By: Wendy Tate, PSM, CIP
The February 2011 issue of Health Affairs published an article criticizing the Food and Drug Administration (FDA)’s humanitarian device exemption (HDE) for deep-brain stimulation in patients with treatment-resistant obsessive-compulsive disorder (OCD). According to Read more
By: Wendy Tate, PSM, CIP
In my world, January is metric month.
I spent last month analyzing data from the 2010 calendar year, calculating statistics, and overlaying the information with our workflow. The result: glowing data that shows we have improved our process since last year (insert cheer here).
Inevitably, when I present this data, I will get asked the following question by my director, the VP for research, my staff, and researchers: “How do we compare to our peer institutions?” [...] Read more
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