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 Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD )
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title

Ethical, Legal, and Social Implications (ELSI) of Genomics Research Project Grant Program (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-17-325

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-17-444

Companion Funding Opportunity

PA-17-446, R21 Exploratory/Developmental Research Grant Award

PA-17-445, R03 Small Grant Program

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

 93.172; 93.399; 93.307; 93.173; 93.853; 93.866; 93.113; 93.865 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Research Project Grant (R01) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research.  Applications may propose studies using either single or mixed methods.  Proposed approaches 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, such as those involving the direct engagement of stakeholders.

Key Dates

 

Posted Date

August 1, 2017

Open Date (Earliest Submission Date)

September 5, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

September 8, 2020

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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

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

Continuing advances in genomic technology coupled with lowered sequencing costs have rapidly increased the numbers of people being sequenced, and are transforming biomedical research.  As knowledge of relationships between genetic variation and human diseases and traits proliferates, the distinctions between basic and clinical genomic research blur, and new findings are altering the practice of medicine.  Meanwhile, information technologies - including personal mobile devices, patient health portals, electronic health records, and cloud storage – are influencing how an individual's genomic data are stored, analyzed, shared, and used in commercial, biomedical and non-medical settings. Taken together these developments may have profound effects on many long-standing societal beliefs and norms.  The purpose of this FOA is to solicit research applications that identify, analyze, and address the ethical, legal and social implications (ELSI) of these genetic and genomic advances for individuals, families, communities and society more broadly. 

To address the broad scope and reach of genomic advances in society, applications are invited from investigators representing a wide range of disciplines, including but not limited to ethics, genetics and genomics, clinical medicine, law, health services 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 either single or mixed 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, such as those involving the direct engagement of stakeholders.

For very small projects, such as those involving single investigators, applicants may wish to consider PA-17-445 the ELSI Small Grant (R03) FOA, which provides a total of up to $50,000 in direct costs a year for two years.  For small projects that cannot be done within the constraints of an R03 budget -  especially those that are primarily exploratory in nature or designed to generate pilot data in preparation for a larger study - applicants should consider PA-17-446 the ELSI Exploratory/Developmental Research (R21) FOA, which provides a total of up to $275,000 in direct costs over two years.

Applicants are strongly encouraged to contact ELSI program officials prior to developing an application.

Areas of Research Interest

The specific areas of research interest targeted through this FOA fall roughly into the following broad domains.  Examples of specific topics appropriate for exploration in each of these domains can be found on the ELSI Research Priorities website at: https://www.genome.gov/27543732.

Genomic Research.  These projects may examine and address the ethical, legal, social and policy issues that arise in connection with the design and conduct of genetic and genomic research.  Research areas of particular interest include:

  • Boundaries Between Research and Clinical Care
  • Data Stewardship and Sharing 
  • Inclusion of Diverse Populations in Research
  • Informed Consent
  • Legal and Regulatory Issues in Genomic Research 
  • Participant Rights and Engagement
  • Re-identification, Security and Data Privacy
  • Return of Genomic Research Results and Secondary Findings

Genomic Health Care.  These projects may examine and address the ethical, legal, social and policy issues that arise in connection with the translation of genetic and genomic research into clinical practice and health care.  Research areas of particular interest include:

  • Clinical and Personal Utility of Genomic Health Information
  • Economics of Genomic Medicine
  • Genomic Medicine and Health Disparities
  • Genomic Medicine in Diverse Healthcare Settings
  • Genomics and Public Health
  • Legal and Regulatory Issues in Genomic Health Care
  • Precision Medicine and Genomics
  • Return, Communication and Use of Genomic Test Results and Secondary Findings
  • Rights and Responsibilities of Patients and Providers

Broader Legal, Policy and Societal Issues.  These projects may examine and address a range of broader legal, policy and bioethical and societal issues raised by the use of genetic and genomic technologies and information in research, clinical or non-medical settings.  Research areas of particular interest include:

  • Citizen Science & Consumer Genetics
  • Downstream Implications of Emerging Genomic Technologies
  • Genetic Determinism and its Effects on Attitudes, Behaviors and Policy
  • Genomic Equity and Social Justice
  • Genomics and Conceptions of Human Identity and Origins
  • Genomics and Shifting Societal Definitions and Norms
  • Non-Medical Uses of Genomic Information
  • The Role of Genetic Exceptionalism in Policy Development

Examples of specific topics appropriate for exploration in each of the three research domains can be found on the ELSI Research Domains website at: http://www.genome.gov/27543732. The research areas and possible research questions described at this website are provided as a general guide to areas of interest and should not be viewed as a comprehensive list of all possible research topics. As genomic research advances and as the interpretation and use of genomic information continues to evolve, applicants are encouraged to identify additional topics and issues ripe for research. 

