tag:blogger.com,1999:blog-12625691.post8969947329745259428..comments2024-02-29T01:43:23.900-05:00Comments on Women's Bioethics Blog: Ethics on the chopping blockLinda MacDonald Glennhttp://www.blogger.com/profile/02378544626277000243noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-12625691.post-60707719755958325422009-03-14T22:29:00.000-04:002009-03-14T22:29:00.000-04:00This post raises some serious concerns. The propos...This post raises some serious concerns. The proposed cutbacks at the University of Tennessee are an example of the economy's downturn causing spending reductions in all the wrong places. The Department of Human Values and Ethics should be expanded, not eliminated.<BR/><BR/>I am also concerned that the post does not mention the fact that "ethics review boards" have a name in this country, "Institutional Review Boards" or IRBs. There are serious problems with government oversight of IRBs including conflicting regulations and outdated oversight. Both the Department of Health and Human Services and the Food and Drug Administration regulate IRBs. They both do it differently and they both do not do a very good job.<BR/><BR/>I agree that IRBs should do more than review protocols and informed consent forms. However, IRBs have limited resources and no clear guidance from the government agencies that oversee them. As a former FDA inspector I conducted about 50 inspections of IRBs. I found as many problems with FDA oversight as I did with IRBs following the regulations. If IRBs are going to be effective there needs to be clear rules that IRBs should follow. And I'm not quite sure who should be making the rules. Perhaps this is one area that should be outside of FDA's jurisdiction (IRBs are the only FDA regulated area that doesn't apply to a specific product).<BR/><BR/>Anyway, I am happy that I discovered this blog. I will return often.<BR/><BR/>Carl from "Carl's Blog on FDA Stuff."Anonymousnoreply@blogger.com