Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations

Celia B. Fisher, Susan Z. Kornetsky, Ernest D. Prentice

Research output: Contribution to journalArticle

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Abstract

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations §§45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.

Original languageEnglish (US)
Pages (from-to)5-10
Number of pages6
JournalAmerican Journal of Bioethics
Volume7
Issue number3
DOIs
StatePublished - Mar 1 2007

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Consensus
Pediatrics
Research Ethics Committees
United States Dept. of Health and Human Services
Research
Language
Advisory Committees
Behavioral Research
child welfare
National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division
Child Welfare
Ethics
Biomedical Research
medicine
regulation

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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Determining risk in pediatric research with no prospect of direct benefit : Time for a national consensus on the interpretation of federal regulations. / Fisher, Celia B.; Kornetsky, Susan Z.; Prentice, Ernest D.

In: American Journal of Bioethics, Vol. 7, No. 3, 01.03.2007, p. 5-10.

Research output: Contribution to journalArticle

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