The Impact of HIV Infection on Society's Perception of Clinical Trials

Abstract

All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Written with the aim of avoiding a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience, or ethical violations like those of the Tuskegee syphilis study, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, society's perception of clinical research has shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in research policies and practices, this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective; our policies should encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects.

National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

“…This includes the right of subjects to participate or not to participate in research studies as well as their right to share in the potential benefits of research. 29 Both must be considered when designing trials and selecting subjects. 30 The Office for Human Research Protections emphasizes the role of IRBs in implementing the equitable selection of subjects.…”

Manufacturing Mistrust: Issues in the Controversy Regarding Foster Children in the Pediatric HIV/AIDS Clinical Trials

“…As the benefits of research participation became recognized, the trend shifted to include, rather than exclude vulnerable categories of subjects, such as minorities, women and children (Mastroianni and Kahn 2001). This shift towards inclusion has been attributed in large part to the early research generated in the field of HIV/AIDS (Levine 1994). The uncontrolled AIDS epidemic created a fearful time for society, but also spurred a time of innovation in research methods and patient participation in research (Dresser 2001).…”

“…As inclusion and a focus on the benefits of research became popular, some urged caution in the rush to develop adult drugs because of fears that adverse effects may not be evident in early use by patients (Levine 1994). A related caution has been voiced today about whether the imperative to include children in research studies can distract from a thorough consideration of the actual benefits of their participation (Ross 2004).…”

Regulatory and Ethical Principles in Research Involving Children and Individuals with Developmental Disabilities

“…The impetus for each code obviously has been to respond to different research challenges of the time, and for each, the hope has been for ethics to define the limits of human research (Emanuel, Wendler, Grady, 2000;Levine, 1994;Vanderpool, 1996). Although each code has separate sections for the inclusion of children and individuals with DD, they have not sufficiently elaborated on the specific dimensions concerned.…”