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This guidance is for potential applicants for support from NHGRI in response to: NHGRI Requests for Applications (RFAs) or Program Announcements with Special Review Criteria (PARs) in which Letters of Intent (LOIs) are encouraged and Parent Funding Opportunity Announcements (FOAs) in which the budget request exceeds $500K in direct costs in any year.

Letters of Intent and Requests for Acceptance of Applications Requesting More than $500,000 Direct Costs. This guidance is for potential applicants for support from NHGRI.

Final

Issued by: National Institutes of Health (NIH)

Issue Date: February 13, 2020

Program Guidance to Potential Applicants for NHGRI Support

Letters of Intent and Requests for Acceptance of Applications Requesting More than $500,000 Direct Costs

This guidance is for potential applicants for support from NHGRI in response to:

  • NHGRI Requests for Applications (RFAs) or Program Announcements with Special Review Criteria (PARs) in which Letters of Intent (LOIs) are encouraged and
  • Parent Funding Opportunity Announcements (FOAs) in which the budget request exceeds $500K in direct costs in any year.

Letters of Intent (LOIs)

NHGRI requests Letters of Intent in all its RFAs and PARs. This section describes what is included in LOIs and what additional information is important for program staff to provide guidance to potential applicants.

NIH-requested information in LOIs

According to NIH policy, LOIs are not required, are not binding, and do not enter into the review of a subsequent application. The information requested in an LOI includes:

  • Descriptive title of proposed activity
  • Name, address, and telephone number of the PD/PI
  • Names of other key personnel
  • Participating institution
  • Number and title of this funding opportunity

This information is useful to the scientific review staff to estimate the potential review workload and plan the review.

Helpful information for NHGRI staff providing guidance to potential applicants

The information requested above in the LOI does not provide NHGRI staff with sufficient information about the scientific focus of potential applications. Thus, to have a meaningful discussion about proposed applications, potential applicants are encouraged to provide staff with a one to two-page document with thisinformation:

  • Goals or specific aims
  • Summary of the project significance, innovation, and generalizability
  • Summary of the approaches to be used
  • Estimated direct and total costs for each year being requested.

This information is not mandatory, but it will allow staff to evaluate the responsiveness of the proposed research to the FOA and whether the research aligns with NHGRI priorities. It also allows program staff to give feedback that may allow applicants to make the proposed research better fit the FOA and NHGRI priorities.

Additional information for some NHGRI RFAs and PARs

The NHGRI initiatives listed below are unique in their program requirements and their relevance to NHGRI’s research mission. Program staff find that, in addition to the information requested above, the following information is useful for providing guidance on these initiatives:

The NIH-requested information for LOIs and the NHGRI-suggested additional information should be included in one e-mail to the program staff contact listed in the FOA.

The Center for Scientific Review staff will evaluate RFA applications for completeness and compliance with application instructions, and NHGRI staff will evaluate their responsiveness. Applications that are incomplete, non-compliant, or nonresponsive will not be reviewed.

  • Letters of Intent (LOIs)

    NHGRI requests Letters of Intent in all its RFAs and PARs. This section describes what is included in LOIs and what additional information is important for program staff to provide guidance to potential applicants.

    NIH-requested information in LOIs

    According to NIH policy, LOIs are not required, are not binding, and do not enter into the review of a subsequent application. The information requested in an LOI includes:

    • Descriptive title of proposed activity
    • Name, address, and telephone number of the PD/PI
    • Names of other key personnel
    • Participating institution
    • Number and title of this funding opportunity

    This information is useful to the scientific review staff to estimate the potential review workload and plan the review.

    Helpful information for NHGRI staff providing guidance to potential applicants

    The information requested above in the LOI does not provide NHGRI staff with sufficient information about the scientific focus of potential applications. Thus, to have a meaningful discussion about proposed applications, potential applicants are encouraged to provide staff with a one to two-page document with thisinformation:

    • Goals or specific aims
    • Summary of the project significance, innovation, and generalizability
    • Summary of the approaches to be used
    • Estimated direct and total costs for each year being requested.

    This information is not mandatory, but it will allow staff to evaluate the responsiveness of the proposed research to the FOA and whether the research aligns with NHGRI priorities. It also allows program staff to give feedback that may allow applicants to make the proposed research better fit the FOA and NHGRI priorities.

    Additional information for some NHGRI RFAs and PARs

    The NHGRI initiatives listed below are unique in their program requirements and their relevance to NHGRI’s research mission. Program staff find that, in addition to the information requested above, the following information is useful for providing guidance on these initiatives:

    The NIH-requested information for LOIs and the NHGRI-suggested additional information should be included in one e-mail to the program staff contact listed in the FOA.

    The Center for Scientific Review staff will evaluate RFA applications for completeness and compliance with application instructions, and NHGRI staff will evaluate their responsiveness. Applications that are incomplete, non-compliant, or nonresponsive will not be reviewed.

NHGRI’s Genomic Data Sharing Expectations

Scope: Applicants should note that NHGRI finds value in and encourages the sharing of smaller project sizes that do not meet the definition of ‘large-scale’ according to the NIH guidance regarding scope of the GDS Policy. Investigators should consult with appropriate NHGRI program staff as early as possible to determine whether the GDS Policy applies to their research study.

