radiation exposures, especially during CT.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States,or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration(formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may NOT simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
Contractual/Consortium Arrangements
In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).
In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-090.html.
Clinical Sites for an Undiagnosed Diseases Network (UDN) (U01): RFA-RM-13-004
Components of Participating Organizations
The Common Fund/Office of Strategic Coordination
Application Receipt Date(s): June 19, 2013
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
The purpose of this funding opportunity announcement (FOA) is to establish 5-7 Clinical Sites (CS) for a national network added to and building upon the NIH Intramural Research Program Undiagnosed Diseases Program (IRP-UDP). Together with the IRP-UDP and a separately funded Coordinating Center (CC), these sites will constitute the NIH Undiagnosed Diseases Network (UDN).
The purpose of the Network is to diagnose both rare and new diseases and, through the support of mechanistic studies, to suggest, where possible, management strategies for the patients. This program will advance laboratory and clinical research building upon the experience and expertise of the IRP-UDP and similar programs to enhance coordination and collaboration among laboratory and clinical researchers across multiple centers and to share resulting data and approaches widely throughout the scientific community.
The Clinical Sites will be selected and funded 3–4 months after award of the CC. This will allow the CC to assist and develop with IRP-UDP investigators a preliminary set of protocols and operating guidelines for consideration by the newly-formed UDN. These draft protocols and guidelines will begin to define an initial framework of common practices across the Network, to be refined and expanded as the Network grows and matures. To the degree possible, common protocols for data collection and common approaches to patient selection, evaluation, and diagnosis will facilitate pooled analyses and cross-site collaborations, ultimately advancing the clinical approach to undiagnosed diseases. Some of these best practices could be modeled after the IRP UDP.
For the purposes of this FOA, undiagnosed diseases are considered to be disorders with long-standing symptoms or signs that have not been diagnosed despite extensive clinical investigation. Undiagnosed diseases include 1) rare, previously described diseases, afflicting less than 200,000 individuals in the United States, that are often not recognized because they are so infrequent; 2) yet-to-be-described disorders, previously unknown to medicine also presumed to be rare; and 3) rare variants of more common diseases.
Rare and yet-to-be-described disorders are a difficult problem for patients, their families and their physicians. The NIH Office of Rare Diseases Research notes that about 6% of patients seeking their assistance have an undiagnosed disease. For those who were ultimately diagnosed, as many as 15% had persistent symptoms without diagnosis for at least 5 years, a difficult and costly delay for patient, family (including other afflicted family members), and physicians who struggle to identify and treat these disorders. This diagnostic odyssey is usually expensive with repeated, sequential diagnostic efforts involving a series of physicians pursuing similar duplicative imaging (with related increased X-ray exposure and other risks) and biomarker investigations.
In addition, these patients present compelling research questions since clarification of the underlying genetics, biochemistry and physiology of these disorders will lead to a better understanding of their disease processes and those of related disorders. Advances in the science of genetics and genomics in medicine have made it possible to understand the causes and potential targets for treatment of some of these diseases. Furthermore, as the cost of genotyping and sequencing continues to fall and the accuracy of these methods increases, these approaches become more attractive as potentially standard means to diagnose these disorders.
The Intramural Research Program – Undiagnosed Diseases Program (IRP-UDP) began in May 2008 and from modest initial recruitment numbers, has over a four-year period received approximately 6,300 inquiries. From these inquiries, the investigators were able to evaluate 2,300 medical records and admit 450 patients to the NIH Clinical Center for thorough, one-week evaluations. Despite the resource limitations of a new pilot program, NIH investigators over the four years since program initiation have responded each year to an average 1,575 inquiries, evaluated 575 medical records for potential participation and admitted 113 patients for evaluation. As these data reveal, even without a systematic approach to advertising the program, there is a substantial unmet demand for these capabilities. This justifies the creation of a Network that will be able to address more inquiries, and potentially be more accessible to patients throughout the country who require these services.
Over a four-year period, the IRP-UDP has made diagnoses in approximately 100 patients (20–25% of those evaluated) whose challenging conditions had perplexed and defeated the diagnostic efforts of many skilled physicians. The IRP-UDP has discovered and described two unknown diseases and identified 15 genes not previously associated with human disease. Much has been learned and many efficiencies gained in the evaluation of patient/family inquiries and of submitted medical records, in diagnostic approaches dictated by organ system involvement, and in engaging the expertise of laboratory scientists studying disease mechanisms.
