19
Nov2018

The IRB Administrator 201 portion of PRIM&R’s IRB Administrator Boot Camp was very insightful and provides a good opportunity to apply critical thinking skills to real life scenarios faced by other IRBs.

In the “Analyzing Framework” session, the recurring theme was “If you don’t ask the right questions, you won’t get the right answers”. Although I am not new to working in an IRB, this thought struck a chord personally. It can be difficult to know which questions to ask when someone calls and you don’t want to seem ignorant. While knowing the right questions to ask is critical, I have realized that I often don’t ask enough questions. When getting a call from a study team member, I want to quickly give them the accurate answer they’re looking for, but I’ve come to understand that many questions involve delving deeper than the inquiry’s surface. Asking appropriate questions is a process to facilitate understanding for both IRB staff and the research community and is crucial to giving and getting the correct answers.

IRB Administrator 201 also presents some information on aspects of an IRB office that administrators may not typically consider in their day-to-day work, like hiring and budgets. Additionally, the policy and procedure exercise included in the course is an opportunity to examine one’s own institution’s standard operating procedures and see if they include necessary elements based on OHRP/FDA guidance and the AAHRPP Tip Sheet. The topics encompassed in IRB Administrator 201 are practical and applicable for all IRB administrators.

The “When Regulations Collide” section included in the course is particularly useful for thinking about complex case studies and regulatory issues. These exercises require the use of critical thinking skills and highlight the importance of examining studies in a multi-faceted manner. A study may be subject to more than one set of regulations, and while aspects of the study may meet the criteria for approvability under one set of regulations, it doesn’t necessarily mean that it meets approvability criteria under a different set of regulations it’s subject to. I enjoy analyzing case studies and appreciate that they demonstrate the importance of knowing the regulations that govern human subjects research and when to apply them.

The presentations on implementation of the revised Common Rule and single IRB review considerations are particularly relevant with regard to the anticipated changes. A great deal of templates and samples were provided as examples of how other institutions are attempting to navigate the Common Rule changes and this is certainly an area in which IRBs can learn from each other. IRB Administrator 201 is an engaging course which includes thought-provoking scenarios and is perfect for administrators who have had at least a few years of experience.

Megan Boyt, CIP, is a Regulatory Analyst in the IRBMED office at the University of Michigan. She pre-reviews biomedical IRB applications from various departments and helps coordinate full board meetings. Megan serves as a liaison between board members and the research community and strives to be an effective facilitator. Prior to joining the University of Michigan, she worked as a Research Compliance Specialist at Wayne State University. Megan has worked in the IRB realm since 2011.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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