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:
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- 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) |
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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)
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Templates
Guides FAQs SciENcv Additional Information |
Section A: Personal Statement |
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Section B: Positions, Scientific Appointments, and Honors |
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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:
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Section C: Contributions to Science |
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Section D: Scholastic Performance (only present on the fellowship version of the Biosketch) |
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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)
Preparation of Agreements for Other Support (at Proposal stage) |
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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
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Flow Charts Job Aids
Additional Information |
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Other Support (at JIT and RPPR stages)
NIH Other Support |
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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:
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)
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Templates
Guides
FAQs
SciENcv Job Aids
Additional Information
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Prepare an Inventory of In-Kind Support and Other Resources |
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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:
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Collect information from Harvard Systems |
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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:
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Certify with Electronic Signature |
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All investigators required to submit Other Support must also electronically sign their respective documents using Adobe e-signature feature. |
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Attach Supporting Documentation |
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Supporting documentation in the form of English-language versions of any Other Support from entities outside the United States, including, but not limited to:
Original agreements and translations must be uploaded to GMAS into the “Outside foreign contracts and agreements” repository. Note: Machine translations (e.g., Google Translate) are acceptable. |
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Undisclosed Other Support |
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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 |
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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 |
Criteria |
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For an element or segment of a project to be considered a Foreign Component it would satisfy all of the following criteria:
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:
Activities that may be considered a significant element of the project include, but are not limited to:
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Undisclosed Foreign Component |
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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:
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- Collecting their disclosure information from GMAS.
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- Follow the link below to go directly to the Other Support download in GMAS:
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https://gmas.harvard.edu/gmas/othersupportdownload (Harvard provided link to automatic GMAS download of xls spreadsheet)
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- For assistance, refer to the Job Aid: GMAS Other Support and Activities Download (Harvard provided PDF)
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- For NIH Other Support disclosures: providing any required unredacted agreements, with English translation if the original is in a foreign language
- Working with their Grant Manager to complete your submission
- Certifying with their electronic signature the completeness and accuracy of the final Other Support document with your electronic signature prior to submission to NIH
Grant Managers
Grant Managers will assist PIs and Key Personnel in organizing, formatting, and completing their submission. This may include:
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- Creating JIT/Continuation Request in GMAS
- Obtaining the disclosure information from the PI or Key Personnel.
- Working with the PI or Key Personnel to complete their Biosketch and Other Support.
- Uploading documents to the JIT/Continuation Request
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- 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
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- 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:
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- Reviewing Biosketch and Other Support for completeness and accuracy.
- Reviewing Contracts/Agreements submitted by the PIs and other Key Personnel for inclusion on Other Support.
- For NIH Other Support disclosures: Ensuring required supporting documentation, including original agreements and English translations, is attached.
- Maintaining original signed (certified) copies of Other Support.
- Submitting finalized Biosketch and Other Support to NIH.
Other Resources
School Contacts
Use the links below to contact your Research Administrator:
Foreign Contract and Agreement Review
School | Main Contact | Email Address |
FAS | Lauren Ferrell | Outsideactivities@fas.harvard.edu |
GSE | Tiffany Blackman | tiffany_blackman@harvard.edu |
HMS | Lindsay Monahan | international_collaborations@hms.harvard.edu |
HSDM | Lindsay Monahan | international_collaborations@hms.harvard.edu |
SPH | Angela Brazeau | oscontracts@hsph.harvard.edu |
HKS | Carrie Kachoria | carrie_kachoria@hks.harvard.edu |
SEAS | Lauren Ferrell | Outsideactivities@fas.harvard.edu |
HLS | Katie McGrath | kmcgrath@law.harvard.edu |
Wyss | Katrin Duevel | katrin.duevel@wyss.harvard.edu |
Other Schools | Contact your OSP Rep with Questions |
General Other Support (Current and Pending) and Biosketch
School | Main Contact | Email Address |
FAS | Lauren Ferrell | Outsideactivities@fas.harvard.edu |
GSE | Tiffany Blackman | tiffany_blackman@harvard.edu |
HMS | Kelly Evans | Kelly_Evans@hms.harvard.edu |
HSDM | Kelly Evans | Kelly_Evans@hms.harvard.edu |
SPH | Melissa Francis | mjfrancis@hsph.harvard.edu |
HKS | Carrie Kachoria | carrie_kachoria@hks.harvard.edu |
SEAS | Pam Baker-Weber | bakerwebber@fas.harvard.edu |
HLS | Katie McGrath | kmcgrath@law.harvard.edu |
Wyss | Katrin Duevel | katrin.duevel@wyss.harvard.edu |
Other Schools | Contact your OSP Rep with Questions |
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.
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