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The regulations at 45 CFR 46.407 allow the Institutional Review Board (IRB) to refer HHS-conducted or -funded research to the HHS Secretary for consideration if the IRB finds that the research does not meet the conditions for approval under the other three categories of research involving children. If an institution’s IRB does not believe the proposed research meets the requirements of 45 CFR 46.404, 46.405, or 46.406 of subpart D, but finds and documents that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children (in accordance with HHS regulations at 45 CFR 46.407(a)), the IRB or other appropriate institutional official may submit the protocol and supporting materials to the Office for Human Research Protections (OHRP) for HHS consideration under the provisions of 45 CFR 46.407(b). Before submitting a protocol to OHRP, the IRB must determine that, in addition to meeting the requirements of 45 CFR 46.407(a) and other applicable sections of subpart D, the proposed research also meets all of the requirements of 45 CFR part 46, subpart A, except those requirements modified by Subpart D.

After receiving recommendations from a panel of experts and following an opportunity for public comment, the Secretary may approve the research under either one of two conditions:

1) The Secretary finds that the research is actually approvable under one of the first three categories of research, despite the IRB’s finding to the contrary; or

2) the Secretary concurs with the IRB’s findings that the research is not allowable under the other three categories and determines that the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting children’s health or welfare, and, in addition, determines that the research will be conducted in accordance with sound ethical principles and that adequate provisions are made for soliciting the assent of children and permission of their parents or guardians as discussed in 46.408.

The Secretary may conditionally approve research under 46.407 providing specific stipulations are met.

See OHRP’s guidance on the 407 review process at:http://www.hhs.gov/ohrp/policy/populations/guidance_407process.html.

Last Reviewed: 01/20/2011

• When should an Institutional Review Board (IRB) or institution request a “407” review for research involving children as subjects?
• What materials must be submitted to the Office for Human Research Protections with a request for a 407 review for research involving children?
• Are the exemptions different for research involving children?
• What is parental permission in the context of research involving children?
• Can parental or guardian permission for research involving children be waived?

• Research with Children