Zelen's design

In this design, patients are randomized to either the treatment or control group before giving informed consent.

In this design, those patients receiving standard care need not be consented for participation in the study other than possibly for privacy issues.

On the other hand, those patients randomized to the experimental group are consented as usual, except that they are consenting to the certainty of receiving the experimental treatment only; alternatively these patients can decline and receive the standard treatment instead.

[citation needed] In comparison, the current predominant design is for consent to be solicited prior to randomization.

[citation needed] There are a number of advantages conferred by the post-randomization consent design.