Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

National Cancer Institute (NCI)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

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 Science Research (OBSSR)

Funding Opportunity Title

Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

Reissue of PA-17-446

Related Notices
None
Funding Opportunity Announcement (FOA) Number

PAR-20-255

Companion Funding Opportunity

PAR-20-254, R01 Research Project Grant
PAR-20-257, R03 Small Grant Program

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.172; 93.399; 93.867; 93.866; 93.113; 93.242; 93.853

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research.  These applications should propose single or mixed methods studies that break new ground, extend previous discoveries in new directions or develop preliminary data in preparation for larger studies. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.

Key Dates
Posted Date

July 29, 2020

Open Date (Earliest Submission Date)

September 19, 2020

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

New Application Due Dates: October 19 2020, February 17 2021, June 17 2021, October 19 2021, February 17 2022, June 17 2022, October 19 2022, February 17 2023, June 19 2023  

Resubmission and Revision Due Dates: November 17 2020, March 17 2021, July 19 2021, November 17 2021, March 17 2022, July 19 2022, November 17 2022, March 17 2023, July 19 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s)

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.

AIDS Application Due Date(s)
Scientific Merit Review

February 2021, June 2021, October 2021, February 2022, June 2022, October 2022, February 2023, June 2023, October 2023

Advisory Council Review

May 2021, October 2021, January 2022, May 2022, October 2022, January 2023, May 2023, October 2023, January 2024

Earliest Start Date

July 2021, December 2021, April 2022, July 2022, December 2022, April 2023, July 2023, December 2023, April 2024

Expiration Date

July 20, 2023  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

     

    Research Objectives and Approaches

    Ongoing advances in genomic technology and data science, and continued improvements in the efficiency and cost of nucleic acid sequencing have rapidly increased the number of people whose genome is being sequenced. Readily available genomic data has transformed biomedical research in a growing number of disease areas and is likely to have a large impact on health care and other aspects of society.  New questions about the ELSI of genomics will emerge as the field continues to evolve.

    Genomic information is used for a growing variety of purposes. New connections are being made between genomics and concepts of personality, health, disease, disability, race, ethnicity, and family. As societal views of genomics change, so do foundational concepts of privacy, identity, health, and disease.  

    At the same time, genomic data science is working to gain new insights by merging genomic datasets with data collected from personal mobile devices, social media accounts, geocoding systems, and electronic health records. Cloud data systems are shaping how genomic data are stored, shared, and used. Artificial intelligence and machine learning approaches are being pursued to make health care recommendations that integrate genomic information with other health associated measures. Against this dynamic backdrop, individuals, communities, and genomic researchers may have different needs and beliefs about the uses of genomic data. 

    In addition, medical applications of genomics, such as gene therapy, polygenic risk scores and healthy genomic screening, continue to develop. Their introduction into clinical settings and populations beyond the reach of major academic medical centers raise new variations of standing ELSI concerns. The priority and utility of applying genomic medicine may vary across diverse medical systems. Relevant issues include how genomic test results are returned to patients, the availability and expertise of health care professionals, and the quantity and quality of genomic data used to inform health care provided to racial and ethnic minority patients. 

    Taken together, these developments may lead to profound improvements in the health and wellbeing of many individuals from genetically and socially diverse populations. However, these developments may also exacerbate health disparities and inequities. Scientific methods, clinical practices, structural factors, and social norms may lead to disparities, inequities, and mistreatment in genomic science and medicine. 

    The purpose of this FOA is to solicit exploratory or developmental research applications that identify, analyze, and address the ethical, legal and social implications (ELSI) of these technological advances for individuals, families, communities and society. The ongoing evolution of genomic research and health care requires a continuing analysis of the legal and normative underpinnings of beliefs, practices and policies regarding research, health and disease.  In addition, as personal genomic information permeates many aspects of society, it has profound implications for how we understand ourselves as individuals and as members of families, communities, and society--and even for how we understand what it means to be human.  Long-held beliefs about the continuum between health and disease may be transformed, as will concepts of free will and responsibility. 

    To address the broad scope and reach of genomic advances, applications are invited from investigators representing a wide range of disciplines; including but not limited to ethics, genetics and genomics, clinical medicine, law, health disparities and inequities research, health services and implementation research, public health, bioinformatics and health information sciences, behavioral and social sciences (e.g., psychology, sociology, anthropology, political science, economics, communication science) and the humanities (e.g., history, religion, philosophy, literature).

