The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety of drugs in development. Until the mid-1970s Phase I trials were conducted on prisoners. After that practice was outlawed, the pharmaceutical industry needed a replacement population and began to aggressively recruit healthy, paid subjects, some of whom came to depend on the income, earning their living by continuously taking part in these trials. Drawing on ethnographic research among self-identified “professional guinea pigs” in Philadelphia, Roberto Abadie examines their experiences and views on the conduct of the trials and the risks they assume by participating. Some of the research subjects he met had taken part in more than eighty Phase I trials. While the professional guinea pigs tended to believe that most clinical trials pose only a moderate health risk, Abadie contends that the hazards presented by continuous participation, such as exposure to potentially dangerous drug interactions, are discounted or ignored by research subjects in need of money. The risks to professional guinea pigs are also disregarded by the pharmaceutical industry, which has become dependent on the routine participation of experienced research subjects. Arguing that financial incentives compromise the ethical imperative for informed consent to be freely given by clinical-trials subjects, Abadie confirms the need to reform policies regulating the participation of paid subjects in Phase I clinical trials.

How are human subjects treated in biomedical research? What are the expressed standards and self-reported behavior of biomedical researchers in regard to what has sometimes been called their "animal of necessity"? What are some of the determinants of the "strict" and "permissive" patterns which describe the standards and behavior of biomedical researchers? These are the important questions asked and answered in Research on Human Subjects. It is a book based on four years of intensive research. Two studies were completed, one on a nationally representative sample of biomedical research institutions, a second on a sample of 350 researchers who actually use human subjects. In their chapters on "the dilemma of science and therapy," the authors look at the tension between the values of humane therapy and discovery in science. They show that the significant minority of researchers who are "permissive" on the issues of informed consent and a favorable risk-benefit ratio are more likely to be those who are "relative failures" in pursuing the science value. Research on Human Subjects also documents the inadequate training that biomedical researchers get in the ethics of research on human subjects not only in medical schools but in their postgraduate training as well. The medical schools pay relatively more attention to the scientific training of their students than they do to the ethical training that should be its essential complement. The local peer review groups that screen research on human subjects in the institutions where it is carried on are another central focus of attention of the research and analysis reported in this book. The peer review groups do a fairly good job but, the authors show, there are various conditions of their relative efficacy which are not met by review groups in many important research institutions. The medical school review groups, for example, have not been outstanding performers with respect to the several conditions of relative efficacy. In the concluding chapter, the authors discuss the general problem of the social responsibilities of powerful professions and make very specific suggestions for policy change and reform for the biomedical research profession and its use of human subjects.