January Newsletter

Time is running out to register and join OHRP in North Augusta, SC on February 19 & 20th, 2025 for our next Research Community Forum (RCF)!

Don’t wait any longer! Register today for what will be OHRP’s only in-person RCF in 2025, Maintaining Public Trust in the Face of Emerging Trends in Research, co-sponsored with Augusta University, Georgia State University, Georgia Southern University, University of Georgia, and Emory University.

Day 1 of the RCF is a fantastic opportunity to meet with OHRP staff face-to-face as we lead interactive sessions that guide audience members through real-time applications of the regulations at 45 CFR 46.

Day 2 will begin with a keynote address from Dr. Carl Elliott titled Blowing the Whistle on Abuses to Human Subjects followed by plenaries and breakout sessions focused on building trust in the community and navigating the ever-changing field of artificial intelligence in human research.

All the presentations at this event meet the criteria in the Certified IRB Professional (CIP) recertification guidelines at https://primr.org/certification/recertification/

Review the agenda and register now to save your spot!

Check out Our New Interactive Scenario on Protecting Participants’ Privacy and Data Confidentiality in Research!

Protecting Privacy and Data Confidentiality is our newest addition to the Considerations for Reviewing Human Subjects Research educational series for IRBs and investigators. Through dialogue between a post-doc and their mentor concerning a study proposal, researchers and IRB reviewers have the opportunity to view aspects of the research design process that may be relevant and meaningful when it comes to considerations for protecting participants’ privacy and the confidentiality of their private data.

Click here to access the training video!

While you’re at it, don’t forget to review our other scenarios including Equitable Selection of Subjects, Minimizing Risks in Research, and Balancing Risks and Benefits. Completion certificates for these trainings are available for your records.

***These trainings offer an invaluable opportunity for investigators and IRB members to learn how to appropriately apply the IRB review criteria for protecting participants in the design of research activities. OHRP would be happy to provide you with these training programs for incorporation into your institution's inhouse learning management system. Send requests to OHRP-edu@hhs.gov.***

Announcing Draft Guidance on Conditions for Including Tissue Biopsies in Clinical Trials

On January 7, 2025, the Office for Human Research Protections and the U.S. Food and Drug Administration issued a draft guidance with that, when finalized, will provide recommendations about including tissue biopsies as part of clinical trials and provide considerations for determining whether a tissue biopsy should be required or optional.  The draft guidance is intended, when finalized, to assist industry, clinical investigators, institutions, and institutional review boards in understanding considerations for tissue biopsies in adults and children as part of clinical trials that evaluate investigational medical products and/or that are conducted or supported by the U.S. Department of Health and Human Services.

Comments about the draft guidance, “Considerations for Including Tissue Biopsies in Clinical Trials: Guidance for Industry, Investigators, Institutions, and IRBs,” can be submitted through March 10, 2025, by following instructions in the Federal Register (90 FR 1173), which can be accessed online.

The text of the draft guidance document appears on OHRP’s website and is also available on FDA’s website.

Summary Report Now Available for the Webinar, On Differing Approaches to Measuring and Ensuring IRB Effectiveness

This webinar marked the culmination of collaborative efforts between OHRP and the FDA to bring together key stakeholders and explore strategies for assessing the effectiveness of IRBs in protecting human subjects, as outlined in the Government Accountability Office’s (GAO) 2023 report. Experts in the field shared their insights on four key approaches for evaluating IRB effectiveness.

Interested in learning more? Click here to watch the recording and access the summary report.

The presentations and panel discussion for this webinar meet the CIP recertification guidelines and are eligible for continuing education units.

Read OHRP’s Recent Publication in the National Council of University Research Administrators (NCURA) Magazine!

On September 19, 2024, OHRP hosted its 7th annual Exploratory Workshop focused on the use of AI in biomedical and social and behavioral research.

In the December 2024 NCURA Magazine issue, OHRP staff member Marianna Azar reflects on the workshop and the timely and engaging discussion of the event panelists.

For more articles published by OHRP in NCURA and other outlets, click here.