National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
National Eye Institute (NEI)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center (FIC)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
R21 Exploratory/Developmental Research Grant
See Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods, that break new ground, extend previous discoveries in new directions, or develop preliminary data in preparation for larger studies.
Approaches may include but are not limited to empirical qualitative and quantitative methods, and conceptual, legal, and normative analyses. Applied research designed to address ELSI issues in genetics and genomics will also be considered responsive. Direct engagement with communities and other stakeholders is encouraged, but not required.
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 20, 2024 | March 19, 2024 | Not Applicable | July 2024 | October 2024 | December 2024 |
June 18, 2024 | July 17, 2024 | Not Applicable | November 2024 | January 2025 | April 2025 |
October 21, 2024 | November 19, 2024 | Not Applicable | March 2025 | May 2025 | July 2025 |
February 20, 2025 | March 19, 2025 | Not Applicable | July 2025 | October 2025 | December 2025 |
June 17, 2025 | July 18, 2025 | Not Applicable | November 2025 | January 2026 | April 2026 |
October 20, 2025 | November 18, 2025 | Not Applicable | March 2026 | May 2026 | July 2026 |
February 17, 2026 | March 18, 2026 | Not Applicable | July 2026 | October 2026 | December 2026 |
June 18, 2026 | July 20, 2026 | Not Applicable | November 2026 | January 2027 | April 2027 |
October 20, 2026 | November 18, 2026 | Not Applicable | March 2027 | May 2027 | July 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The 2020 NHGRI Strategic Vision notes that genomics has become increasingly woven into the fabric of biomedical research, medical practice, and society and points to the continued importance of focusing on ethical, legal, and social implications (ELSI) research. As biomedical investigators are applying genomic knowledge and tools to study an expanding range of diseases and traits in a wide array of settings, novel ELSI questions continue to emerge.
Innovations in gene editing, gene therapy, polygenic risk scores, and genomic testing across various life stages continue. However, the use of new genomic technologies and information is not always preceded by confirmation of their validity, reliability or utility across populations. Sufficient evidence may be lacking to determine whether new innovations are transferrable across health care settings or valid in populations whose genomic data were not used in their discovery. Professional norms, systemic practices, and societal forces may affect the uptake of genomic medicine across communities. Furthermore, significant distribution and re-distribution of financial and genomic healthcare resources may be needed to achieve genomic equity in the United States and abroad.
Globally, genomic data are being generated, shared and commercialized in an array of settings from academic medical centers to the pharmaceutical industry to law enforcement. Fueled by advances in informatics and sequencing technologies, genomic data is increasingly merged with data from personal mobile health devices, electronic health records, direct-to-consumer tests, social media accounts, assays of environmental exposures, and geocoding systems. The size and scope of research datasets continue to grow, at the same time that broad data sharing has become standard scientific practice. In response, models of data ownership and data stewardship are under scrutiny and in flux. Assessing how governance strategies and technology can be used to ensure that genomic data are ethically sourced and responsibly shared remain considerable challenges.
Translating genomic research and data into fair and appropriate benefits for society presents another set of challenges. The relative dearth of genomic data collected from populations who remain underrepresented in biomedical research and underserved in the healthcare system threatens the just and equitable distribution of benefits from genomic innovation. Potential inequity may be exacerbated by the application of artificial intelligence and machine learning approaches to genomic data analysis. These methods will not produce accurate results if the data upon which they are trained lack broad representation. Efforts to help ensure that the human genome reference sequence and population-based genomic datasets better represent existing human genomic diversity and genetic ancestry are underway. However, evaluating and addressing the availability and quality of genomic information across different groups is an ongoing challenge.
