How are US institutions implementing the new key information requirement?

J Clin Transl Sci. 2020 Jan 10;4(4):365-369. doi: 10.1017/cts.2020.1.


Recent revisions to the Federal Policy for the Protections of Human Subjects require that informed consent documents begin with a "concise and focused presentation" of the key information a participant requires. Key information "must be organized and presented in a way that facilitates comprehension." The regulations do not specify what information be included, nor how it must be presented to facilitate comprehension. It is unknown how institutions and Institutional Review Boards (IRBs) are interpreting the current regulations. We conducted a review of randomly sampled available key information templates at 46 US medical institutions to determine how they are implementing the new regulations.

Keywords: Revised Common Rule; implementation; informed consent; key information; regulatory guidance; research ethics; review.