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In today\u2019s episode of More than Meets the IRB, we hear from awardee of the Presidential Medal of Honor Dr. Anthony Fauci on some of the ethical challenges he faced in addressing the HIV/AIDS pandemic. It\u2019s an engaging and wide-ranging narrative: from Fauci\u2019s publicly denouncing the FDA\u2019s process of delivering certain drugs to individuals to his receiving presidential acknowledgement for a creative idea of how to bring drug access to these patients. \n\nDr. Anthony Fauci has been the director of the National Institute of Allergy and Infectious disease for over 30 years . He has played a critical role in research of HIV/AIDS and other immunodeficiencies. \n\nEarly Drug Development \n\nWhen the government didn\u2019t make available certain drugs quickly to the community of HIV/AIDS patients, they would acquire them through illicit groups known as Buyers Clubs (as featured in the 2013 film The Dallas Buyers Club). \n\nWe learn about the iconic randomized control trial of AZT as well as the treatment of patients with AIDS and similar diseases. A double-blind placebo controlled trial, published in the New England Journal of Medicine in 1987, successfully demonstrated the effectiveness of AZT. The delivery of the drug to those that needed it wasn\u2019t easy (or approved) so the researchers came up with a creative solution on how to provide AZT to those who so urgently needed it. \n\nWhat is Parallel Track?\n\nParallel Track denotes access to unproven drugs after a proven drug exists. It makes available (with appropriate informed consent) experimental drugs to those who do not meet the requirements for a drug trial for various reasons, such as geographic or demographic incompatibility. \n\nParallel Track represented a way to get HIV/AIDS drugs to the gay community outside the confines of a randomized controlled experiment, but doing so violated the rigid and durable guidelines of the regulatory bodies; Dr. Fauci recalls that \u201cthe federal government and the FDA thought this was anathema.\u201d The passion of the activists and Dr. Fauci\u2019s experience meeting with patients convinced him that this extraordinary measure was both appropriate and necessary for dealing with the AIDS crisis. \n\n\u201cEither you go blind or you die\u201d \u2013HIV/AIDS Patient \n\nDuring the AIDS crisis, the rigor and ingrained nature of drug development regulations came up against the urgency and vigor of the activist community. In Dr. Fauci, this conflict caused a \u201csea change in my attitude toward the flexibility versus the rigidity of the scientific and regulatory community: that is, my relating to and putting myself in the place of a patient or a potential patient\u2026. That was brought home to me by the AIDS activists.\u201d