26
Jul2017

PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. In this post, Sarah Luery describes her experience as a principal investigator (PI) and master’s student submitting to the IRB, and shares tips (now as an IRB Administrator) to demystify the IRB process. Read more

21
Jul2017

PRIM&R's IBC Boot Camp, which takes place September 18-19 in Denver, CO, will provide information, tools, and guidance for IBC, IRB, and IACUC professionals to help them keep compliance intersections from turning into compliance roadblocks. Attendees will learn strategies for improving integration and communication among regulatory groups and investigators to best support research that is ethical, collaborative, and interdisciplinary. IBC personnel will have opportunities for benchmarking, sharing resources such as SOPs, and networking with colleagues in the field. Read more

18
Jul2017

Voracious Science, Vulnerable Animals is Dr. John Gluck’s account of his transformation from primate researcher to animal research ethicist. It challenges readers to consider the “voracious” pursuit of new discoveries in biomedical research, the justification for using primates and other animals in that pursuit, and the role of IACUCs in promoting ethical animal use. Read more

14
Jul2017

This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries. Read more

11
Jul2017

Recently, PRIM&R submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan. Read more

7
Jul2017

Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”? My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops. Read more

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