Myth and Reality of Informed Consent in Clinical Trials
Verheggen, Frank W.S.M.
van Wijmen, Frans C.B.
Medicine and Law: World Association for Medical Law 1997; 16(1): 53-69
Informed consent is a prerequisite for any medical intervention or for participation in scientific research. Legal requirements in health care towards informed consent provide qualifications of information disclosure and focus on procedures to obtain a valid consent. The premise of informed consent as a rational decision making process implies an informed consideration, assessment and patient choice and may be perceived as an ideal in the nature of a myth. These principles and assumptions will be discussed to obtain more insight into informed consent in clinical trials. A cogent model of informed consent is presented, which could be useful in clinical trials. We suggest a gradual distinction between informed consent in regular treatment vs. clinical trials, based on concepts like achievable benefits and risk disclosure. Suggestions are made for further empirical research, to obtain more insight into the myth and reality of informed consent in clinical trials.
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Patients' Perceptions on Informed Consent and the Quality of Information Disclosure in Clinical Trials Verheggen, Frank W.S.M.; Jonkers, Ruud; Kok, Gerjo (1996-11)In a survey on 26 clinical trials we studied how patients experience and evaluate the information disclosure on the clinical trial they are enrolled in and which factors influence patients' perceptions of information disclosure. ...
Patients' Perceptions on Informed Consent and the Quality of Information Disclosure in Clinical Trials Verheggen, Frank W.S.M.; Jonkers, Ruud; Kok, Gerjo (1996-11)
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