This funding opportunity and a related FOA (RFA-RM-12-020, “Coordinating Center for an Undiagnosed Diseases Network”), together with the ongoing IRP-UDP and NIH program staff, will create the NIH Undiagnosed Diseases Network. The Network will increase the availability of diagnostic services, expand the geographic distribution of patient access sites, foster opportunities for collaboration between laboratory and clinical investigators, and provide resulting data and protocols to the broader community. These efforts will lead to new knowledge regarding the biochemistry, physiology, and mechanisms of these diseases and improve diagnostic and management options for patients afflicted with them.
Objectives of this Research Program
The objectives of this program are to:
Improve the level of diagnosis and care for patients with undiagnosed diseases through the development of common protocols designed by an enlarged community of investigators;
Facilitate research into the etiology of undiagnosed diseases, by collecting and sharing standardized, high-quality clinical and laboratory data including genotyping, phenotyping, and documentation of environmental exposures; and
Create an integrated and collaborative research community across multiple clinical sites and among laboratory and clinical investigators prepared to investigate the pathophysiology of these new and rare diseases and share this understanding to identify improved options for optimal patient management.
This program seeks to provide improved patient access to state-of-the-art diagnostic methods, by expanding the available expertise and facilities serving patients with these unusual disorders and to accelerate discovery and innovation in diagnosing and treating these patients. The IRP-UDP will establish, as an additional element of this overall program, training programs in genomics and genetics of undiagnosed diseases at the NIH Clinical Center and potentially at other sites. In addition to the clinical infrastructure, gene function studies will be supported through a variety of funding mechanisms to elucidate the biologic mechanisms of identified genetic variants in disease causation, leading to potential pathways to improved treatments. Such funding mechanisms may include subsequent supplements to the CS supported by this FOA to foster collaboration among laboratory and clinical investigators.
The IRP-UDP investigators will assist in the development of the new Clinical Sites by sharing lessons learned over the past four years in approaches to inquiries, evaluation of medical records, and detailed assessment of phenotype, environment and genotype in patients and families selected for diagnostic investigation. To facilitate sharing this knowledge, the IRP-UDP will establish a Consultation Core, available by phone, internet, or visits to or from new CS, to advise on the processes of patient application, review and acceptance, as well as phenotyping, data collection and interpretation, ultimately leading to a diagnosis. The IRP-UDP will also establish and make available to the new CS specialized Core Laboratories for technologies such as DNA or RNA sequencing, gene expression, proteomics, lipidomics, and glycomics that it will establish in FY13 for investigation of its existing patient cohort. Once the new CS are established and running smoothly, they will be invited to compete, along with IRP-UDP, to provide these functions Network-wide.
It is hoped that sharing these lessons will facilitate the development of the new sites and that the infusion of an expanded group of investigators will invigorate and develop new directions and best practices for use by all. The CC and new Clinical Sites are anticipated to bring new ideas and alternative approaches to refine and improve upon current IRP-UDP practices and adapt them for use outside the unique setting of the NIH Clinical Center.
It is the intent of the NIH to establish a Network CC several months prior to the selection of the new CS. This will permit a careful study and codification of the processes used and refined by the IRP-UDP since 2008 for consideration for Network-wide adoption and refinement by the Network Steering Committee once the new sites are awarded. Although every undiagnosed patient is unique and requires some individualized investigation, certain core components are expected to be relevant to all patients. All CS (including the IRP-UDP) will thus be expected to utilize common investigative and data collection protocols, to the degree possible, to facilitate pooling of data to enhance the scientific and diagnostic value of the resulting information. All data from UDN patients will be submitted as soon as they are collected to the CC for cleaning, quality control, and compilation in a Network-wide dataset to be distributed periodically to all CS (including the IRP-UDP) as agreed upon by the Network Steering Committee.
