PATIENTS PERCEPTIONS ON INFORMED CONSENT AND THE QUALITY OF INFORMATION DISCLOSURE IN CLINICAL-TRIALS

In a survey on 26 clinical trials we studied how patients experience a nd evaluate the information disclosure on the clinical trial they are enrolled in and which factors influence patients' perceptions of infor mation disclosure. Our objective was to obtain more insight thereby in how informed consent is applied in the daily practice of clinical tri als. Interviews were held with 198 adult patients and 32 trial-clinici ans. Instead of focusing on patient comprehension of the information d isclosed we analyzed patient perceptions of informed consent. Patients proved to be quite satisfied with the oral and written information di sclosure. Patients' perceptions of the manner and content of informati on disclosure are influenced by more general attitudes towards medical care, research and institutions, Patients' trust in medical experimen ts, belief in the integrity of physicians and interest in medical affa irs have an impact on the way patients perceive information disclosure . To improve the quality of the informed consent procedure, we propose a patient motivation classification (PMC) to enable trial-clinicians to gain more insight into patient motivation. Relevant factors found i n our data have been used as criteria for classification. An informed decision making checklist (IDC) is suggested for patients as a general outline for patient education, covering relevant socio-psychological factors of enrolment.