Establishing the standard of care in research ethics: The role of the expert witness

Jon F. Merz1

1 Department of Medical Ethics & Health Policy, Perelman School of Medicine at the University of Pennsylvania,  Blockley Hall Floor 14, 423 Guardian Drive, Philadelphia, Pennsylvania 19104-4884 USA, merz@upenn.edu

Expert witnesses in litigation play a key role in establishing the standard of care, deviance from which is a necessary element in establishing tort liability. I will describe in detail two cases in which I was hired by litigants as an expert witness to demonstrate methods by which standards of care may be established. Both cases involved deaths of human subjects in research. Both cases turned in part on the foreseeability of risks, the adequacy of Institutional Review Board (IRB) review, and the appropriateness of informed consent disclosure. In one case, a large multi-site clinical trial, the standard of care for disclosure was established by detailed examination of the consent forms approved by 225 IRBs for the trial for which forms were available for review. This review demonstrated that the disclosure deemed necessary by the plaintiff was in fact required by only one of those boards. In the second case, a subject collapsed and died immediately after completing a 2-minute step test, an objective fitness test included in an otherwise interview-based non-interventional study. A thorough review of the literature demonstrated that the risk of death was foreseeable and should have led to the exclusion of high risk patients, including the deceased subject, and not merely to inclusion of the risk in the consent form. The challenges facing expert witnesses, including assuring intellectual rigor, maintaining objectivity, and accommodating litigation strategies, will be discussed.


Biography

Jon Merz is an Associate Professor in the Department of Medical Ethics & Health Policy in the Perelman School of Medicine at the University of Pennsylvania. Dr. Merz holds a BS in Nuclear Engineering from Rensselaer Polytechnic Institute, MBA from the University of North Florida, JD from Duquesne University School of Law, and PhD in Engineering & Public Policy from Carnegie Mellon University. Dr. Merz has taught research ethics in the Penn Masters of Bioethics program since 1997; he has served on 3 IRBs over the last 25 years, and has moderated the IRB Forum [http://www.irbforum.org] since 2003.