The Revised Common Rule (RCR), slated to take effect Jan. 22, 2019, adds some new required elements to informed consent processes/forms, and also requires informed consent to begin with a “concise and focused presentation” of “key information” describing why some might, or might not, want to join a research study.
A revised plain language informed consent template is now available on the IRB’s website. The revised template includes the new RCR requirements. The separate “concise and focused presentation” template and completed example also remain available for anyone needing to address that requirement in a separate document.
Important note: When creating a new submission, picking up an old study’s documents and trying to adapt them for a new study is just asking for trouble. It always has been (because you pretty much always leave some old study text in your new study documents, which means you get an automatic contingency), but it is particularly important to NOT do that with the RCR taking effect. Not only does the RCR have new requirements that didn’t apply in the past, but we fully expect to keep revising any new templates and tools we’ve created specifically to meet RCR requirements. No matter how much advance prep we do, we’re confident that we’ll find things that aren’t working the way we expected, or as efficiently as they could, and we’ll need to make changes. So please pick up a fresh informed consent template each time you create a new study’s consent form and start from scratch, rather than trying to adapt an old study’s form to the new study’s content and requirements.