Foreword: Law, Medicine and Socially Responsible Research

Abstract

S. Rebecca Holmes-Farley^ and Michael A. Grodin^^ As we stand at the threshold of the twenty-first century, certain issues in research ethics have taken center stage. Some have been brought to the fore by changes in scientific knowledge or by political or economic factors; others are continuing reminders of areas not yet adequately addressed. This Symposium issue of the American Journal of Law & Medicine seeks to identify and discuss some of the research issues most likely to face us in the new millennium. Several authors, notably Norman Fost, Leonard Glantz and George Annas, offer insights and proposals regarding existing federal regulations. Others undertake an analysis of less conventional issues. Kathleen Boozang, for instance, discusses the interplay between holistic medicine and the physician-patient relationship. Dorothy Nelkin and Lori Andrews delve into the complexities of research on dead bodies. In the final article, Jesse Goldner reviews both historical and contemporary attempts to provide legal disincentives to those who would engage in scientific misconduct. Because our present perceptions are often a function of where we have been, it may be instructive to recount a few of the pivotal moments in twentieth century research ethics. A starting point for our reflections is the formal recognition of the principle of informed consent. notion of consent has played a role in American research ethics and law since as far back as the 1830s,l but it was not until the Nuremberg war crime trials following World War II that consent principles were formally reduced to writing. Nuremberg Code, comprised of ten principles on human experimentation, originated from the final judgment rendered in the Doctors' Trial at the end of World War II.2 most oft cited of its principles is the first: The voluntary consent of the human subject is absolutely essential.3 Reducing this principle to writing was critical not only in the context of the trial but also because the United States disregarded this principle in its zealous pursuit of the war effort.4 During World War II, the United States committed flagrant abuses of individual rights. As has often been the case in this country's history, many of the subjects whose rights were violated were members of vulnerable populations-the disenfranchised, incompetent and impoverished. In 1941, President Franklin Roosevelt created the Office of Scientific Research and Development.5 One of its functions was to oversee the Committee on Medical Research (CMR). CMR, in turn, conducted research aimed at anticipating, preventing or ameliorating the health problems faced by American soldiers.6 In a wellintentioned effort to protect its military forces, the United States began routine testing of potentially therapeutic agents on nonconsenting populations. When the United States became concerned that its military force would succumb to debilitating bouts of dysentery, it tested experimental vaccines on the mentally retardedlearning, in the end, that the vaccines were too toxic for common use.7 Appeals to utilitarianism were made in a feeble attempt to justify government-sponsored research that violated human dignity. Around the same time, some 500 inmates at the Stateville Prison in Illinois volunteered to act as subjects for the testing of an antimalarial therapy,8 while mentally retarded persons in Pennhurst, Pennsylvania and mentally ill patients at Ypsilanti State Hospital, Michigan were used to test anti-influenza preparations.9 Office of the Surgeon General of the U.S. Army tested a promising antiinfluenza vaccine on select enrollees in the Army Specialized Training Program.0 In the period surrounding World War II, tens of thousands of U.S. servicemen were exposed involuntarily to chemical warfare agents.ii More recently, we have learned of unconscionable radiation experiments performed on mentally retarded children, terminally ill patients, servicemen and others from 1944 to 1974. …