title: Limits on risks for healthy volunteers in biomedical research.
abstract: Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.
authors.affiliation: National Institute for Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU-03, Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
authors.forename: David B
authors.initials: DB
authors.lastname: Resnik
mesh_terms: D032762:Autoexperimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D032882:Comprehension; D028744:Ethics Committees, Research; D033161:Government Regulation; D064368:Healthy Volunteers / Q000331:legislation & jurisprudence; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D026706:Paternalism; D035842:Research Subjects; D018570:Risk Assessment; D014481:United States