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

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)  

National Cancer Institute (NCI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute on Minority Health and Health Disparities (NIMHD)

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

The Health of Sexual and Gender Minority (SGM) Populations (R01) 

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-12-111

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PA-15-261

Companion Funding Opportunity

PA-15-262, R03 Small Grant Program

PA-15-263, R21 Exploratory/Developmental Grant

PA-15-260, R15 Academic Research Enhancement Award (AREA)  

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

93.865, 93.399, 93.396 , 93.395, 93.394, 93.393, 93.273, 93.855, 93.856, 93.173, 93.121, 93.279  93.242, 93.307    

Funding Opportunity Purpose

The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of diverse population groups and thereby improve the effectiveness of health interventions and services for individuals within those groups.  Priority is placed on understudied populations with distinctive health risk profiles. This funding opportunity announcement (FOA) focuses on sexual and gender minority (SGM) populations, including lesbian, gay, bisexual, transgender, and intersex populations.  Basic, social, behavioral, clinical, and services research relevant to the missions of the sponsoring Institutes and Centers may be proposed.      

Key Dates
Posted Date

May 18, 2015

Open Date (Earliest Submission Date)

September 5, 2015

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.

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

September 8, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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 to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
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
Purpose

This FOA calls for research on the health of lesbian, gay, bisexual, transgender, intersex, and related populations.  In reference to LGBTI health, an Institute of Medicine (IOM) Report (March 2011) stated that the "existing body of evidence is sparse and that substantial research is needed."  Despite improvements, there remains a need for further research on the health of these populations.  Applicants are urged to read the IOM report, which delineates numerous extant research gaps. 

SGM populations encompass several partially overlapping groups, which are defined in the IOM report as follows:

  • One group includes individuals whose sexual orientation—as typically conceptualized in terms of sexual attraction, behavior, and/or sexual orientation and identity—is not exclusively heterosexual. This group includes people who label themselves (or are labeled) as gay, lesbian, or bisexual, as well as people who do not adopt such labels but nevertheless experience same-sex attraction or engage in same-sex sexual behaviors.
  • A second group includes individuals whose gender identity differs from the sex originally assigned to them at birth; whose gender expression varies significantly from what is traditionally associated with or typical for that group; and/or who vary from or reject traditional cultural conceptualizations of gender in terms of male-female dichotomy. This group includes people who label themselves (or are labeled) as transgendered, transsexual, cross-dressers, transvestites, and/or two-spirit.
  • A third group includes individuals who are born with external and/or internal genitalia that vary from typical male or female genitalia, or a chromosomal pattern that varies from XX (female) or XY (male). This group includes people who label themselves (or are labeled) as intersex or with Disorders of Sexual Development [DSD]. 

Following recent usage, the term Sexual and Gender Minority [SGM] is used to designate both these populations overall and the individuals within these populations.  Applicants may adopt other classification frameworks and terminologies as appropriate for their proposed research.

Recent data from national health surveys and targeted studies suggest that prevalence rates for some health conditions are higher among SGM populations than for the general population. This FOA encourages research that will enrich scientific understanding of how sexual orientation and gender identity influence health, perceptions and expectations about health, health behaviors, and barriers and access to health-related services.

Research Priorities

This FOA encourages research that describes the biological, clinical, behavioral, and social processes that affect the health and development of SGM populations and individuals and their families, and that leads to the development of acceptable and appropriate health interventions and health service delivery methods that will enhance health and development of these populations. Research submitted to this FOA should focus on clearly defined health outcomes, rather than on general measures of “well-being” or “adjustment.” This FOA encourages researchers to investigate new research questions related to the health and development of SGM populations and individuals and their families and to develop and/or apply innovative methodologies to improve understanding of mechanisms affecting their health and development.

This FOA encourages four main types of research.

  • Basic social and behavioral science studies addressing the processes involved as individuals discover, uncover, address and/or adapt to their sexual orientation and claim or do not claim identity as SGM, and how these processes affect the mental and physical health of the individual.
  • Research leading to interventions to ameliorate health disparities in SGM populations. Formative research may be necessary because evidence-based preventive and treatment interventions for SGM individuals, particularly for adolescents and young adults, are scarce.
  • Large-scale design, implementation and evaluation of preventive and/or treatment interventions addressing health issues in SGM populations.
  • Research on how family structures and processes-including both families of origin and families of choice-affect the health of SGM individuals and their family members, including whether and how being raised in a family headed by SGM individuals affects the health, development, and well-being of children.    

