Med Law. 2001 ; 20(4): 515-23.

Informed consent in two Swedish prisons: a study of quality of information and reasons for participating in a clinical trial.

LynÃ¶e N, Sandlund M, Jacobsson L.

Unit of medical ethics, Ume University, Sweden.

OBJECTIVES: To study the quality of informed consent in two samples of prisoners participating in a therapeutic trial. RESULTS: All participants (n=43) were aware of the fact that they had participated in a research project, that they were free to abstain from participation, and that they were free to withdraw from participation at any time. All but six were aware of the objective of the clinical trial and all but three understood the implications of participating. Twenty individuals did not consider the pros and cons. When making their respective decisions, no one felt that they had been subjected to undue persuasion or force. Concerning the reasons for participating, a majority (n=35) supposed that participation would benefit themselves' as the primary reason. Some (n=11) considered the benefits for future patients and science. No differences concerning gender or age were discerned. CONCLUSIONS: The results do not indicate that the informed consent procedure in general was inadequately performed. Rather, the answers provided and the subjects who withdrew indicate that participation was perceived as fully voluntary.