Informed consent: how much and what do patients understand?
OBJECTIVE
We sought to evaluate the degree of patients' understanding of several aspects of the informed consent process for surgery and clinical research.


METHODS
We conducted a systematic search of PubMed (1961-2006) to identify relevant articles.


RESULTS
We retrieved 23 and 30 eligible for inclusion articles regarding informed consent for surgery and clinical research, respectively. Regarding surgery, adequate overall understanding of the information provided and of the risks associated with surgery was shown in 6 of 21 (29%) and 5 of 14 (36%) studies providing relevant data, respectively. Regarding clinical research, adequate understanding of the aim of the study, the process of randomization, voluntarism, withdrawal, and the risks and the benefits of treatment was shown in 14 of 26 (54%), 4 of 8 (50%), 7 of 15 (47%), 7 of 16 (44%), 8 of 16 (50%), and 4 of 7 (57%) of studies providing relevant data, respectively. Satisfaction by the amount of the given information was shown in 7 of 12 (58%) studies involving surgery and 12 of 15 (80%) studies involving clinical research.


CONCLUSIONS
Further attention should be drawn on enhancing patients' understanding regarding several components of the informed consent process for surgery and clinical research.
Falagas
Matthew E
ME
Alfa Institute of Biomedical Sciences (AIBS), Athens, Greece. m.falagas@aibs.gr
Korbila
Ioanna P
IP
Giannopoulou
Konstantina P
KP
Kondilis
Barbara K
BK
Peppas
George
G
D035843:Biomedical Research; D032882:Comprehension; D006801:Humans; D007258:Informed Consent; D010358:Patient Participation; D012107:Research Design; D013514:Surgical Procedures, Operative