Research should be designed so that it is readily discernable whether the findings from the study sample can be generalized to other populations.  Applicants should provide a precise description of the target population and of the sampling methods to be employed, paying attention not only to sexual behavior, identity, orientation, and gender characteristics, but to such variables as age, generational cohort, race/ethnicity, culture, geography, socioeconomic status, and physical and psychological qualities.  Given the diversity of SGM populations, and their unknown distribution in the general population, it is expected that most projects will focus on one or a few well-defined groups.  

Proposed research may draw from the full range of approaches within biological, clinical, behavioral, and social sciences, including both quantitative and qualitative approaches. Applicants are encouraged to build on and/or incorporate approaches and findings from research on other types of health disparities and from research on the influences of sex and gender in biological and behavioral functioning. Proposed research projects must consider the potential risks to and vulnerability of research participants and must ensure their confidentiality and protection. The ethical and legal implications of the proposed research on SGM populations must be considered. While the primary domain of interest is populations within the United States, research with non-U.S. populations is acceptable if the applicant can demonstrate the proposed work will contribute to scientific understanding of U.S. SGM populations.

Examples of research areas include but are not limited to the following and combinations of these approaches:

Epidemiology and Epidemiological Methods
  • Epidemiological studies to characterize SGM populations across the lifespan, by age, race/ethnicity, sexual orientation and gender identity, education, occupation, social networks, family structures, and urban/rural or geographic locations.
  • Research on the similarities and differences in development, nature and diversity of health-related roles perceptions, attitudes, and expectations that influence sexual orientation and gender identity in SGM populations and in other populations.
  • Studies to improve measures and methodologies related to SGM populations, including studies that address various logistical and ethical challenges in obtaining representative samples of populations that may be for a number of reasons hidden or difficult to reach.
  • Studies that develop new tools for assessing and evaluating how social and peer influences impact SGM health, including new information technologies that may influence  such health behaviors.
  • Studies of how social structures, including the internet, built environments and legal and cultural expectations may influence the health, including emotional health and resilience, of SGM populations. Of particular interest are studies that address SGM individuals who may have unique experiences overcoming discrimination or social marginalization associated with being in other minority groups such as ethnic/racial minority groups, immigrants and refugees. 
  • Studies of SGM-health relevant issues in elderly and aging populations such as (but not limited to) end of life and long-term care planning and the role of biological and chosen families in social support and caregiving situations.
Socio-Demographic Characteristics and Human Development, cross-sectional and longitudinal
  • Studies of health-relevant demographic and socioeconomic characteristics of SGM populations.
  • Studies of interactions and influences of sexual orientation and gender-related characteristics with affective, cognitive, personality and identity processes including identity processes related to race and ethnicity that may differentially affect health and health risk behaviors among SGM populations.
  • Studies of the determinants and consequences of the timing of individuals' recognition of and disclosure to others of their sexual or gender identity on their health and health risk behaviors.
  • Research on how the health and health outcomes of SGM individuals are colored by interpersonal relationships, social networks, religious affiliations, and by family relationships, structure, and processes.  This includes research on how characteristics of family or origin affects the process and health consequences of "coming out".
  • Studies of protective and resiliency factors and of coping processes within and between SGM populations, including how these factors and processes are related to health, partner selection, partner concurrency, family structures, sexual practices, and cross-generational family relationships.
  • Research on how health-related outcomes may be influenced by changing social perceptions and attitudes toward SGM populations.
  • Research on the role of social networks on the health, health-related behavior, and use of health care among SGM populations.
  • Research on how gender identity and sexual orientation may be related to health, health behaviors, and health care use across the life course and how health-related outcomes differ across groups. (See Background section for discussion of clusters.)
  • Research on barriers to SGM individuals seeking health care treatment, including such factors as fear of stigmatization, prior negative experiences related to their sexual orientation or gender identity, and fear that health care providers lack knowledge and experience working with SGM individuals.
Health Concerns and Conditions
  • Studies of suicidality and stress-related illnesses in SGM populations, including prevalence, risk and protective factors, and of preventive interventions.
  • Longitudinal studies of the mechanisms by which experiences of stigmatization, discrimination, and violence may affect health in SGM populations. Such studies could include examination of bullying and harassment of youth in schools and employment venues.
  • Studies of social network dynamics and how they may foster behavioral risks or, conversely, resiliency and protective norms that help buffer the cumulative effects of discrimination, abuse, or stigma.
