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Defining and Describing Benefit Appropriately in Clinical Trials

Published online by Cambridge University Press:  01 January 2021

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Institutional review boards (IRBs) and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.

Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal.

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Copyright © American Society of Law, Medicine and Ethics 2000

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References

This is the outdated but persistent distinction between “nontherapeutic” and “therapeutic” research. See, for example, World Medical Association Declaration of Helsinki, “Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects,” revised 1996, reprinted in JAMA, 277 (1997): 925–26; see also Capron, A.M., “Ethical and Human-Rights Issues in Research on Mental Disorders That May Affect Decision-Making Capacity,” N. Engl. J. Med., 340 (1999): 1430–34; Rolleston, F. and Miller, J.R., “Therapy or Research: A Need for Precision,” IRB, 3, no. 7 (1981): 1–3; Levine, R., “The Need to Revise the Declaration of Helsinki,” N. Engl. J. Med., 341 (1999): 531–34.Google Scholar
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