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Keywords:

  • randomized clinical trials;
  • research ethics;
  • trial participants

Abstract. Madsen S, Holm S, Riis P (Copenhagen University Hospital, Herlev, and University of Copenhagen, Blegdamsvej, Denmark). Ethical aspects of clinical trials: the attitudes of the public and out-patients. J Intern Med 1999; 245: 571–579.

Objectives.  To investigate attitudes to clinical research amongst potential research participants.

Design.  Questionnaire-survey.

Setting.  Two medical out-patient clinics and the background population.

Subjects.  A total of 508 randomly selected citizens in Copenhagen County (64% responded) and 200 consecutive patients attending the out-patient clinics (64% responded).

Outcome measures. Attitudes toward different aspects of clinical research.

Results.  Positive attitudes toward medical research were disclosed. The majority found scientific testing necessary, although only a minority considered participation a moral obligation. Both personal benefits and altruistic motives for participation were highly rated, whereas former positive experiences from trial participation had only minor impact on decisions. Several respondents stated former trial participation had changed their attitudes negatively. Lack of feedback of results was of major importance for this change. Attitudes are significantly influenced by the presence of independent research ethics committees, whereas trial technicalities such as drawing lots and blinding was found problematic by only a few respondents. Altruistic motives of physicians to conduct trials were highly rated by a majority of respondents, but the motive of promoting doctors’ careers was also judged important. Respondents rated nondiscomforting procedures as acceptable or having only a small impact or strain on their lives.

Conclusion.  Attitudes toward medical research are positive amongst out-patients and the general public. Altruistic and nonaltruistic motives both concerning trial participation and concerning the motives of physicians to conduct medical research were rated highly. Lack of feedback concerning results of trials to participants was important for a negative change in attitude toward participation.