Many of the specific topics listed on the ELSI Research Domains website are relevant to the design and implementation of genomic research or genomic medicine studies and may be appropriately examined in conjunction with a variety of planned or ongoing genomic research projects. Potential applicants are encouraged to explore possible collaborations with genomics or other researchers conducting such studies.  Potential applicants are also 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 NHGRI is interested in research that addresses:

  • the ethical, legal, and social issues 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 generation of data and development of tools 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.  Examples of topics of specific interest to NHGRI 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 on affected individuals, their families, and 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
  • Studies that take into consideration the perspectives of diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities
  • Studies on models of participant and community engagement or participatory research methods in cancer genomics research
  • Studies on public engagement, including analysis of communication strategies and tools, 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 to improving genomic-based targeted therapies for diverse subpopulations

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 National Institute on Aging (NIA) is interested in research that focuses on the ethical, legal and social issues related to aging and genomics.  Examples of topics of particular interest include: research on the anticipated and actual impact of genetic and genomic information; studies on ethical, regulatory and policy challenges in aging research (such as clinical trials, population-based studies) incorporating genetic and genomic technologies; issues raised by the collection, storage and use of biological samples and associated data; studies that incorporate and investigate the perspectives of diverse communities; and studies on models of participant and community engagement or participatory research in aging research. The ultimate goal of this research will be to understand how people make sense of and act upon genetic and genomic information related to aging and diseases of aging; to inform the ethical conduct of aging research involving genetic and genomic information and data; and overall to improve outcomes related to aging and diseases of aging.

  • Clinical, behavioral, and social datasets have large amounts of individual level data.  When combined with biomarker and genetic data, risk assessment is needed to determine the chance of re-identification.
  • With respect to sharing summary statistics, there is uncertainty and inconsistency across the research community as to whether summary statistics from genetic studies can be shared publicly, or whether they should be considered as ‘restricted access’ data along with individual level information. The determination that summary statistics belong in the category of restricted access individual level data outcomes is costly because of the extra protective measures and personnel needed to ensure compliance. Approaches to risk assessment include but are not limited to determination of the ability to reidentify study participants, and delineation of potential risks and established benefits that should be considered to define principles of summary data sharing. In certain cases, large amounts of data may need to be redacted from a dataset to render summary data sharable; for example, redaction of data where use by commercial entities is prohibited may mean recalculation of entire findings from datasets, which may skew results. In assessing the question of open versus restricted access for meta-analysis summary statistics considerations are of the likelihood that any individual harm or contravention of informed consent could occur if such data are open versus what damage is done by slowing or preventing access to these data should access be restricted.
  • Risk assessment is needed for how changes in the science of a particular disease would impact the disease community with respect to informed consent. An example is the shift from the term “autism” to include the term “autism spectrum”; or the term “Alzheimer’s disease” to include “Alzheimer’s disease related dementias” when the science motivates this shift. Assessment is needed to determine how such a change can most easily be appreciated by the study population and research community at large, and how this impacts subject understanding of informed consent and the ability to share data.  Evaluation of how to best inform subjects of their genetic data in the context of imaging and/or cognitive assessment outcomes is also needed. 

NICHD has specific interest in research that addresses a range of ethical, legal and social issues for individuals and communities related to genetic and genomic research involving the following areas:

  • The implications of using genomic technology to identify genetic causes of disease and disability that may or may not have available treatments and possible intended and unintended secondary uses of this data.
  • The implications of applying genomic technologies for carrier screening, fetal or prenatal diagnosis (including noninvasive prenatal screening), and/or newborn screening.
  • The implications of the use of genomic technologies to diagnose and treat benign gynecologic disorders and fertility-related disorders.
  • The implications of research on human genetic determinants of HIV and/or infectious disease transmission, acquisition and associated co-morbidities among vulnerable populations of mothers, infants, children, adolescents and young adults, in the US or in international settings.
  • The ethics of returning secondary findings with implications for adult-onset conditions in the newborn or child and identification of risks for other family members as a result of genomic technologies applied in fetuses or newborns on a population basis.
  • The ethics of returning genetic research results about HIV and/or other infectious diseases among vulnerable populations in resource limited settings, especially among marginalized groups of youth.
  • The ethics of informed consent for genetic screening and genetic testing, especially among vulnerable populations (e.g., pregnant women, fetuses, children/newborns, individuals with intellectual and developmental disabilities, youth affected by or at high risk of HIV and/or other infectious diseases).  This includes research on views of other stakeholders, such as community members and IRBs or ethics committees.
  • The implications of pharmacogenomic discoveries in children and the lifetime clinical utility of the "portable genome."
  • The ethical issues related to implantable devices and cognition-altering therapies for developmental conditions identified by genomic technologies.
  • The ethical implications of the potential for correcting human disease via gene editing technologies that impact the germline and future generations.

The NIDCD 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 hearing, balance, taste, smell, voice, speech, and language.

