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20 Med. & L. 515 (2001)
Informed Consent in Two Swedish Prisons: A Study of Quality of Information and Reasons for Participating in a Clinical Trial

handle is hein.journals/mlv20 and id is 531 raw text is: Med Law (2001) 20:515-523 Medicine and Law CYOZMOT 2001 Informed Consent INFORMED CONSENT IN TWO SWEDISH PRISONS: A STUDY OF QUALITY OF INFORMATION AND REASONS FOR PARTICIPATING IN A CLINICAL TRIAL Niels Lynoe' Mikael Sandlund and Lars Jacobsson' Abstract: 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. Keywords: Informed consent; prisoners; research ethics; clinical trial; drug addiction. INTRODUCTION Involving human beings in medical research raises questions about ethical assessment. In Sweden clinical trials combined with professional care include assessments of the importance of the project (which is contrasted with the possible risk of harming potential participants), discussions about the best way * Unit of medical ethics, Umei University, Sweden. ** Department of Clinical Sciences, Division of Psychiatry, Umei University, Sweden * Department of Clinical Sciences, Division of Psychiatry, Umei University, Sweden 515

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