FDA Waives IRB Review of Certain Clinical Studies of Azidothymidine (AZT)Source: IRB: Ethics and Human Research, Vol. 8, No. 6 (Nov. - Dec., 1986), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564241 .

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November/December 1986

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FDA Waives IRB Review of Certain Clinical Studies of Azidothymidine (AZT)

At the request of the Burroughs Wellcome Company, the Food and Drug Administration announced on Sep- tember 30 that it has granted a waiver for the requirement for IRB review of clinical research in the use of azido- thymidine (AZT) in the treatment of certain patients with acquired immu- nodeficiency syndrome (AIDS). IRBs may, however, elect to review such studies at any time, in which case the waiver will no longer apply, and FDA's IRB regulations will be fully applicable. Even though a waiver has been granted, informed consent must be obtained from each subject who receives AZT for the treatment of AIDS. Federal law and regulations do not permit a waiver of this requirement.

In its review of Burroughs Well- come's request for a waiver, FDA had to determine that granting a waiver would be in the best interests of the patients who would receive AZT under a "treatment IND." In view of prelimi- nary findings that the drug significantly prolongs survival, FDA concluded that AIDS patients meeting the inclusion criteria in the Burroughs Wellcome protocol can be expected to benefit from receiving the drug. FDA also believes that adequate mechanisms exist to ensure the protection of human subjects participating in studies of AZT.

The Clinical Research Subgroup of the National Institute of Allergy and Infectious Diseases reviewed and approved the treatment protocol and will participate in continuing review under terms of the IND. The subgroup also approved the model informed consent form. These factors, together with FDA's review and acceptance of the IND, constitute evidence, in the agency's view, of acceptable alternate mechanisms to protect the rights and welfare of persons receiving AZT under a "treatment IND."

For detailed information on the patient eligibility criteria established under this treatment investigational new drug exemption contact the AZT Treatment IND information line at (800) 843-9388.

NNOTATIONS

Curran, William J. "Protecting Con- fidentiality in Epidemiologic Investiga- tions by the Centers for Disease Con- trol." New England Journal of Medicine 314(16) (April 17, 1986), 1027-28 [W. J. Curran, Health Policy Management Dept., Harvard School of Public Health, Harvard Medical School, 677 Hunting- ton Ave., Boston, MA 02115].

In a case that pitted the Centers for Disease Control against Procter and Gamble, the company sought the dis- closure of data from studies about women who used tampons and had developed toxic shock syndrome. The court found the CDC's interest to prevail, emphasizing that it is the mission of the CDC to protect the public's health and that they cannot conduct research unless confidentiality is ensured.

Holleb, Arthur I., editor. "Ethics and Cancer." Ca-A Cancer Journal for Clinicians 36(2) (March/April 1986) [*American Cancer Society, 90 Park Avenue, New York, NY 10016].

Among the five articles solicited for this special issue is one by Robert J. Levine on the physician's decision- making process regarding patient re- ferral for randomized clinical trials. The author examines the conflict between obligations to science and to individual patients.

Meinert, Curtis L. Clinical Trials: Design, Conduct, and Analysis. New York: Oxford University Press, 1986. $75.00.

This is a comprehensive general text for practitioners of clinical trials, including principles of trial design, data

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