Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a ¿one size fits all¿ approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the ¿I¿ from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.
AIDS is systematically changing attitudes and practices regarding the regulation and use of drugs. The complex framework and rigorous research protocols developed by the Food and Drug Administration prior to the 1980s to minimize risk to subjects is shifting in the epidemic's wake to maximize innovation. The FDA has adopted new procedures hastening access to investigational drugs and easing drug importation for personal use, which, in effect, transfers decisions about the benefits and risks of drugs from the agency's staff to patients and their physicians. While the FDA's tilt toward embracing consumer rights may continue in the near future, disappointing results could prompt the agency to reassert its authority in controlling drug policy more restrictively.
From the treatment IND to drug importation, to the parallel track and beyond, AIDS advocates have largely succeeded in doing what earlier FDA critics were unable to do: take more decisions out of the hands of government and the research establishment and cede them to patients and their physicians. The profound ethical and clinical implications are discussed.
Promises of confidentiality of HIV-related medical records and protection from discrimination based on HIV seropositivity are two of the legislative inducements state governments have offered to encourage voluntary HIV testing. Yet neither can be granted without impact on others whose interests range from those of a lover to those of an insurer. Politics as well as practicalities prevent the absolute protection of records from unauthorized disclosure and of individuals from discrimination. This article details the already enacted statutory compromises that have been made to resolve the conflicts of these competing interests and closely examines the myriad fine decisions made in reaching those legislative decisions.
Commentary Health AffairsVol. 9, No. 3 Drug Approval and AIDS: Benefits for the ElderlyDavid J. Rothman and Harold Edgar AffiliationsProfessor of Social Medicine and director of the Center for the Study of Society and Medicine at the College of Physicians and Surgeons of Columbia University in New York CityJulius Silver Professor of Law, Science, and Technology at Columbia Law SchoolPUBLISHED:Fall 1990No Accesshttps://doi.org/10.1377/hlthaff.9.3.123AboutSectionsView articleView Full TextView PDFPermissions ShareShare onFacebookTwitterLinked InRedditEmail ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions View articleTOPICSPharmaceuticalsHIV/AIDSDiseasesClinical trialsAccess to careDrug useRegulationElderly patientsHuman experimentationElderly care Loading Comments... Please enable JavaScript to view the comments powered by Disqus. DetailsExhibitsReferencesRelated Article MetricsCitations: Crossref 2 History Published online 1 January 1990 InformationCopyright © by Project HOPE: The People-to-People Health Foundation, Inc.PDF downloadCited byAIDS, Activism, and the Politics of HealthNew England Journal of Medicine, Vol. 326, No. 2AIDS, Activism, and Ethics17 May 2016 | Hospital Practice, Vol. 26, No. 7