Program Formation and Governance
The awards funded under this FOA will be cooperative agreements (see Section VI.2.A. Cooperative Agreement Terms and Conditions of Award). Close interactions among awardees and NIH will be required to develop this complex Network. Shortly after the award, CS Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and key co-investigators will meet with CC representatives, IRP-UDP investigators and NIH program staff to plan approaches, identify barriers, and propose solutions for creating and maintaining the UDN.
The UDN governance will rest with the Network Steering Committee in collaboration with NIH program officials, with advice from an External Scientific Panel, and subject to oversight by a UDP Working Group of the NIH Common Fund. The Steering Committee may establish subcommittees and working groups to facilitate development, implementation, and monitoring of specific Network functions such as patient recruitment, patient selection and assignment to specific CS, clinical evaluation, final diagnosis, and access to Core Laboratories, as needed.
A Steering Committee composed of PD(s)/PI(s) from all sites (including the Clinical Sites, CC and the IRP-UDP) and the NIH Project Scientist(s) will be responsible for the scientific direction of the Network. The Steering Committee will meet quarterly during the first year and two to three times per year or as needed subsequently.
The UDN Steering Committee will be the operational group through which the NIH UDP Working Group interacts with the UDN. The UDN Steering Committee will identify scientific and policy issues that need to be addressed at the Network level and develop recommendations to the NIH UDP Working Group for addressing such issues. Working through the CC, the Steering Committee will develop and implement an approach for network-wide patient selection and assignment to Clinical Site, as well as evaluation, imaging and laboratory investigation, final diagnosis, and follow-up. It will also ensure dissemination of program data, clinical protocols, training schedules and other materials to the wider scientific community.
An External Scientific Panel (ESP) will be named by NIH program officials and will be responsible for monitoring Network activities and making recommendations to the UDP Working Group and NIH regarding process and substantive issues that arise during Network operations.
An Interim Executive Committee composed of the IRP-UDP PD/PI, the CC PD/PI, and the NIH Project Scientist(s) will collaborate and communicate on a regular (likely weekly) basis to prepare draft protocols and preliminary materials prior to award of the new Clinical Sites. Once the new sites are added to the Network, the Chair of the Steering Committee, the PD/PI of the CC, the NIH Project Scientist(s), and the PD/PI of the IRP-UDP will continue to engage in regular (again, likely weekly) phone conferences to facilitate the program’s maturation from 6–8 individual sites to a functional, integrated and effective Network of investigators.
Core Laboratories for specialized technologies will be established by the IRP-UDP in FY13 and made available to new CS in FY14 and FY15 for investigation of genes implicated in their UDP patients, as described above. To facilitate data sharing and pooled analyses, Core Laboratories would typically provide these services Network-wide but depending on capabilities at the individual CS, such testing could be conducted locally according to agreed-upon standards, with resulting data submitted for Network-wide analyses and deposition. A competition for providers of Core Laboratory functions, to which the new CS may apply, will be conducted once the new CS are established and running smoothly. The Network SC will be tasked with developing an equitable process for prioritizing access to these resources, whether at the IRP-UDP, the new CS, or their contractors or collaborators, to be reviewed and approved by the Network’s External Scientific Panel and the NIH Working Group. This process will likely involve a subcommittee or working group to define priorities for access, formats for requests, and expectations for turnaround and follow-up as needed.
Data Sharing Under This Initiative
Data from the UDN are expected to be handled so as to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that the project datasets (phenotypic, environmental, covariate, process, and other relevant data) and associated genotyping data from the Network will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information. Information such as study protocols, descriptions, bioinformatic tools, and publications are expected to be made available through an open access section of a database such as dbGaP, other public web sites, and publication in the scientific literature.
Mid-Course Review (July 2017)
Applicants should describe their plans to participate with the CC in preparing yearly reports for the Network leadership, the External Scientific Panel, and the NIH UDP Working Group. The yearly report for FY17 will include a more detailed report which an external group will use to make recommendations on the continuation or shut-down of the UDN effort.
This review group will also be asked to make recommendations for orderly close-out of this project either in FY18/FY19 if the mid-year review determines that close-out is warranted, or for issuing a renewal solicitation to continue the project through final closeout in FY22.
