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What a “waiver of documentation of consent” means, exactly

Recent discussions we’ve overheard lead us to think there are different ideas of what constitutes a “waiver of documentation of consent”. The concept is indeed a bit tricky, since the word “documentation” has a couple of different meanings in the consent context.

The first thing we think of regarding consent documentation is the written consent form. Typically, a subject signs the consent form, is given a copy of the signed form, and the original goes into the investigator’s files. This signing of a consent form is described both in federal regulations and in IRB policies.

Another type of documentation the UAMS IRB requires is separate documentation of the consent process. This record is not part of the consent form itself; instead, it records that a consent process occurred and provides some details about that process. This documentation is required by UAMS IRB policy 15.5.

A “waiver of documentation of consent” refers to waiving the requirement that the investigator obtain a signed consent form for some or all subjects [45 CFR 46.117(c), UAMS IRB Policy 15.3]. This means the IRB can still require a separate note documenting a consent process even if a consent documentation waiver is granted. This waiver simply means no consent form will be signed and returned to the investigator. The IRB will, in many cases, require written information about the study to be given to subjects even if it grants a waiver of consent documentation.