2008 Webinar: Handling Incidental Findings in Human Subjects Research

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Overview

With the advent of so many new and complex areas of medical research, the probability of incidental findings has risen, bringing many questions to the forefront. Incidental findings occur in a number of ways, and the goal of this webinar is to help participants respond when they do arise.

During this webinar, expert presenters focused on the legal and ethical considerations during Handling Incidental Findings in Human Subjects Research: Legal and Ethical Perspectives, a collaborative webinar with the American Society of Law, Medicine and Ethics (ASLME).

The speakers covered an exciting spectrum of issues that IRB members should prospectively consider and ask how these issues may impact their institution.

Michelle Mello, JD, PhD, believes that investigators have an obligation to respond to incidental findings. During the webinar, she will discuss the scope and limits of this professional obligation to respond to incidental findings.

Benjamin Wilfond, MD, notes that the approach to incidental findings without clear and proximate benefit is challenging. Among other topics, he will discuss disclosure with pediatric subjects and the special ethical challenges facing this population.

About ASLME

ASLME provides high-quality scholarship, debate, and critical thought to the community of professionals at the nexus of law, medicine, and ethics. For nearly three decades, ASLME has fulfilled its mission by providing extensive opportunities for interdisciplinary education to its members. ASLME also publishes the premier, peer reviewed multidisciplinary journal highly accessible to anyone interested in law, medicine, and ethics, titled The Journal of Law, Medicine & Ethics. It is one of the top rated journals in its field and is available as a membership benefit in ASLME.

Faculty

Michelle Mello, JD, PhD
Michelle Mello is Professor of Law and Public Health in the Department of Health Policy and Management at the Harvard School of Public Health. She holds a JD from Yale Law School; a PhD in Health Policy and Administration from the University of North Carolina at Chapel Hill; a MPhil from Oxford University, where she was a Marshall Scholar; and a BA from Stanford University.

Dr. Mello conducts empirical research into issues at the intersection of law, ethics, and health policy. She is the author of more than 70 articles and book chapters on the medical malpractice system, medical errors and patient safety, research ethics, mass tort litigation, the obesity epidemic, pharmaceuticals, clinical ethics, and other topics. Current and recent projects include an investigation of the impact of the medical malpractice crisis on physician supply in Pennsylvania; a study of factors contributing to medical errors in the hospital; a study of legal relationships between academic investigators and industry sponsors of clinical trials; and a feasibility study of an administrative “no-fault” system of compensating medical injuries. As a Greenwall Faculty Scholar, Dr. Mello is also studying ethical issues confronting the pharmaceutical industry.

Dr. Mello is Director of the Program in Law and Public Health at the Harvard School of Public Health and Co-Chair of the School’s Human Subjects Committee. She teaches courses in public health law and public health ethics at the Harvard School of Public Health and Harvard Law School. She was the 2006 recipient of the Alice S. Hersh New Investigator Award from AcademyHealth for outstanding promise in the field of health services research.

Benjamin Wilfond, MD
Benjamin S. Wilfond, MD is director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Hospital and is professor and chief of the Division of Bioethics in the Department of Pediatrics at the University of Washington School of Medicine. He is also an adjunct professor in the Department of Medical History and Ethics. Additionally, Dr. Wilfond is an attending physician in the Chest Clinic in the Division of Pulmonary Medicine at Seattle Children’s Hospital. He is the Co-Director of the Regulatory Support and Bioethics Core for the Institute of Translational Health Sciences (ITHS) and coordinates the ITHS Research Bioethics Consult Service.

He earned his MD from the University of Medicine and Dentistry of New Jersey-New Jersey Medical School. He completed his pediatric residency and his fellowship in pediatric pulmonology and medical ethics at the University of Wisconsin. He has held faculty positions at the Department of Pediatrics, University of Arizona; Social and Behavioral Research Branch, National Human Genome Research Institute; and the Department of Clinical Bioethics, NIH Clinical Center.

Dr. Wilfond's scholarship focuses on ethical and policy issues related to genetic testing, genetic research and pediatrics research. He has recently worked on issues related to newborn screening, disclosure of genetic research results, and pediatric biobanks. He is a member of the Ethics Subcommittee of the FDA Pediatric Advisory Committee, the National Children's Study Federal Advisory Committee, the March of Dimes Bioethics Advisory Committee, and the editorial board of the American Journal of Bioethics.