PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work.
Since the 2016 Advancing Ethical Research Conference (AER16), some of what I’ve learned about human subjects research has changed. The new Common Rule was published in the Federal Register, and now we wait to see whether the regulations will begin to go into effect in 2018. My institution is preparing for the NIH’s Single IRB Review Policy in Multi-Site Research and the challenges this re-organization of NIH-sponsored research presents. Meanwhile, around these regulatory and policy changes, the politics of research funding and healthcare lend a sense of uncertainty in clinical research.
This flux in the industry has been a challenge. Familiarity with regulations and policies often leads to process efficiency. For researchers, IRB members, and other research professionals in my institution, adapting to new regulations and policies requires patience and time; time which might otherwise be spent moving research forward. As an IRB administrator, new regulations demand new ways for communicating what has changed and new processes for reviewing and supporting research.
But attending, the AER16 prepared me for many of these new changes. The opening remarks in last year's panel, A New Framework for Human Subjects Research? An Update from NAS, (which included Barbara Bierer, MD, Steven Joffe, MD, MPH, and Heather Pierce, JD, MPH, and was moderated by Alexander Capron) challenged me to think about how regulations can be analyzed in light of new research practices. Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist (which included Michelle Biros, MD, Neal Dickert, Jr., MD, Ph.D., and Robert Silbergleit, MD, and was moderated by Christine Grady) offered a focused look at the research enrollment process in contexts where certain ethical mandates could be challenged. This session placed particular emphasis on research in emergency medicine and the vulnerabilities of participants—on one hand, participants with diminished decision-making are vulnerable to coercion, but they can also be denied research interventions that could potentially be beneficial.
These and other sessions at the conference enabled me rethink practices at my institution. For example, IRB reviewers at our institution noted that protocols from the emergency department involving similar participant populations often lacked consistency in how these participants were recruited and how they were asked for and provided consent. This caused confusion for the IRB and took additional work with research staff to address issues before approval. In response to this confusion, I facilitated a working group of IRB members, IRB administrators, and research coordinators from the emergency department to develop a set of standardized practices for enrolling participants with diminished capacity in studies for the department.
While still unfinished, the efforts of this working group fostered more consistent, efficient practices for researchers and IRB staff at my institution—practices that are grounded in the ethical principles of justice and respect for persons. And these practices we've already implemented have better prepared us for revisions in the Common Rule (for example, the emphasis on “the special problems of research that involve a category of subjects who are vulnerable to coercion or undue influence” in the equitable selection of subjects in the revised Section 111(a)(3)).
So, while adapting to changes in foundational regulations and policies can be difficult, the collaborative learning environment of AER16 enabled me to help my institution address areas where we could improve efficiency. And, more generally, the strategies and relationships developed at the conference and in the process of putting together our working group can now be employed to address other changes like the new Common Rule and the NIH’s Single-IRB policy. We are better positioned to adapt to changes and create new tools to improve research.
Seth Hall, associate director of the Human Research Office at the University of Mississippi Medical Center, was a member of the PRIM&R Blog Squad for the 2016 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blog on Ampersand to give our readers an insiders view of our annual conferences.