Hot off the presses — the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued the long-awaited draft guidance on “Key Information and Facilitating Understanding in Informed Consent.” OHRP has required a “key information” discussion at the beginning of consent processes since the 2019 Implementation of the Revised Common Rule, and FDA has indicated it is moving toward a similar requirement. This draft guidance is a pretty clear sign FDA means what it said in its proposed rule harmonizing its regulations with OHRP’s.
One thing that has been missing is clear guidance on what that “key information” portion should address. That lack is not entirely a bad thing; as we heard at a conference once, “Without specifics, everything’s compliant.” The UAMS Human Research Protection Program took its best guess when creating our key information templates. We’ll be reviewing this draft guidance closely to see what it recommends. But keep in mind that every study is different, and we wouldn’t take any particular guidance as gospel regarding key information content. Consent processes, including the key information section, should always be tailored to the particular study and target population.