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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


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