The Revised Common Rule (RCR), slated to go into effect Jan. 21, 2019, will bring some changes* to informed consent requirements. And that asterisk by “changes” is intentional, as the federal Office for Human Research Protections (OHRP) has said that it may issue guidance regarding some RCR consent requirements. Well, here we are, a mere three months before the RCR takes effect, and still no guidance. While we’re waiting, however, we’d like to address one of the more notable RCR informed consent changes and take our best guess at what it means, using some currently available resources.
The RCR will require informed consent to “begin with a concise and focused presentation of the key information” most likely to help a potential subject or LAR understand why they might or might not want to participate in the research. What’s more, this summary “must be organized and presented in a way that facilitates comprehension.” OHRP’s explanation of this requirements says this section of the form must be relatively short, but doesn’t give specific length requirements. Nor does it describe specific formatting suggestions. OHRP does say that for relatively simple studies, this “concise and focused presentation” might make up the bulk of the consent form.
OHRP, in its preamble to the RCR, says this “concise and focused” explanation should address the following items in “sufficient detail”: 1) the fact consent is being sought for research and participation is voluntary; 2) the purposes of the research; how long the participant’s involvement will last; and the procedures to be followed in the research; 3) reasonably foreseeable risks or discomforts; 4) reasonably foreseeable benefits that might come from participation; and 5) appropriate alternative procedures or treatments that might be advantageous to subjects. OHRP also helpfully notes in the preamble language that “a discussion of the key information to be included in the beginning section of the consent form, and how it will operate in practice, may be further clarified in future guidance.” We’ll keep you posted re any guidance as soon as we hear anything.
Meanwhile, we’ll pat ourselves on the back a bit regarding some other informed consent changes in the RCR, because the UAMS IRB is already doing some of these things. For example, the rule will require that informed consent describe any possible future use of data stripped of identifiers, which our IRB already has PIs address in their consent forms. Other issues our IRB considers in its reviews and that the RCR addresses are a discussion of whether there is possibility of commercial profit stemming from the use of the subject’s information; whether any clinically relevant research results will be given to subjects; and whether the research might include whole genome sequencing.
OHRP has created educational materials all about the RCR, including a video dedicated to informed consent changes. We encourage everyone to take a look at these. Other OHRP RCR resources can be accessed via the same linked web page.