'Risky' research and participants' interests: the ethics of phase 2C clinical trials

Biomedical research involving human participants is highly regulated and subject to stringent ethical requirements. Clinical research ethics, regulation and policy have tended to focus almost exclusively on the protection of participants' interests against harms that might result from taking part in research. Less consideration, however, has been given to the interests that patients may themselves have in research participation, even in trials that may be beyond the bounds of current clinical research practice. In this paper, we consider the case of a suggested extension to clinical trial protocols to explore the ethics of participation in ‘risky’ research. We argue that patients may have a strong interest in taking part in research, and that even when greater-than-usual risks may be present, such research can be both ethically and scientifically justified. Finally, we suggest that there might be scope in some cases to assert a right to participate in research, and that the possibility of such a right merits further consideration.