I’ve been the Human Protections Administrator at my institution for seventeen years, have had my credentials as a Certified IRB Professional (CIP®) since 2014; our institution recently achieved full accreditation from Association for the Accreditation for Human Research Protection Programs (AAHRPP®), yet, I still have a literal “List of Conundrums” posted on my office wall. How many of you can relate to this? I’m sure I’m not alone! To paraphrase a common idiom, “We may not have it all together, but together we have . . . most of it.” So, let’s all meet up at the all-virtual 2022 PRIM&R Annual Conference (PRIMR22), December 12 -15 with workshops December 6 & 8! There is a packed agenda with crossover content for the entire research community.
There are many difficulties in the IRB world that I’m looking for clarification about at the PRIMR22. One of my current missions is to educate investigators at my institution (and myself, for that matter) about the IRB’s purpose. I am often asked to help with IRB submissions for projects that do not require IRB review, and parceling out the QA/QI projects from human subjects research is an unending task. After I pondered this issue for a while, however, I realized that the IRB is asked to oversee too many exceptions to the “human subjects research” rule. We need flexibility and innovation in research oversight, but mission creep is a serious problem. Where does the mission creep end? Can we petition for a more effective and definitive use of IRB review? I am really looking forward to breakout sessions about community and institutional outreach and HRPP flexibility on Monday and Tuesday to jump-start my goal.
Along with that rationale, I would like guidance on how to encourage and facilitate discussion at IRB meetings. I’ve recently developed an orientation for new IRB members, but my more immediate concern is the lack of engagement from our current membership. Too often, when we ask for questions or comments at meetings, we’re met with crickets. How do we get IRB members, regardless of experience or expertise, to engage? Several concurrent breakout sessions at PRIMR22 offer learning objectives and valuable strategies to facilitate effective meetings with fruitful discussions and consistency in review. I’m grateful that I can watch recordings, so I don’t miss anything!
My interests also point to diversity, equity, and inclusion initiatives, equity in study design and recruitment, and learning how to lead change and develop a DE&I work plan for our HRPP. Many sessions at the conference offer insight into these issues, and I’m especially looking forward to Thursday’s workshop, The IRB and Diversity, Equity, Inclusion, and Justice (DEIJ): Lead? Follow? Or Get Out of the Way?
The big question that shadows my conundrums ─ mission creep, engagement, DE&I ─ is “Whose job is it, and how can we make it happen?” and I’m looking forward to the 2022 PRIM&R Annual Conference pointing us all in the same direction to work on answers.
Ericka Seidemann, BS, MA, CIP, is the Human Protections Administrator for Woman’s Hospital, one of the largest women’s specialty hospitals in the United States, in Baton Rouge, Louisiana. She has served as the HPA at the Woman’s Hospital Research Center for 15+ years. She has been a clinical study coordinator and also has laboratory experience as an embryologist/andrologist as a Technical Supervisor. Her interests include research ethics and DE&I research initiatives. At the 2022 PRIM&R Annual Conference, she is most looking forward to learning how to improve healthcare disparities with research opportunities for underserved populations and also applying leadership skills to help those in the research community.
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