Non-human data submission and release timeline: Genomic data sharing plans for NHGRI-funded or -supported projects to generate non-human genomic data proposed after January 25, 2016 should include pre-publication timelines for data submission and release consistent with NIH GDS Policy expectations for human genomic data. (See NHGRI’s Guidance for Data Submission and Release)

Explicit consent for data sharing: As of January 25, 2021, NHGRI expects that all human data generated by NHGRI-funded or -supported research will be derived from specimens or cell lines for which explicit consent for future research use and broad data sharing can be documented. For more information on this expectation, including how to request an exception to use samples that lack explicit consent, see NOT-20-011.

Read more about NHGRI’s implementation of the NIH GDS Policy.

  • NHGRI’s Genomic Data Sharing Expectations

    Scope: Applicants should note that NHGRI finds value in and encourages the sharing of smaller project sizes that do not meet the definition of ‘large-scale’ according to the NIH guidance regarding scope of the GDS Policy. Investigators should consult with appropriate NHGRI program staff as early as possible to determine whether the GDS Policy applies to their research study.

    Non-human data submission and release timeline: Genomic data sharing plans for NHGRI-funded or -supported projects to generate non-human genomic data proposed after January 25, 2016 should include pre-publication timelines for data submission and release consistent with NIH GDS Policy expectations for human genomic data. (See NHGRI’s Guidance for Data Submission and Release)

    Explicit consent for data sharing: As of January 25, 2021, NHGRI expects that all human data generated by NHGRI-funded or -supported research will be derived from specimens or cell lines for which explicit consent for future research use and broad data sharing can be documented. For more information on this expectation, including how to request an exception to use samples that lack explicit consent, see NOT-20-011.

    Read more about NHGRI’s implementation of the NIH GDS Policy.

Applications Requesting More than $500K in Direct Costs in Any Year

Applicants planning to submit applications that request more than $500K direct costs in any year MUST get approval from NHGRI. The request should be sent to a program director at least six to eight weeks prior to the anticipated submission date (NOT-OD-02-004).

The e-mail requesting approval should include:

  • Name of PI
  • Title of Project
  • Name of Institution
  • Anticipated submission date
  • One to two pages about the proposed project, including:
    • Goals and specific aims
    • Summary of the project’s significance, innovation, and generalizability
    • Summary of the approaches to be used
    • Estimated direct and total costs for each year being requested. 

If approved, the document acknowledging that NHGRI will accept this application should be submitted in a cover letter along with the application.

The only exceptions to this policy are RFAs or PARs that specifically allow budgets more than $500K direct costs per year.

  • Applications Requesting More than $500K in Direct Costs in Any Year

    Applicants planning to submit applications that request more than $500K direct costs in any year MUST get approval from NHGRI. The request should be sent to a program director at least six to eight weeks prior to the anticipated submission date (NOT-OD-02-004).

    The e-mail requesting approval should include:

    • Name of PI
    • Title of Project
    • Name of Institution
    • Anticipated submission date
    • One to two pages about the proposed project, including:
      • Goals and specific aims
      • Summary of the project’s significance, innovation, and generalizability
      • Summary of the approaches to be used
      • Estimated direct and total costs for each year being requested. 

    If approved, the document acknowledging that NHGRI will accept this application should be submitted in a cover letter along with the application.

    The only exceptions to this policy are RFAs or PARs that specifically allow budgets more than $500K direct costs per year.

Communication with NHGRI Staff

Science is dynamic and that is especially true of genomic science. Thus, any applicant—whether new or established, whether submitting an application for the first time or a renewal — is strongly encouraged to have a conversation with a program director about a proposed application. These discussions should take place, ideally, 10-12 weeks or more before an application is due. Advice from program staff can help prospective applicants focus their proposed research so that it is responsive to an FOA and the research priorities of NHGRI, or result in a recommendation that the proposed research is a better fit for another NIH institute. Without program advice, applicants may waste their opportunities to receive support for research that could be of interest to NHGRI and for their ideas.

NHGRI program directors are always interested in discussing proposed projects with potential applicants. If prospective applicants do not know whom to contact, all FOAs list at least one institute program contact. Also, see the NHGRI information on program director scientific areas.

  • Communication with NHGRI Staff

    Science is dynamic and that is especially true of genomic science. Thus, any applicant—whether new or established, whether submitting an application for the first time or a renewal — is strongly encouraged to have a conversation with a program director about a proposed application. These discussions should take place, ideally, 10-12 weeks or more before an application is due. Advice from program staff can help prospective applicants focus their proposed research so that it is responsive to an FOA and the research priorities of NHGRI, or result in a recommendation that the proposed research is a better fit for another NIH institute. Without program advice, applicants may waste their opportunities to receive support for research that could be of interest to NHGRI and for their ideas.

    NHGRI program directors are always interested in discussing proposed projects with potential applicants. If prospective applicants do not know whom to contact, all FOAs list at least one institute program contact. Also, see the NHGRI information on program director scientific areas.

Last updated: February 13, 2020

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