Genomic information can have profound implications for how people understand themselves as individuals, and in relationship or contrast to others. History is replete with examples where the value and predictive nature of genomic information was overstated, misappropriated and weaponized to the detriment of targeted communities and to society more broadly. Such examples are often thought of as part of the field’s troubled and distant past. However intentional and unintentional misinterpretations and misuses of genomic research that disparage groups of people have resurfaced. Extreme examples are typified by people reimagining current genomic findings as justification for racist beliefs and actions. Other problematic examples include research suggesting that complex phenotypes such as hypertension, diabetes, and depression can be meaningfully explained by genomic factors without accounting for the effects of social determinants of health. The rise of oversimplified attributions of individual and group differences to genetic causes threatens the integrity of genomic science and research.
Overall, ongoing advancement and change in the conduct of genomic research and the translation of genomic science may require key stakeholders to revisit, revise and reiterate the norms and responsibilities that guide the field. New ELSI questions continue to arise about genomics while other questions endure, resurface, or are transformed. Yet, at the forefront of genomics remains an incredible array of opportunities to improve the health and wellbeing of genetically and socially diverse people.
The purpose of this NOFO is to solicit applications for research projects that identify, examine, and address the ELSI of advances in genomics for individuals, families, communities, groups, institutions, and society.
To address the broad scope and reach of genomics and corresponding ELSI issues, applications are invited from investigators representing a wide range of academic disciplines, including, but not limited to, bioethics, the humanities (e.g., history, religion, philosophy, literature), behavioral and social sciences (e.g., psychology, sociology, anthropology, political science, economics, communication science), law, genetic and genomic science, genetic counseling, clinical medicine, health services and implementation science research, health disparities and inequities research, health communication, public health, and data science.
Applications are encouraged from multidisciplinary investigator teams who represent a broad range of disciplines, lived experiences and perspectives.
Applications may propose studies using either single or mixed methods. Approaches may include, but are not limited to, conceptual, legal, and normative analyses in addition to empirical qualitative and quantitative methods. Applied research conducted to address real-world ELSI issues facing genomics or to facilitate the uptake of ELSI findings may also be proposed.
NIH encourages applicants to consider the use of variables provided in the PhenX Toolkit which provides recommended standard measures for use in biomedical research. These measures have been selected by domain experts using a consensus process. The Toolkit provides protocols for collecting data, and tools to help investigators incorporate protocols into their studies. Using protocols from the PhenX Toolkit facilitates cross-study analysis, potentially increasing the scientific impact of individual studies. Of note, the Social Determinants of Health (SDOH) Collections may be important for some ELSI projects to consider. In addition to protocols for core SDOH measures, the collection includes measures at individual and structural levels.
Population Descriptors
For the purpose of this NOFO, population descriptors are defined as variables used to describe or distinguish people from each other based on perceived or actual differences. Population descriptors may be used for example, to describe who is participating in a study, what groups are being compared, or to whom particular study findings may apply.
Descriptors measuring the complex concepts of race, ethnicity, genealogical ancestry and genetic ancestry are commonly employed in biomedical, health services, genomic and ELSI research. In the United States, there are real and measurable impacts of one’s racial, ethnic or ancestral identity on health, wellness, and life experiences. It may be valid and valuable to use population descriptors in a given analytical context. However, in some cases socially constructed population descriptors like race and ethnicity are used as proxies for human genetic variation in genetic and genomic research, which can lead to conflation between social and biological groups and can cause harm (NASEM Report Using Population Descriptors in Genetics and Genomics Research).
Similarly, sex, gender, gender identity and sexual orientation are complex, related constructs that are conceptually distinct (NASEM Consensus Report, Measuring Sex, Gender Identity, and Sexual Orientation). They are commonly studied aspects of human identity that impact health, access to health care services, and experiences with discrimination; however, they are often mismeasured and misrepresented in research. Investigators using sex- and gender-related population descriptors in their analyses must understand the distinctions between different measures, and choose accordingly.
Overall, the scientific questions to be addressed should guide whether and which population descriptors are used in a given study. Investigators should use established theory, frameworks, or scientific evidence to inform their use of population descriptors. Investigators must consider which population descriptors measure the phenomena of interest, and whether other validated variables (e.g., social determinants of health) may be more directly associated with those phenomena. The communities or groups involved in a study may have important insights about the most relevant descriptors to use. Investigators can consider collecting data on multiple descriptors of a concept, while also collecting only necessary data in pursuit of well-defined research goals.
