Doorsteps we’ve crossed in 2009

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When your mission is to advance ethical research, it’s of tantamount importance to know that one’s work doesn’t exist in a bubble. Research—from the bud of an idea to a full-grown harvest of results—has widespread effects on those conducting it, those who review protocols, the communities who participate, and science at large.

"People conducting research [...] Read more


OHRP has posted clarifying language on its website regarding OHRP-approved assurances and OHRP-registered Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs). Regarding registered IRBs, the fact that an IRB or an IEC is registered with OHRP does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46, and does not mean that the IRB or IEC has the appropriate competence or expertise to review a particular research project.

Regarding approved assurances, the fact that OHRP has approved an institution's assurance does not mean that OHRP has determined that the institution is complying with the requirements [...] Read more


Posted on the IRB Forum
March 1, 2009

To our colleagues in bioethics:

We need your help. We need you to write letters, and we need it fast.

Here at the University of Tennessee medical school, the Dean has informed us that he intends to eliminate our entire department. Last summer he informed our chair, Dr. Terry Ackerman, that he wanted to do this, and now the machinery to effect his plan is in motion.

Earlier today the UT Board of Trustees approved a revised policy for "discontinuing academic units," thereby activating the process in earnest.

A final decision about us will ultimately require the approval of the Chancellor [...] Read more


By Andrew Olmstead, director, member services and development, IRBNet

IRBNet, a frequent exhibitor at PRIM&R’s conferences, recently talked with Dr. Greg Koski about his views on critical issues IRBs face today. We have excerpted the beginning of their discussion here, but you can read the complete version by downloading the PDF at the bottom of the post. Please note that the inclusion of this article should not be construed as PRIM&R's endorsement of IRBNet or IRBNet's product.<[...] Read more


January Webinar Recap

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Posted by Anne Meade, web and distance education coordinator

On Thursday, January 29, 2009, PRIM&R held a webinar titled Refocusing on IRB’s Crucial Issues: New Year, New Lens. This 90-minute session was presented by Bruce Gordon, MD, chairman of the IRB and professor of Pediatrics at University of Nebraska Medical Center, and Moira Keane, MA, director of the University of Minnesota Research Subjects’ Protection Programs. Ms. Keane and Dr. Gordon presented information on how to take advantage of the flexibility provided in the federal regulations for managing human subjects research programs while maintaining the highest ethical and regulatory standards.

PRIM&[...] Read more