Exceptions to Use of a Single IRB During the COVID-19 Public Health Emergency

Conducting research involving human subjects during COVID? Read here for information on requesting an exception to the use of a single IRB.

NIH released a Guide Notice to inform the extramural research community how NIH is implementing the Office for Human Research Protections (OHRP)’s determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Continue reading

Researchers, if You Received a Survey, Please Provide Us with Your Perspective on the Impact of COVID-19

Since March, COVID-19 has greatly impacted the way we all work. NIH has been tracking how well our policies meet the needs of our research community in response to the ongoing pandemic. To get a better understanding of how COVID-19 is impacting our extramural researchers, we launched the Impact of COVID-19 on Extramural Researchers Survey in mid-October. If you received an invitation to take this survey, please take 15-20 minutes to complete it. This survey will be open until Friday, November 13th. The results from the survey will inform policy and program decisions, so participation is critical. Continue reading

Automated Trainee Diversity Report Required with RPPRs for Most T, K and Research Education Awards Beginning October 30, 2020

An automatically generated Trainee Diversity Report will replace the manual report that signing officials are required to submit with RPPRs for most institutional training, career development awards and research education grants, effective October 30, 2020.  The automated report will leverage existing electronic demographic data entered by trainees in the Personal Profile of eRA Commons to minimize the need for manual data entry by recipients and reduce their burden. Continue reading

Institutions to Submit FCOI Policy Electronically in eRA Commons, Effective November 12, 2020

NIH requires institutions to maintain an up-to-date, written, and enforced policy to identify and manage Investigator Financial Conflicts of Interest (FCOI) and to post the policy on their publicly accessible website. Starting November 12, 2020, NIH recipients will be required to submit their publicly assessible FCOI policy to NIH via the eRA Commons Institution Profile (IPF) Module. Continue reading

NIH Will Continue to Accept Preliminary Data as Post-Submission Material Through August/October 2021 Councils

In recognition of the fact that COVID-19 may still be adversely affecting the ability of applicants to generate preliminary data, NIH will continue to accept a one-page update with preliminary data as post-submission materials for applications submitted for the August/October 2021 council (beginning with applications submitted for the January 25, 2021 due date for Summer 2021 review meetings), ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. Continue reading

Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) Module

Effective November 12, 2020, NIH funded recipients will be required to submit their publicly assessible Financial Conflict of Interest (FCOI) policy to NIH via the eRA Commons Institution Profile (IPF) Module (IPF Module). A PDF of the FCOI policy must be submitted by the institutional signing official (SO) via the IPF Module under a new tab labeled, “Policy Documents”.   Continue reading

Friendlier Approach for Cross-Referencing NOSIs in FOAs Used for Submission

Going forward, you will no longer see individual Notices of Special Interest (NOSIs) cross-referenced in the Related Notices section of the funding opportunity announcements (FOAs) they use for application submission. Instead, FOAs identified for use with NOSIs will include a single link at the top of the Related Notices section that takes you to two NOSI tables – one for active and another for expired NOSIs associated with the FOA. The table format enables you to see, at a glance, the NOSIs that are still active along with the expiration date, activity code(s), and participating organizations. Continue reading

Guidance on Charging Personal Protective Equipment for Grants that Support Clinical Trials and Clinical Research

NIH has received many inquiries from recipients regarding their ability to direct charge personal protective equipment (PPE) costs to their clinical trials and clinical research awards. In this recent Guide Notice, NIH provides criteria for applicants/recipients on when it is appropriate to direct charge PPE costs. Continue reading