Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for “Minimal” Risks


  • David Wendler

    1. David Wendler heads the Unit on Vulnerable Populations in the Department of Clinical Bioethics at the National Institutes of Health, as well as serving on the IRB for the National Institute on Drug Abuse and the NIH bioethics consultation service.
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When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than “minimal” risks, according to guidelines accepted around the world. We need a new standard for what “minimal” risks are, however—one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.