How significant can a two-word change be? In the case of a small revision to the informed consent regulations in the Revised Common Rule (RCR), two little words may spur investigators and IRB reviewers to think about the informed consent process more expansively.
The change, as noted in a recent AAHRPP webinar on understanding in informed consent:
“An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and (2018 RCR addition) consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
What does the addition of the words “discuss and” mean for us, exactly? We think it highlights the importance of the overall consent process, which was a theme in the RCR’s consent-related changes. Elsewhere the RCR refers to a “concise and focused presentation” of “key information…organized and presented in a way that facilitates comprehension.”
How do we apply this “discuss and…” requirement in practice? Investigators should provide enough information about their consent process in new submission to allow the IRB to adequately consider whether this regulatory provision is met. And for some consent processes, such as those completed electronically, take care to note how this discussion requirement will be met, OR to indicate why it isn’t necessary for this particular consent process.
We picked up a lot of interesting tidbits from this webinar today; we’ll be sharing more of them on the blog in the days ahead. Stay tuned!