This month's research ethics roundup covers scientists' problems with ClinicalTrials.gov, thoughts from the inventor of CRISPR, the FDA's "Animal Rule," and so-called "parachute science." Read more
24Aug2022
18Aug2022
While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use. Read more
11Aug2022
I am a wholehearted supporter of freedom of information laws and rules that provide insight into the workings of public institutions. There are occasions, however, when people make requests for information with a goal of frustrating effective public administration. In these cases, the aim is not accountability and transparency, but rather to use these laws to stop researchers from doing their job. I propose that the biomedical research community should ask legislators to give us the ability reject requests for public information where it is clear that requestor is making a frivolous and vexatious request. Read more
9Aug2022
In 2022, we surveyed IACUCs and Animal Resource Programs (ARPs) to learn more about changes, both temporary and permanent, to the regulated work environment for animal research oversight and laboratory animal care. At PRIMR22, we will take a deep dive into regulatory implications for remote work and oversight activities and examine the impact of recent changes to the labor market on ARPs. Read more
8Aug2022
We are finally witnessing increasing adoption of digital pathology in clinical practice. Pathologists are beginning to embrace and utilize artificial intelligence (AI) tools and ideas to augment routine pathology practice. All stakeholders in pathology need to fully understand the ethical frameworks required to develop, deploy, and maintain transparent, trustworthy, explainable, scalable, interoperable, and sustainable digital AI tools. Read more
5Aug2022
Are you excited about PRIMR22? Interested in sharing your thoughts on the conference with the rest of PRIM&R’s audience? If so, consider applying for the PRIMR22 Blog Squad! Whether you work with IRBs, IACUCs, conflict of interest programs, or any other aspect of the research ethics and oversight field, there’s a place for you. Read more