Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors, investigators, and Institutional Review Boards.[i] The guidance provides suggestions on which topics of information should be included in the key information section of an informed consent as well as how information can be presented and formatted in an informed consent to aid prospective subjects’ understanding of a clinical trial.Continue Reading Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent