NIH Guidance

June 21, 2022

Faculty Disclosure Guidance for NIH submissions

Sponsor-specific tools and resources for submissions to the National Institutes of Health (NIH)

NIH Grants Policy Statement

NIH released its new Grants Policy Statement in December 2021. Visit the NIHGPS (NIH Website) site for more information on significant changes.

NIH Uniform Guidance and Prior Approvals

Refer to Federal Research Terms and Conditions (NSF Website), located on the NSF website.

Harvard Submission Process

Submissions of proposals and progress reports are due to your School’s submitting office according to their deadline policy for review and authorization.  Submission deadlines vary by the submitting office; for Harvard Chan SPA submit 7 business days before the sponsor’s due date; for OSP and HMS ORA submit 5 business days before the sponsor’s due date.  Please use the links listed below for more information on each submitting office’s deadline policies:

• For deadline submissions to OSP
• For deadline submissions to HMS ORA
• For deadline submissions to Harvard Chan SPA

Disclosure Guidelines for NIH submissions

NIH requires disclosure of all resources made available to a researcher in support of and/or related to any of their research endeavors, regardless of whether they have monetary value and regardless of whether they are based at Harvard.  The information provided on this page summarizes key steps in the NIH submission process and is not a replacement for the complete and comprehensive agency guidance. To ensure submissions are compliant,  faculty should review the policy and guidance information accessible through the links at the top of the page.

The National Institutes of Health (NIH) has issued new requirements for Other Support reporting and Biographical Sketches (Biosketches) submitted on or after January 25, 2022. Keep in mind the following when submitting your NIH proposal, Just-In-Time (JIT) materials, or Research Performance Progress Reports (RPPRs). These changes may require additional time on your part.

NIH Pre-award and Post-award Disclosures Summary Chart

The NIH Pre-award and Post-award Disclosures Summary Chart (NIH provided PDF) is a helpful reference outlining information regarding pre-award and post-award disclosure information in the Biographical Sketch and Other Support proposal sections. The table identifies where these disclosures must be provided in proposals as well as in project reports.

Biosketch (at proposal stage)

Section A: Personal Statement

Provide a brief description of why the investigator is well-suited for the role on the proposed project. This section may include ongoing and completed projects from the past three years that the applicant wishes to highlight (previously in Section D).

Section B: Positions, Scientific Appointments, and Honors

The NIH specifies that the list must include the following, whether or not remuneration is received and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).  List in reverse chronological order: All positions, both domestic and foreign All scientific appointments, both domestic and foreign All affiliations with foreign entities or governments All titled academic, professional, or institutional appointments Any relevant academic and professional achievements and honors.

Section C: Contributions to Science

Briefly describe up to five of your most significant contributions to science. The description of each contribution should be no longer than one half page, including citations. While all applicants may describe up to five contributions, graduate students, and postdoctorates may wish to consider highlighting two or three they consider most significant.

Section D:  Scholastic Performance (only present on the fellowship version of the Biosketch)

With the reorganization of Research Support to Section A, Section D has been reduced to Scholastic Performance and is solely present on the fellowship version of the Biosketch.

Preparation of Agreements for Other Support (at Proposal stage)

NIH Other Support

Prepare an Inventory of In-Kind Support and Other Resources

All Harvard individuals who are designated as Key Personnel on an NIH award/subaward are required to report all their research support to NIH via the Other Support form, which is required at JIT and with each RPPR if their support has changed since the last submission. To provide a complete list of resources and support, all Key Personnel must take inventory of all resources provided or otherwise supported externally and available in support of their research.  This may include:  Supplies and Equipment, including high value material that is not broadly available.   Facilities, including any office/lab space or other facilities that are not Harvard owned or leased, and not otherwise made broadly available. *Note that institutional resources, including core facilities or shared equipment, should not be included as Other Support, but instead listed under Facilities and Other Resources within the proposal application.  Personnel, including postdoctoral researchers, students, and other lab personnel, paid from an external source or self-funded and working on the research of the reporting Key Person.  Other In-Kind Resources, including Research Collaboration Agreements (RCAs) or other agreements or commitments that may involve the performance of research or exchange of resources in support of your research endeavors. This includes DUAs and MTAs if the exchange covers high value data/materials that are not broadly available.  Outside Funding Support, including funding received directly or through another entity at which you have an affiliation (including the Harvard Affiliates). This includes external start-up packages.

Collect information from Harvard Systems

Harvard systems may contain information pertaining to potential sources of in-kind and other resources. Please note, the first two options are only available to individual Key Personnel; no one else has access to the OAIR report or the GMAS Other Support and Activities report:  Download the GMAS report (which includes data from OAIR and Agreements Modules) through a direct link to your Other Support and Activities (Link to GMAS for automatic download of Excel report).   Export your current activities separately: Exporting Current Outside Activities from OAIR (Harvard provided PDF) Exporting Data Use Agreements from the DUA module (Harvard provided PDF)

Certify with Electronic Signature

All investigators required to submit Other Support must also electronically sign their respective documents using Adobe e-signature feature. How to Electronically Sign a PDF” (Harvard provided PDF)

Attach Supporting Documentation

Supporting documentation in the form of English-language versions of any Other Support from entities outside the United States, including, but not limited to: contracts grants, and any other agreements specific to appointments, affiliations, and/or employment with an institution or entity outside the U.S. Original agreements and translations must be uploaded to GMAS into the “Outside foreign contracts and agreements” repository. Job Aid: Outside foreign contracts and agreements document repository (Harvard provided PDF) Note:  Machine translations (e.g., Google Translate) are acceptable.

