Nuremberg Code.49 The human subject regulations are an accepted fact of modern research. The relevant U.S. regulations, 45 CFR 46, are just two decades old, but two generations of investigators now regard them as a matter of course that ultimately strengthen research. Many conceivable experiments that could produce interesting data simply are not done. Moral boundaries are respected; they may be porous, but they are constantly patrolled by Institutional Review Boards. The Advisory Committee on Human Radiation Experiments discovered that the IRB system is far from perfect and some unethical experiments still proceed (Advisory Committee on Human Radiation Experiments 1995, 97)— and this is one reason for NBAC’s existence, to continue an unfinished agenda of human subject protections. There can be little doubt, however, that norms of clinical research have changed over the past few decades. LeRoy Walters, in responding to a previous draft of this paper, noted that the RAC process could take on even the world’s best known experts in an emerging and highly conspicuous field, in part because of its process and stature. Success may have depended on several features of the RAC process (Walters 1997, 98): open public meetings, involvement of nationally recognized experts, expertise spanning biology, medicine, law, ethics, public policy, and consumer advocacy, appointment of experts familiar with the field but not direct competitors, use of expert ad hoc consultants when needed, rotation of membership, regular and accurate coverage by the public media, and frequent revision of the “points to consider” document. One lesson from the Cline case is that when the potential rewards are exceedingly large, human subject protections are all the more important, because scientific priority and fame are powerfully seductive. The Cline case tested the IRB and recombinant DNA review processes. The punishment meted out was swift and fair. Cline remained a scientist, but was stripped of his chairmanship, lost several grants, and found getting grants much harder than before his infraction. The main damage was to his reputation and ability to do science. Few molecular biologists would fail to recognize Martin Cline’s name even after more than a decade and a half. His censure was meaningful to the scientific community. If indeed Dr. Cline’s actions were driven by a desire to enhance his reputation, then the penalty that mainly damaged that reputation was appropriate and proportionate.
H-21