Protecting Research Participants: Why, How, and How Much?

Clinical research with human subjects is key to progress in understanding and improving human health. Research of this type that is supported by the U.S. government follows a system of federal rules and regulations that were designed to protect human participants and ensure that clinical research is conducted in an ethical manner. These regulations were put into place several decades ago and have since undergone only modest changes. In the ensuing years, research has significantly grown and diversified, and although the system of oversight and protection in the United States has also grown, many believe the oversight system has not kept pace with changes in research. The same regulations and procedures apply to research whether it involves previously collected blood samples, surveys of behavior, or first-in-human evaluation of drugs or biologics. In 2011, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published an Advanced Notice of Proposed Rulemaking (ANPRM) that presaged the most comprehensive change to the regulations for protecting human subjects since their inception. Seeing the proposed regulatory changes as an opportunity to reexamine how research participantsoughtto be protected, Glenn Cohen, then the codirector, and Holly Lynch, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, brought a diverse group of scholars in research ethics together at a 2010 conference to engender creative and innovative ideas. The product is the timely and wide-ranging volumeHuman Subjects Research Regulation: Perspectives on the Future, edited by Cohen and Lynch.

Cohen and Lynch divide the book into five parts: 1) “Regulation of Risk,” 2) “Protection of Vulnerable Populations,” 3) “Redefining the Researcher-Participant Relationship and the Role of IRBs,” 4) “Specimens, Data, and Privacy,” and 5) “Paradigm Shifts in Research Ethics.” One important thread throughout the book is the perceived struggle between promoting ethical research on the one hand and protecting research participants on the other, and the tension between inadequate protection and burdensome overregulation. Historically, a strong focus on protecting research participants because research was thought to be risky has been tempered by perceptions of research as beneficial to society and sometimes to participants. Previous attempts at regulatory reform may have been stymied by disagreement between those who see the current system as providing inadequate protection and those who fear that it stifles research. The ANPRM’s stated goals—seeking to better protect research participants while facilitating valuable research and reducing burden, delay, and ambiguity for researchers—might even be seen as contradictory.

The contributions in part 1 of the book highlight both promoting research and protecting subjects; Rosamond Rhodes recommends a new category ofde minimusresearch risk that would need little oversight, while Ana Iltis argues for retaining continuing reviews even for low-risk research as an important protection for participants. The tension between protection and broader engagement continues in part 2. Efthimios Parasidis argues for more explicit protections for military personnel by defining this population as vulnerable, while Adam Braddock calls for children to play a more active role as research partners. Osagie K. Obasogie reminds us in a discussion of research with prisoners that careful normative analysis is needed to balance protections with responsible inclusion of vulnerable populations. In addition to normative analysis, empirical evidence is critical to knowing how well we are protecting participants while promoting important research, as Michael McDonald and others discuss. Part 3 offers insightful proposals that would serve both to protect participants and to promote research by engaging and empowering various stakeholders; Seema K. Shah focuses on investigators and sponsors, Alexander M. Capron on participants, Laura Stark on institutional review boards, and Govind Persad on the public. Part 4 continues this pattern by considering the research use of biospecimens and data. Contributors debate privacy risks, which some of them think are overemphasized, against the value of research using biospecimens and express different views about broad or blanket consent, the risks of identifiability, and the value of oversight and data security for research with biospecimens.

My favorite part of the book is the final section on paradigm shifts in research ethics, the section that seeks to reimagine what research ethicsshouldbe. The innovative proposals in this section engage the reader with a variety of ideas, including more clearly defining the realm of research covered by the regulations, basing reforms on the model of employment and labor laws, and delegating the risk-benefit analysis to individual prospective participants. For me, the most radical and yet perhaps most important proposal comes from Greg Koski, former director of OHRP. Koski notes that the regulatory apparatus for research oversight was built on an “implicit assumption, if not an explicit accusation, that . . . scientists will harm their human subjects . . . [and] are somehow irresponsible, bad people.” He suggests developing and implementing a professional model for human subjects research similar to the one that governs physicians’ conduct, which starts with the assumption that physicians care about their patients, are competent, and are expected to attend to their patients’ safety, dignity, and health needs. Rebuilding the whole human subjects protections enterprise may not be feasible or even advisable. Nonetheless, reinforcing the foundation of research ethics with an assumption and expectation that researchers and research teams are ethically responsible and do care about participants could go a long way.

Human Subjects Research Regulation: Perspectives on the Future,I. Glenn Cohen and Holly Fernandez Lynch, eds., Boston: MIT Press, 2014. 392 pages. $33.00 paperback.

Christine Grady, RN, PhD,is the chief of the Department of Bioethics in the Clinical Center of the National Institutes of Health.

Disclaimer:  The views expressed are those of the author and do not represent the policy or positions of the National Institutes of Health or the Department of Health and Human Services.

Grady C.IRB: Ethics & Human Research2015;37(4):19-20.