    Applications may propose multi-disciplinary studies using single or mixed research methods.  Proposed methods may include but are not limited to data-generating qualitative and quantitative approaches, legal, economic and normative analyses, and other types of analytical and conceptual research methodologies, including those involving the direct engagement of stakeholders.

    Applications to this FOA should propose exploratory or developmental studies that can be accomplished in two 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-20-257, the ELSI Small Grant (R03) FOA, 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-20-254, the ELSI Research Project Grant (R01) FOA, which provides funding for up to five years. Note that not all Institutes participating in this R21 FOA participate in the R03 FOA.

    Applicants are strongly encouraged to contact ELSI program officials at the participating Institutes prior to developing an application.

    Areas of Research Interest

    There is continued interest in issues that arise in connection with the design and conduct of genetic and genomic research; the translation of genetic and genomic research into clinical medicine and health care; and the legal, regulatory, policy, economic, ethical, and societal issues raised by the use of genomics. Examples of some emerging topics appropriate for exploration are outlined below.  

    The increased integration of personal genomic information into many aspects of modern life raises new and urgent research questions. Genomic information may begin to influence behavior as well as our concepts of health and disease, responsibility and justice, family, identity and community.

    Proposed research could: 

    • Analyze and measure normative, legal, economic, behavioral, and other impacts of genomics on society
    • Assess the roles that stakeholders play in shaping interpretations of genomics
    • Examine uses and misuses of genomic information, analyze how such uses influence the meaning and power of genomic information, and anticipate downstream effects on socio-cultural norms and institutions
    • Develop and test strategies to address misrepresentations, misunderstandings, and misuse of genomics at an individual, institutional, or systemic level

    New data science approaches present challenging questions about governance, data control, privacy, consent, and participation of mistreated, underserved or underrepresented populations. Making acceptable decisions and polices about the use and flow of genomic and health data is a multi-dimensional problem that must consider stakeholders’ goals and values. Proposed research could: 

    • Study evolving values and norms surrounding data use, privacy, and protection; as well as gaps in current policies and statutes related to genetics and genomics
    • Design and evaluate tools to aid individual, family, and community decision-making about use of and access to their data
    • Inform evidence-based policy and data stewardship frameworks that facilitate open science and account for a variety of preferences
    • Explore the implications of new data science approaches and uses of existing data in unexpected ways 

    The rapid innovation and adoption of new genomic technologies may be unfamiliar, futuristic, or even threatening to some individuals or communities.  Special consideration is required for communities who have been historically mistreated, underserved or underrepresented in biomedical research.  To help ensure that genomic research and medicine are acceptable and accessible to these communities, and to help ensure health equity in its implementation, proposed research could:

    • Explore how priorities and values concerning the use of genomics differ among communities and how they can inform genomic science
    • Assess how mistreated, underrepresented and underserved communities define the utility of genomic medicine 
    • Define what it means to advance equity and diversity in genomics, and how to adapt research and clinical approaches in response
    • Explore how genomics may alleviate or exacerbate current health disparities or inequities
    • Assess and address how ethical, historical, social, economic, legal, regulatory, socio-cultural and contextual factors surrounding genomics serve as barriers or facilitators to the uptake of genomic medicine in mistreated, underrepresented and underserved communities
    • Assess and address the implications of new and emerging genomic technologies, including concerns and barriers to the adoption and accessibility of such technologies

    Additional topics of interest are listed on the 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 evolution in the interpretation and use of genomic information.  As appropriate to the area of exploration, applicants may propose research to be conducted as an independent project or embedded within an existing genomic research project; and/or include genomic researchers as subject matter experts on ELSI research project teams.  

    Applicants are encouraged to explore other relevant funding opportunities developed by NHGRI and by other NIH Institutes and Centers (ICs).

    The following research areas of interest have been identified by the participating ICs.

    The National Human Genome Research Institute (NHGRI) is interested in research that addresses:

    • The ELSI that arise from genomic research and genomic health care across a broad spectrum of diseases and conditions
    • The broader implications of the expansion of genomic research and genomic health care and of the use of genomic information in non-medical settings

    This includes basic normative and conceptual research, and the development of tools and generation of data that can be applied across many different diseases and conditions.  Projects focused on a single disease or disorder may be of lower priority for NHGRI unless generalizability is clearly shown.  Some examples of topics of specific interest to NHGRI are listed above.  Additional sample topics are available on the website referenced above. 

