February 10, 2017 12:30 - 2:00 PM
Lectures and Panels
2016-2017
Room TBD
Harvard Law School, Cambridge, MA

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.

Panelists 

  • Pilar Ossorio, Professor of Law and Bioethics, University of Wisconsin Law School

  • Barbara Bierer, 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

Moderator 

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School 

This event is free and open to the public.

Part of a monthly series of seminars run by the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, with support from Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Harvard Program in Therapeutic Science.

Tags

bioethics   health law policy   holly fernandez lynch   human subjects research   privacy   regulation   research