To enhance the rigor and replication of proposed research, applications to this notice should be transparent in the Research Plan about the use of population descriptors. Applications should also be transparent about the use of race, ethnicity or ancestry as proxies for other contributing factors, and acknowledge the challenges and limitations of doing so.
Community and Stakeholder Involvement
There are a variety of communities and stakeholders whose knowledge, perspectives and experiences can inform and improve the field of genomics. Community or stakeholder involvement in any and all phases of a research project is encouraged, where appropriate, but not required. For the purposes of this NOFO, the term community refers to "a group or groups of people affiliated by geographic proximity, special interest, or similar situations" (Centers for Disease Control and Prevention, 2011). The term stakeholders refers to individuals, organizations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavor (Deverka et al. 2012). Community and stakeholder involvement may include a range of methods or approaches that vary in level and intensity, including, but not limited to, establishment of advisory boards or panels, stakeholder-driven research, community-oriented research, or community-based participatory research.
Areas of Research Interest
The following research areas of interest have been identified by the participating ICOs.
National Human Genome Research Institute
The NHGRI is interested in research that addresses:
Research which focuses on the acceptability and accessibility of genetics or genomics to all communities is highly encouraged, particularly communities that have been underrepresented, underserved and/or mistreated. These communities could include, but are not limited to, racial, ethnic, sexual and gender minorities, people with disabilities, those from disadvantaged backgrounds or those living in medically underserved areas.
Further detail on topics of interest is included on the NHGRI ELSI Research Domains website at: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program/domains. The examples provided here and online serve as a general guide to areas of importance and should not be viewed as a comprehensive list of research topics. Applicants are encouraged to propose topics and issues that are ripe for research, especially given rapid advances in genomic science and continued growth in the interpretation and use of genomic information.
Research projects may develop tools and findings that can be applied across many diseases and conditions. Projects focused on a single disease or disorder may be of lower priority for NHGRI unless generalizability or transferability of findings and resources is clearly demonstrated and described.
Fogarty International Center
The Fogarty International Center (FIC) is interested in supporting research on ethical issues related to human genome research relevant to low- and middle-income countries (https://datahelpdesk.worldbank.org/knowledgebase/articles/906519), in particular, studies conducted by investigators in these countries.
National Cancer Institute
The NCI is interested in research that focuses on the ethical, legal, and/or social implications of genetics and genomics in cancer-related research, care, and public health contexts; with additional emphasis on incorporating diverse populations and addressing cancer disparities. In particular, the NCI is interested in the following:
The ultimate goal of this research will be to understand how people make sense of and act upon genetic and genomic information related to cancer; to inform the ethical conduct of cancer research involving genetic and genomic information and data; and overall to improve outcomes related to cancer.
National Eye Institute
The National Eye Institute (NEI) is interested in supporting projects that address ethical, legal and social issues arising from genomic research relevant to our mission of eliminating vision loss and improving quality of life through vision research, especially those that are relevant to NEI’s Strategic Plan (i.e., to understand the eye and visual system, prevent and treat vision diseases, and expand opportunities for people who are blind or require vision rehabilitation).
National Institute of Allergy and Infectious Diseases
NIAID is NOT interested in supporting clinical trials under this announcement but would consider non-IND trials, e.g., social/behavioral-relevant trials.
