RESEARCH ETHICS

Eliminating the daily life risks standard from the definition of minimal risk

D B Resnik

Correspondence to:
Correspondence to:
Dr D B Resnik
National Institute of Environmental Health Science, National Institute of Health, Box 12233, NH06, Research Triangle Park, NC 27709; resnikd{at}niehs.nih.gov

The phrase "minimal risk," as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the "daily life risks" standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that "minimal risk" should be defined as simply "the probability and magnitude of the harm or discomfort anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests".

Abbreviations: IRB, institutional review board

Keywords: risk; research; minimal risk; definition; ambiguity; federal regulations

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• Wendler, D., Jenkins, T. (2008). Children's and Their Parents' Views on Facing Research Risks for the Benefit of Others. Arch Pediatr Adolesc Med 162: 9-14 [Abstract] [Full Text]  
• Perna, M A (2006). "Fair's fair argument" and voluntarism in clinical research: But, is it fair?. J. Med. Ethics 32: 478-482 [Abstract] [Full Text]  
• Wendler, D., Belsky, L., Thompson, K. M., Emanuel, E. J. (2005). Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research Without a Prospect of Direct Benefit. JAMA 294: 826-832 [Abstract] [Full Text]