Zelen’s Randomized Consent Design

Zelen’s design (also known as the randomized consent, or prerandomization, design) is a type of randomized controlled trial in which randomization occurs before participants give informed consent to participate. In 1979, Marvin Zelen proposed the randomized consent design method for researchers and clinicians for easy enrollment of patients into clinical trials. This entry explains Zelen’s design and its purpose, single and double consent options, as well as advantages and disadvantages. The entry concludes with an overview of the ethical issues surrounding the use of Zelen’s design in clinical research.

Limitations of Conventional Informed Consent

In a conventional randomized controlled trial, participants provide informed consent before being randomly allocated to (usually) the intervention or control treatment groups. This can present a number of difficulties for researchers and ...

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