August Newsletter

August 2023

Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data in Ann Arbor, Michigan on Sep 26-27th

Join OHRP and NIH staff and colleagues in the human research protection world for 2 fruitful days of discussion. Conference highlights include the ethical challenges and opportunities presented by AI technologies and innovations in informed consent. This conference will also cover challenges and best practice with using NIH’s Certificates of Confidentiality to manage, share, and protect research data.

Gather your colleagues for this upcoming meet and learn function!

Find details and register here

OHRP’s 6th Annual Exploratory Workshop (EW), Old Trips, New destinations: Exploring the Ethical and Practical Considerations of Psychedelics Research, will be livestreamed on Thursday, Sept 14th!

Join OHRP for this free live streamed event on Thursday, September 14, 2023, from 9:45 a.m. to 4:15 p.m. EDT. No registration is required.

Experts in the field will deliberate on the ethical, practical, and legal questions pertaining to psychedelics research, including unique risk considerations, issues pertaining to informed consent, study design and integrity, inclusion of vulnerable groups, as well as the importance of preserving public trust. This is a timely and important discussion that responds to tremendous interest in this topic from diverse stakeholders, including patients, researchers, funders, regulators, and policymakers at both the state and federal levels.

Visit the event website for details and tell your colleagues about it. Make sure to download the agenda flyer to share with your colleagues!

Updated Human Research Protection Foundational Training

OHRP offers a free online foundational training delivered in 5 lessons with completion certificates. This comprehensive training provides a basic understanding of the framework for protecting research participants for HHS (or federally)-conducted or supported research including the Belmont ethical principles and the regulatory requirements of the revised Common Rule. The lessons are kept concise and are written for easy understanding. This training may be useful for institutions who want to engage or recruit lay members to their IRBs and/or train community leaders on human subjects research.

Updates have been made to the training including further explanation of the three Belmont principles: Justice, beneficence, and respect for persons and additional clarification related to single IRB mandate.

Click here to access the training.

Draft Guidance on Limited Institutional Review Board Review and Related Exemptions – Open for Public Comment – Last Chance for Comment on August 15

OHRP recently announced a new draft guidance document, “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions.” The draft guidance document applies to human subjects research that is conducted or supported by HHS. It is intended primarily to help entities implement the requirement for limited review of research by an institutional review board (IRB) to meet the conditions of four exemptions found at 45 CFR 46.104(d). When finalized, this will provide OHRP’s first formal guidance on this topic.

The draft guidance can be viewed on OHRP’s website here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-frequently-asked-questions-limited-institutional-review-board-review-related-exemptions/index.html

Notice of this draft guidance appeared in the June 16, 2023 issue of the Federal Register (88 FR 39438), which can be accessed at: https://www.federalregister.gov/d/2023-12924

This draft guidance has a public comment period of 60 days, which closes on August 15, 2023. Details about how to submit public comments are in the Federal Register notice or on OHRP’s website here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/frequently-asked-questions-limited-institutional-review-board-review-related-exemptions/index.html