Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background:

Since its founding in 1990, the NHGRI Ethical, Legal, and Social Implications (ELSI) Research Program has supported empirical, analytical, and conceptual research to anticipate and address the ELSI of genetics and genomics. This broad focus has created a large, diverse, and multidisciplinary community of researchers. As a result, the NHGRI has periodically sponsored a conference to bring together those in the field of ELSI research as well as those interested in ELSI research, known as the ELSI Congress. This multi-day conference with national and international representation affords ELSI researchers the opportunity to present their work and keep abreast of current research and scholarship in the field. Typically, the ELSI Congress accommodates 300 to 400 attendees and includes plenary presentations, concurrent platform and panel presentations that are peer reviewed, and dedicated sessions for trainees and early career scholars that support networking and career development.

In 2020 and 2022, the ELSI Congress was held virtually due to the COVID-19 pandemic. The two virtual conferences were widely attended and included a higher number of international attendees than in previous Congresses. The virtual format and lack of registration fees promoted broader and more equitable attendance. The virtual format enabled recording and archiving of presentations on the Center for ELSI Resources and Analysis (CERA) platform known as ELSIhub as an enduring record of the content from these conferences. The most recent ELSI Congress was held in June 2024 in New York City as a hybrid conference, and it was the final conference organized under the current U13 award.

Proposed Scope and Objectives:

This funding opportunity will support three ELSI Congresses, to be held biennially in 2026, 2028 and 2030. The ELSI Congress is anticipated to be a multi-day research conference comprising a mix of invited plenary lectures, submitted individual presentations, panel sessions, and poster sessions, but may involve other innovative components as well. The awardee will be responsible for selecting and securing appropriate venues, conference publicity, and archiving presentations. The awardee will work with site hosts and vendors before and during the conference, arrange for AV needs, register attendees, arrange travel for plenary speakers, prepare conference materials, and conduct a post-conference survey of attendees. The awardee will develop materials and resources to help attendees navigate the conference, such as a conference website and/or app. In addition, the awardee will develop a robust process for invitation, submission, review, and selection of abstracts as part of the conference programming process.

The awardee will work in consultation with the NHGRI ELSI Research Program staff to form an Organizing Committee with representation from across the ELSI research community. The ELSI Congress Organizing Committee will identify one or more themes for the Congress; design the program; and identify and invite plenary speakers. The awardee will also publicize the conference and invite abstract submissions to ensure broad and accessible participation in the conference including among trainees, international ELSI researchers, researchers conducting ELSI-relevant work in NIH and NHGRI consortia and programs and other individuals interested in ELSI research regardless of whether they receive funding from the NHGRI ELSI Research Program or self-identify as ELSI researchers. The ELSI Congress Organizing Committee will include representatives from various career stages (including trainees), disability communities, and ELSI researchers based outside the United States to ensure a broad array of perspectives in the planning of an inclusive conference. The awardee will develop a transparent process to peer-review abstract submissions. The awardee will also develop a process for review of travel award applications from trainees, researchers from resource-limited institutions, and/or researchers from low- and middle-income countries.

The NIH recognizes that the value of conferences is enhanced when persons from diverse backgrounds and perspectives are included in all aspects of conference planning and implementation and when attendees are assured of a safe, respectful, and inclusive environment free from discrimination, harassment, and other barriers that might prevent or inhibit one’s participation. NIH encourages conference grant applicants to enhance diversity by increasing the participation of individuals from diverse backgrounds, including those from underrepresented groups, in the planning, implementation, and participation in the proposed conference. Per NIH Notice of Interest in Diversity NOT-OD-20-031, underrepresented groups include individuals from nationally (US) underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women. Applications for NIH support of conferences and scientific meetings must include a plan to enhance diversity in all aspects of conference planning and implementation. Diversity plans will be assessed during the scientific and technical merit review of the application. Though the proposed plans will not be scored individually, they will be considered in the overall impact score (see Updated Guidelines on Enhancing Diversity and Creating Safe Environments in Conferences Supported by NIH Grants and Cooperative Agreements, NOT-OD-21-053). Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants as an eligibility or selection criteria. The race, ethnicity, or sex of participants will not be considered by NIH in the application review process or when making funding decisions. 

NIH is also committed to changing the culture of science to end sexual harassment and other forms of harassment, including harassment on the basis of race, color, national origin, sex/gender, disability, and age in NIH-funded activities. Harassment, in any form, is detrimental and presents obstacles that hinder an individual’s ability to fully participate in science. Only in safe, respectful, and inclusive environments can individuals achieve their fullest potential and support the mission of the NIH. As stated in NOT-OD-15-152, Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities, consistent with existing federal civil rights laws, it is expected that organizers of NIH-supported conferences employ strategies that seek to prevent or mitigate the effects of discrimination and harassment, sexual and otherwise. 