NIAID is interested in supporting projects that focus on ethical, legal, and social implications of genomic research that derive from domestic or international research on HIV/AIDS, other infectious diseases including those transmitted by vectors; immunologic and allergic diseases, or organ transplantation; and other ELSI issues arising from genomics that are relevant to NIAID's scientific mission. Applications should consider the following:
Eunice Kennedy Shriver National Institute of Child Health and Human Development
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in supporting ELSI research on topics relevant to NICHD's populations of interest, including children; adolescents; pregnant and/or lactating individuals; and persons with intellectual, developmental, and/or physical disabilities across the lifespan.? NICHD is particularly interested in research that relates to the Institute’s high-priority research areas: see https://www.nichd.nih.gov/grants-contracts/research-areas/priorities for current research priorities, and https://www.nichd.nih.gov/about/org/strategicplan regarding research themes for the Institute.? Please note that applications assigned to NICHD that address the mission and priorities of other Institutes that are not participating in this NOFO will not be prioritized for funding by NICHD.
Specific topics of interest to the NICHD include, but are not limited to, ELSI research on the following, subdivided by the NHGRI ELSI research areas:
Genomics and sociocultural structures and values
Genomics at the institutional and system level
Genomic research design and implementation
Genomic healthcare
National Institute on Deafness and Other Communication Disorders
The NIDCD is interested in addressing ethical, legal and social issues, related to normal and disordered process, that evolve from genomic research in our mission areas of hearing, balance, taste, smell, voice, speech, and language.
National Institute of Dental and Craniofacial Research
The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan (see:?https://www.nidcr.nih.gov/about-us/strategic-plan). Within the goals of this notice, and as related to its mission, NIDCR is interested in ELSI research in the following areas:?
National Institute on Drug Abuse
The National Institute on Drug Abuse (NIDA) is interested in research that focuses on the ethical, legal, social, and policy issues related to genetic, epigenetic, and genomic research on addiction and addictive substances, especially those that align with NIDA’s Strategic Plan (https://nida.nih.gov/about-nida/noras-blog/2022/09/nida-releases-its-2022-2026-strategic-plan). NIDA encourages applicants to consider developing novel collaborations between the ELSI and Addiction research communities. ELSI research topics of particular interest to NIDA include, but are not limited to, the following:
National Institute of Environmental Health Sciences
The NIEHS is interested in addressing social, ethical, and legal concerns in research related to gene-environment (G x E) interactions, genetic susceptibility to environmental exposures, and ELSI issues related to research involving children, aged populations, tribal communities, and other vulnerable populations impacted by specific environmental exposures. NIEHS is interested in environmental justice and health disparities issues associated with the identification of vulnerable populations in G x E studies and the incorporation of social determinants of health into the G x E research framework. The potential evolving ELSI issues associated with developing improved health risk assessments that leverage emerging findings from combined epigenomics, exposomics, and genomics research is particularly welcome. Identifying, developing, and testing strategies for responsibly reporting back health results from research on G x E interactions to study participants is relevant. Exploring best practices to identify and share actionable environmental exposures (e.g., giving participants and communities access to resources to mitigate environmental exposures) and exploring how people and communities respond and modify their behavior with report-back is also of interest.
NIEHS is additionally interested in research on potential stigmas, discriminations, and privacy concerns associated with either identification of subpopulations at disease/disorder risk due to genetic susceptibility of environmental exposures or potential identification of individuals living in geographic areas linked to high exposures of environmental pollutants. Exploration of best practices to protect the privacy and use of G x E research data at the community level is of particular interest as well. ELSI issues surrounding community engagement approaches and best practices to establish sustainable infrastructures to conduct community-based/community-led research in G x E is also needed.
National Institute of Mental Health
The NIMH is interested in research to address a range of ethical, legal and social issues for individuals and communities relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH.
Areas of emphasis include but are not limited to:
NIMH encourages projects that will partner with/embed within existing large-scale psychiatric genetics research efforts and others global research network to facilitate answering questions relevant to the execution of that research and implementation of the findings. Such networks include, but are not limited to, PsychENCODE, PsycheMERGE, Psychiatric Genomics Consortium, the Autism Sequencing Consortium, the Convergent Neuroscience Research Network, the Genes 2 Mental Health Network, and the Global Mental Health Genetics Network, Collaborative Hubs for International Research in Mental Health and Collaborative Hubs to Reduce the Burden of Suicide among American Indian and Alaska Native Youth. NIMH also strongly encourages groups to leverage existing ELSI resources developed by NHGRI under prior ELSI funding calls.
