Human Rights and the Failure of Research Governance

Abstract

and where the medical model of disability and an interventionist research trend has a strong presence. These governance bodies are part of a self-regulating professional culture that has been passive regarding the rights of research participants and whose values about what is appropriate research, who should bear the risks in research, and whether the risks are morally acceptable continue to clash with ethical codes (Sharav, 2003;Waring & Lemmens, 2004;Weijer, 2002).IRBs operate behind closed institutional doors and often report to the research office that promotes research and seeks funding for it-an institutional conflict of interest (Maschke, 2003). How is it possible that a profession with a tarnished human rights record became the ethical gatekeepers in research? The answer is that the medical profession is a powerful lobbying group and government was deferential to its self-regulating research interests (Sharav, 2003;Waring & Lemmens, 2004;Weijer, 2002).Related to this governance climate is the discipline of biomedical ethics. Singer rightly notes that the discipline is not homogenous in its ethical views. However, it did share a broad-based human rights pulse in its infancy that stemmed from concerns over research exploitation and abuse (Annas, 2005;Katz, 1993;Rothman, 1991). That pulse weakened over the years, and medical ethics never became an effective institutional human rights force within research centers. This is not to suggest that biomedical ethics lacks influence. Bioethics programs exist in leading academic research centers, and medical ethicists serve on national committees that inform public policy. But the human rights focus in medical ethics became less sharp in its institutional homes as the discipline became integrated into what is called the industrial medical research complex. Leading bioethics centers receive funding from corporate research sponsors, and ethics has become an effective marketing tool to recruit research participants and to promote research technology (Elliott, 2001). Universities, hospitals, and staff have become entrepreneurial and are producing, testing, and taking out patents on drugs and medical devices and advertise to recruit research participants by noting that research has been approved by a research ethics committee (Wilson, 2004). There is also a trend in