Benjamin Wilfond: Informed Consent with ROMP

In this installment of the More than Meets the IRB: A Joint Initiative of Washington University in St. Louis, and PRIM&R, we talk about the ethical and regulatory considerations of research on medical practices (ROMP). Dr. Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics and a pulmonologist at Seattle Children’s Hospital, recently published a study on the ethical and informed consent considerations of research on the types of care that work best in clinical practice. Such research blurs the line between clinical risk and research risk, which can present novel questions and challenges to IRBs. That the research involves the use of clinical practices on real patients, suggests Dr. Wilfond, means that innovative approaches to informed consent are needed. For example: in a survey Dr. Wilfond conducted on a general population, 85% of respondents said that they would prefer to discuss their participation in a randomized treatment trial with their doctor rather than with an investigator or research administrator. According to Dr. Wilfond, innovation in informed consent–which is necessary in the face of recent innovations in research–demands a willingness on the part of IRBs to shoulder some of the risk in determining how best to protect research subjects while advancing the general medical understanding.