Per the NIH Grants Policy Statement 14.6.3 Plans to Promote Safe Environments at Conferences, conference grant applicants recommended for funding will be required to provide to NIH upon request as part of Just-In-Time (JIT) materials a “safety plan” that will be communicated to all conference/meeting attendees. Safety plans must include all of the following elements:

• Statement of commitment to provide a safe environment.
• Expectations of behavior 

o Including list of behaviors considered harassing (specific emphasis on harassment, sexual, racial, ethnic, or otherwise).

• Instructions on how to confidentially report alleged violations of the expectations of behavior to conference organizers.
• Description of how the organizers will assess allegations and the consequences for those who are found to violate the expectations of behavior.
• Information explaining that individuals who have questions, concerns or complaints related to harassment are also encouraged to contact the conference organizer or the HHS Office for Civil Rights (OCR).
• Information about how to file a complaint with HHS OCR (see OCR’s webpage, Filing a Civil Rights Complaint).
• Information explaining that filing a complaint with the conference organizer is not required before filing a complaint of discrimination with HHS OCR, and that seeking assistance from the conference organizer in no way prohibits filing complaints with HHS OCR.
• Information explaining how individuals can notify NIH about concerns of harassment, including sexual harassment, discrimination, and other forms of inappropriate conduct at NIH-supported conferences (see NIH’s Find Help webpage).

R13/U13 applicants must also provide to NIH upon request as part of Just-in-Time (JIT) materials:

• a description of the strategy that will be used to communicate the Safety Plan to conference attendees and a plan to document allegations and resulting actions.
• information on the steps the organizers will take to ensure a safe and respectful environment for all attendees, free from discrimination and harassment.

Additionally, all NIH sponsored and/or supported conferences must be held at accessible sites, as outlined by section 504 of the Rehabilitation Act of 1973 and, as applicable, the Americans with Disabilities Act of 1990. Conference registration materials should provide a questionnaire that will allow attendees with disabilities to voluntarily identify any special needs, so that conference organizers can make plans to accommodate these needs. NHGRI encourages the awardee to develop a proactive approach in designing a conference that enables participation by individuals with differing abilities or who may require various accommodations or features in order to fully participate in the conference. This proactive approach to accessibility should begin early in the conference planning process. All conference platforms (e.g., website, registration, abstract submission, live-streaming, etc.) should include accessibility features, such as being screen reader-friendly and keyboard accessible. The awardee should consider strategies to maximize the accessibility of the ELSI Congress for people with disabilities including, but not limited to, real-time high-quality captioning, accessible slides, and other materials provided in advance, provision of accessibility guidelines for platform and poster presenters, adequate spacing for mobility aids, and conference formats that enable the use of assistive technologies and other supports. Meeting formats, including social and networking events, should include accessibility features to enable participation from all conference attendees.

The conference awardee will describe how they will facilitate broad attendance through the use of in-person and virtual content to maximize participation and allow attendance by individuals who may be unable to attend in-person due to limited travel funds, disabilities, medical concerns, family obligations, and/or other circumstances. To the extent feasible, virtual attendees should have the ability to seamlessly and actively participate in most conference presentations and sessions including, but not limited to, viewing presentations with sufficient video and audio quality, posing questions to presenters, and joining virtual networking sessions.

This NOFO requires inclusion of a Dissemination Plan to describe how the research presented at the Congress will be preserved and disseminated. Dissemination approaches could include posting of conference content, including abstracts, posters, recordings, and resources on publicly accessible platforms; development of a special issue in a relevant journal; and/or other approaches. The ELSI Congress awardee will collaborate with relevant programs, such as the CERA, to publicize and disseminate information about the conference and its outcomes. While the CERA does periodically organize seminars and workshops, the ELSI Congress is beyond the scope of the CERA award. However, the CERA does have a broad goal of facilitating new research collaborations and increasing uptake of ELSI research through outreach and dissemination activities which would allow for collaboration with the ELSI Congress awardee.

Support of conferences is contingent on the fiscal and programmatic interests and priorities of the individual NIH Institutes and Centers (ICs). Therefore, a conference grant application is required to contain a permission-to-submit letter from any one of the participating ICs' conference grant contact person (see Contacts List). Applicants are urged to initiate contact well in advance of the chosen application due date and no later than 6 weeks before that date. Please note that agreement to accept an application does not guarantee funding. In general, NIH will not issue a conference grant award unless the Federal award date can precede the conference start date.

The website, NIH Support for Conferences and Scientific Meetings ,centralizes information regarding grants for scientific conferences. The Contacts and Special Interests section of that website includes contact information for the participating ICs as well as information about each IC's specific interests and funding parameters.

