14
Apr2022

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

6
Apr2022

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

31
Mar2022

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

29
Mar2022

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed three AER21 sessions on implementing OHRP and FDA regulations. In each session, the presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared. Read more

22
Mar2022

Ensuring that women are represented in research studies and in science fields is an important part of advancing science and ensuring that women justly benefit from research. Research done using only male animals during preclinical trials and predominantly male subjects in human clinical trials leads to knowledge gaps that negatively impact women’s treatment and health outcomes. In recognition of women’s history month, we're highlighting some PRIM&R resources that explore the importance of considering sex as a biological variable and shifting to appropriate sex balance in research studies. Read more