  • Studies of current and emerging patterns of drug and alcohol use and substance use-related risk behaviors and outcomes, including HIV/AIDS and other infectious diseases in SGM populations and communities (including such topics as differential contexts of substance use, social diffusion of particular forms of substance use, and related risk behaviors and distribution networks). 
  • Studies of the interactions of measured health differences associated with sexual orientation and gender-related characteristics with other forms of health disparities (associated with, for example, race/ethnicity, the prevalence and incidence of HIV/AIDS and other infectious as well as noninfectious diseases, socioeconomic status, geography, etc.).
Biological and Clinical Factors
  • Research with transgender people, including transsexual people who intend to seek, have sought, or have received hormonal or surgical interventions.
  • Studies of the acoustic factors that contribute to perception of femininity and masculinity and of other non-voice factors (such as articulation, prosody and body language) that interact to create the perception of femininity or masculinity.
  • Longitudinal or retrospective studies of the health and developmental effects of gender assignment in cases of infants born with ambiguous genitalia.
  • Developmental and longitudinal studies of gender-related and other biological and behavioral characteristics of intersex [DSD] people, including follow-up studies of persons who have received hormonal or surgical interventions.
  • Studies of the development and evaluation of approaches to psychosocial assessment and counseling for intersex [DSD] people and their families.
  • Studies of competency and training needs among clinicians, employers, and other service providers who work with SGM populations.
  • Research to develop and evaluate training and knowledge dissemination programs for clinicians, employers, and service providers on SGM-related topics.
Intervention and Services Research
  • Studies to evaluate the stability, fluidity, and other temporal attributes of social norms and networks and how such attributes affect perceptions, attitudes, and behaviors among SGM individuals and populations.
  • Conversely, studies that utilize findings on the social norms and networks within SGM populations to develop novel designs and approaches for targeted disease prevention interventions.
  • Comparative effectiveness of treatment approaches to change voice to match individuals' chosen gender.
  • Research that develops and evaluates new preventive, treatment, counseling and rehabilitative interventions for substance abuse [including the abuse of tobacco, alcohol and drugs]  and co-occurring health and mental health disorders that are sensitive to the needs and characteristics of SGM people
  • Network-based intervention designs that build on the diffusion capacities of social support networks among individuals.
  • Studies of the beliefs, expectations, norms, and attitudes of SGM populations regarding substance abuse and mental health services, including how such beliefs, expectations, norms, and attitudes affect service utilization and effectiveness.
  • Exploration of the utility of and efficacy of the use of SGM-frequented venues for developing, implementing, and evaluating new interventions to promote health and behavioral risk reduction, and to provide linkages to health services and care. 
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.

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.   

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:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • 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) (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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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? 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 New Investigators, or 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? 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? 

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 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.
  • Program balance; this allows us some flexibility in reaching for innovative research if all the best scoring applications are on the same topic.
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

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.

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.

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 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: 301-710-0267

Scientific/Research Contact(s)

Susan Newcomer, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6981
Email: newcomes@mail.nih.gov

Rebecca Liddell Huppi, PhD
National Cancer Institute (NCI)
Telephone: 301-496-4995
Email: liddellr@exchange.nih.gov

Robert Freeman
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-433-8820
Email: jarroyo@mail.nih.gov

Philip O. Renzullo, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301 451-2764
Email: prenzullo@mail.nih.gov

Lana Shekim, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: shekiml@nidcd.nih.gov

Melissa Riddle, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: riddleme@mail.nih.gov

Jeffrey Schulden, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1526
Email: schuldenj@nida.nih.gov

Catherine Roca, MD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: rocac@mail.nih.gov

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: alvidrezjl@mail.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)

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

Shane Woodward
National Cancer Institute (NCI)
Telephone: 301-496-8791
Email: woodwars@mail.nih.gov

Judith Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Ann White Devine
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-402-5601
Email: adevine@mail.nih.gov

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@nidcd.nih.gov 

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: mconnell@nida.nih.gov

Tamara Kees
National Institute on Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

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