AIDS Research Alliance Institutional Review Board
An Institutional Review Board (IRB) is a committee of individuals responsible for ensuring the ethical treatment of participants in human clinical research studies. The IRB accomplishes this by carefully reviewing, prior to initiation and on an ongoing basis, all research protocols, informed consent documents and advertisements used to promote participation in a study.
The IRB is charged with being an advocate and protector of the rights and welfare of potential study participants; ensuring that studies are designed to minimize risk and maximize potential benefit to patients, ensuring that qualified investigators use appropriate research designs; and ensuring that the privacy of participants – and their freedom to withdraw from a study at any time – is strictly observed. In accordance with federal regulations, all research using human subjects must be reviewed and approved by an IRB (also known as a Human Subjects Protection Committee). Therefore, most institutions that conduct a large number of clinical research studies maintain their own IRB.
AIDS Research Alliance maintains its own IRB (Federal Wide Assurance Number: FWA00000941). As ethical gatekeepers, this volunteer panel is a critical part of our mission. The AIDS Research Alliance IRB meets monthly to review new clinical trials protocols, informed consent documents, proposed study advertisements and all ongoing clinical studies. On occasion, at the request of the institution, the IRB meets to review studies on an expedited basis.
The AIDS Research Alliance IRB has undergone two FDA audits in 1995 and 2005. These audits revealed no material findings in the procedures, composition or documentation of the ARA IRB.
History of Institutional Review Boards
Prior to 1906, when the Pure Food and Drug Act was passed, there were no uniform rules regulating the ethical use of humans in research. In December 1946, an American military tribunal held criminal proceedings against German physicians for forcibly conducting medical experiments on thousands of concentration camp prisoners. The Nuremberg Code established many of the basic principles governing the ethical conduct of research involving humans, and primarily holds that it is "absolutely essential" to have the voluntary consent of the human subject undergoing any experimentation.
Unfortunately, this code of behavior was sometimes ignored. During the Tuskegee Syphilis Experiment (1932-1972) in Alabama, four hundred low-income African American males diagnosed with syphilis were monitored for 40 years to determine the natural progression of the disease. To ensure that they were actively denied treatment – an increasingly difficult task given the discovery and widespread use of penicillin to cure the disease in 1943 – the men’s names were given to local physicians, draft board doctors and PHS venereal disease eradication programs. By the end of the experiment, 28 of the men had died directly of syphilis, 100 were dead of related complications, 40 of their wives had been infected, and 19 of their children had been born with congenital syphilis.
In 1974, the U.S. Department of Health, Education and Welfare – suffering from public outcry when a journalist exposed the experiment – raised to regulatory status NIH's “Policies for the Protection of Human Subjects.” Among other things, the policies established that an independent committee – an IRB – must evaluate all human research studies as a mechanism to protect human subjects.
AIDS Research Alliance Institutional Review Board Members:
Seymour Young, M.D. - Chair
Neurologist - Desert Oasis Health Care
Herminio Reyes, M.S., Ph.D. - Vice Chair
Biomedical/Pharmaceutical Industry Consultant
Patient Advocate and Educator
Mark Arnold, R.N.
Staff Registered Nurse-Medical/Surgical -
Cedars-Sinai Medical Center
Alan Bloom, Esq.
International Taxes, DirecTV
Dawn Brewer, Esq.
Law Offices of Dawn Brewer
Jose Castro II, Pharm.D.
Pharmacist - Soliant Health
John Dratz, Jr., Esq.
Law Offices of John Dratz, Jr.
Stephen Fefferman, Psy.D.
Anthony Mills, M.D.
Internal Medicine - Private Practice
Tom Zaharakis, MD
Internal Medicine / Nephrology - Private Practice
Alternate:
William D. King, MD, JD
T.H.E. Clinic
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