The Network can be envisioned as beginning with a phase of network design prior to Clinical Site award; this Design phase will involve only the CC, IRP-UDP, and NIH program staff and not the new CS. Once the new CS are awarded, subsequent phases involving them will include: 1) start-up; 2) full network operation; and 3) mid-course review. Should the mid-course review be successful, a repeat solicitation for Network continuation and eventual close-out will be released; if unsuccessful, modest close-out funding may be provided.
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; Asian American Native American Pacific Islander 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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Applications for a clinical site grant may be submitted by individuals located at the same institution as an applicant for the CC submitted under FOA RFA-RM-12-020, but an individual may not be the PD/PI of RFA-RM-12-020 and the clinical site grant.
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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-13-004.html.
Differentiation and Integration of Stem Cells (Embryonic and Induced-Pluripotent) Into Developing or Damaged Tissues (R01): PAR-13-094
Also note: Differentiation and Integration of Stem Cells (Embryonic and Induced-Pluripotent) Into Developing or Damaged Tissues (R21): PAR-13-095
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-095.html.
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The primary focus of the FOA is to promote in vivo studies of stem cells in animal models and in humans (if applicable) to better understand how stem cells function within developing or damaged tissues. This is the important first step for successful transition of stem cell research into clinical applications. The areas of emphasis would include systematically profiling and cataloging changes at genetic and epigenetic levels that take place in stem cells and their microenvironment. The purpose is to gain in-depth knowledge of the mechanisms involved in: progressive differentiation of Embryonic Stem Cells (ESCs) into embryonic lineages, progenitor cells and specialized cell types; adult stem cells/progenitor cells during tissue regeneration and wound healing; and Induced Pluripotent Stem Cells (iPSCs) at the site of injury during stem cell therapy. Understanding the basic mechanisms and application of knowledge-based approaches would allow researchers to generate iPSCs that are more closely related to the ESCs at both genetic and epigenetic levels. Furthermore, it is expected that replicating developmental mechanisms would ameliorate the safety concerns associated with incomplete differentiation and improper integration of cells in damaged or diseased tissues during stem cell therapy. The bottom-up approach outlined in this initiative would be instrumental in inventing rapid and efficient methods for generating patient-specific iPSCs for clinical use.
Stem cell therapy holds the potential to dramatically change the treatment of human diseases and injuries. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation in vivo. In order to precisely control cell proliferation and differentiation of ESCs in vitro requires systematic analysis of the molecular and genetic signals that regulate these processes in vivo during development, adult tissue homeostasis, as well as wound healing. Recent developments with iPSCs suggest some specific factors may be involved in de-differentiating of human somatic cells into cells similar in characteristics to the pluripotent ESCs. However, techniques must be devised to introduce these factors safely into the cells and control the processes that are induced by these factors. Uncontrolled differentiation of stem cells at the site of damage (caused by disease or injury) can lead to teratoma formation. Furthermore, inadequate differentiation or inappropriate integration could also exacerbate tissue pathophysiology, further diminish function, and/or or promote maladaptive function.
Recent advances in stem cell research show that targeted differentiation of stem cells into specific cell types offer the possibility to treat a variety of human conditions, including spinal cord injury, stroke, burns, birth defects, neuro-developmental disorders, heart disease, muscular dystrophy, and diabetes.
Evidence shows that stem cells may repair diseased and damaged tissues by increasing vascular supply through the creation of new blood vessels, reducing inflammation, enhancing the innate tissue repair mechanisms and reducing ongoing cell death. Although some of these trials have demonstrated partial integration of stem cell-derived cells into damaged tissues with minimal long-term risk, the precise molecular and cellular mechanisms underlying the restorative effects of stem cells are not fully understood.
Thus, stem cells offer exciting promise for future therapies, but significant knowledge gaps exist at genetic and epigenetic levels, leading to limited understanding of the intracellular events, tissue level interactions, and trophic influences that are essential for promoting long-term differentiation and integration of stem cells into damaged tissues. Also, understanding these basic mechanisms is central to preventing possible deleterious side effects of stem cell therapy.
