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Paid in Full?
Each weekday hundreds of people make their way from the Philadelphia subway station immediately beneath the offices ofAmerican Journal of Bioethics into our building, which houses not only the University of Pennsylvania Center for Bioethics and AJOB but also two large clinical trials firms. Bioethics staff ride the elevator alongside two or three research subjects every day, each wearing a bandage or bearing a mark of some kind. Often they are self-evidently homeless, bringing along a form of shelter. It is not difficult for these subjects to find our building or the research it contains. Philadelphia is home to Guinea Pig Zero, an informal magazine that circulates among those who find part or even full-time work as research subjects. Zero reviews area clinical trials, rating the pain vs. gain ratio of everything from the dermatological trials that go on in our building to lumbar punctures and even, until recently, early trials of gene transfer research. Philadelphia is also papered with ads for research studies; whether on the subway or in the student newspaper, on the radio or in the shelters, it is difficult to find a public space that is not advertising part-time work as a human subject. Many of the ads promise therapy, pointing not to payment in dollars but to clinical benefit, and dancing perilously between an offer to treat a patient and an inducement to enroll a subject. One of the most in-demand advertising firms in New Jersey specializes in reaching potential human subjects with carefully targeted ads that feature what can at best be described as deliberately ambiguous characterizations of the role of the research subject.
In this issue of AJOB, Christine Grady of the U.S. National Institutes of Health targets the question of reward for research, asking and answering the question of how much inducement could properly be considered inappropriate. While her focus is on financial inducement, the Open Peer Commentary articles accompanying this important Target Article raise the broader issue of the roles and relationships in which subjects and researchers should engage. Although the deleterious effects of undue inducements in research have barely been discussed in the literature of clinical research, bioethics, or health policy, they are enormously important for the health and welfare of the subjects involved. The question of how subjects should be paid is also among the hottest issues in healthcare marketing. More importantly, those who are considering the renewal of international codes of conduct in research, and those who would extend existing U.S. research subject protections, will do well to consider the debate in these pages.
Three years ago I argued in JAMA that undue financial or therapeutic inducement to research subjects could be prevented through the adoption of a formula to control the subject income/inducement ratio (McGee 1997). The present collection points to the urgency not of adopting a particular formula, or even a particular rule that governs coercion in clinical research recruiting and consent practices. Rather, it is made clear in these pages that the orientation of subjects toward a prospective research trial is an important part of the informed consent process, perhaps more important even than the determination of minimal risk or the degree of disclosure of risk that is necessary in consent forms. The question at hand is how and when a research subject's perception, and even capacity to consent, can be colored by the context of the subject-scientist relationship. It is a discussion we hope you will join.
McGee, G. 1997. Subject to payment? JAMA 278(3):199-200.