Returning Results to Research Participants: A Health Policy and Bioethics Consortium
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 joined 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.
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
Pilar Ossorio, Professor of Law and Bioethics, University of Wisconsin Law School
Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School
This event was free and open to the public.
Kat McGowan, "More research volunteers are getting their medical test results. Should we cheer — or worry?," STAT (December 1, 2016)
Attachment B: Return of Individual Research Results, Secretary’s Advisory Committee on Human Research Protections (SACHRP) Recommendations (July 21, 2016)
Attachment D: Recommendations Regarding Return of General Research Results, Secretary’s Advisory Committee on Human Research Protections (SACHRP) Recommendations (April 25, 2015)
Learn more about the Health Policy and Bioethics Consortia.
The Health Policy and Bioethics Consortia are hosted and organized by the Harvard Medical School Center for Bioethics and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Harvard Program in Therapeutic Science. This monthly series convenes international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. Support provided by the Oswald DeN. Cammann Fund at Harvard University.
VIDEO: Welcome Remarks, Aaron S. Kesselheim and Holly Fernandez Lynch
VIDEO: Barbara Bierer, "Using Data for the Public Good: Sharing Aggregate and Individual Results"
VIDEO: Pilar Ossorio, "Returning Individual Findings to Research Participants"
VIDEO: Audience Q&A