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What we worry about when we worry about the ethics of clinical research

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Abstract

Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals to risks for the benefit of others. Yet, many other activities that expose some individuals to risks for the benefit of others are not subject to extensive regulation and oversight. This difference raises the question of whether clinical research is distinct from these activities in normatively relevant ways and, if so, what implications this difference (or differences) has for how clinical research should be regulated and conducted. The present manuscript attempts to answer this question by comparing clinical research to two other activities that expose some individuals to risks for the benefit of others. This comparison highlights an aspect of clinical research which has received relatively little attention, namely, the active role investigators play in exposing subjects to risks. I argue that this aspect explains much of the ethical concern expressed regarding clinical research. I end by considering the normative significance of this feature and the implications it has for how clinical research should be regulated and conducted.

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Notes

  1. Because there currently is no definitive way to diagnose the disease, patients typically are given a diagnosis of “probable” Alzheimer disease, pending confirmation at autopsy.

  2. I will consider below the possibility that the concern in this case focuses on the difficulty involved in obtaining permission from the children’s parents or guardians.

  3. One might object that this research could be conducted in adults and need not enroll children. While that might be the case, no one objects to children participating in charitable car washes on the grounds that adults can wash cars. Moreover, there is evidence that the first manifestations of Alzheimer disease may occur relatively early in life. If these signs occur early enough, research with individuals who definitively do not have the disease may be possible in minors only.

  4. Another claim that I will not consider in depth is the claim that clinical research is inherently problematic because it conflicts with physicians’ obligation to do what is best for their patients. While the participation of physicians may introduce an additional concern, it does not seem to account for the fundamental ethical concern raised by clinical research. The studies that involve inserting needles in subjects’ backs seem troubling even when one does not know whether the investigator is a physician, a Ph.D., or a technician trained to perform lumbar punctures specifically for research purposes.

  5. This is not always the case. A famous sports example involves Muhammad Ali defeating George Foreman by adopting a tactic, which later came to be known as the rope-a-dope, that involved Ali staying motionless, conserving energy, while Foreman punched him. At first, the audience thought Ali was just standing there and getting killed in the Congo. Only later, as the fight went on, did the audience realize that Ali’s physical passivity was part of a strategy to tire Foreman out. In the end it worked, and Ali was shown to be brilliant, tough, and courageous, although frequently motionless.

    .

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Authors and Affiliations

  1. Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD, 20892, USA

    David Wendler

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  1. David Wendler
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Correspondence to David Wendler.

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The opinions expressed are the author’s own. They do not represent any position or policy of the NIH or the Department of Health and Human Services.

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Wendler, D. What we worry about when we worry about the ethics of clinical research. Theor Med Bioeth 32, 161–180 (2011). https://doi.org/10.1007/s11017-011-9176-y

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