Abstract
Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or "undue influence," on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit-driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.
Original language | English (US) |
---|---|
Pages (from-to) | 3-20 |
Number of pages | 18 |
Journal | Accountability in Research |
Volume | 7 |
Issue number | 1 |
DOIs | |
State | Published - 1999 |
Keywords
- Clinical trials
- Healthy volunteers
- Human experimentation
- Informed consent
- Labor relations
- Medical ethics
- Research regulation
- Research subjects