    The NCI is interested in research that focuses on the ethical, legal and social issues related to cancer and genomics. In particular, the NCI is interested in the following:

    • Studies on the anticipated and actual psycho-social and behavioral impact of genetic and genomic information and delivery methods on affected individuals, their families, and populations
    • Studies that examine and aim to improve the communication processes and disclosure of information about cancer genetics and genomics in a variety of contexts (clinical encounters, telemedicine, family communication, direct-to-consumer advertising)
    • Studies that explore the emerging ethical, legal, and social implications of having individuals’ genetic and genomic information made available online (through social media, electronic medical records, telemedicine, and participation in research on the Internet)  
    • Studies evaluating the ethical, legal, and/or social implications of communication strategies and tools used to share or disseminate genetic and genomic information with individuals, families, and communities/populations
    • Studies on the ethical, regulatory, and policy challenges in cancer research involving genetic and genomic information (e.g. clinical oncology trials, population-based studies, observational studies, etc.), including research on innovative approaches to those challenges
    • Studies on the issues raised by the collection, storage, and future research uses of biological samples and of associated data (e.g. participant preferences, informed consent, governance, privacy and security, and data sharing), including innovative approaches to these issues; additionally, multi-level studies examining patient, caregiver, provider, organizational, and health system perspectives on these issues
    • Studies that take into consideration the perspectives of diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities (including perspectives on genomic-based targeted therapies)
    • Studies on models of participant and community engagement or participatory research methods in cancer genomics research
    • Studies on the ethical/legal/social implications of the use of genomic technologies to address cancer disparities
    • Studies addressing ethical/legal/social challenges of improving genomic-based targeted therapies for diverse subpopulations
    • Intervention studies that examine uptake of personalized genomic testing and the adoption of risk-reduction health behaviors (diet, physical activity, obesity/weight loss) after receiving testing results in diverse populations   
    • Studies of how context affects use of genomic technologies and related patient outcomes of cancer care delivery (examples of context include community setting vs. academic setting, availability of relevant clinical expertise, extent of clinical team collaboration, patterns and channels of communication, and use of various IT systems)

    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.

    The NEI is interested in addressing ethical, legal and social issues related to normal and disordered processes that evolve from genomic research in our mission areas of understanding mechanisms of visual function; preventing, treating, or reversing vision loss; and addressing the special health problems and requirements of the blind.

    The NIA is interested in research that focuses on the ethical, legal and social issues related to aging and genomics.

    • The ethical, legal, and social issues that arise from genomic research and genomic health care across a broad spectrum of aging research incorporating genomics
    • The broader implications of the expansion of genomic research and genomic health care for the aging population
    • The use of genomic information on the aging population in medical and non-medical settings

    This includes basic normative and conceptual research and the generation of data and development of tools that can be applied across aging and genomics, including Alzheimer’s Disease (AD) and Related Dementias (RD). 

    The NIEHS is interested in addressing social, ethical, and legal concerns in research related to gene-environment interactions, environmental health hazards, 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. 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. NIEHS is additionally interested in research on the bioethical issues related to data sharing requirements of biosamples collected in environmental health studies in vulnerable or unique populations as well as the stigma associated with either identification of subpopulations at particular disease risk due to genetic susceptibility of environmental exposures or potential identification of individuals living in geographic areas linked to high exposures of environmental pollutants. 

    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:

