The best things in my Ufe have come to me by accident and this book results from one such accident: my having the opportunity, out of the blue, to go to work as H. Tristram Engelhardt, Jr. 's, research assistant at the Institute for the Medical Humanities in the University of Texas Medi cal Branch at Galveston, Texas, in 1974, on the recommendation of our teacher at the University of Texas at Austin, Irwin C. Lieb. During that summer Tris "lent" (...) me to Chester Bums, who has done important schol arly work over the years on the history of medical ethics. I was just finding out what bioethics was and Chester sent me to the rare book room of the Medical Branch Library to do some work on something called "medical deontology. " I discovered that this new field of bioethics had a history. This string of accidents continued, in 1975, when Warren Reich (who in 1979 made the excellent decisions to hire me to the faculty in bioethics at the Georgetown University School of Medicine and to persuade Andre Hellegers to appoint me to the Kennedy Institute of Ethics) took Tris Engelhardt's word for it that I could write on the history of modem medical ethics for Warren's major new project, the Encyclopedia of Bioethics. Warren then asked me to write on eighteenth-century British medical ethics. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.