We’ve revised IRB Policy 15.1 to reflect the requirements of the Revised Common Rule. While it will be added to the usual spot on our website after January 19, we wanted to make it available for reference before that date.
A quick recap of the most notable changes to the informed consent information requirements:
Consent must begin with a “concise and focused summary of key information” directed at helping subjects decide why they might or might not want to join a study.
Two new required elements of informed consent must be added when applicable — 1) a statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will share in those profits and 2) whether clinically relevant research results, including individual results, will be returned to subjects. (Note that it doesn’t require results to be returned, only that subjects be told whether they will be returned or not.)
Remember that a plain language informed consent template that incorporates all the Revised Common Rule requirements is also available on the IRB’s website, as is a template for just the “concise and focused summary” part. If you haven’t already started using these templates or otherwise meeting revised Common Rule requirements, please go ahead and start doing so now. Any new studies submitted from now on will likely be approved only after the Revised Common Rule takes effect.