Note: Applicants are encouraged to look at the R13 Frequently Asked Questions for a listing of common questions regarding the preparation and submission of conference grant applications.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• 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

Support of conferences is contingent on the fiscal and programmatic interests and priorities of the individual NIH Institutes and Centers (ICs). Therefore, a conference grant application is required to contain a permission-to-submit letter from any one of the participating ICs' conference grant contact person (see Contacts List). Applicants are urged to initiate contact well in advance of the chosen application due date and no later than 6 weeks before that date. Please note that agreement to accept an application does not guarantee funding. In general, NIH will not issue a conference grant award unless the Federal award date can precede the conference start date.

The website, NIH Support for Conferences and Scientific Meetings ,centralizes information regarding grants for scientific conferences. The Contacts and Special Interests section of that website includes contact information for the participating ICs as well as information about each IC's specific interests and funding parameters.

Note: Applicants are encouraged to look at the R13 Frequently Asked Questions for a listing of common questions regarding the preparation and submission of conference grant applications.

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

Descriptive Title of Applicant's Project: Enter the title of the scientific conference.

Cover Letter: Advance permission to submit an application is required for all NIH conference grant applications, including new, resubmission, renewal, and revision applications. Cover letters for a new application cannot be recycled for a resubmission or revision; rather a new letter is required. Advance permission to submit an application should be requested early in the process and no later than six weeks before the application due date. All applicants must include the permission-to-submit letter from the Scientific/Research Contact who has agreed to accept assignment of the application. Applications that do not include the permission-to-submit letter will not be accepted for review. Note that advance permission to submit an application does not guarantee funding.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments: Diversity Plan

Applicants must include a Diversity Plan attachment in the Other Attachment section. The PDF-formatted document must be named “DiversityPlan.pdf” (no spaces) and must not exceed 1 page in length. Applications that do not include a Diversity Plan attachment will not be accepted for review.

The Diversity Plan must:

Specifically describe plans to enhance diversity by broadening the participation of individuals from diverse backgrounds, including those from underrepresented groups (e.g., underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women) in the selection of and/or the makeup of:

• Organizing committee
• Speakers
• Invited attendees (e.g., plenary speakers, panel discussants, etc.)
• Audience

Applicants should consider the geographical conference area from where anticipated attendees will come, the expected size and composition of the audience, as well as the method of selection in describing efforts under the Diversity Plan and how these efforts will be assessed afterwards. Where applicable, applicants should describe the success of previous strategies to enhance diversity in the planning and implementation of conferences.

Other Attachments: Dissemination Plan

Applicants must include a Dissemination Plan attachment in the Other Attachment section. The PDF-formatted document must be named “DisseminationPlan.pdf” (no spaces) and must not exceed 1 page in length. The Dissemination Plan should include a robust plan for how the research presented at the Congress will be preserved and disseminated. Dissemination approaches could include posting of conference content on publicly accessible platforms including abstracts, posters, recordings, and resources; development of a special issue in a relevant journal; and/or other approaches. NHGRI encourages investigators to consider disseminating research findings and products via publicly accessible platforms such as the Center for ELSI Resources and Analysis.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

Describe in the Personal Statement of the Biographical Sketch senior/key persons’ past experiences with enhancing diversity by promoting broad participation in biomedical research. 

R&R Budget

All Instructions in the How to Apply - Application Guide must be followed with the following additional instructions.

The appropriate NIH IC conference award contact should be consulted for guidance regarding any IC-specific budget requirements. Enter the direct costs requested. Facilities and Administrative (F&A) costs are not allowed. Provide a narrative justification for each proposed personnel position, including the role of the individual in the conference and the proposed level of effort. Include information regarding efforts to obtain funding for this conference from other sources.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees or speakers' fees. Services necessary to ensure an inclusive and accessible hybrid meeting.  Applicants should include costs necessary for the preparation, preservation, and dissemination of conference products.

Non-allowable costs: Meals/food and beverages; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment and personal expenses (such as tips; bar charges; personal telephone calls; laundry charges) dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; local participants' expenses; facilities and administrative costs/indirect costs.

Registration: To promote accessibility and maximize attendance of a variety of individuals interested in ELSI research, registration costs for attendees should not exceed $500 per meeting for in-person attendees and $100 per meeting for virtual attendees. Applicants should consider establishing reduced registration fees for trainees, researchers from resource-limited institutions, researchers from low- and middle-income countries and/or other attendees who may have limited travel funds available. 

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Note that this section will be called "Conference Plan" in the system-generated Table of Contents.

Conference Overview

Describe the objectives, specific program, and logistical arrangements for the conference. Describe the meeting and session formats anticipated. Describe plans for dedicated sessions for trainees and early career scholars that support networking and career development. Describe the key topics to be covered, problems to be addressed, and developments or contributions the conference might stimulate. Describe the process for invitation, submission, review, and selection of abstracts as part of the conference programming process. Describe the process for review of travel award applications from trainees, researchers from resource-limited institutions and/or researchers from low- and middle-income countries.

