By Holly Fernandez Lynch Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.” We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon. The conference…
By Michelle Meyer I’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments…
Cutting-Edge Issues in the Ethics of Conducting Biomedical Research Thursday, October 9, 2014, 7:45 AM – 2:15 PM Saul Farber Auditorium, Bellevue Hospital, 27th Street and First Ave (462 First Ave.), New York City Registration is required for the conference. Informed consent and Institutional Review Boards (IRBs) are the cornerstones of modern bioethical research but they…
By Art Caplan A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include: Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to connote a wide range…
A Conversation with the HHS Office of the Inspector General Tuesday, September 30, 2014 12:00 PM – 1:00 PM Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave. Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office…
Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center at Harvard Law School, has been appointed by Secretary of Health and Human Services Sylvia Burwell to a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP is a Federal Advisory Committee charged with providing expert advice and recommendations to the…
By Zachary Shapiro Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to…
By Arthur Caplan Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains: I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values…
