Provider-Related Issues

Withdrawing consent after randomization

Last Updated: Jan 2, 2013

We have been experiencing a recent rash of patients signing consent and then withdrawing when they are not happy with their randomization.

Deb's Image

Anybody have any suggestions on how to avoid having patients consent to a study and then after randomization, having them withdraw because they are not happy with their randomization? This has happened in studies without a placebo control.

We all know how much work it takes to confirm patient eligibility and to have them sign consent. We always discuss what randomization means and why it is important to have some patients in the control group. Of course we disclose the right to withdraw at any time, but this withdrawal happens very early on in the process.

I'm wondering if it's because patients are becoming more informed (a good thing). Thoughts?

Linda Parreco's Image

Deb, thanks for posting your observation and posing the question to the AccrualNet community. It will be interesting to see if others have had similar experiences. Just curious, have the withdrawals all been on the same study--or has it been a random occurance? 


Deb's Image

Hi Linda,

This has occurred on different studies. Deb

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