Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials

Objectives. To investigate attitudes to clinical trials in non-cancer trial participants. Design, Questionnaires at entry, during, and after participation in a clini cal study, Setting. Participants in: (i) ROC: a clinical study comparing systemic inte rferon-alpha -2A treatment vs. prednisolone enemas in ulcerative colitis; a nd (ii) MRCRUC: a clinical study investigating low-field magnetic resonance imaging as a new modality for the evaluation of patients with inflammatory bowel disease. Subjects, Thirty-two patients in ROC and 47 patients in MRCRUC. Outcome measures. Attitudes towards different aspects of clinical research. Results. The majority found scientific testing of clinical methods necessar y, having positive attitudes towards both participation by themselves and o thers. The creation of a personal moral problem by denying participation wa s rejected by a large majority, and still both personal and altruistic moti ves for participation were highly rated. An important motive for accepting inclusion was the expectation of being 'a special patient' during the trial . The presence of research ethics committees controlling clinical research had a significant positive impact on decisions to participate, and drawing lots and blinding were found problematic by only a minority. Patients value d their satisfaction with participation in the trials highly, and would alm ost all accept a request to participate in future trials. The most importan t reason for this was a feeling of receiving better care and information th an expected outside a trial setting, primarily determined by the patients s eeing only one physician during the trials, A pronounced wish to obtain fol low-up information was expressed. Conclusion. Attitudes towards medical research are positive with both altru istic and nonaltruistic motives for participation. Expectations of being tr eated as 'a special patient' in the trial were important in accepting to pa rticipate. Seeing the same physician at control visits was an important fac tor for satisfaction with participation.