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

22
Jun2017

In January 2018, the new single IRB (sIRB) requirement for National Institutes of Health (NIH)-funded multi-site studies will go into effect. NIH’s goal for this mandate is to reduce administrative burden that does not actively contribute to protection of human subjects. The NIH posits that this policy will also result in opportunities for enhanced oversight by the reviewing IRB. Read more

21
Jun2017

In May, PRIM&R hosted the webinar Introduction to Research Misconduct for IACUC, IRB, and IBC Professionals. This webinar provided foundational knowledge in research misconduct for regulatory professionals who work in the human subjects protections and animal care and use fields. After the webinar, one of the presenters, Jim Kroll, PhD, responded to some of the attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand. Read more

Page 4 of 180« First...23456...102030...Last »