Human Subjects Research

  • Read more: Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking
    Article

    Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

    By Timo Minssen I am happy to announce the following publications: 1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication) Abstract:   On 18th December 2014, the…

  • Read more: European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)
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    European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)

    By Timo Minssen The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic. While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative…

  • Read more: The Medical Liability Climate: The Calm Between Storms Is the Time For Reforms
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    The Medical Liability Climate: The Calm Between Storms Is the Time For Reforms

    By: Michelle Mello, JD, PhD Stanford Law School and Stanford University School of Medicine On November 4, Californians will vote on Proposition 46, a ballot initiative to adjust the $250,000 state’s noneconomic damages cap in medical malpractice cases for inflation, raising it to $1.1 million virtually overnight.  It’s a long overdue move – California has one of…

  • Read more: 10/22/14: “Human Subjects Research Regulation” Book Launch
    Article

    10/22/14: “Human Subjects Research Regulation” Book Launch

    Book Launch: “Human Subjects Research Regulation: Perspectives on the Future” Wednesday, October 22, 2014 12:00 PM – 1:00 PM Harvard Law School Library Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave. This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website. MIT Press recently…

  • Read more: Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics
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    Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics

    The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory…

  • Read more: The Fight Against Antimicrobial Resistance: Important recent publications
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    The Fight Against Antimicrobial Resistance: Important recent publications

    By Timo Minssen One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels. A recent medical review on drug resistant tuberculosis supports…

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

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

    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 HIV infection, regardless…

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

    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…

  • Read more: Trials of HIV Treatment-as-Prevention: Ethics and Science. Friday, March 7
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    Trials of HIV Treatment-as-Prevention: Ethics and Science. Friday, March 7

    High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART…

  • Read more: OHRP Revises Guidance on Remuneration for Human Research Subjects
    Article

    OHRP Revises Guidance on Remuneration for Human Research Subjects

    by Suzanne M. Rivera, Ph.D. The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation.  And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human…