    • Implementation of psychiatric genomic medicine that takes into account cultural practices and values to promote inclusion and equity in mental health outcomes.  
    • ·    Studies on outreach and community engagement in neuropsychiatric genetics research study design and execution, especially the inclusion of diverse cultural values and perspectives from populations currently underrepresented in the scientific community and/or the research subject population whose populations may be the focus of increased recruitment efforts for neuropsychiatric research (See PAR-20-027 and PAR-20-026 - Genetic Architecture of Mental Disorders in Ancestrally Diverse Populations)
    • ·     Advance understanding on how to avoid or mitigate against stigmatization, group harms, and unintended negative social implications/exacerbations of structural inequalities when conducting research addressing the genomic underpinnings of cognitive and behavioral traits across the spectrum of human phenotypic variation (e.g. intelligence, sexual orientation, gender identity, socio-economic activities) when examined in the context of their contribution to risk and resilience in mental health outcomes
    • ·    Research related to implications of investigating genetic risk for mental health disorders in communities that experience sustained systemic community stressors that may influence risk for poor mental health outcomes, such as the experience of marginalization, discrimination, and/or racism
    • ·    Investigations into how to appropriately contextualize genetic information with environmental, cultural, intervention combinations and response, mental and physical health comorbidities, and societal (e.g. systemic racism) factors when assessing diagnosis, disorder trajectory, treatment recommendations, and drug-drug interactions in diverse patients
    • ·    Research related to the implementation of Artificial Intelligence that integrates genetic information with environmental and other health information in the diagnosis and/or stratification of clinical populations for treatment. The goal should be developing efficient computational strategies to reduce model bias, improve data coverage, equity, fairness towards underrepresented minorities (e.g., through Generative Adversarial Networks & Digital-Twin technology)
    • Research on the use of genetic screening and genetic testing for neuropsychiatric disorders in medical practice, especially among vulnerable and/or underserved populations, including the implications for:
    • ·    Ethical and cultural issues surrounding informed consent, data sharing, and privacy for data collected in a heath care setting (i.e. EHR or health-care system biobanks)
    • ·    Return of results and communication of primary findings and secondary findings in a health care setting (e.g. how would the communication of the absence/presence of genetic findings influence patient behavior or encourage/discourage individuals from seeking treatment)
    • ·    The ethical issues related to early intervention therapies (e.g. somatic gene editing, drugs, behavioral) for neuropsychiatric developmental conditions identified by genomic technologies, especially in 1) disorders with late childhood, adolescent or adult onset; or 2) early childhood onset disorders that present with a broad spectrum of severity in outcomes. These studies should consider differences in cultural practices and values across different communities
    • ·    Use of genomics in Precision Medicine, both for clinical and personal decision making, including indications favoring specific interventions (e.g. genetic testing that suggests favoring biological rather than psychosocial interventions; pharmacogenomic testing favoring higher-risk treatments as potentially more effective than those with lower risk; absence/presence of genetic finding discouraging providers from considering all available treatment options)
    • ·    Effects on the legal and regulatory landscape and existing structural inequalities. (e.g. avoiding discrimination in employment, housing, military service, etc. based on genetic risk of mental disorder and/or use of preventive interventions or services)
    • Studies on ethical, legal, and social implications raised by the collection, storage, and future research uses of biological samples and genetic data collected for neuropsychiatric research (e.g. participant preferences, informed consent, governance, privacy and security, and data sharing)
    • ·    Risk assessment is needed for how changes in the science of a neuropsychiatric disease would impact the research subject community (i.e. those living with the disorder and their families who have contributed data or samples to prior research) with respect to informed consent. An example is the increased understanding of the genetic interrelatedness of neuropsychiatric disorders, pleiotropy and locus heterogeneity as it applies to consent for use in related disorder research. Assessment is needed to determine how such a change can most easily be appreciated by the study population and research subject community at large, and how these changes impact subjects understanding of informed consent and the ability to share data and samples 
    • ·    Investigations relating to ethical and cultural issues raised by collections of data and samples from vulnerable and underserved populations in US, including Tribal communities, and populations in different cultural contexts in LMICs, whose populations may be the focus of increased recruitment efforts for neuropsychiatric research (See PAR-20-027 and PAR-20-026 - Genetic Architecture of Mental Disorders in Ancestrally Diverse Populations

    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 Genomics Psychiatry Cohort, the Autism Sequencing Consortium, the Convergent Neuroscience Research Network, the Genes 2 Mental Health Network, Autism Biomarkers Consortium 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.

    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; neurogenetic research with human brain tissue; collecting and sharing human neurogenetic data, such as de-identification, privacy, and re-use practices; predictive/diagnostic neurogenetic research related to brain 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.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Resubmission
    Revision

    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 FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Award Budget

    Application budgets are limited to a combined total of no more than $275,000 in direct costs for the two year project, with no more than $200,000 in direct costs in a single year

    Budgets should include costs required to develop and implement the proposed Resource Sharing Plan.

