Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenters
Alyson Karesh, MD
Senior Clinical Advisor
Office of Medical Policy (OMP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Alyson Karesh is currently Director, Division of Clinical Trial Quality, Office of Medical Policy, Food & Drug Administration (FDA). She served as Pediatric Team Leader in the Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research (CDER) at the FDA. Dr. Karesh and her team provided scientific and regulatory advice regarding the development of drugs and biologic products in the pediatric population to FDA review divisions, pharmaceutical companies, and other agencies. Dr. Karesh received her medical degree from Medical College of Virginia and completed her pediatric residency at Children’s Hospital of Pittsburgh.
Suzanne R. Pattee, JD
Regulatory Counsel
Office of Clinical Policy (OCP)
Office of Clinical Policy and Programs (OCPP)
Office of the Commissioner (OC) |
US Food and Drug Administration (FDA)
Suzanne Pattee is a regulatory counsel with the Office of Clinical Policy in the Office of the Commissioner where she addresses policy for the ClinicalTrials.gov data bank, clinical trial design, and informed consent. She previously worked in CDER for the Division of Clinical Trial Quality in the Office for Medical Policy (OMP), and in the Office of Policy in the Office for Pharmaceutical Quality (OPQ).
Before joining FDA in 2009, Suzanne was a vice president at a rare disease foundation where she led policy initiatives in clinical trials, orphan drug policies, and many others. She also led bioethics issues and outreach for a biotechnology trade association and addressed health policy for a biotechnology company. Suzanne was a member of the Secretary’s Advisory Committee for Human Research Protections and served on the board of an accreditation association. Suzanne earned her law degree from George Washington University, and her bachelor’s degree in biology from The College of William and Mary.
Abstract
At the 2024 FDA Regulatory Education for Industry Conference, Alyson Karesh and Suzanne R. Pattee discuss key information in informed consent. They explain informed consent as an ongoing process involving sponsors, investigators, and IRBs, detailing its basic and additional required elements necessary for potential participants to make an informed decision about study participation. Drawing on a proposed FDA rule and joint draft guidance with OHRP, they highlight two provisions intended to improve consent materials and facilitate participant understanding. The first requires that consent forms must begin with key information, presenting critical details about the study concisely and organized for comprehension, including the voluntary nature of participation, study purpose, main risks and benefits, duration, and alternatives. The second provision mandates that the entire consent be organized and presented to facilitate understanding, suggesting tools like simple language, clear formatting, grouping information, and using visual aids. They emphasize that these improvements aim to enhance participant comprehension and decision-making, potentially improving study enrollment and retention, and encourage stakeholders to implement these approaches now as they align with the revised common rule for federally funded research.