Includesor supported

the subject. Inthe assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research. (b) Except as provided in paragraph (a) of this section, biomedical or behavioralor supported by DHHS shall not involve prisoners as subjects. Subpart D Additional DHHS Protections for Children Involved as Subjects in Research Source: 48 FR 9818, March 8, 1983; 56 FR 28032, June 18, 1991. §46.401 To what do these regulations apply? (a) This subpart applies to allchildren as subjects, conducted or supported by the Department of Health and Human Services. (1) This includesby Department employees, except that each head of an Operating Division of the Department may adopt such nonsubsta