NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE THE CLINICAL TRIAL HAS BEEN COMPLETED AND THE TESTED DRUG APPROVED FOR USE. For further information regarding FDA regulated clinical trials, contact FDA staff listed at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm134476.htm.
(Human Subjects Protections)
|February 26, 1993|
Waiver of Applicability of Title 45 CFR Part 46, Requirement
for Local IRB Review for the Investigational
New Drug d4T in the Parallel Track
The April 15, 1992, Federal Register Issue (57FR13244), entitled "Investigational New Drugs, Antibiotics, and Biological Product Applications; Clinical Hold and Termination; Final Rule Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People with AIDS and Other HIV-Related Disease" provides background concerning the parallel track mechanism of expanded access.
The investigational drug d4T under Bristol-Meyers Squibb Company A1455-900 protocol is a drug in the parallel track. The enclosed Federal Register Notice of February 16, 1993 (58FR8600) indicates that the Secretary, Department of Health and Human Services, waived local Institutional Review Board (IRB) review requirements under Title 45 CFR Part 46 for the protocol cited, on December 8, 1992. Further, the Food and Drug Administration has also waived its requirement for local IRB review. Therefore, institutions are not required to review the parallel track protocol, but each local IRB retains the option to review the protocol.
For further information, please contact Diane Aiken, Building 31, Room 5B59,, Office for Protection from Research Risks, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892, (301) 496-7041.
Gary B. Ellis, Ph.D.
Office for Protection from Research Risks