Friday, February 10, 2017
12:30 – 2 p.m.
Harvard Law School
Wasserstein Hall
Milstein East C (2036)
Cambridge, MA 02138
Clinical investigators, public health advocates, and IRBs have been struggling to develop appropriate policies on how to return results to patients involved in research studies. These results may come in a variety of forms, ranging from aggregated study results to individual results to incidental findings. Experts disagree over the optimal timing, how researchers should consider the burden that these results can place on patients, and whether there are circumstances in which certain findings should be withheld.
Is clinical utility the appropriate standard, or does mere curiosity suffice to trigger disclosure obligations? How certain must the results be, and what if there is reason to believe that the results will be difficult for participants to understand – or cause them harm? Two experts in the field of research law and ethics will join us to engage these and other questions, and help conceive a way to move forward in the best interests of patients and the medical research enterprise.
Experts:
Barbara Bierer, MD
Program Director, Regulatory Foundations, Law and Ethics Program, Harvard Catalyst and faculty co-director, Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and Harvard
Pilar Ossorio, JD, PhD
Professor of Law and Bioethics, University of Wisconsin Law School
Moderator:
Holly Fernandez Lynch, JD, MBioethics
Executive Director, Petrie-Flom Center
Faculty, Center for Bioethics, Harvard Medical School