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September 2005Vol. 6, No. 7New Protections for Children as Research Subjects

The Office of Human Research Protections (OHRP) recently published guidance on the use of children as subjects in all research funded or conducted by the U.S. Department of Health and Human Services (HHS). This pertains to the 45 CFR 46.407 review process as required under subpart D of HHS Protection of Human Subject Regulations at 45 CFR part 46. The OHRP guidance refers to five topics:

  • Institutional review board findings necessary to submit a protocol to OHRP for 407 consideration and/or review
  • Steps in the submission process
  • OHRP's response to submissions
  • Schedule and details for panel review
  • Potential outcomes of the review process

Full text of the guidance can be found on the HHS website at (Editor's note: This link is no longer available, but the OHRP web page regarding children as research subjects can be found at