Conference Planning and Organization

Describe the Organizing Committee including its role in conference planning, the expertise that will be represented, and how members will be selected. Describe how early career scholars and individuals from disability communities will be included in the Organizing Committee.

Describe plans for publicizing the conference to all interested attendees including trainees, international ELSI researchers, researchers conducting ELSI-relevant work in NIH and NHGRI consortia, and other individuals interested in ELSI research, regardless of whether they receive funding from the NHGRI ELSI Research Program or self-identify as ELSI researchers. Describe plans to develop materials and resources to help attendees navigate the conference, such as a conference website and/or app.

Describe how broad attendance will be facilitated using in-person and virtual content to maximize participation. Describe plans to allow virtual attendees to actively participate in most conference sessions including viewing presentations with sufficient video and audio quality, posing questions to presenters, and joining virtual networking sessions.

Applicants should describe how they will proactively design a conference that enables participation by individuals with differing abilities or who may require various accommodations or features in order to fully take part in the conference. Applicants should describe planned approaches and strategies to maximize the accessibility of the ELSI Congress for people with disabilities, including both in-person and virtual attendees.

Family Care

Attendance for some individuals will be dependent on the availability of resources for family care. The application should describe plans to identify resources for childcare and other types of family care at or in close proximity to the conference site to allow individuals with family care responsibilities to attend. The information should allow attendees to make arrangements for family care as needed.

Planning for Future Meetings

Applicants should note that this NOFO allows applications for 3 conferences to be held biennially in 2026, 2028, and 2030. Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible:

• conference topic(s)
• tentative dates, locations, and attendees
• plans for future conferences dependent upon, for example, the outcome of the first year's conference or developments in the field
• plans to assess and evaluate each conference to ensure iterative improvement in future years

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

A Resource Sharing Plan is not applicable for this NOFO

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 and responsiveness by NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at [email protected] when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

After considering all of the review criteria, briefly summarize the significant strengths and weaknesses of the application and judge the likelihood that the proposed conference will have a substantial impact on the pursuit of the goals of NIH supported research, which are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. 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.
• Inclusion of investigators and institutions not currently funded under the Center for ELSI Resources and Analysis (CERA) in response to RFA-HG-23-027

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining conference approaches, setting project milestones and timelines, and conducting conference activities.
• Ensuring that the software, resources, materials, etc. produced as part of this project are released appropriately.
• Preparing conference products and publications in a timely manner.
• Adhering to policies regarding sharing of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH and NHGRI.
• Not disclosing confidential information.
• Interacting with other relevant NHGRI and NIH activities, as needed, to promote synergy and consistency among similar or related projects
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist/Scientific Officer (PS/SO) at NHGRI is a dual role held by a NHGRI Program Director. In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination.  The responsibility for final decision-making will be determined by Institute/Center leadership and may reside with senior management, separate organizational components, and/or oversight committees. Because it is anticipated that the Program Director may participate in activities that may rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors or other Senior NIH Program management staff will provide oversight and will manage the conflict accordingly.. The PS/SO will be named in the Notice of Award.

The PS/SO will have the following substantial involvement:

• Serving as a liaison, helping to coordinate activities among and for the recipients, including acting as a liaison to the NHGRI and as an information resource for the recipients about genome research and ELSI research activities. The PS/SO will also coordinate the efforts of the Recipient(s) with other groups conducting similar studies.
• Reporting periodically on the progress of the Recipients to the NHGRI Director and to the National Advisory Council for Human Genome Research.
• Assisting Recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice on the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding.
• Curtailing, withholding or reducing support for any Recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH or NHGRI staff who may assist the Recipient(s) as designated by the PS/SO.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.

Areas of Joint Responsibility include:

If there are multiple awards working toward a common goal, close interaction between the participating Recipient(s) and the PS/SO will be required, to manage, assess, and implement the awards. This is accomplished by:

• Meeting at least monthly via virtual meeting to share information on resources, methodologies, tools, conference planning updates, etc.
• Establishing best practices for conference planning as appropriate.
• Setting priorities, deciding optimal approaches, and contributing to the adjustment of approaches as warranted.
• In addition to the PD(s)/PI(s), key co-investigators and pre-and postdoctoral trainees, including those who are members of under-represented groups or those from different but related disciplines, are eligible to attend these meetings.

The PS/SO will assist and facilitate the group process and not direct it.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Nicole Lockhart, PhD

National Human Genome Research Institute  (NHGRI)
Telephone: 301-480-2493
Email: [email protected] 

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-219-6235
Email: [email protected]

Deanna Ingersoll 

National Human Genome Research Institute  (NHGRI)
Telephone: 301-435-7858
Email: [email protected]

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.

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 2 CFR Part 200.