July Newsletter

OHRP’s 25th Anniversary

Last month, OHRP celebrated the organization’s 25^th anniversary. We would like to thank our readers for their commitment to human research protections and remind readers of OHRP’s online educational resources, which are free and include the following:

• Participant-centered informed consent training
• About Research Participation – information for potential research volunteers
• Human subjects regulations decision charts consistent with the 2018 Requirements
• Guidance and video tutorials about reporting incidents to OHRP
• Human research protection program resources

Updates Regarding OHRP’s Planned Changes to the Federalwide Assurance Form

Through the requirements of the Paperwork Reduction Act, OHRP is working to revise the Federalwide Assurance (FWA) form, OMB No. 0990-0278, to adopt the changes in the 2018 Requirements for assurances at 45 CFR 46.103 and other burden-reducing, non-regulatory changes. The proposed changes to the FWA form include all of the following:

1. Removing the Pre-2018 Common Rule requirement that institutions provide a statement of ethical principles
2. Removing the Pre-2018 Common Rule requirement that an institution designate one or more IRBs to review the research to which the FWA applies
3. Removing “check the box”, or the option for U.S. institutions to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D to all of an institution’s nonexempt human subjects research regardless of the source of support
4. Eliminating the requirement for institutions outside the U.S. to provide procedural standards they apply for human subjects research when assuring compliance with the Terms of the Federalwide Assurance

More information about the proposed changes are found in the 2017 Revised Common Rule Preamble at §__.103. The proposed changes are expected to result in a shorter, simplified FWA application process and reduce burden on respondents.

Public comments on this item can be made on or before July 14, 2025. Commenters must follow instructions in the ADDRESSES section of the Federal Register notice.

Implementing approved changes to the FWA will involve software system updates to the applications that operate OHRP’s FWA and IRB registries. There may be a future pause on submitting and processing FWA and institutional review board registration applications to allow for launching software upgrades. OHRP will notify the regulated community in advance about any scheduled downtime.

Updates to URLs for Incident Reports and Subpart C Certification

The hyperlinks to the OHRP Incident Report Form and U.S. HHS Subpart C Certification Form have been updated. If you have these pages bookmarked, you may receive an error that the URL no longer exists. Please be sure to update your bookmarks to the correct links:

https://oashsps.my.site.com/ohrpwebforms/s/incident-web-form

https://oashsps.my.site.com/ohrpwebforms/s/prisoner-web-form