30
Aug2018

Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. On March 7, PRIM&R hosted a webinar, Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape, to educate HRPP professionals on FDA guidance, recent legislation, and ethical questions related to expanded access. The webinar featured Richard Klein, the former director of the FDA's Patient Liaison Program in the Office of Health and Constituent Affairs, and Beth E. Roxland, JD, MBioethics, an Attorney, Bioethicist, and Senior Advisor on Law, Health Policy and Ethics at Roxland Consultants, Ltd. After the webinar, Mr. Klein responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more

23
Aug2018

Welcome to Research Ethics Reading List, a new feature from Ampersand where we feature books in or adjacent to the field of research ethics that we think you’ll find interesting, motivating, inspiring,  challenging, or some combination of the four! In this edition we look at books about tech industry bias and blind spots; the powers, perversions, and potential of heredity; animal Infections and the next human pandemic; and more! Read more

21
Aug2018

On May 30, 2018, the four-year Right to Try (RTT) movement culminated in a new federal law, with the stated goal of providing terminally ill patients with a new route of access to early phase investigational drugs that are currently in clinical development and not approved or generally available to all patients in need. RTT laws seek to remove federal FDA oversight and regulations from the pre-approval process, in which patients seek to access experimental drugs in development outside of the clinical trials in which the drugs are being tested, despite the fact that terminally ill patients already had the right to request such access under FDA regulations for decades through the Expanded Access Program. Read more

13
Aug2018

You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order. Read more