Challenges to Human Subject Protections in US Medical Research

Abstract

United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.

Does Waiver of Written Informed Consent from the Institutional Review Board Affect Response Rate in a Low-Risk Research Study?

“…3 In recent years, increasing attention has been given to the importance of human subjects' protection in general and to the informed consent process specifically. 4 The purpose of the current study was to compare participation rates in a minimal-risk survey among older patients with hypertension from before to after waivers of written informed consent and HIPAA authorization were granted from our Institutional Review Board (IRB).…”

Ethics behind closed doors: do research ethics committees need secrecy?

“…7 8 At the same time there are doubts about the effectiveness of these independent committees in protecting patients 9 – 11. Doubts have arisen in the aftermath of some high profile scandals in the ethics of research in the United Kingdom and United States 12 13. Guidance on research governance within the public sector to parallel governance within the pharmaceutical industry is therefore welcome.…”

Coexisting Commitments to Ethics and Human Research: A Preliminary Study of the Perspectives of 83 Medical Students

“…Performing research that involves human participants is ethically complex, however, and ethical and scientific considerations in human research historically have been viewed as being in tension (Freedman 1987;Michels 1999). Some have asserted that ethical restrictions, while necessary, directly impede scientific progress (Woodward 1999). Controversies in human research ethics have centered on ethical safeguards as burdensome, disproportionate, and distorting of scientific findings (Brody 1998;Edlund et al 1985;Faden 1996;Gray 1975;Katz 1972).…”