BOX 8.6
Examples of Protocols Referred for Review by the Secretary of DHHS Under 45 CFR 46.407, by Year of Referral and Institution


The New England Medical Center Hospital: Study of myoblast transfer in Duchenne muscular dystrophy. Not approved but few details are publicly available. (56 FR 49189)


Children’s Hospital of Pittsburgh: Proposed study of cognitive function and hypoglycemia (generated through the use of an insulin clamp) in children with insulindependent diabetes mellitus. Approved. (58 FR 40819)


University of Washington: Study of precursors to diabetes in Japanese-American youth. Public comment on departmental recommendation for approval initially requested August 7, 2002 (67 FR 51283-51284). Reopened for public comment in December, 2002 (67 FR 77495). No final decision from the Secretary of DHHS. (


Harbor-UCLA Medical Center: Test of dilute smallpox vaccine in children ages 2 to 5. Disapproved by the Secretary of DHHS and the Commissioner of FDA for reasons related to expected lack of availability of the vaccine and not to Subpart D requirements.

(67 FR 66403;


University of California, Los Angles: Longitudinal study of prolonged HIV infection, antiretroviral therapy, and thymus performance involving comparisons between infected and noninfected children. No final decision from the Secretary of DHHS.

(68 FR 42061;

University of North Carolina: Longitudinal study of newborn infants with cystic fibrosis involving flexible fiber-optic bronchoscopy and procedural sedation. No final decision from the Secretary of DHHS.

(68 FR 35414;

Albert Einstein College of Medicine: Study of the role of metabolism in sleep mechanisms in adolescents. No final decision from the Secretary of DHHS.

(68 FR 35415;

Rhode Island Hospital: Study of the effects of small to moderate amounts of alcohol on sleep, waking performance, and circadian phase. No final decision from the Secretary of DHHS.

(68 FR 17950;

SOURCE: Kopelman and Murphy, (in press) and Office for Human Research Protections (through January 2004).

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