Monday, March 09, 2009

Ethics on the chopping block

[Cross posted from the Research Ethics blog] Two related stories came to my attention this week. Reading the first one, I was worried. But when I came across the second story, I thought, this needs to be talked about! In two places, both affected by the now globally worrisome economy, strict budget cuts are being made. And the first thing on the chopping block? Ethics.

The University of Tenneessee is considering closing down The Department of Human Values and Ethics in the College of Medicine along with a number of other science and medicine programs. Here's the story from the AAPR Bulletin Today: Possible University of Tennessee job cuts will draw protest.

Across the globe in New Zealand, the government will sign off on disbanding the country's Bioethics Council on Monday. The Bioethics Council was created in 2002 in response to public concern that the government was making decisions — in an ad hoc and unadvised manner — on complex and controversial biotech and genetic issues without considering the unique ethical, cultural and spiritual demographics of the country. Here is the story, from the Radio New Zealand newsfeed: Bioethics Council to be Disbanded

So what does this have to do with research ethics and ethics review boards? Well, plenty.

We should be concerned that the first cuts insitutions and governments want to make are on what they apparently consider to be highly expendable programs, like ethics. Seems to me that in perilous times, we just might need ethics a little more.

Ethics review boards, in either academic or medical settings, should be doing more than reviewing protocols, providing approvals and monitoring ongoing research in a silo somewhere, unconcerned that these kinds of cuts, as they don't name "research ethics" explicitly, have nothing to do with them. While reviewing research takes up a tremendous amount of time and energy, as I well know chairing an ethics review board myself, there is a certain amount of advocacy, outreach and education that an ethics review board must be committed to doing, on an ongoing and iterative basis.

So a few words on each of the three things I've identified here that ethics review boards should be committed to doing:

Advocacy for what? For strong ethics programs that are ideologically and financially supported by the administrators of the institution, situated logically within broader programs that have a commitment to research ethics; for fair, transparent and ethical processes in any context; and for fair treatment of not only participants — yes, that is our mandate — but also novice and experienced researchers, ethics review board members and others involved in research processes without whom researchers couldn't do their work. In these two cases, I would hope that those involved in research ethics at the University of Tennessee and from across NZ would speak out against the discontinuation of these broader ethics programs.

Outreach? Yes, outreach. Ethics review board members can do a great deal of outreach in their own departments and schools by articulating and clarifying what it is an ethics review board does, the kinds of principles upon which we base our deliberations and decisions, the challenges as well as the kinds of rewards that this work affords those who are dedicated to it and the kinds of broader values that ethics review boards, at their best, should be committed to upholding — things like autonomy of persons, voluntariness, maintaining dignity and integrity of persons and facilitating ethically sound research.

Outreach also implies making strong connections between ethics review boards, bioethicists and clinical ethicists, educators and other persons and programs within and between institutions.

Finally, education. As ethics review board members and those who are committed to research ethics in perhaps other ways, it's important, perhaps imperative, that we educate people not only about "what it is we do" but also why it's important to have people, who are concerned with ethics, hanging around. Bioethicists, clinical ethicists, research ethicists, those concerned with environmental ethics, business ethics...the list goes on. Usually most institutions don't think a great deal about these kinds of programs — and the associated dedicated people — until something goes wrong and suddenly, the institution turns to the same programs and people for help, advice and guidance. Seems that UT and NZ might not have anywhere to turn soon.

posted by Nancy Walton, Ph.D. at

1 comment:

Carl's Blog on FDA Stuff said...

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.

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.

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).

Anyway, I am happy that I discovered this blog. I will return often.

Carl from "Carl's Blog on FDA Stuff."