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

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

29
Jun2017

This week’s Research Ethics Roundup the ramifications of only using male lab mice in preclinical research, why so few lab chimpanzees have been sent to sanctuaries, Public Citizen’s letter to the Department of Health and Human Services (HHS) on new SUPPORT trial findings, and the ethics of pricing a Zika vaccine. Read more

28
Jun2017

PRIM&R's Regional Connections Program is designed to encourage research ethics professionals in a given geographic area to connect and build relationships. To that end, we offer support to individuals and institutions who would like to organize and host a Regional Connections event for their community. In this post, Kirstin Morningstar, MBA, CIP, CPIA, regulatory services director, Mary-Colette Lybrand, MS, CCRP, CIP, regulatory services manager, and Alyson Stearns, CIP, regulatory services specialist, in the Office of Research Administration at the University of Texas at Arlington share more about an innovative Regional Connections event initiated by their institution. Read more

27
Jun2017

Among scientists in the field of education, there are many who believe that all educational research, regardless of purpose, should be exempt from IRB processes and procedures. While the government did not approve education as a new category of excused research under the new proposed Common Rule that is currently slated to take effect in January 2018, there remain many areas of consideration that might be affected, including confidentiality, authentication of online participants, consent and assent, and questions around what constitutes research when conducting data collection activities in school settings. Read more

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