Additional protections for children involved as subjects in research--Department of Health and Human Services. Final rule

Fed Regist. 1983 Mar 8;48(46):9814-20.


The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.

MeSH terms

  • Behavioral Research*
  • Child
  • Ethics Committees, Research
  • Federal Government*
  • Government Regulation*
  • Human Experimentation*
  • Humans
  • Minors*
  • Nontherapeutic Human Experimentation
  • Parental Consent
  • Patient Advocacy / legislation & jurisprudence*
  • Risk Assessment
  • Therapeutic Human Experimentation
  • United States
  • United States Dept. of Health and Human Services