Physician duties in the conduct of human subject research

Abstract

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.

Consentimiento Informado en Investigación Clínica: Un Proceso Dinámico

“…El otorgamiento del consentimiento informado que hace un sujeto es un voto de confianza hacia el investigador y, en contraprestación, este debe mantener un proceso continuo de valoración de riesgos para la seguridad del sujeto participante a medida que la investigación avanza y así determinar la permanencia del sujeto en el estudio (51). Esto convierte al CI en un proceso dinámico de permanente diálogo y evaluación de riesgos.…”

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

“…Engaging in human research is itself seen as an ethical duty in this paradigm, and optimal scientific approaches may be reliant on the adoption of optimal ethical practices (Fried 2001). This new model of the relationship between science and ethics reinvigorates interest in recurring questions related to the ethical role of scientific design, the value of human research safeguards, whether ethical considerations are seen as detracting from scientific endeavors, under what circumstances ethically problematic research would be tolerated if the results were scientifically valuable, and the fundamental legitimacy of ethical controversies in human research (Brody 1998).…”