By Holly Fernandez Lynch Yesterday, President Obama’s Commission for the Study of Bioethical Issues released its fifth report: Privacy and Progress in Whole Genome Sequencing. I haven’t had a chance to digest it yet, but for now, just wanted to call it to everyone’s attention. The gist seems to be privacy, privacy, privacy. Here are the…
By Laura Stark Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the amendments instituted the four-phase review process and the requirement that manufacturers get informed consent from people receiving experimental drugs. If…
By The Petrie-Flom Center What were they thinking? Placebo-controlled trials before informed consent Franklin G. Miller, Ph.D., Department of Bioethics, National Institutes of Health October 25, 2012 – 4pm Shapiro Clinical Center JCRT 5A (East Campus), Beth Israel Deaconess Medical Center, Boston, MA Sponsored by the Program in Placebo Studies and the Therapeutic Encounter; Martinos Center for Biomedical Imaging; MGH; BIDMC Division of General Medicine and Primary Care;…
by Jonathan J. Darrow In a Petrie-Flom Center event last month, Dr. Alan Wertheimer raised the question of why consent is needed in ethical research. Without commenting on his answer to the question (attendees were asked not to do so), I would like to offer two principal lenses through which an answer can be understood:…
By Adriana Lee Benedict Earlier this year, the World Health Organization’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) issued a report calling for, inter alia, increased support for innovative pharmaceutical R&D funding mechanisms. Although lack of financing has posed a challenge to implementation of alternative approaches to R&D, the increasing…
by Suzanne M. Rivera, PhD For a variety of reasons, racial and ethnic minorities in the US do not participate in clinical research in numbers proportionate to their representation in the population. Although legitimate mistrust by minorities of the healthcare system is one reason, institutional barriers and discrimination also contribute to the problem. The equitable inclusion of…
by Suzanne M. Rivera, Ph.D. One of the peculiar legacies of unethical human experimentation is an impulse to protect people from perceived research risks, even when that means interfering with the ability of potential participants to exercise their own wills. Fears about the possibility of exploitation and other harms have resulted in a system of research…
by Jonathan J. Darrow A research study reported today in the New England Journal of Medicine found that physicians are able to discriminate between clinical trials with high levels of rigor versus those with low levels of rigor, as well as between clinical trials that are funded by industry and those that are funded by…
By Cansu Canca A recent New York Times article drew attention to an issue with increasing importance as technology develops. Gene samples collected under conditions of anonymity reveal more and more information that may be of crucial importance for the subjects or their relatives. Researchers feel a moral obligation to disclose these important findings, which…
By The Petrie-Flom Center “In Plain Sight: A Solution to a Fundamental Challenge in Human Research”Journal of Law, Medicine, and Ethics, Forthcoming (Lois Shepard and Margaret Foster Riley, UVA) From the abstract: The conflict of interest created when physician-researchers combine medical research and treatment is a long-standing and widely recognized ethical challenge of clinical research…
