Much of my AER16 schedule focused on risks in vulnerable populations. For me, an important backdrop for these topics was presented in the Plenary Session A New Framework for Human Subjects Research? An Update from NAS, moderated by Alexander Capron. The presenters, Barbara Bierer, MD, Steven Joffe, MD, MPH, and Heather Pierce, JD, MPH, did not discuss research risks or vulnerable populations, but they discussed how the current regulatory and policy framework fits with current research practices.
The overall theme was that a search for new regulatory and policy solutions to support human research is a viable idea, given that research has changed drastically since the Common Rule was last updated. But what the presenters did not have was a crystal ball. There is no sure way to determine what changes, if any, would be made to federal laws and policies that direct human subjects research.
Still, research has already evolved under the current regulations, and another session, A6: Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations captured some of this evolution. Lianne Urada, PhD, MSW, LCSW, Brandon Brown, MPH, PhD, and Celia Fisher, PhD, spoke about the barriers to research in certain participant populations and how researchers address these issues. While the type of participants they described—sex workers and substance users—are not typically defined as “vulnerable populations” under the Common Rule, these participants encounter social and structural constraints to their research participation because of the potential stigma of their status. Specifically, these participants could be coerced into participation by social forces, or they might be exposed to arrest or violence if a breach of confidentiality occurred.
In addition, the social and structural forces acting on these participants translated into self-censorship and barriers to full participation; for instance, some participants may not give their full names to researchers because of mistrust, thereby making data collection from medical records impossible.
Engaging in ethical research of these populations (and protecting the Belmont Report’s principles of beneficence, justice, and respect for persons) required the presenters to understand the macro and micro influences on their research participants’ perceptions of mutual respect, trust, and risk. Each presenter relied on a community advisory board (CAB) to identify the social, structural, and personal constraints on participation in their study, and to determine workable solutions to encourage participation. For Dr. Brown’s research of HPV vaccination in Peruvian sex workers, a CAB helped identify sufficient non-monetary benefits to support participation, including the establishment of non-governmental health clinics. Dr. Fisher’s use of a CAB helped address specific research mistrust issues to foster participant trust—which would have otherwise been absent from a basic informed consent procedure. Dr. Urada directly mobilized Mexican sex workers to identify issues that the population specifically wanted addressed in research, and thereby tied the objectives of the research to the specific needs of the participant population.
While IRBs are required to include members who understand relevant cultural backgrounds and sensitivities, nothing in the current federal regulations required Drs. Urada, Brown, and Fisher to identify the macro and micro constraints which limited research on their participant populations or to convene CABs to foster participant trust and satisfaction with the research. But of course, regulations aren’t ethics. The Belmont principles supplied the ethical guidance necessary to address the unique participant risks. Thankfully, even when the regulations and policies do change, beneficence, justice, and respect for persons will continue to support and guide the evolution of human subjects research.
Seth Hall, associate director of the Human Research Office at the University of Mississippi Medical Center, is 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 are blogging here, on Ampersand, to give our readers an inside peek of what happened at the conference in Anaheim, CA.