The Ethics Police?: The Struggle to Make Human Research Safe
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Research on human beings saves countless lives, but has at times harmed the participants. To what degree then should government regulate science, and how? The horrors of Nazi concentration camp experiments and the egregious Tuskegee syphilis study led the US government, in 1974, to establish Research Ethics Committees, known as Institutional Review Boards (IRBs) to oversee research on humans. The US now has over 4,000 IRBs, which examine yearly tens of billions of dollars of research -- all studies on people involving diseases, from cancer to autism, and behavior. Yet ethical violations persist.
At the same time, critics have increasingly attacked these committees for delaying or blocking important studies. Partly, science is changing, and the current system has not kept up. Since the regulations were first conceived 40 years ago, research has burgeoned 30-fold. Studies often now include not a single university, but multiple institutions, and 40 separate IRBs thus need to approve a single project. One committee might approve a study quickly, while others require major changes, altering the scientific design, and making the comparison of data between sites difficult.
Crucial dilemmas thus emerge of whether the current system should be changed, and if so, how. Yet we must first understand the status quo to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. Robert Klitzman thus interviewed 45 IRB leaders and members about how they make decisions. What he heard consistently surprised him.
This book reveals what Klitzman learned, providing rare glimpses into the conflicts and complexities these individuals face, defining science, assessing possible future risks and benefits of studies, and deciding how much to trust researchers -- illuminating, more broadly, how we view and interpret ethics in our lives today, and perceive and use power.
These committees reflect many of the most vital tensions of our time - concerning science and human values, individual freedom, government control, and industry greed. Ultimately, as patients, scientists, or subjects, the decisions of these men and women affect us all.
current system remain uncharted and unknown. Yet this lengthy document, too, has generated debates. For instance, under these proposals, researchers would decide for themselves whether their study is “minimal risk” and therefore exempt from IRB review. Investigators would simply then register their study with their IRB, complete a simple (approximately one-page) form, and immediately begin conducting the research. But under this arrangement, investigators conducting research similar to the
for future research: to explore more fully exactly how much and what type of initial and ongoing training chairs, members, and staff do and should have, of what it consists, and what specific gaps persist. Several members felt that to become fully knowledgeable and comfortable on the IRB took a few years, raising questions of what is learned over that time “on the job,” and what exactly heightened their confidence and comfort. These processes of socialization over time—how individuals enter
for each committee. Nonetheless, a few IRBs felt justified in requesting changes in studies that had been approved elsewhere (e.g., by the NIH), and appeared to take pride in having detected an important ethical problem that had been previously overlooked. One committee, for instance, was the only one to complain about a multisite study requiring patients to agree to enroll in a registry before entering a study. As Cynthia said, Chapter 4: Defining Research and How Good It Needs to Be 109 We
of a larger community, but that does not generally appear to be the case here. Interviewees frequently ascribed these variations to differences in “community values or predilictions,” but the evidence did not support such assumptions. Instead, it seems that this phrase is a crude and inaccurate stand-in for differences Chapter 6: From “Nitpicky” to “User-Friendly” 167 in committee values—that is, each IRB is, in essence, its own mini-society, with its own idiosyncratic characteristics on any
types of government statutes have been explored.8 IRBs are each very cautious, but nonetheless vary widely in their decisions, in ways that have been shown to impede science. Researchers often blame frustrations that they feel on IRBs.19 Yet these boards essentially serve as the “local face” of federal agencies and regulations. IRBs are therefore commonly “stuck in the middle” between regulators and researchers, implementing and monitoring regulations they did not devise. While investigators may