Wednesday, November 10, 2010

Symposium Addresses Ethics

Symposium Addresses Ethics, Standards, Beneficiaries of Research

Madison, Wisconsin - Drawing on issues raised by this year's Go Big Read selection, a fall symposium at the University of Wisconsin-Madison will address responsible conduct and ethical decision-making in research.

The Integrating Research Ethics and Scholarship (IRES) is an initiative, sponsored by the Graduate School, that offers both novice and seasoned researchers and scholars educational opportunities and resources that reflect best practices in ethics education and scholarly integrity.


A public evening session, "Who Decides and Who Profits: Research at UW-Madison," will feature a panel discussion about the decision-making and administrative processes behind campus research. The panel will include a mix of researchers, research administrators and deans.

"We are hoping to put an open, public face on how we, as an institution and as individuals, go about the process of research," says William Mellon, professor of pharmacy and associate dean for research policy, who will moderate the discussion. "In general, researchers are interested in producing results that will benefit people. Most researchers are motivated by making a difference."

Discussion topics will include the costs and benefits of research, research oversight and infrastructure at UW-Madison, how the public can influence the research agenda, how federal and state money is spent and why basic science research is done.

"To the general public, the nature of how research gets done - the organization and administration - is not transparent and so complex. There are many misconceptions," says horticulture professor Irwin Goldman, one of the panel members.

I attended the evening panel discussion held on November 4, 2010. The event was video-recorded; when it becomes available, I’ll link to it here.

The moderator was William Mellon, the Associate Dean for Research Policy. The participants were Susan Ellis Weismer, Associate Dean in the College of Letters and Science, Professor, Communicative Disorders; Sharon Dunwoody, Interim Associate Dean for Graduate Education, Evjue-Bascom Professor of Journalism and Mass Communication; Eric Sandgren, Director, Research Animal Resources Center, Associate Professor, Experimental Pathology; Nichelle Cobb, Director of the Health Sciences Institutional Review Board; Richard Moss, Senior Associate Dean for Basic Research, Biotechnology, and Graduate Studies, School of Medicine and Public Health, Professor of Physiology; Irwin Goldman, Professor of Horticulture; and Jill Sakai, University Communications.

The event was interesting in a geeky sort of way though it did not answer the questions posed in the advertising. I enjoyed it and came away with some new insight. One thing that struck me was the gigantic chasm between oversight of human-based research and animal-based research.

The event grew out of the university’s Go Big Read campus-wide book circle’s first selection (a play on the university’s Go Big Red athletic slogan): The Immortal Life of Henrietta Lacks, by Rebecca Skloot.

Before, via email, and during the panel discussion, the audience was invited to submit questions. These were vetted and edited by Associate Dean Mellon, and no follow-up was allowed.

Nichelle Cobb, Director of the Health Sciences Institutional Review Board, the committee responsible for oversight of human-based experiments answered questions read by Mellon concerning human experimentation. She said that even the use of tissue left over from surgery is highly regulated, and that informed consent is expected and required in certain cases.

It is apparently common and accepted practice in hospital admissions to include a generic approval clause in the fine print granting permission for the use of incidental tissue residues. These tissues are apparently not associated with a patient’s identity and apparently may be used generically in research. On the other hand, if a researcher has a specific desire for certain types of tissues from certain patients, then informed consent is required, and if there is a profit motive behind the collection of specific tissues, then the request, according to Cobb, would be almost certainly denied.

This sensitivity to the use of leftovers from surgery on humans is at distinct odds with the de facto rubber-stamping of nearly any requested use of whole live animals. Yet we hear repeatedly by industry spokespersons and other vested parties that the oversight of experiments on animals is more stringent than oversight of experiments on humans. For instance:

The U.S. Department of Agriculture has set rigorous standards for the use of animals in research that are more stringent than those used for human studies. Our Commitment to Ethical Animal Care and Use. (p 7) Johnson and Johnson
I had not previously looked into these claims and had merely assumed that they were false, but as a result of the panel discussion, I did a little research. I can say now, and support it with evidence, that such a claim – that animal-based research is more highly regulated than human-based research is absolutely ludicrous. I imagine that those who make such claims are either repeating falsehoods they’ve heard or else are making them up themselves.

I submitted two questions to the panel, neither of which was asked fairly by Mellon.

The first one had to do with the ever-growing body of research demonstrating through meta-analyses and retrospective reviews that clinical care of human patients is not being appreciatively improved as a result of basic biomedical research using animals.

When a protocol comes before an Animal Care and Use Committee for approval, there is a near certainty that the research results will provide no new knowledge that will lead to an improvement of human patient care. [See for example, Lindl T, Völkel M & Kolar R. 2005 and 2006.] Yet the public is told that the oversight committees weight the costs to the animals against the potential benefits to humans. But the costs to the animals are a lifetime of being caged in bleak tight confinement, often-serious discomfort, stress, and almost always death, and the benefits to humans are nil.

