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

Abstract

The use of foster children as subjects in the pediatric HIV/AIDS clinical trials has been the subject of media controversy, raising a range of ethical and social dimensions. Several unsettled issues and debates in research ethics underlie the controversy and the lack of consensus among professional researchers on these issues was neither adequately appreciated nor presented in media reports. These issues include (1) the tension between protecting subjects from research risk while allowing them access to the possible benefits of research; (2) the blurring of the potentially conflicting roles of investigator and physician and the boundaries between research and therapy; (3) the adequacy of Institutional Review Board oversight; and (4) trust and the relationships among physicians, investigators and industry. The media controversy about the pediatric HIV/AIDS clinical trials can be seen as a means of "manufacturing mistrust" in health care, research and social services that have not always met the needs and expectations of the public. In an era of emerging infections, it is critical to the public's health that people understand the role of rigorous and ethical research in the development of safe and effective care. Investigators, journalists and the public need to become knowledgeable about major ethical issues in the conduct of research in order to engage in dialogue about balancing research risks and benefits and to be able to distinguish fact from distortion in an era of multiple and rapid transmission of information.

Pediatric clinical trials

“…[47] Most of the times, the considerations that go into the decisions are not only not clear-cut but are also contrasting, if not conflicting. For example, consider the conflict between protecting subjects from research risk while allowing them access to the benefits of research and the blurring of potentially conflicting roles that treating doctors don when they also act as researchers.…”

“…For example, consider the conflict between protecting subjects from research risk while allowing them access to the benefits of research and the blurring of potentially conflicting roles that treating doctors don when they also act as researchers. [47] The media should always provide the true information, act as a watchdog and ensure that enough pressure is built to punish the wrong-doers. However, they should also play a role in educating the general public of the necessity of carrying out ethical pediatric research.…”