External Event: OHRP: On Differing Approaches to Measuring and Ensuring IRB Effectiveness

Oct 17 • All Day

On Differing Approaches to Measuring and Ensuring IRB Effectiveness

October 17, 2024
12:00 pm to 2:00 pm EDT
Registration Required

This webinar represents the culmination of OHRP’s and FDA’s efforts to convene interested parties to examine approaches for measuring Institutional Review Board (IRB) effectiveness in protecting human subjects, as recommended by the Government Accountability Office (GAO) in its 2023 report on IRBs. In this webinar, you will hear from experts in their fields about four key approaches for attempting to measure IRB effectiveness that we learned about during our meetings with a variety of interest-holders: (1) post-approval monitoring to verify compliance with IRB requirements, relevant regulations, and institutional policies, (2) accreditation and peer review; (3) study participant considerations, and (4) the quality of IRB deliberations. After the presentations and a panel discussion, members of the public will have the opportunity to ask questions and provide thoughts on this important topic.

Agenda:

Opening Remarks (12:00 – 12:10 pm)


Introductions and Setting the Stage (12:10 – 12:20 pm)

Moderator: Holly Taylor, MPH, PhD
Research Bioethicist, NIH Clinical Center

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Panelist 1 – On Measuring IRB Effectiveness through Post-Approval Compliance Monitoring (12:20 – 12:35 pm)

Speaker: Rachel Lally, MPH, CIP
Assistant Vice President for Research, Penn State University

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Panelist 2 – On Measuring and Ensuring HRPP and IRB Effectiveness through Accreditation (12:35 – 12:45 pm)

Speaker: Nichelle Cobb, PhD, CIP
Senior Advisor for Strategic Initiatives for AAHRPP

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Panelist 3 – On Measuring and Ensuring HRPP and IRB Effectiveness through Peer Review (12:45 – 12:55 pm)

Speaker: Benjamin Mooso, MS, CCRP
IRB Director at UC San Diego, and CARE-Q

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Panelist 4 – The Participant Experience as a Proxy for IRB Effectiveness (12:55 – 1:10 pm)

Speaker: Luke Gelinas, PhD
Senior IRB Chair, Advarra

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Panelist 5 –On Measuring and Ensuring IRB Effectiveness Through the Quality of IRB Deliberations (1:10 – 1:25 pm)

Speaker: Laura Stark, PhD
Associate Professor at the Center for Medicine, Health, and Society, Vanderbilt University

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Panel Discussion and Audience Questions (1:25 – 2:00 pm)

Content created by Office for Human Research Protections (OHRP) and copied here for your information.
Find content here: https://www.hhs.gov/ohrp/education-and-outreach/irb-effectiveness-webinar/index.html 

Register

Oct 17, 2024

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