Source: OVPR's Website

Over the past year, NIH has posted three notices (NOT-OD-21-073, NOT-OD-21-107, NOT-OD-21-110) that update its submission requirements and Grants Policy Statement.  These new requirements will be implemented in a staggered timeline, effective: 

• Immediately and
• on or after January 25, 2022.

Ultimately, the totality of revisions will not be required until January 25, 2022; please see below for Harvard’s implementation plan.  As a PI, you are urged to work in partnership with your local unit/School to ensure all necessary information is included in your proposals, just-in-time documentation, and progress reports in a timely manner, including in accordance with the review requirements of your School’s submitting office (see below for specific deadline policies).  All submissions, JIT requests, and RPPRs due on or after January 25, 2022, must adhere to the revised requirements described in the NIH notices above. Failure to follow these may cause NIH to withdraw your application from consideration.

Effective Immediately:

1. Submission of proposals and progress reports are due to your School’s submitting office according to their deadline policy for review and authorization but no later than 5 business days before the sponsor’s due date.  Use the links listed below for additional information on the specific deadline policies for each submitting office.
   1. For submissions to OSP
   2. For submissions to HMS ORA
   3. For submissions to Harvard Chan SPA
2. Immediate notification of previously undisclosed Other Support.  For more information, see NIH Other Support FAQ 2.
3. Biosketch
   1. Disclosure of all positions, scientific appointments, and affiliations with both domestic and foreign entities or governments are to be included.
   2. Use of SciENcv is strongly recommend for creation of your Biosketch in the new March 2021 format and in doing so:
      1. Ensures that all the appropriate disclosures are provided
      2. Prepares your Biosketch for the required changes that go into effect on January 25, 2022
      3. For assistance with SciENcv, please refer to the manual or for instructional videos check out this tutorial and webinar.
4. Other Support
   1. For submissions before January 25 2022, continue to use the current Other Support forms (rev 03/2020).  
   2. Harvard’s recommended version of the form is posted here, along with a guide to what types of other support should be included in each section.  Additional guidance for Harvard Chan School of Public Health can be found here.
   3. Include consulting activities as Other Support when research is conducted as part of the consultation.  For more information, see NIH Other Support FAQ 15.
   4. For submissions prior to January 24, 2022, Other Support pages should not include an e-signature.
5. In preparation for the January 25, 2022, Other Support form changes, researchers must:
   1. Update disclosure information in OAIR to include all outside activities. For detailed information on what to include in your disclosure certification, please see guidance from OVPR.
   2. Begin the process of gathering and retaining copies (for your records) of foreign agreements related to research activities, appointments/employment or other support/resources from foreign institutions.  If the original is in a foreign language, a copy translated into English must be submitted as supporting documentation with applications on or after January 25, 2022.  A non-certified translated copy of an agreement is acceptable through January 24, 2022.
   3. NIH may request such agreements as part of their review process, effective immediately; consult with your School’s submitting office for guidance on the appropriate next steps.

Effective on or after January 25, 2022

1. Use SciENcv for Biosketch preparation and updates.  Details on changes to the Biosketch format (rev 12/2020) and Other Support forms (rev 12/2020) can be found on the Biosketch NIH Format pages, Instructions, and Sample and Other Support websites.
2. Changes to Biosketch include revisions to Section A, B, and D
   1. Section A incorporates the previous Section D: Research Support.  This section may include ongoing and completed projects from the past three years that the applicant wishes to highlight.
   2. Section B has been renamed “Positions, Scientific Appointments, and Honors.”  The NIH specifies that the list must include the following, whether or not renumeration is received and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary):
      1. All positions, both domestic and foreign
      2. All scientific appointments, both domestic and foreign
      3. All affiliations with foreign entities or governments
      4. All titled academic, professional, or institutional appointments
      5. Any relevant academic and professional achievements and honors.
   3. 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.
3. Changes to Other Support include reorganization of the format page, electronic signatures, and supporting documentation for foreign activities and resources.
   1. Reorganization of the Other Support format page includes
      1. Separation of funded projects and in-kind contributions into different sections;
      2. Details on the locale or site where research is/was conducted for Active, Pending, or Completed Projects/Proposals as well as for research using resources listed within in-kind contributions; and
      3. Reporting of the total award amount for Active and Pending Projects/Proposals.
   2. Electronic signatures are required for each PD/PI or senior/key personnel to certify their respective Other Support form prior to submission. 
      1. Details on how Harvard PDs/PIs or senior/key personnel will e-sign their respective Other Support is in development and will be updated as details become available.
   3. Supporting documentation for all foreign activities and resources that are reported in Other Support must be attached to the submitted application.  This includes copies of contracts, grants, or any other agreement specific to the senior/key personnel.  An English translation must be provided if the original document is in a foreign language.
      1. Details on the submission of Supporting Documentation will be updated; the internal procedures are in development.