NIH Pre- and Post-Award Disclosures

January 11, 2022

Not sure whether a particular activity should be reported in the biosketch, other support, or annual project reports? Check out this new resource – NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support.

Extending Existing Guidance for Preparing Applications During COVID-19 

January 11, 2022

For Spring 2022 due dates, NIH recently extended the guidance that while grant applications should not include contingency or recovery plans for problems resulting from the COVID-19 pandemic, investigators may address effects due to the pandemic on productivity or other scoreable issues in the personal statement of the biosketch. NIH also extended the special exception for post-submission material to applications submitted for the August/October 2022 Council rounds.

Reminder: Unique Entity ID (UEI) Required Starting January 2022

January 5, 2022

For grant applications due on or after January 25, 2022, applicants must have a Unique Entity ID (UEI)  at the time of application submission, as the federal government transitions from DUNS numbers. Wondering how to get a UEI? On January 12, 2022, the Office of Management and Budget (OMB) is offering a repeat of the popular webinar “All about the Unique Entity ID (SAM) for the Recipient Community”.

Ensuring Smooth Submission of Inclusion Data

December 20, 2021

NIH requires participant-level data in progress reports for all clinical research that come in on applications for due dates January 25, 2019 or later (see our Inclusion Across the Lifespan policy).  Grantees use the Inclusion Enrollment report template provided through NIH’s Human Subjects System (HSS) to provide the required data. To successfully submit the report, obtain the template by selecting the Download Participant Level Data Template button on the Inclusion Enrollment Report screen.

Should I Report the Sex or Gender of Study Participants to NIH?

December 16, 2021

NIH uses sex/gender to indicate that either sex or gender may be reported for inclusion enrollment purposes. The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the study’s context. Participants always have the option not to identify with either sex/gender category. If both sex and gender identity are collected, investigators may choose which one to report based on the scientific question(s) that are the focus of the study.