Clinical Research

  • Read more: Good news for many South African HIV patients—with a big glitch

    Good news for many South African HIV patients—with a big glitch

    By Nir Eyal On Wednesday, South African Health Minister Aaron Motsoaledi announced that, as of January 2015, HIV-positive patients in the country would start receiving free antiretroviral treatment once their CD4 count fell below 500, instead of current threshold of less than 350. Some patient groups would start receiving antiretrovirals immediately upon being diagnosed with…

  • Read more: When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine

    When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine

    By I. Glenn Cohen Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA…

  • Read more: Michelle Meyer: Misjudgements Will Drive Social Trials Underground

    Michelle Meyer: Misjudgements Will Drive Social Trials Underground

    Michelle Meyer has a new piece in Nature – an open letter on the Facebook study signed by a group of bioethicists (including PFC’s Executive Director Holly Fernandez Lynch) in which she argues that a Facebook study that manipulated news feeds was not definitively unethical and offered valuable insight into social behavior. From the piece: “Some bioethicists have…

  • Read more: Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

    Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

    The Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and…

  • Read more: Translating “ELSI” into Policy

    Translating “ELSI” into Policy

    By Wylie Burke When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the…

  • Read more: Art Caplan: Facebook Experiment Used Silicon Valley Trickery

    Art Caplan: Facebook Experiment Used Silicon Valley Trickery

    By Arthur Caplan Art Caplan has a new opinion piece on NBCNews about a recently published study in The Proceedings of the National Academy of Sciences, where a  Facebook scientist teamed up with two academics to subtly tweak the news feeds of nearly 700,000 Facebook users. From the piece: “The question of whether or not an experiment is…

  • Read more: Informed consent in social media research

    Informed consent in social media research

    By Winston Chiong Cross-posted from Geripal I’m simultaneously a behavioral researcher, an ethicist, and a hopeless Facebook addict, so I’ve been thinking a lot about last week’s controversial study (Kramer et al, PNAS 2014) in which researchers manipulated the emotional content of 689,003 Facebook users’ News Feeds. In summary, users who saw fewer of their…

  • Read more: How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why that May Be a Good Thing

    How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why that May Be a Good Thing

    By Michelle Meyer By now, most of you have probably heard—perhaps via your Facebook feed itself—that for one week in January of 2012, Facebook altered the algorithms it uses to determine which status updates appeared in the News Feed of 689,003 randomly-selected users (about 1 of every 2500 Facebook users). The results of this study—conducted…

  • Read more: REGISTRATION OPEN: 9/18 conference on post-trial access

    REGISTRATION OPEN: 9/18 conference on post-trial access

    By The Petrie-Flom Center Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave. This event is free and open to the public, but due to limited seating registration is required. Please register online. Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in…

  • Read more: Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

    Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

    By Timo Minssen In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees…