by Wendy Tate, PSM, CIP
By this time almost everyone is familiar with the advance notice of proposed rulemaking (ANPRM) that recommends vast changes to the human subject regulations known as the “Common Rule.” As I read the memorandum, table of changes, and 92-page document, one thing kept popping into my mind: What about the subparts?
Being “in the trenches” at a university that supports both medical and social/behavioral research, I find it frustrating to apply subpart B (research involving pregnant women) to non-biomedical research and/or minimal risk biomedical research. Granted, subpart B is not technically part of the “Common Rule,” and as such is not included in the recent ANPRM. [...] Read more
By: Wendy Tate, PSM, CIP
While everyone is talking about DHHS’s advance notice of proposed rulemaking (ANPRM), I thought I would discuss another topic on many people’s minds right now: the start of the school year.
Here at the University of Arizona, we are gearing up for the influx of students, faculty, and support staff returning from their summer vacations and ramping up their human research projects. [...] Read more
Welcome to another installment of our featured member interviews in which we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!
Today we’d like to introduce you to Sylk Sotto-Santiago, MBA, MPS, CPIA, research compliance manager/officer in the office of research and sponsored programs at the University of Denver.
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by Elizabeth White, program manager, United States Department of Energy (DOE)Active participation and input from community/unaffiliated members is critical to any institutional review board (IRB). How do we ensure that community members feel empowered and educated in order to freely express their opinions on proposed research? This was the topic of a workshop organized by the University of Southern California (USC) and the DOE in December 2010. The pre-conference program, Enhancing the Contributions of Community IRB Members, was held in conjunction with the 2010 Advanced Ethical Research Conference. It was attended by prominent individuals in the field of human subjects protections and community [...] Read more
Welcome to another featured member interview in which we continue to introduce you to PRIM&R members, a group of dedicated individuals working to advance ethical research on a daily basis. Please read on to learn more about Brenda Hayes, instructor and director, grant and proposal development at Morehouse School of Medicine and director, Community Partnership Development (COEHD).
When and why did you join the field?
I have been in health care for several decades [...] Read more