• IRB: ETHICS & HUMAN RESEARCH

Making Voices Matter

Abstract: In this set of invited commentaries, Rebecca Dresser, Stephanie Solomon Cargill, Nancy M. P. King, and Carl Elliott focus on the issue of giving research participants a voice in ethics and policy discussions about the conduct and oversight of human subjects research. In addition to identifying normative and practical justifications for giving research participants a “voice at the table,” they raise important questions about who should listen to research participants’ voices, how and when they should listen, and how they should respond to what they hear.

Key words: clinical trials, human research subjects, engaging research participants, research participants as partners

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The authors of this set of invited commentaries focus on the issue of giving research participants a voice in ethics and policy discussions about the conduct and oversight of human subjects research. In addition to identifying normative and practical justifications for giving research participants a “voice at the table,” they raise important questions about who should listen to research participants’ voices, how and when they should listen, and how they should respond to what they hear.

In the anchor piece for the theme issue, Rebecca Dresser lays out the case for including the voices of research subjects in ethics and policy discussions regarding research with humans and its oversight. She says participants should be members of institutional review boards (IRBs) and other institutional committees that address research ethics issues and develop relevant policies.

Dresser acknowledges the challenges involved with determining which research subjects should be included, how to integrate subjects’ voices into decision-making processes, and what weight to give those voices in making research ethics and policy decisions. The authors responding to her commentary—Stephanie Cargill, Nancy King, and Carl Elliott—focus on some of those challenges. For instance, Cargill identifies important advantages and disadvantages of direct and indirect approaches for incorporating the voices of research participants in research ethics and policy discussions. Direct approaches such as making research participants members of IRBs and other committees give participants a voice in face-to-face, real-time oversight processes. But direct approaches present resource challenges for both research participants and the institutions that seek participants’ input. While indirect approaches may be less resource intensive, they may not capture perspectives and concerns that would emerge from research participants’ direct involvement with IRBs and other committees. For instance, efforts to indirectly learn about research participants’ perspectives from the relevant published literature will be hampered if little has been published or what has been published covers narrow issues and reports perspectives from participants who are not a representative sample of those who enroll in studies.

In the second commentary, King suggests that the wholesale enlistment of experienced research subjects in making needed changes to the oversight of human subjects research may not be the only path for making those changes. She uses a hypothetical deception research study to illustrate concerns about ensuring that participants’ voices are not unassailable and that incorporating their voices into the research enterprise does not let researchers off the hook from independently knowing about relevant ethical issues. King also describes a debriefing model for deception studies that could facilitate robust involvement of experienced subjects in the research process and provide a relational and communicative means to increase the trustworthiness of researchers and of the research enterprise itself.

Finally, Elliott draws from the experiences of actual research participants to consider what it would mean for researchers, funders, IRBs, and institutions to act on research participants’ suggestions and concerns. For instance, Dresser points out that research participants’ preferences and interests should not completely control research ethics decisions and policies. Yet Elliot raises concerns about those with power to make changes failing to take seriously the voices they hear. An example is when participants say it is unfair that they, and not research sponsors, have to pay for medical treatment if they are injured in a research study. Despite recommendations from major advisory bodies that have addressed the issue and unlike nearly every other country in the developed world, the United States has no national policy requiring sponsors to pay for such treatment. In Elliot’s view, research participants’ real power comes not from expressing their views as members of relevant committees, but from refusing to enroll in studies they believe are conducted under unfair conditions.

As current and future policy initiatives that foster “patient engagement” and “participants as partners in the research enterprise” move forward, much will be learned about how these initiatives seek the voices of actual research participants and whose voices are expressed. But much will also be learned about whether researchers, funders, IRBs, and institutions hear those voices, and how they respond.