NIMH will only award non-trials or mechanistic clinical trials under this announcement. Groups wishing to address the Safety, Efficacy, and Effectiveness of Preventive, Therapeutic, and Services Interventions should apply through the NIMH Clinical Trial Pipeline.
National Institute of Neurological Disorders and Stroke
The NINDS is interested in research that addresses ethical, legal, and social issues for individuals and communities that emerge from human genome research in the domain of NINDS’s core mission and the topics and disorders for which NINDS serves as a primary lead at the NIH. Please visit: https://www.ninds.nih.gov/About-NINDS. Areas of interest specific to NINDS include but are not limited to the ethical, legal, and social implications of: aspects of neurogenetic research with human participants, such as differing stakeholder views on return of research results to participants or patient consent-related issues (including, but not limited to, waivers of informed consent or exceptions from informed consent), or therapeutic misconception, including for rare genetic diseases; neurogenetic research with human nervous system tissue; development and/or application of gene therapy and gene editing technologies for neurogenetic disorders; issues collecting and sharing human neurogenetic data, such as de-identification, privacy, and re-use practices; predictive/diagnostic neurogenetic research related to nervous system disorders; management and understanding of uncertain individual neurogenetic research results and secondary findings; and issues pertaining to neurogenetic research with children, patients with rare diseases, and other vulnerable populations who may have a limited ability to consent for themselves.
NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy).
While this funding opportunity also accepts clinical trials, only applications proposing mechanistic clinical trials or studies (studying pathophysiology or mechanism of action of an intervention, but not safety or efficacy) or basic experimental studies with humans (BESH) will be supported by NINDS.
Applications for clinical trials studying efficacy or safety will not be supported, and may be better suited for PAR-22-142, PAR-21-237, or other relevant clinical trials funding opportunities supported by NINDS. In addition, applications addressing ethical issues associated with and resulting from research on emerging technologies and advancements supported by the BRAIN Initiative will not be supported and may be better suited for RFA-MH-21-205.
Office of Research on Women's Health
The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director and works in partnership with the NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations.
For this NOFO, ORWH is interested in supporting research that addresses health equity in genomic research that will eliminate health inequities among women, including those who are understudied, underrepresented, and underreported (U3). The evolving conceptualization of factors relevant to the understanding and promotion of minority health and to the understanding and reduction of health disparities is illustrated in the NIMHD Minority Health and Health Disparities Research Framework. Applying such a framework to genomic research will help to advance the community engagement, access to genomic technology, acceptability of genomic approaches, and interventions to the public needed to advance the equitable use of genomics to improve health in US populations.
There is also a crucial need to address sex and/or gender influences in genomic research relevant to women's health, and, where appropriate, include both sexes to better understand the influence of sex as a biological variable (SABV) on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for women and men. For additional guidance, please review the 2019-2023 Trans-NIH Strategic Plan for the Health of Women.
Related Notices of Funding Opportunity
Applications to this NOFO should propose exploratory or developmental studies that can be accomplished in two to three years. Often these applications perform pilot or feasibility studies or are used to generate data in preparation for a larger study.
For very small projects, such as those involving single investigators, focused conceptual or analytical studies, or secondary data analyses, applicants may wish to consider PAR-23-295 the ELSI Small Research Grant (R03) NOFO, which provides a total of up to $50,000 in direct costs a year for two years. For larger multi-disciplinary studies that are building on preliminary data and require funding beyond two years, applicants may wish to consider PAR-23-293 the ELSI Research Project Grant (R01) NOFO, which provides funding for up to five years. Note that not all Institutes and Offices participating in this R21 NOFO participate in the R01 or R03 NOFOs.
Data sharing
Recipients must comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports broad appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan. Applications directed to NHGRI should ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.
