Niels Lynöe1, Birgit Näsström, Mikael Sandlund. 1. Dept of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden. niels.lynoe@medicin.umu.se
Abstract
OBJECTIVE: To study the quality of the information provided to and the procedure for obtaining the consent of chronically ill patients participating in a clinical trial. All patients included in a clinical trial concerning a lipid-lowering treatment over a 1-year period were asked to participate in the present research ethical study. MATERIAL AND METHODS:Patients (n = 55) on hemodialysis or in a prerenal state were selected. About 2 weeks after being recruited, the patients received a questionnaire concerning different aspects of the information provided. None of those responsible for providing information and obtaining consent were aware of the research ethical study in advance. RESULTS: A total of 44 patients answered the questionnaire (response rate 80%). All but one participant perceived the information provided as being very good or fairly good. None felt that they had been forced to participate in the trial. A total of 12 patients stated that they had delegated the decision making to their doctor. Compared to the younger patients, elderly participants more often stated that they had only been informed orally (p = 0.027). Those who stated that they were only informed orally tended to let the doctor decide whether or not they should participate in the trial. CONCLUSIONS: The study indicates that, compared to younger patients, elderly patients tended to be informed about the trial only orally and were also inclined to let the doctor decide whether or not they should participate. Providing information both orally andin writing and providing sufficient time for consideration may improve the informed consent process for severely ill patients.
RCT Entities:
OBJECTIVE: To study the quality of the information provided to and the procedure for obtaining the consent of chronically ill patients participating in a clinical trial. All patients included in a clinical trial concerning a lipid-lowering treatment over a 1-year period were asked to participate in the present research ethical study. MATERIAL AND METHODS:Patients (n = 55) on hemodialysis or in a prerenal state were selected. About 2 weeks after being recruited, the patients received a questionnaire concerning different aspects of the information provided. None of those responsible for providing information and obtaining consent were aware of the research ethical study in advance. RESULTS: A total of 44 patients answered the questionnaire (response rate 80%). All but one participant perceived the information provided as being very good or fairly good. None felt that they had been forced to participate in the trial. A total of 12 patients stated that they had delegated the decision making to their doctor. Compared to the younger patients, elderly participants more often stated that they had only been informed orally (p = 0.027). Those who stated that they were only informed orally tended to let the doctor decide whether or not they should participate in the trial. CONCLUSIONS: The study indicates that, compared to younger patients, elderly patients tended to be informed about the trial only orally and were also inclined to let the doctor decide whether or not they should participate. Providing information both orally andin writing and providing sufficient time for consideration may improve the informed consent process for severely ill patients.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach