Informed consent in clinical trials.
A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.
Verheggen
F W
FW
University Hospital Maastricht, The Netherlands.
van Wijmen
F C
FC
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000592:standards*; D003657:Decision Making; D006801:Humans; D007258:Informed Consent; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D010358:Patient Participation