Withdrawal and Changing Their Mind

Part of Decentralized Trials (DCT) Training: Remote and Electronic Consent.

About 2 minutes. Free, in your language, no account needed.

Withdrawal must be as easy as joining

If consenting took two clicks and withdrawing takes three phone calls, the consent was not as free as it looked.

Participants should know, from the start, exactly how to stop and who to tell.

Distinguish what they are withdrawing from

A participant may want to stop the intervention but continue safety follow-up. They may want to stop visits but allow existing data to be used. They may want everything to stop.

These are different, and assuming the broadest one loses data the participant was willing to give. Assuming the narrowest one overrides their wishes.

Ask, and record precisely what they chose.

Data already collected usually stays

In most studies, data collected before withdrawal remains in the dataset. Removing it would bias the result and may be impossible once it is in an analysis.

Participants are told this at consent. If they are surprised, that is worth noting, because it suggests the original conversation did not land.

Devices and product come back

A withdrawal means arranging return of the wearable, the tablet, the unused investigational product. Accountability still applies.

Do this promptly and gently. Chasing a device from somebody who has withdrawn, weeks later, is an unpleasant conversation that better scheduling avoids.

Stop the data flowing

Connected devices keep transmitting until somebody turns them off. A participant who withdrew on Tuesday and whose wearable is still reporting on Friday is a data protection problem.

Know how to deactivate each data stream and confirm it stopped.

Record the date and the reason if they give one

The reason is optional for them and useful to the study. A pattern of withdrawals citing the device burden is telling you something about the design.

Do not try to talk them out of it

Understanding a concern is fine. Persuading is not, and remotely it lands harder than you think.