20
Sep2018

You are a physician at a Catholic hospital investigating a new treatment for a women’s health condition. This healthy volunteer study requires an unpleasant and somewhat risky procedure, so you do not expect to meet your enrollment target. The first five participants are nuns who say their primary motivation is altruism. What, if anything, should you do? Read more

11
Sep2018

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

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