Clinical Research

  • Read more: Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3 (Re-Identification Symposium)

    Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3 (Re-Identification Symposium)

    This post is part of Bill of Health’s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM By Daniel C. Barth-Jones In Part 1 and Part 2 of this symposium contribution I wrote about a number of…

  • Read more: Press and Reporting Considerations for Recent Re-Identification Demonstration Attacks: Part 2 (Re-Identification Symposium)

    Press and Reporting Considerations for Recent Re-Identification Demonstration Attacks: Part 2 (Re-Identification Symposium)

    By Michelle Meyer This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM Daniel C. Barth-Jones, M.P.H., Ph.D., is a HIV and infectious disease epidemiologist.  His work in…

  • Read more: Informed consent workshop today and tomorrow; papers available

    Informed consent workshop today and tomorrow; papers available

    By Laura Stark The first session on “vulnerable populations” just wrapped up at the workshop on “Frontiers of Informed Consent” at Northeastern University in Boston—with great talks on migrant, refugee, and indigenous communities and conflicts between law, ethics, and logistics of informed consent. Today and tomorrow, there will be talks and discussion on IRBs and…

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

    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…

  • Read more: Experiment vs. innovative treatment in bacterial transplants

    Experiment vs. innovative treatment in bacterial transplants

    By Nicholson Price There’s a fascinating and tragic story coming to its conclusion at UC Davis, which points at the fine line between clinical innovation and experimental treatment.  Two neurosurgeons just resigned, following the resignation of the med school’s dean last year.  The neurosurgeons, going off anecdotal evidence that some patients with deadly glioblastomas lived…

  • Read more: Henrietta Lacks and the HeLa genome

    Henrietta Lacks and the HeLa genome

    By Nicholson Price A few days ago, NIH announced an agreement with the family of Henrietta Lacks.  When she was being treated for an aggressive tumor, cells were taken without her consent or knowledge and used to create the HeLa cell line, which is tremendously widespread in biomedical research today – the story is well-chronicled in…

  • Read more: Art Caplan on the NIH’s Agreement Regarding Control of Henrietta Lacks’ Cells

    Art Caplan on the NIH’s Agreement Regarding Control of Henrietta Lacks’ Cells

    By Arthur Caplan Art Caplan has a new opinion piece up at nbcnews.com on the longstanding controversy over the use of the cells of Henrietta Lacks, a poor African American woman who died of cervical cancer in 1951, for research that has generated billions of dollars through scientific research over more than six decades. This research…

  • Read more: Shifting the burden of proof regarding placebo controls

    Shifting the burden of proof regarding placebo controls

    By Annette Rid Placebo controls usually get special treatment. Almost all ethical guidelines for research specify how to use placebo controls, in particular when an established or proven effective treatment exists. To list just a few: guidance issued by the World Medical Association, CIOMS and the Council of Europe all have provisions dedicated to the…

  • Read more: Art Caplan on GlaxoSmithKline research conduct in China

    Art Caplan on GlaxoSmithKline research conduct in China

    By Arthur Caplan An article in today’s New York Times explores allegations of improper research practices at GlaxoSmithKline’s research and development center in Shanghai, China. The article quotes Art Caplan in reference to evidence that researchers proceeded with drug trials in humans before animal studies were complete: “If that’s true, it’s a mortal sin in…