In Research Ethics Reading List posts 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! Books featured are a combination of new releases, classics in the field, or underexposed gems we think are worth a look. Read more
In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more
Among the speakers at IACUC19, one in particular, Leland S. Shapiro, PhD, touched me in a unique way. A brain tumor survivor and fellow martial artist (I have a brown belt in Tae Kwon Do), Dr. Shapiro related his story in an unusually funny and endearing fashion. He shared his full experience, from his initial symptoms, to his struggle to find a doctor. His frustration and moments of almost giving up, his perseverance and fight—his ultimate triumph. As he explained, he is a living legacy of animal-based research. And I think this is something we can all relate to and find similar stories of in our own circles: family members, friends, neighbors saved by medical interventions made possible by animal research. Read more
The last few years have seen a growing call across the research enterprise to increase transparency around animal research—why we do it, why it’s important, and what it has accomplished. I also wonder whether there is another layer of transparency we ought to be promoting—namely, transparency about the ethical dimensions of animal research and its oversight. Specifically, how might being more open about the ethical issues and questions that are part of the day-to-day work of those involved in animal research serve our collective goals of educating and engaging the public; increasing their understanding, trust, and support for the animal research enterprise; and reframing the public conversation? Read more
Today is the 40th anniversary of the Belmont Report, the foundational document on which our federal oversight system for human subjects research is based. This milestone warrants a pause in our busy day to reflect on its impact and its legacy. Read more
