One of the primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research?
At the 2017 Advancing Ethical Research Conference I attended two panels focused on these questions and the importance of listening to participant voices. The first panel “Innovations in Research with Overlooked Perspectives” moderated by Dr. Warren Capell, with panelists Dr. Suzanne Carlberg-Rachich, Dr. Wendy A Cook, and Dr. Carol Juliet Weil, was a look at the participant perspective using empirical assessment methods. During this panel, each presenter shared experiences and lessons learned from specific participant populations about their views on research participation. The populations included intravenous drug users, military personnel, and cancer patients who chose to donate biospecimens. Each of these presentations emphasized that the larger context of participant’s lives is extremely important in how they view consent and research protections.
The second panel, “When Citizens Do Science: The Democratization of Research”, moderated by Dr. P. Pearl O’Rourke with panelists Dr. Jamie Holloway, Sally Okun, and Dr. Alicia Zhou, also focused on the participant perspective but within biomedical research. Many patients that choose to be research participants have an increased interest in being included as active partners on projects, and in some cases may help drive research questions.
The main takeaway from these panels for me was that listening to the participant perspective is critical to evaluate the effectiveness of the safeguards and protections put in place by IRBs. The regulatory requirements aren’t a substitute for participant voices, and some populations may have context-specific concerns for research participation that should be included in the research design. For example, Dr. Cook interviewed military personnel about their research experiences. One theme that arose from those interviews was that repeatedly missing work or other activities to participate in research might create a stigma around the individual, because their colleagues may assume they are ill. This concern would be important to consider while designing a project, but without the research into these participant attitudes, researchers may not realize these issues. Ultimately, both panels highlighted that participants should be considered partners in the research enterprise and the best way to protect participants is to listen to their perspective.
Jennie Wyderko, MS is the research compliance officer at Western Carolina University located in Cullowhee, North Carolina. She oversees and coordinates the IRB, IACUC, and IBC for the campus. She is also responsible for oversight of export controls, responsible conduct of research, and conflict of interest as related to research.
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Save the date for PRIM&R’s 2018 Advancing Ethical Research Conference, taking place November 14-17 in San Diego, CA.