Applicants are strongly encouraged to contact NIH Scientific/Research Staff at the relevant participating ICO(s) listed at the end of this NOFO, prior to developing an application to discuss whether their application is responsive.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are limited to a combined total of no more than $275,000 in direct costs for the two or three-year project period with no more than $200,000 in direct costs in a single year.
Budgets should include costs required to implement the proposed Data Management and Sharing Plan and the proposed Resource Sharing Plan.
The scope of the proposed project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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
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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.
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 their 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
2. Cost Sharing
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Budgets should include any funds required to support sharing of scientific data under this NOFO. NIH provides guidance on allowable costs for data management and sharing here. For projects generating genomic data derived from research participants, investigators should also consider costs associated with complying with the NIH and NHGRI GDS Policy expectations (e.g., obtaining samples with explicit informed consent for future research use and broad data sharing, implementing processes to seek new consent from study participants, etc.).
Applications that include community members or stakeholders as research team members or advisors should describe their research roles in the budget justification and describe budgetary support to enable their successful involvement in the project.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Research projects that will use population descriptors in the analyses should name and define those variables, provide a rationale for their use and note any associated limitations. Variables whose use should be explained include population descriptors related to race, ethnicity, genealogical ancestry, genetic ancestry, sex, gender, and sexual orientation. The rationale should be supported by established theory, frameworks, or scientific evidence. The Research Strategy should describe how planned use of the selected variables relates to the proposed research question(s), and describe any assumptions or limitations associated with their use.
Applicants who propose to address or analyze race, ethnicity, genealogical ancestry or genetic ancestry are strongly encouraged to review the 2023 National Academies of Sciences, Engineering, and Medicine (NASEM) report, Using Population Descriptors in Genetics and Genomics Research: A New Framework for an Evolving Field and Recommendations for Transforming the Use of Population Descriptors in Human Genetic and Genomics Research. Those proposing to address or analyze concepts related to sex and gender are strongly encouraged to review the 2022 NASEM report Measuring Sex, Gender Identity, and Sexual Orientation.
Applicants are not required to include in their scientific analyses any variable that is required for NIH inclusion enrollment reporting. Do not explain in the Research Plan any variables that are collected solely for the purpose of NIH inclusion enrollment reporting that will not be used in data analysis.
NIH encourages applicants to consider the use of variables provided in the PhenX Toolkit which provides recommended standard measures for use in biomedical research. These measures have been selected by domain experts using a consensus process. The Toolkit provides protocols for collecting data, and tools to help investigators incorporate protocols into their studies. Using protocols from the PhenX Toolkit facilitates cross-study analysis, potentially increasing the scientific impact of individual studies. Of note, the Social Determinants of Health (SDOH) Collections may be important for some ELSI projects to consider. In addition to protocols for core SDOH measures, the collection includes measures at individual and structural levels.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
All applications, regardless of the amount of direct costs requested for any one year, must develop a Resource Sharing Plan consistent with the goals of the proposal.
The Resource Sharing plan should summarize whether and how research findings and products (e.g., publications, meeting reports, software, websites, research tools) will be made available to relevant communities and stakeholders. Applicants should include a proposed timeline for implementing the Resource Sharing Plan, name the platform(s) or mechanism(s) that will be used to make research findings and products publicly accessible, and indicate who will be responsible for implementation. Applicants sharing software are encouraged to use software licenses that allow for unrestricted redistribution and modification of the software. Additionally, NHGRI encourages investigators to consider disseminating research findings and products via publicly accessible platforms such as the Center for ELSI Resources and Analysis.
Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with the NHGRI’s data sharing expectations explained below. Additional information can be found at genome.gov/data-sharing.
Per NOT-HG-21-022, NHGRI expects applications awarded under this NOFO to share comprehensive metadata and phenotypic, clinical, and environmental exposure data associated with the study; use standardized data collection protocols and survey instruments for capturing data, as appropriate; and use standardized notation for metadata (e.g. controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses.
