The research ethics community was saddened to learn of the recent loss of Dale Hammerschmidt, MD, to brain cancer on April 5, 2022. Dr. Hammerschmidt, a longtime Minnesota resident including attending, practicing, researching, and teaching at the University of Minnesota Medical School, was a recipient of the 2005 PRIM&R Special Service award for his contributions to the organization and the human subjects protections community. Read more
This month's Research Ethics Roundup covers the latest in right-to-try, social media data access, FDA extrapolation of drug indications, return of genetic results, and a lawsuit about USDA inspections. Read more
In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning protocols were quick to give not-human subject research determinations because the application was presented as a software development project. More recently, many IRBs improperly issue exempt determinations because the application is presented as a secondary-use data project. Read more
NASEM has impaneled an impressive committee of experts to evaluate current and future uses of population descriptors in genomic research. This is going to require a deeply challenging examination—a communal reckoning, really—of how terms like race, ethnicity, and ancestry are perceived by diverse stakeholders in the genomic research community and the public at large. Read more
In April of 2020, the Bioethics Research Center at Washington University School of Medicine announced a survey, aiming to understand the ethical, regulatory, and practical barriers to conducting and overseeing COVID-19 research. Principle investigator and director of the center James DuBois, DSc, PhD, is pleased to report the results of the survey. Read more
While all IACUCs should be conducting some form of post-approval monitoring given current IACUC requirements, there is no mandate for a formal post-approval monitoring program that operates separate from other IACUC activities that are already mandated. With the change in annual review requirements, IACUCs are now able to critically examine their post-approval monitoring goals and potentially separate them from the goals of annual reviews. Read more
