One noticeable new aspect of the Revised Common Rule is the requirement to include a “concise and focused” presentation of key information that would help a subject decide whether or not to join a study in the consent process. Although guidance as to what form this summary should take is only trickling out, we have created a template to use to draft this summary for written consent forms (and to help guide consent discussions that don’t involve written consent forms). We gratefully tip our hats to the University of Kentucky, whose templates we have adapted to UAMS use.
A couple of things to keep in mind about this template:
- The completed template should be short. We used an invented FDA-regulated study to draft this template, to demonstrate that even investigational product studies can be summarized briefly.
- You do not need to wait until the Revised Common Rule (RCR) implementation date of Jan. 19, 2019, to start using this template. This summary is not inconsistent with current consent regulations, so you can start using it right away. In fact, we encourage people to start working with it, to get used to the process to speed approvals in the RCR era.
- While the FDA has not updated its regulations in concert with the RCR, it has said the RCR is “not inconsistent” with FDA regulations. So FDA regulations will have to comply with two sets of regulations, the FDA regs and the RCR. When possible, please encourage study sponsors to keep this “concise and focused presentation of key information” requirement in mind. Not only does it help these studies meet both sets of regulations, but this summary can help people understand the often long and confusing consent forms for industry-sponsored trials.
- These templates are also available on the UAMS IRB’s “Templates and Training” page.