Specific Areas of Research Interest
This scope of this FOA includes, but is not limited to, the following areas of stem cell research:
In vivo stem cell development and tissue ontogenesis
Genetic and epigenetic changes occurring during transition of ESCs into common progenitor cells and specific tissue stem cells within the embryo
Analysis of Gene Regulatory Network (GRN) of ESCs, common progenitor cells and tissue stem cells
Migration and homing of tissue specific stem cells, including the germ stem cells, to the target region during embryogenesis
Maintenance of stem cell populations and function
Interactions between stem cells and neighboring cells/tissues; trophic influences
Functioning of stem cells in damaged/diseased tissues
Reprogramming
Profiling reprogramming factors present in the egg cytoplasm
Reprogramming of somatic cells
Derivation of specialized somatic cell types in vitro from ESCs/iPSCs
Derivation of germline stem cells from ESCs/iPSCs in vitro
Interactions between stem cells and host tissues; trophic influences
Strategies to promote functional integration and differentiation (trophic, pharmacological, tissue bioengineering, activity-mediated)
Preventing abnormal differentiation, overgrowth, tumor-formation, and other negative consequences; immunological and inflammatory reactions
Migration of stem cells across capillary walls; across blood-brain barrier
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; Asian American Native American Pacific Islander 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 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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-094.html.
NIH Summer Research Experience Programs (R25): PAR-13-104
Components of Participating Organizations
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism
National Institute of Biomedical Imaging and Bioengineering
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute of Environmental Health Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): April 2, 2013; April 2, 2014; April 2, 2015, AIDS: May 21, 2013, May 21, 2014 and May 21, 2015
The objectives of the NIH Summer Research Experience Programs (referred to as the “Summer Research Program”) are to provide high quality research experiences for high school and college students and for science teachers during the summer academic break. The NIH expects that such programs will:
Help attract young students to careers in science;
Provide opportunities for college students to gain valuable research experience to help prepare them for graduate school; and
Enhance the skills of science teachers and enable them to more effectively communicate the nature of the scientific process to their students.
The programs should also contribute to enhancing overall science literacy. Summer Research Programs that complement or expand existing summer educational and training programs are encouraged.
Special Note: Not all participating Institutes and Centers (ICs) support all aspects of this program. Therefore, prospective applicants must consult the Table of IC-Specific Information, Requirements and Staff Contacts in this announcement to determine if your application will be accepted for review, and should contact staff at the relevant IC (see also Section VII) to discuss the proposed Program.
Support for science teachers at the K-12 and college level will be limited to those programs with a clear plan for how the teachers will utilize their summer experience in their teaching during the school year.
Applications that demonstrate the potential to impact students and teachers from diverse backgrounds are particularly encouraged.
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; Asian American Native American Pacific Islander 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); Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); U.S. territories or possessions; Native American tribal organizations (other than federally recognized tribal governments), and faith-based or community-based organizations. All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
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 SF424 (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.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
PD(s)/PI(s) of Summer Research Programs must have current NIH grant support with one of the participating NIH Institutes/Centers (ICs). If the PD/PI has support from multiple ICs, the applicant must specify which IC the application should be assigned to (see Cover Letter). The PD/PI should be an established investigator in the scientific educational area(s) in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed Summer Research Program.
The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required (See Section VI.3. Reporting)
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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Preceptors/Mentors
Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to providing an enriching research experience for the participating students or teachers. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to participate as preceptors/mentors.
Participants
Only high school and college students and science teachers from elementary and high schools, community colleges, and college teachers from NIH AREA (R15)-eligible institutions are allowed to participate in this program (See http://grants.nih.gov/grants/funding/area.htm). Not all participating ICs support all categories of participants. Prospective applicants must consult the Table of IC-Specific Information, Requirements and Staff Contacts and should contact staff at the relevant IC (see also Section VII) to discuss their proposed research experience program.
Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Applicants are strongly encouraged to contact the relevant Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-104.html.
Limited Competition: Global Health Research and Research Training eCapacity Initiative (R25): PAR-13-107
Components of Participating Organizations
John E. Fogarty International Center
Application Receipt/Submission Date(s): May 15, 2013; May 15, 2014
This FOA encourages applications from current or former FIC grantees or collaborators who propose innovative research education programs to teach researchers at low and middle income country (LMIC) institutions the knowledge and skills necessary to incorporate Information and Communication Technology (ICT) into global health research and research training. The initiative is intended to leverage the capacity that has been built through prior FIC support by building on the established research programs, research training programs, or collaborations. The proposed programs should aim to significantly increase the ability of researchers to use, adapt, and integrate ICT approaches, thus establishing electronic capacity (eCapacity) at LMIC institutions. In addition, participants in the proposed programs should develop into adaptable users of ICT who are able to sustain ICT activities as changes arise in technology.
