Human Subjects Research

  • Read more: Academic Freedom and Responsibility

    Academic Freedom and Responsibility

    by Suzanne M. Rivera, Ph.D. Earlier this month, the American Association of University Professors (AAUP) recommended that researchers should be trusted with the ability to decide whether individual studies involving human subjects should be exempt from regulation.  The AAUP’s report, which was prepared by a subcommittee of the Association’s Committee on Academic Freedom and Tenure,…

  • Read more: You Talkin’ to Me?

    You Talkin’ to Me?

    by Suzanne M. Rivera, Ph.D. The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects.  Equitable in this context means that the risks and benefits of the study are distributed fairly.  Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and…

  • Read more: Accentuate the Negative

    Accentuate the Negative

    by Suzanne M. Rivera, Ph.D. While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.”  Calling upon his own work, which is focused on…

  • Read more: Film Review: How to Survive a Plague

    Film Review: How to Survive a Plague

    By Suzanne M. Rivera How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today.  Beginning at the start of the epidemic, when little was known about the HIV…

  • Read more: Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

    Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

    By Leslie Francis In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements. A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles…