It’s hard to grasp how little you know. Having worked as an IRB administrator at a research hospital for a little over a year, I think I’ve come far in understanding ethical review of medical research. The learning curve is steep, but my study of the regulations and supporting materials, as well as help from the professionals I work with, provided me with a base of knowledge about ethical research. I applied what I learned in my day-to-day work, and when unique events arose, I went back to source material or relied on my colleagues to find to a solution.
Then I attended PRIM&R’s 2016 Advancing Ethical Research conference (AER16), and I realized how much more I have to learn. The conference was a whirlwind, with each speaker shedding new light on various facets of human subjects research. Looking back, the conference generally impressed upon me that the Belmont Report is not just an antique, passed down from prior generations to determine if proposed research is ethical or not. Instead, the Belmont Report is a present and active influence on how professionals in our industry examine how ethical research can be improved and advanced.
For instance, during Innovations A: Innovations in Public Perceptions of Research and Risks, Linda Petree, BA, CIP, discussed how her research on the different perspectives among stakeholders (including subjects, researchers, and IRB members) related to the disclosure of incidental findings to research subjects in neuroimaging studies. After finding that subjects failed to understand incidental findings reports, Ms. Petree’s research supported the provision of resources that explain reports in lay language. Incidental findings are what laypeople may believe to be a natural–or at least potential–benefit to participation in research, yet there’s no value in a participant getting information that s/he doesn’t understand. Therefore, providing a way for participants to fully understand incidental findings directly impacts the actual value of the research to the participants.
One of my goals in attending this year’s conference was to expand my “toolbox” to improve ethical review at my institution. In this, the conference proved invaluable. I found new ways to look at how research subjects interact with a study by critically thinking about the use of Community Advisory Boards to reduce vulnerability by providing greater insight. Since the conference, the broad concept of “vulnerability” means more than a heightened protection for specific populations under the Common Rule. Instead, a population’s vulnerability, such as the lay participants in Mrs. Petree’s research, can shape study design to increase the potential benefit to participants. A Community Advisory Board is a valuable method to understand the strengths and weaknesses of a participant population from those who know that population best. By considering participants’ strengths and weaknesses, research can become more participant-focused: participants become more than sources of data.
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.