    Award Project Period

    The scope of the proposed project should determine the project period.  The maximum project period is 2 years.

     

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • 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. Territory or Possession

    Other

    • 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
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    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 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)– 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.
    • o   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 to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

    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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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.

    2. Cost Sharing

    This FOA 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.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

     

    Section IV. Application and Submission Information
    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 FOA. 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    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.

    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:

    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, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, are expected to include a resource sharing strategy consistent with achieving the goals of the program.  

    NIH encourages data sharing efforts that allow for aggregation and/or reuse of data, and maximize the value of research participant contributions.?Where applicable, this could include the use of validated and/or harmonized measures and provision of associated metadata to contextualize data for future users. To increase the scientific impact of individual studies and facilitate collaboration, comparison, and replication, NIH also encourages investigators to make data collection tools, instruments, and other resources publicly accessible through platforms such as the Center for ELSI Resources and Analysis or other appropriate mechanisms.

    In developing a Resource Sharing Plan, applicants are encouraged to include the following:

    • A summary of the data, tools, instruments, and/or other resources used in the project that will be shared
    • For projects involving human subjects, the procedures used to obtain informed consent during the project and to protect research participant confidentiality when data are shared during or after the project
    • A rationale and justification for any data, tools, instruments, and/or other resources used in the project that will not be shared
    • The platform(s) or other mechanism(s) that will be used to make the data, tools, instruments, and/or other resources publicly accessible; or the process by which a researcher can request them if not publicly accessible
    • The conditions under which data will be made publicly accessible or shared upon request, including any restrictions on or requirements for future use 
    • The personnel who will be responsible for implementing and managing the Resource Sharing Plan, including making data, tools, instruments, and/or other resources available 
    • The proposed timeline for implementing and managing all aspects of the Resource Sharing Plan, including but not limited to when data, tools, instruments, and/or other resources will be available

     

    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.

    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 Policy on Late Application Submission.

    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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number 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. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    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 level of innovation, the conceptual framework where applicable, 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.

    In addition, for applications involving clinical trials: 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.

     

    Overall Impact

    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).

    Scored Review Criteria

    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.

    Significance

    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?

    Investigator(s)

    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?

    Innovation

    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 

    Approach

    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? 

    Environment

    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 are proposed, 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?

    Additional Review Criteria

    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.

    Study Timeline

     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)?

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan
     

    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.

    Vertebrate Animals

    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 Animal Section.

    Biohazards

    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.

    Resubmissions

    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.

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations

    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.

    Applications from Foreign Organizations

    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.

    Select Agent Research

    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).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

    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:

    • 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.
    • Will receive a written critique.

    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:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    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 VI. Award Administration Information
    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 grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.

    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 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees 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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    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)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Joy Boyer
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-402-4997
    Email: boyerj@mail.nih.gov

    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

    Charlisse Caga-Anan
    National Cancer Institute (NCI)
    Telephone: 240-276-6738
    Email: charlisse.caga-anan@nih.gov

    Cheri Wiggs
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: wiggsc@nei.nih.gov

    Marilyn Miller
    National Institute on Aging (NIA)
    Telephone: 301-496-9350
    Email: millerm@nia.nih.gov

    Kimberly A. McAllister
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3287
    Email mcallis2@niehs.nih.gov

    Tara Dutka
    National Institute of Mental Health (NIMH)
    Telephone: 301-451-3074
    Email: tara.dutka@nih.gov   

    Geetha Senthil
    National Institute of Mental Health (NIMH)
    Telephone: 301-402-0754
    Email: geetha.senthil2@nih.gov           

    Khara Ramos
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-594-2614
    Email: khara.ramos@nih.gov

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    Deanna Ingersoll
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-78
    Email: Deanna.Ingersoll@nih.gov

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 240-276-6277
    Email: wolfreyc@mail.nih.gov

    Karen Robinson-Smith
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: kyr@nei.nih.gov

    Traci Lafferty
    National Institute on Aging (NIA)
    Telephone: 301-496-8987
    Email: laffertt@nia.nih.gov

    Jenny Greer
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3332
    Email: jenny.greer@nih.gov  

    Rita Sisco
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-2805

    Anna Taylor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-827-3565
    Email: taylorann@ninds.nih.gov

    Section VIII. Other Information

    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.

    Authority and Regulations

    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.

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