Are we promoting true informed consent in cardiovascular clinical trials?
The purpose of this study was to determine variables contributing to patient participation in randomized clinical trials while assessing the potential relationship of these variables to a valid consent process. Two hundred forty-seven patients were administered a questionnaire after they made their decision about participation. Numerous variables were explored for their relationship to patient participation. Of particular significance were the variables of education, perception of having enough time to decide, and the person approaching the patient. Results of this study reveal the need for further evaluation of informed consent as a process, focusing on the areas of patient autonomy and comprehension.
DeLuca
S A
SA
Department of Cardiology, Cleveland Clinic Foundation, Ohio, USA.
Korcuska
L A
LA
Oberstar
B H
BH
Rosenthal
M L
ML
Welsh
P A
PA
Topol
E J
EJ
D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D007872:Legal Guardians; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000331:legislation & jurisprudence; D010358:Patient Participation / Q000331:legislation & jurisprudence; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*