The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, 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. In particular, NIEHS has an interest in supporting collaborations between scientists and the public for the development of culturally appropriate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of the comprehensibility and effectiveness of educational interventions used (i.e., whether they raise environmental health literacy). NIEHS is additionally interested in research on the bioethical issues related to ownership of biosamples collected in environmental health studies, data sharing requirements when it involves data derived from tribal-based environmental health studies, or stigma associated with identification of genetic conditions that put individuals at greater risk from environmental exposures.

The NINDS is particularly interested in applications which address subjects relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH, see http://www.ninds.nih.gov/about_ninds/mission.htm.

NIMHD is interested in supporting research that seeks to understand or address cultural preferences, values and norms to ensure equitable and ethical uptake of the output of genomic research and genomic medicine.

NIMHD is also interested in supporting research that seeks to understand or address mechanisms and pathways that contribute to health disparities in genomic medicine.  Health disparities arise through an interplay of multiple factors such as genetic, cultural, and structural operating at multiple levels e.g., individual, family/household, community, built environment, and healthcare factors.

The research must focus on one or more U.S. minority or health disparity populations (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). Research may use available secondary data, health system data and/or collection of primary data.  

Genomic Research

  • Advance understanding of self-identified race and ethnicity (SIRE) and ancestry informative markers (AIMs) in genomics and biomedical research to enhance ability to describe research participants’ diverse backgrounds and experiences in scientifically and socially meaningful ways.
  • Advance creation of linguistic guidelines for discussing social categories and reporting on population variability and health disparities.
  • Advance understanding on how to avoid or mitigate against stigmatization, group harms, and unintended social implications of research for populations.
  • Ethical analysis and/or ways to address cultural and structural barriers and facilitators to enable research participation for racial and ethnic minorities and health disparities populations, including but not limited to, assessing the social value and relevance of research, inaccessibility to research, culturally incongruent research design and/or conduct of research, population mistrust, inadequate health insurance coverage, and legal status in United States.
  • Means within the informed consent process that allows for participants with diverse preferences and cultural norms to take part without compromising study integrity.

Genomic Health Care

  • Research addressing the relationship between race and ethnicity and health outcomes, particularly with outreach into communities that do not traditionally participate in genomics or biomedical research.
  • Communication of the relationship between ancestral biomarkers and self-identified race and ethnicity to individuals and families receiving genomically-based clinical test results.
  • Application of genomic medicine with health disparities populations addressing challenges, barriers and patient and provider knowledge, attitudes and beliefs. 
  • Ways to implement genomic medicine uptake such that equity is achieved, and health disparity populations can participate aligned with their norms and values.
  • Understanding the contribution of genomic, psychosocial, and cultural factors that may have a role in health disparities.
  • Developing a health equity and social justice lens for the development of diagnostic tools, screening criteria, and treatment plans that take into account genetic diversity and environmental and social factors.

Broader Legal, Policy and Societal Issues

  • Implications of genomic variation research and genetic ancestry testing for understanding identity, race and ethnicity, and relationships within and among human populations.
  • Develop tools to address differences in patient and provider knowledge, attitudes, and beliefs around core concepts such as privacy, return of results, ensuring trust in genomic medicine.
  • Implications of policies for health disparities populations within genetic research and genomic health care

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
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials

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 not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 5 years, but given how quickly the field is evolving, it is expected that many projects will be no more than 3 years in duration.  Longer project periods should be well justified.  Additional consideration for longer projects may be given to new or early stage investigators.  All applicants are strongly encouraged to discuss project length with Scientific/Research Staff prior to submission.    

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)
  • 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

Buttons to access the online ASSIST system or to download application forms 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, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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: 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 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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 there a strong scientific premise for the project? 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?  

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?   

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?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?  

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?   

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children 

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 children 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

For Renewals, the committee will consider the progress made in the last funding period.

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 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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 progress report, 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

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

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

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

Tracy King
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-402-1822
Email:   tracy.king@nih.gov

Bracie Watson
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone:  301-402-3458
Email:  watsonb@nidcd.nih.gov

Symma Finn
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-541-4258
Email: finns@niehs.nih.gov

Adam Hartman
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: hartmanad@mail.nih.gov

Nancy L. Jones
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone:301-594-8945
Email. nancy.jones@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)

Monika Christman
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7860
Email: Monika.Christman@nih.gov

Carol Perry
National Cancer Institute (NCI)
Telephone:  240-276-6282
Email:  perryc@mail.nih.gov

Linda Whipp
National Institute on Aging (NIA)
Telephone:  301-402-7731
Email:  whippl@nia.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-435-6975
Email:  clarkb1@mail.nih.gov

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone:  240-464-7558
Email:  myersjc@mail.nih.gov

Molly Puente
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-451-1373
Email: puentem@niehs.nih.gov

Vicky Haines
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1365
Email: vhaines@mail.nih.gov

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.