Is the Consent Form a Legal Document?

If you have ever considered volunteering to participate in a clinical trial, you know how much paperwork is associated with the Informed Consent process. Hopefully, the research was explained to you by a physician or nurse who also answered any questions you may have had.

Then you were probably handed a daunting document - the Consent Form - to sign. Chances are the Consent Form was quite long, detailed, and did not exactly read like WebMD magazine or USA Today. You may or may not have taken it home with you, read it carefully, and asked questions of the study team or other experts you may know. At some point, if you were enrolled in the clinical trial, you signed the Consent Form.

What exactly does that signature convey and how much legal weight does the Consent Form carry?

While the careful and formal way in which Consent Forms are presented to potential participants may suggest that they are binding legal documents, they're not. All your signature on a Consent Form documents is that you did, in fact, acknowledge that you understand the study and voluntarily agree to participate in the study. It does not compel you to participate. It does not mean you can't change your mind. It does not prevent you from withdrawing later on.

In short, your signature on the Consent Form documents your voluntary participation. It does not legally require you to participate. It just seems a lot more official than it really is.

-Joe

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