Informed consent in clinical trials

Author(s): Vanwijmen, F. C. B.

Journal/Book: Health Policy. 1996; 36: Customer Relations Manager, Bay 15, Shannon Industrial, Estate Co, Clare, Ireland. Elsevier Sci Ireland Ltd. 131-153.

Abstract: 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.

Note: Review <VS-Card> FWSM Verheggen, Univ Limburg Hosp, P Debyelaan 52, POB 5800, 6202 AZ Maastricht, Netherlands

Keyword(s): informed consent; patient accrual; trial participation; patient decision making; BREAST-CANCER; DECISION-MAKING; PATIENT; INFORMATION; PARTICIPATION; PREFERENCES; PHYSICIANS; PARENTS; RECALL; PRESCRIPTION

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