Office for Human Research Protections Incident Report Form

The U.S. Department of Health and Human Services (HHS)’ Office for Human Research Protections (OHRP) is requesting reinstatement of OMB No. 0990-0477, the OHRP Incident Report Form, with changes, for a three-year period. Reinstatement will be necessary because the current collection is approved by OMB through May 31, 2024, and a request for OMB to extend its approval has gone beyond the required time span for submission to OMB prior to that expiration date. This reinstatement information collection request includes two new information elements on the Incident Report form: IORG # for Reviewing IRB; and, Revising research policies and procedures as a corrective action plan category, if it applies. The inclusion of these data elements did not affect the burden estimate. The purpose of the Incident Report form is to facilitate organizations’ or institutions’ prompt reporting of specific human subject protection incidents to OHRP in a simplified standardized format. Respondents for this information collection are organizations and institutions conducting or reviewing HHS conducted or supported human subjects research in compliance with the HHS Federal Policy for the Protection of Human Subjects (the Common Rule), which is codified for HHS at 45 CFR part 46, subpart A.

The latest form for Office for Human Research Protections Incident Report Form expires 2027-09-30 and can be found here.

Incident Report

Federal Enterprise Architecture: Health - Consumer Health and Safety

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