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In 1977, Zelen proposed a new design for clinical trials with the aim of increasing recruitment by avoiding some of the problems associated with obtaining informed consent. These 'randomised consent' designs have proved controversial, and have not often been used. This paper explains the statistical aspects of single and double randomised consent designs and reviews some of the ethical issues. All identified published cancer treatment trials using a randomised consent design are considered in some detail. Reasons for and against the use of these designs are summarised.

Type

Journal article

Journal

Eur j cancer

Publication Date

11/1995

Volume

31A

Pages

1934 - 1944

Keywords

Biomedical and Behavioral Research, Ethics, Medical, Humans, Informed Consent, Neoplasms, Randomized Controlled Trials as Topic, Research Design