The federal Food and Drug Administration (FDA) has released the final version of its guidance on informed consent. This guidance finalizes a draft guidance that dates to 2014.
This guidance addresses a lot of those random little questions that we don’t often think about. For example, page 27 indicates that when a subject provides consent the same day they begin participating in an IND or IDE trial, “the subject’s case history must document that the subject provided consent prior to participation in the research… .” This requirement means the study team must ensure the subject’s record specifies consent was obtained before participation began. The guidance also includes advice about when a short form consent process might be appropriate. We usually think about short form consent processes in the context of consenting subjects who don’t speak English well. However, a short form consent process may also be appropriate for, say, a visually impaired person who cannot see well enough to read a complete consent form.
The guidance also includes an FAQs section that distills some useful information about a variety of topics.
Copies of the complete guidance and of the federal register notice of its release are available via the link above. The federal register notice contains some background information not included in the guidance itself.