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)

NIH Biographical Sketch (Biosketch)
General Information	Resources
Background: A biosketch is a streamlined version of your CV (curriculum vitae) requested by most funding agencies and institutions. NIH requires them in both competing applications and progress reports. Find instructions, blank format pages, and sample biosketches below. Instructions: The biosketch format page (NIH Website) has been updated for application and RPPR submissions due dates on/after January 25, 2022 (See NOT-OD-21-073 (NIH Website) / NOT-OD-21-110 (NIH Website) for specific changes and details) All positions, scientific appointments, and affiliations with both domestic and foreign entities or governments must be included. Use of SciENcv (NIH website) is strongly encouraged for Biosketch preparation and updates.  For assistance with SciENcv refer to the instructional videos available on HTP (SciENcv course bundle on HTP) that includes: Overview of the NIH Biosketch Tool (Harvard provided HTP course) Creating an NIH Biosketch (Harvard provided HTP course) Changes to Biosketch include revisions to Section A, B, and D.  Details on changes to the Biosketch format (rev 12/2020 (NIH provided DOC)) can be found on the Biosketch NIH Format pages, Instructions, and Sample (NIH Website).	Templates –Biosketch format (rev 12/2020) (NIH provided DOC) -Biosketch NIH Format pages, Instructions, and Sample (NIH Website) Guides –Guide to Biosketch and Other Support (Harvard provided PDF) FAQs –FAQs – NIH Biosketch (rev 1/6/2022) (Harvard provided PDF) –NIH FAQs – Biosketches (NIH Website) SciENcv –SciENcv (NIH Website) –SciENcv tutorials on HTP (Harvard provided course bundle) Additional Information –NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support (NIH provided PDF)
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)
General Information	Resources
Background: Preparing and uploading your agreements ahead of time will facilitate and expedite the submission of your Other Support for Just-in-Time and RPPR. Instructions: Locate and compile contracts or agreements with a foreign organization, government, or individual (excepting sponsored agreements that are in GMAS) for any of the following Conducting research as part of consulting; Providing support for individual’s research; An appointment, affiliation, or employment. To help identify which contracts need to be submitted as supporting documentation.  Refer to the NIH Agreements Flow Chart (Harvard provided PDF) the video of the NIH Agreements Flow Chart (Harvard provided MP4) walks through the flow chart process Retain these agreements (a copy of the original document as well as the English translation).  Further guidance will be provided on this page on the appropriate steps for deposition into GMAS.	Flow Charts –NIH Agreement Flow Chart (Harvard provided PDF) –NIH Agreement Flow Chart (Harvard Provided MP4) Job Aids –Job Aid: GMAS Other Support and Activities Download (Harvard provided PDF) –Job Aid: Outside Foreign Contracts and Agreements (Harvard website for grant managers) Additional Information –Consulting Agreement Addendum (rev 12/07/2021) (Harvard provided DOC)

Other Support

NIH Other Support
General Information	Resources
Background: Other Support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at Harvard.  This includes resources and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g. biologics, chemical, model systems, technology, etc.). Such as: All active and pending grants, whether or not they are based at Harvard Internal awards in direct support of a research project In-kind resources (e.g. office/lab space, equipment, personnel, materials not freely available, etc.).  In-kind resources may not necessarily have a readily ascertainable monetary value Foreign support made to a trainee or fellow working in the lab (e.g. “sponsored fellow” supporting your laboratory’s research efforts) Positions, affiliations, and appointments that are related to a foreign talent (or similar type) program All other resources (domestic or foreign) available in direct support of your research endeavors Additional details may be found in the 2019 Notice: NOT-OD-19-114 Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components (NIH Website) and the supporting FAQs (NIH Website).  Notice: NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NIH Website). Instructions: The NIH Other Support website (NIH Website) has been updated for application and RPPR submissions due dates on/after January 25, 2022 (See NOT-OD-21-073 (NIH Website) / NOT-OD-21-110 (NIH Website) for specific changes and details) Changes to Other Support include reorganization of the format page, electronic signatures, and supporting documentation for foreign activities and resources.  Additional details can be found on the NIH Other Support website (NIH Website) including changes to the Other Support form (rev 12/2020 (NIH provided DOC)), as well as instructions and FAQs. Use of SciENcv (NIH Website) is strongly encouraged for Biosketch preparation and updates.  For assistance with SciENcv refer to the instructional videos available on HTP (SciENcv course bundle on HTP) that includes: Overview of the NIH Biosketch Tool (Harvard provided HTP tutorial) Creating an NIH Biosketch (Harvard provided HTP tutorial)	Templates –Other Support – Template (rev 4/6/2022) (Harvard provided DOC) –Other Support form (rev 10/2021) (NIH provided DOC) –K Award: Mentor Current and Pending Support template (Harvard provided DOC) Guides –Guide to Biosketch and Other Support (Harvard provided PDF) –Other Support Form – Guide (rev 5/4/2022) (Harvard provided PDF) –NIH Foreign Component Decision Guide (Harvard provided PDF) FAQs -FAQs – NIH Other Support (rev 3/27/24) (Harvard provided PDF) –NIH FAQs – Other Support and Foreign Components (NIH Website) SciENcv –SciENcv (NIH Website) –SciENcv tutorials on HTP (Harvard provided course bundle) Job Aids –Job Aid: Outside foreign contracts and agreements document repository (Harvard provided PDF) -Job Aid: Just-In-Time Job Aid (Harvard website) –Job Aid: GMAS Other Support and Activities Download (Harvard provided PDF) Additional Information –NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support (NIH provided PDF) –Exporting Current Outside Activities from OAIR (Harvard provided PDF)  –Exporting Data Use Agreements from the DUA module (Harvard provided PDF)  –How to “Electronically Sign a PDF” (Harvard provided PDF)
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

Foreign Component and International Activities
General Information	Resources
Background: International collaboration is a key element to scientific research and progress; and while this is recognized and supported by federal funders, like NIH and NSF, they are subject to certain limitations and disclosures.  This includes disclosure of foreign participation at the time of proposal submission and throughout the life of the grant. Additional details may be found in the 2019 Notice: NOT-OD-19-114 Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components and the supporting FAQs; the July 21, 2020 policy topic: Protecting U.S. Biomedical Intellectual Innovation; as well as the recent March 12, 2021 Notice: NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021.  Requests for NIH prior Approval must be submitted through your School’s Grants office. Instructions : The addition of a Foreign Component to a NIH funded project requires NIH prior approval and must be disclosed at the time of proposal submission, or added to an ongoing NIH grant through a Prior Approval request.  A foreign component (NIH Website)  is defined as performance of any significant element or segment of the project outside the United States either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended.  To assist in the determination of whether or not a particular international activity or collaboration rises to the level of a Foreign Component, please use the “NIH Foreign Component Researcher Decision Guide (Harvard provided PDF)”.	Guides –NIH Foreign Component Decision Guide (Harvard provided PDF)
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.