54 results match your criteria: "and Bioethics at Harvard Law School.[Affiliation]"
Why accountability matters for universal health coverage and meeting the SDGs.
Lancet
March 2019
Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel.
Ann Intern Med
October 2018
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, Massachusetts (I.G.C.).
A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and oversight bodies. These challenges stem primarily from the engagement of patients in roles other than research subject, such as advisors, study personnel, and co-investigators, which gives rise to questions about appropriate levels of protection, training, and education, as well as identifying and managing conflicts of interest.
View Article and Find Full Text PDFRevised 'Common Rule' Shapes Protections For Research Participants.
Health Aff (Millwood)
May 2017
Barbara E. Bierer is faculty co-director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center); director of the Regulatory Foundations, Ethics and Law Program, Harvard Catalyst; and a professor of Medicine at Brigham and Women's Hospital and Harvard Medical School, in Boston, Massachusetts. Mark Barnes is a partner at Ropes and Gray LLP, a visiting lecturer at Yale Law School, and faculty co-director of the MRCT Center. Holly Fernandez Lynch is executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and faculty in the Harvard Medical School Center for Bioethics.
Investigators and institutions have begun to prepare for new federal protections of study participants set to take effect in 2018.
View Article and Find Full Text PDFMitochondrial Replacement Therapy: Unmade in the USA.
JAMA
February 2017
Professor of Law and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, Massachusetts.