Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Ann Meeker-O’Connell, MS
Director
Office of Clinical Policy (OCP)
Office of the Chief Medical Officer (OCMO)
Office of the Commissioner (OC)
US Food and Drug Administration (FDA)
Ann Meeker-O’Connell is the Director of the Office of Clinical Policy in the Office of the Commissioner at FDA. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including FDA efforts related to clinical trial modernization and clinical quality by design. She received an M.S. in Pharmacology and was an NIH Integrated Toxicology Fellow at Duke University.
Abstract
During the 2024 Clinical Investigator Training Course (CITC) virtual conference, Ann Meeker-O’Connell, head of FDA’s Office of Clinical Policy, emphasizes that informed consent is an ongoing dialogue and process, far beyond merely a signed document. FDA regulations require consent before participation in clinical investigations, stipulating it must be in understandable language, free of exculpatory language, and obtained without undue influence or coercion. The presentation outlines eight mandatory basic elements that aim to provide participants or their representatives with the necessary information to make an informed decision. Proposed regulations introduce “key information” as a new mandatory initial section of the consent, designed to be concise, focused, and presented first to facilitate understanding about why an individual might or might not want to participate. This “key information” could even form the entirety of the consent for very simple, minimal-risk trials. Meeker-O’Connell stresses the need for innovation in consent design, encouraging the use of technology such as e-consent, images, videos, and graphics to enhance comprehension and engagement, particularly for diverse populations. IRBs, clinical investigators, and sponsors share responsibility for ensuring consent processes are adequate and truly participant-centered, moving away from lengthy, complex documents towards clearer, more effective communication.