A survey of the opinions on 'informed consent' of women currently involved in clinical trials within a breast unit.

Research indicates there is confusion in the minds of patients and the public surrounding the issue of 'informed consent'. This confusion is compounded when patients are asked to participate in a clinical trial. This study aimed to survey, by self-completed postal questionnaires, the experiences and opinions of 100 randomly selected healthy volunteers not in a clinical trial, 100 healthy volunteers in a clinical trial and 100 breast cancer patients in a clinical trial. A 71% response rate was achieved. The results indicate that there are areas in the current procedure which scored highly and some where improvements could be made. Overall, 72% of respondents indicated they were satisfied with the level of support they are currently receiving. The results also show that healthy volunteers in a clinical trial were better informed about the trial than the corresponding cancer patients. They were given more written information (86% versus 60%, P < 0.005), had a better indication of their time commitment (81% versus 62%, P < 0.025), were better informed of possible physical discomforts (61% versus 43%, P < 0.05), were better informed of possible side-effects (75% versus 57%, P < 0.025) and were more aware of their rights to withdraw from the trial (84% versus 46%, P < 0.005). Patients were also asked for their opinions on their requirements for giving informed consent. The overwhelming majority of the women responding to Questionnaire 2 wanted all the information and support outlined. Only two areas scored below 90%: those were concerned with wanting assurance that all information about the patient will be kept confidential (75%) and those wanting information on protection of the patient's privacy (66%). This response appears to be against the general trend. These results clearly show that most patients require access to a wide range of information prior to consenting to treatment or inclusion in a clinical trial.