Applications are invited that include the following research education objectives:
1. Provide educational opportunities, such as courses and workshops, for LMIC researchers to gain the expertise needed to implement ICT activities that are relevant to global health research and research training at their institutions.
and
2. Provide mentored, targeted practicum ICT project support that will allow researchers to use acquired ICT knowledge and skills to directly enhance research or research training at their LMIC institutions.
Recently, ICT research tools have transformed biomedical research and have become an essential part of many types of research projects. However, access to these resources and the capacity to use them in global health research are often lacking in LMIC institutions. One aim of this FOA is to increase this research capacity through programs that enhance the capabilities needed for specific global health research projects (such as the use of surveillance, epidemiology, and geospatial technology tools) and programs that target a broader global health research community. Programs could focus on one or more types of ICT, including mobile health, modeling, bioinformatics, biostatistics, or other areas.
Global health research projects are increasingly distributed across multiple countries, resulting in collaborations and networks that require electronic communication, data sharing, and new forms of research training. While ICT platforms for facilitating online collaborations and e-learning are becoming more accessible in LMICs, there is a need for LMIC institutions to develop institutional capacity to create their own electronic learning, training, and collaboration resources. This FOA also aims to increase research training capacity through programs that enhance the capabilities of researchers to develop and sustain innovative distance learning platforms or open educational, collaboration, or library electronic resources.
Proposed programs may include courses, workshops, practicum experiences, and learning or experimental laboratories that are short- or medium-term (i.e., less than 12 months). While the proposed programs should be aimed at educating researchers, other members of the research support community may also be participants if their involvement will aid the incorporation of ICT into research and research training.
This FOA addresses the need for expert users of ICT and is not intended to support the basic discovery or development of new ICT. Programs should not intend to use support provided through this opportunity for master’s degree or Ph.D. training in informatics, engineering, or computer science. However, programs should aim to drive innovation in research and research training through the use of novel ICT implementation and educational approaches.
It is expected that the research education opportunities supported by this initiative will enhance the career development of participants from LMICs and increase collaborative research and research training at their institutions. In addition, it is expected that some of the faculty leaders, mentors, or program partcipants at LMIC institutions will develop into expert resources for the future dissemination of ICT approaches.
The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers, or for public education and outreach on health-related research to a variety of audiences. Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. As such, each application must include a plan to evaluate the activities proposed (see Section IV, Evaluation Plan). For some types of projects, a plan for disseminating results may also be appropriate and may be required as well (see Section IV, Dissemination Plan).
The proposed research education program may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
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; Asian American Native American Pacific Islander 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), and non-domestic (non-U.S.) Entities (Foreign Institutions). All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) entities (foreign institutions) are 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. Non-domestic entities are restricted to institutions in “low and middle income” countries (as defined by the World Bank according to Gross National Income per capita as “low income,” “lower middle income,” and “upper middle income”; see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Applicants must be current or former Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or collaborators of FIC research, research training, or research education grants (R03, R21, R01, R24, R25, R00, U01, D43, S07). PDs/PIs should leverage the qualifying grant, which may entail applying with the co-investigators and collaborators from the current or previous grant or bringing in new collaborators to add expertise or expand the scope of the proposed program.
Individuals from U.S. and LMIC institutions that meet the criteria above are eligible to apply and partnerships between countries are encouraged as long as the capacity building efforts are focused in the LMIC institution(s). Individuals from high income country institutions outside of the U.S. may serve as partners or collaborators in the programs.
Any qualifying individuals with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
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 and programmatically (with respect to the ICT capability to be enhanced) distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Preceptors/Mentors
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award. Applicants are encouraged to include faculty members at LMIC institutions as mentors where appropriate.
Participants
Participants in proposed programs must be recruited from low and middle income countries (as defined by the World Bank according to gross national income (GNI) per capita as “low income,” “lower middle income” and “upper middle income”). For a list of country classifications see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).
Applications must describe the intended participants and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Where relevant, identify the career levels essential for participation in the planned program.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-107.html.