HRPP Newsletter July 2022
New VA IRB Review Workflow
As of July 1, the review workflow for VA studies has changed so that studies are submitted to and endorsed by the VA RDC prior to submission to the IRB. Currently, the VA endorsement process occurs after IRB pre-review. Post IRB-review, VA studies will be approved with an administrative hold as they are currently. Once the RDC issues final approval, the IRB administrative hold will be lifted. Moving the RDC endorsement process to occur prior to IRB review will provide the RDC with the opportunity to review any VA-required modifications, will align the process with other ancillary committees such as the UWCCC PRMC, and ultimately will help to shorten overall review times for VA studies. Please see this guidance for additional details and contact vhamadrdcoordinator@va.gov with questions.
Reliant Staff Departures
We are sad to announce the departure of two long-time colleagues, Carol Pech and Brandy Stoffel, who are both leaving the UW to join Huron Consulting Group. Carol has been with the IRB since 2006, first in the IRB Associate Director role, and more recently as the Associate Director of the Reliant Team within the Office of Research Compliance. During her tenure in the IRB, Carol led the development of one of the nation’s first Reliance programs. She showed the foresight to recognize the future needs of study teams looking to conduct multi-site research and the leadership to develop our stellar Reliant program and team, which included Brandy and Mike Bingham. Fortunately for us, as consultants, they will continue to be an invaluable resource to IRB staff and study teams navigating the complex world of single IRB review as we rebuild our reliance team and hire new leadership.
AAHRPP Reaccreditation Update
Thank you to everyone who assisted in the AAHRPP reaccreditation preparation and who participated in interviews for the site visit. AHRPP had some wonderful things to say about our program, particularly the pre-submission IRB consultation services, RELIANT, and the FDA/IND/IDE resources we have here on campus. There are a few niche areas of concern (primarily regarding documentation processes) that we will be implementing changes to address, and we’ll be on our way to a successful reaccreditation. Thank you all for your efforts to make our HRPP a high-quality program!
Upcoming Education Opportunities
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Clinical Research Training Program Research Forum: Fit for Purpose (12pm-1pm on 7/20/22) — Learn how quality is different from compliance
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PREP: Introduction to Community-Based Research (11am-12pm on 7/27/22) — Learn the basics of Community-Based Research, with practical advice, examples, and discussion of resources
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Clinical Research Training Program Research Forum: Drugs & Devices in Research: An Introduction to Navigate FDA Oversight Requirements (12pm-1pm on 8/17/22) — Gain an understanding of how FDA drug and device requirements apply to research activities