What to do when the person who needs to sign a consent form isn’t in the room with you?

Sometimes the person whose signature needs to be on a consent form isn’t able to meet face-to-face with an investigator during the consent process. Examples include the parent of a hospitalized infant who was transported here, the out-of-town legally authorized representative (LAR) of a hospitalized patient, or someone considering joining a telemedicine study. Fortunately, both the regulations and available technology allow us to create some work-arounds to this problem.

Methods other than a face-to-face discussion maybe acceptable if they allow for an adequate exchange of information and documentation. For example, the consent form may be faxed or emailed to the LAR, with a consent discussion following by telephone. After the discussion, and after all questions have been answered, the subject can sign the form and fax or email the signed form back to the study site.

Note that some minimal risk studies may qualify for a waiver of documentation of consent. This waiver means that consent discussion will occur, but no signed consent form will be collected. See UAMS IRB Policy 15.3 for more information when such a waiver may be granted. Also, see our separate blog entry describing the difference between a waiver of consent documentation, and a waiver of consent.