Holly Fernandez Lynch to continue Seminar Series with “Evaluating IRB Quality and Effectiveness” on May 13
615 N. Wolfe Street
Holly Fernandez Lynch, John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at Penn’s Perelman School of Medicine, will continue the Berman Institute’s 2018-19 Seminar Series with “Evaluating IRB Quality and Effectiveness” on May 13.
Fernandez Lynch says, “Empirical data demonstrate many problems with the existing system of research ethics oversight by Institutional Review Boards, including inconsistency, delay, burden, and nontransparency. However, evaluating positive elements of IRB quality and effectiveness is far more challenging. How can we tell if IRBs are successfully doing what they were created to do and whether efforts to reform the system will improve outcomes?”
Fernandez Lynch is also the Assistant Faculty Director of Online Education, helping to lead the university’s first online master’s degree, the Master of Health Care Innovation, and other online offerings. Her scholarly work primarily focuses on human subjects research ethics and regulation, with current projects relating to voluntariness in research participation, defining and evaluating Institutional Review Board quality and effectiveness, access to investigational products, and patient engagement in research.
Professor Fernandez Lynch is the author of Conflicts of Conscience in Health Care: An Institutional Compromise in 2008 (MIT Press), and has also co-edited several volumes on topics including human subjects research; biospecimens research; FDA policy; “nudging” health; law, religion, and health; big data and health care; and transparency in health care. She has been involved with sponsored research projects addressing the health of professional football players, recruitment of participants to clinical trials, and oversight of patient-centered outcomes research.Professor Fernandez Lynch was appointed to the Secretary’s Advisory Committee on Human Research Protections (SACHRP), U.S. Department of Health and Human Services, in 2014; she is also an active member of the SACHRP Subcommittee on Harmonization. She served as Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School from 2012-2017, and was Teaching Faculty at the Harvard Medical School Center for Bioethics. Before that, she practiced FDA law at Hogan & Hartson, LLP (now Hogan Lovells), served as a bioethicist with the Human Subjects Protection Branch at the NIH’s Division of AIDS, and was Senior Policy and Research Analyst for President Obama’s Commission for the Study of Bioethical Issues.
Professor Fernandez Lynch received her BA in health and societies, her JD, and her Master of Bioethics all from the University of Pennsylvania. As an undergraduate, she participated in LDI’s Summer Underrepresented Minority Research (SUMR) program in 2002.