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We’re not the only ones wondering about new informed consent regulations

As noted in a recent IRB Research News and Tips blog item, the revised Common Rule will require some changes to the current way we present and document key elements of informed consent information. We have yet to hear specifics about how those new requirements, slated to take effect in January 2018, are to be implemented, as no guidance has been issued on them yet. A writer for PRIM&R’s Ampersand blog weighs in with her thoughts regarding implementing the new requirements. She indicates institutions may be on their own, at least at the beginning, in figuring out how to present this key information.

Here at UAMS, we haven’t made any final decisions regarding what will be expected regarding this requirement. However, we know we have been thinking about ways to make consent processes more meaningful and comprehensible to potential subjects for a long time. One tool we offer is the plain language informed consent template. While not all of the template information would need to be included in a presentation of key elements, the writing style may be adaptable to such a concise presentation. What other methods do you think might meet this requirement of a concise and focused presentation of consent elements?