November Newsletter

Next In-Person Research Community Forum (RCF) – February 19 & 20th, 2025. Augusta, GA

Join OHRP in Augusta, GA as we co-host the next RCF, “Maintaining Public Trust in the Face of Emerging Trends in Research”, with Augusta University, Georgia State University, Georgia Southern University, University of Georgia, and Emory University!

On Day 1, participate in OHRP-led interactive sessions and learn how to apply the regulations at 45 CFR 46 through case scenarios. Attendees with a working knowledge of the regulations will find these sessions particularly helpful.

Day 2 will feature a keynote address from Carl Elliott titled “Blowing the Whistle on Abuses to Human Subjects” as well as plenaries and tracks focused on building trust in the community and navigating the ever-changing field of artificial intelligence in human research.

This RCF will meet the educational needs of HRPP and IRB administrators, IRB members, researchers, and study teams involved in biomedical and/ socio-behavioral human subject research. This event is eligible for CIP continuing education credits.

Review the agenda and register now to save your spot!

2024 OHRP Exploratory Workshop on AI in Human Research – Archive Video, Slides, and other Materials Now Available!

OHRP’s Exploratory Workshop on the ethics and governance of human research involving AI has received over 2980+ views since September! If you missed this event or simply wish to re-watch parts of it, visit www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2024-workshop/index.html. While there, you can download the slides for the workshop and shortly, obtain a summary report of the event.

OHRP Staff at PRIM&R 2024 Conference in Seattle

OHRP staff will be supporting the following office hour sessions at the PRIM&R Conference this year:

• Monday November 18: 7:15-8:15 AM; 12:30-1:30 PM
• Tuesday November 19: 7:15-8:15 AM; 12:30-1:30 PM
• Wednesday November 20: 7:15-8:15 AM

Come see us with your questions or just come by to say hello.

Visit the OHRP booth at #320 to pick up a Common Rule reg book or a Belmont Report and play with our interactive touch screen program to find out about our resources.

OHRP Announcement: Final Rule Amending Subparts B, C, and D of 45 CFR Part 46 for Conformity to the Revised Common Rule

The Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) announces the publication of a final rule that includes non-substantive amendments to HHS’s regulations for the protection of human subjects at 45 CFR part 46. This final rule amends subparts B, C, and D, which provide additional protections for certain populations in research. Administrative changes needed to be made to these subparts to ensure that subparts B, C, and D align with the 2018 revision to subpart A, known as the Common Rule, which provides a robust set of protections for research subjects. For example, this final rule updates regulatory citations that were renumbered in the revised Common Rule and adds new language based on the transition provisions in the revised Common Rule. This final rule also includes other non-substantive technical changes to ensure conformity between the Common Rule and subparts B, C, and D of 45 CFR part 46.

There are no substantive amendments included in this final rule, which is effective upon publication. Institutions may choose to update their materials accordingly.

This final rule can be viewed online here:
https://www.federalregister.gov/documents/2024/10/24/2024-24399/department-of-health-and-human-services-policy-for-the-protection-of-human-research-subjects-update