To ensure that maximal scientific benefit is derived from this significant public investment, this funding opportunity aims to advance and accelerate research by supporting rapid sharing of the resulting data with the broad scientific community. All resulting scientific data should be submitted to an established repository as described in the Data Management and Sharing Policy guidance and NHGRI’s guidance on where to submit scientific data.
Where human biological samples will be studied, they are expected to have been obtained using a documented informed consent process that allows for future research use and broad data sharing (NOT-HG-20-011). If new human biospecimens will be collected, or if clinical application is included in the application, the consent process should be described at a high level in the Research Plan and detailed in the Human Subjects Section.
NHGRI strongly encourages studies that propose to derive genomic data from human specimens and cell lines to obtain participant consent either for general research use through controlled access or for unrestricted access. Similarly, consent language should avoid both restrictions on the types of users who may access the data and restrictions that add additional requirements to the access request process. NHGRI acknowledges that this will not always be possible or appropriate. In addition, individual participants who do not consent to future research use or broad sharing of their data (i.e., submission of their data to a publicly accessible data repository) may still participate in the primary study if consistent with study design. Additional guidance on informed consent can be found in the NHGRI Informed Consent Resource.
Applicants are encouraged to get feedback from the communities in which the research will be performed regarding plans for how individual level data resulting from the research projects will be shared with the scientific community for research purposes. Feedback and recommendations for data access, protection of participant and patient privacy and confidentiality, and management of health information should be integrated into the project’s Data Management and Sharing Plan. Note that any project receiving NIH funding that collects or uses identifiable, sensitive information is automatically issued a Certificate of Confidentiality (CoC).
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this NOFO:
If the research project uses population descriptors related to race, ethnicity, genealogical ancestry, genetic ancestry, sex, gender, or sexual orientation in the analyses, does the application name and define those variables, provide a rationale for their use, and note any associated limitations?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
3. Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
4. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
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Dave Kaufman
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email:dave.kaufman@nih.gov
Nicole Lockhart
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: lockhani@mail.nih.gov
Rene Sterling
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-1275
Email: rene.sterling@nih.gov
Bracie Watson, PhD
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.402.3458
E-mail: watsonb@nidcd.nih.gov
Rosemary McKaig, Ph.D., M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3214
Email: rmckaig@niaid.nih.gov
Charlisse Caga-Anan
National Cancer Institute (NCI)
Telephone: (240) 276-6738
Email: charlisse.caga-anan@nih.gov
Barbara J Sina
FIC - FOGARTY INTERNATIONAL CENTER
Phone: 301-402-9467
E-mail: sinab@mail.nih.gov
Miri Gitik, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-827-3523
E-mail: miri.gitik@nih.gov
Rajeev K Agarwal, Ph.D.
ORWH - Office of Research on Women's Health
Phone: 301-451-7058
E-mail: agarwalraj@mail.nih.gov
Elena K Gorodetsky, M.D., Ph.D.
ORWH - Office of Research on Women's Health
Phone: (301) 402-1770
E-mail: egorod@mail.nih.gov
Amy Tsou, MD, MSc
National Institute of Neurological Disorders and Stroke (NINDS)
Email: amy.tsou@nih.gov
Phone: 240.987.2815
Kimberly A McAllister, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-3287
E-mail: mcallis2@niehs.nih.gov
Mollie Minear, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: mollie.minear@nih.gov
Alicia Yesiu Chou, MS
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-4874
E-mail: alicia.chou@nih.gov
Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-78658
Email: Deanna.Ingersoll@nih.gov
Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: samantha.tempchin@nih.gov
Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: ann.devine@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov
Victoria Quach Tran
FIC - FOGARTY INTERNATIONAL CENTER
Phone: 240-726-0654
E-mail: vicky.tran@nih.gov
Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Clark Phillips
NIEHS - National Institute of Environmental Health Science
Phone: 984-287-4037
Email: clark.phillips@nih.gov
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov
Diana Rutberg, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4798
E-mail: dr258t@nih.gov
Gabriel Hidalgo
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Email: gabriel.hidalgo@nih.gov
Phone: 301.827.4630
Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.