Undisclosed Other Support

Immediately notify your Research Administrator (Harvard website) of undisclosed Other Support (i.e., information that was missing from a proposal at Just-In-Time (JIT) or a Research Performance Progress Report (RPPR)).

Foreign Component and International Activities

Criteria
For an element or segment of a project to be considered a Foreign Component it would satisfy all of the following criteria: The project element or segment is performed outside of the United States The project element or segment is in support of the specific aims of an NIH funded project The project element or segment is considered significant (see below) toward the completion of the NIH project aims. Applicants and recipients should first identify whether a portion of a project will be conducted outside of the U.S. before determining whether the activities are significant.  While NIH has not explicitly defined “significant”, the measure of significance is subjective and should be carefully considered.  Activities that should always be disclosed as a Foreign Component include, but are not limited to: The involvement of human subjects or animals residing in a foreign site, extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or Any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Activities that may be considered a significant element of the project include, but are not limited to: Collaborations with investigators at a foreign site anticipated to result in co-authorship, Use of facilities or instrumentation at a foreign site, or Receipt of financial support or resources from a foreign entity
Undisclosed Foreign Component
If you think that you may have an undisclosed Foreign Component associated with your NIH project(s), please contact your School’s Research Administrator  for additional support or to make a Prior Approval request.

Roles and Responsibilities Pertaining to NIH Grant Disclosure

Principal Investigators and Key Personnel

Principal Investigators and Key Personnel are expected to be forthright and transparent about relationships, resources, and activities.  Investigators and Key Personnel will provide a complete and accurate disclosure on their Biosketch and Other Support.  This includes:

1. Collecting their disclosure information from GMAS.

• Follow the link below to go directly to the Other Support download in GMAS:

https://gmas.harvard.edu/gmas/othersupportdownload (Harvard provided link to automatic GMAS download of xls spreadsheet)

• For assistance, refer to the Job Aid: GMAS Other Support and Activities Download (Harvard provided PDF)

2. For NIH Other Support disclosures: providing any required unredacted agreements, with English translation if the original is in a foreign language
3. Working with their Grant Manager to complete your submission
4. Certifying with their electronic signature the completeness and accuracy of the final Other Support document with your electronic signature prior to submission to NIH

• How to Electronically Certify and Sign a PDF Document (Harvard provided PDF)

Grant Managers

Grant Managers will assist PIs and Key Personnel in organizing, formatting, and completing their submission.  This may include:

1. Creating JIT/Continuation Request in GMAS
2. Obtaining the disclosure information from the PI or Key Personnel.
3. Working with the PI or Key Personnel to complete their Biosketch and Other Support.
4. Uploading documents to the JIT/Continuation Request

• Assisting the PI with uploading, as needed, foreign agreements for review
• For NIH Other Support disclosures:  ensuring required supporting documentation, including original agreements and English translations, is attached

5. Formatting and reviewing for completeness and accuracy.

School or Central Reviewers

School or Central Reviewers will coordinate with Grant Managers and PIs or Key Personnel to ensure the accuracy and completeness of the submission.  This includes:

1. Reviewing Biosketch and Other Support for completeness and accuracy.
2. Reviewing Contracts/Agreements submitted by the PIs and other Key Personnel for inclusion on Other Support.
3. For NIH Other Support disclosures: Ensuring required supporting documentation, including original agreements and English translations, is attached.
4. Maintaining original signed (certified) copies of Other Support.
5. Submitting finalized Biosketch and Other Support to NIH.

Other Resources

Definitions

NIH and NSF Definition of Research:

A systematic study directed toward fuller scientific knowledge or understanding of the subject studied.

Harvard University Definition of Scientific Appointment:

Any academic or research appointment, including visiting, adjunct or temporary academic appointments, with a university, college, governmental or non-profit research institution and any fiduciary or executive level appointment with a for-profit entity engaged in commercial or research activities of a biomedical nature.

Harvard University Definition of Research:

Adheres to the Federal Policy for the Protection of Human Subjects (known as the “Common Rule” as defined in HHS regulation 45CFR46).  Teaching/training in research methods may also constitute Research for the purposes of NIH’s definition.

The Common Rule defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45CFR46.102(l))

Harvard University Definition of Conducting Research:

To be a Project Director, Principal Investigator or to otherwise be responsible for the design, conduct or reporting of research regardless of title or position (e.g., an Investigator). This definition does not normally include service on scientific or clinical advisory boards or more general scientific consulting unless it is anticipated that the individual will make a direct and significant intellectual contribution to a specific research project for the entity.

Harvard University Definition of Research as Part of Consulting:

To be responsible for the design, conduct or reporting of Research regardless of title or position.  This does not normally include service on scientific or clinical advisory boards or more general scientific consulting, unless the Principle Investigator or Senior/Key Personnel is anticipated to make a direct and significant intellectual contribution to a specific Research project for the entity.  Such an activity may result in earning authorship on a publication describing or supporting a research activity, or any consulting activity that otherwise meets the definition of Research.

Harvard University Definition of Support:

Any resources (i.e., financial, in-kind, personnel, provision of high-value materials that are not freely available) made available to a Principle Investigator or Key Personnel for use by this individual to pursue their Research. This includes in-kind resources directly provided to the individual (e.g., office/laboratory space, equipment, supplies or employees or students funded by outside sources). This does not include institutional resources, such as core facilities or shared equipment, that are made broadly available.