Thus, in every approved project, and generally all projects are approved, the ethical weighing that occurs is this: no likely benefit to humans vs. certain suffering and death to the animal = an approved project.

How could an informed honest person argue that this system is ethical?

One of the panelists, Irwin Goldman, Professor of Horticulture, was a spokesperson in the university’s strong efforts to host the Department of Homeland Security and USDA jointly sponsored BSL-4 laboratory, the National Bio and Agro-Defense Facility (NBAF).

The university argued vigorously that the NBAF would be perfectly safe and should be built in the Town of Dunn, a few miles from Madison, and successfully cajoled some local politicians to get behind their effort. [See my essays: "regrettable consequences" July 30, 2009; UW Experts Dead Wrong, again. July 28, 2009; Are UW Vivisectors Anti-Knowledge? June 8, 2007. NBAF Fiasco Reveals Idiocy of UW Decision-Makers. May 10, 2007; Wanna buy a bridge? March 12, 2007.]

But the Government Accounting Office reported in 2009 that the lab would pose unnecessary risks if it were built anywhere on the mainland. The GAO reported that the Department of Homeland Security’s analysis of the risks was flawed in a multitude of ways. See: Observations on DHS’s Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island. United States Government Accountability Office. Report to Congressional Committees. 2009.

So I asked whether it was ethical for the university to ask the Department of Homeland Security to build the facility here and to tell the public that there was no appreciable risk, without first seeking an analysis of the risks from experts at the university?

Apparently the university had conducted no independent analysis of the risks; instead, they merely argued that the facility would be an economic boon to the community and that any concern over safety was mere hand wringing by uniformed or misinformed Luddites. Mellon twisted this question, like my question about the ethical weighing of costs and benefits of experiments on animals, into something nearly unrecognizable.

There was no discussion with the audience. There were no follow up questions.

A couple interesting tidbits:

Associate Dean Mellon started out by saying that the panel, or maybe IRES, was: “[O]ur initial foray into this area.” Public discussion about ethics is apparently a new idea at the university.

Mellon “read” a question that asked what the university was doing to counter the negative press about its use of animals. There was much hemming and hawing, but Jill Sakai of University Communications said she was aware that a recent telephone opinion poll by a group named CURES or C.U.R.E.S. or something like that, there was no opportunity for follow-up questions, had found great support for university research.

As far as I can tell, there isn’t an organization by this name. I contacted Ms. Sakai (twice) and asked her for a reference or a link, or any information whatsoever she might have about this survey, but she said she knew nothing, had nothing, and could point to nothing about it. This seems odd to me given her significant “knowledge” of it at the panel.

Associate Dean Mellon had told me in an email that the panel would not address animal research, but of course, with two vivisectors (Moss and Sandgren) on the panel, it did. Mellon also told the audience that the university is planning a series of “forums” specifically addressing the use of animals. The “forums” were proposed by the university as part of their successful efforts to defeat Dane County Resolution 35, though Mellon didn’t mention that. As of this writing, as far as I am aware, the “forums” planning committee has met only once. If the IRES symposium can be used as a indication of the substance and value of these promised “forums,” they may be more form than substance.

P.S. and a little aside: I recently participated in a genuine forum with actual discussion with the audience at the First Unitarian Society of Madison, Wisconsin. One of the other two panelists was Eric Sandgren. You can watch it here. Sandgren told the audience [beginning at about 16:08 and then again at 1:10;15] that he had opposed Resolution 35 because it had a fatal flaw, the committee proposed by the Resolution created would decide for the County whether experiments on monkeys are ethical. The actual text reads:
BE IT FURTHER RESOLVED that the Panel’s “Final Report” will include a recommendation to the Dane County Board of Supervisors either to officially endorse or officially oppose experimenting on monkeys in Dane County.
Eric may need some reading remediation. He should look up the meaning of recommendation.


Eric Sandgren said...

Hi Rick,

You seem to be confused. Here is text from the Resolution:

BE IT FURTHER RESOLVED that the Citizens Advisory Panel will ...

• Solicit information and opinions from the experts to help answer these questions: ...

o Is experimenting on monkeys ethical? ...

• Write a report documenting and explaining the Panel’s conclusions....

As stated in the resolution, and as claimed by me, the committee was charged with answering the question "Is experimenting on monkeys ethical?"

Eric Sandgren

Rick Bogle said...

Yes, the people on the panel were to try and form an opinion and to report their opinions and reasons for them back to the County Board. They were not charged with making a decision for the Board -- which seemed to be what you implied was their role -- and was why you said you opposed it.