Friday, March 19, 2010

Biddy Martin on Basso

This is the letter sent to all UW staff regarding the Basso affair:
Subject: Statement on animal research
Date: Fri, 19 Mar 2010
From: Chancellor Biddy Martin
To: Students, faculty and staff,

Animal-based research, at UW-Madison and across the nation, raises complicated issues that are also emotionally charged. Reasonable people can disagree about the appropriateness of animal research, and we respect people's rights to make their views known.

Let me affirm once again UW-Madison's support for animal-based research, including research involving non-human primates. We base that support on its benefits to human and animal welfare, and, hence, to society at large. The university is committed to ensuring the ethical care and treatment of those animals, and is responsible for abiding by the standards and regulations set by the federal government.

As you know, UW-Madison is a large university with an enormous research enterprise. We have 530 principal investigators (research team leaders) and 6,700 individuals on campus who are certified to work with animals. Together, they perform research using 1,035 protocols (a detailed research plan). Generally speaking, the people who work with animals do their work with a strong sense of responsibility and without problems.

With the help and investment of dedicated animal caretakers, veterinarians, faculty, and staff, the university has done a very good job of overseeing animal research on our campus. Though there have been few major problems, problems do occur in an environment such as UW-Madison that is as large as many small cities. It is our responsibility to take timely and appropriate measures when they do. The details of a troubling and complicated case are being made public this week and I would like to take this opportunity to establish some context for what you will read and hear.

Federal regulations give responsibility for compliance in this area to animal care and use committees (ACUC). These are made up primarily of researchers and veterinarians with expertise in the care of animals; all committees also include at least one community member. UW-Madison has five local committees that are coordinated by an All-Campus Animal Care and Use Committee (AC ACUC). The committees report to an institutional official, a position that is mandated by federal regulation, and carries authority and responsibility for compliance. The institutional official for UW-Madison is Professor William Mellon, an associate dean of the Graduate School. The institutional official reports to the chancellor. The provost is my designee for the oversight of safety and compliance on campus.

The particular case at issue concerns a UW-Madison researcher whose work on brain function in non-human primates has been published in major international journals and whose research is widely considered among her peers to hold promise for the treatment of disorders as debilitating as Huntington's and Parkinson's disease.

The researcher, Dr. Michele Basso, has been cited by university animal care committees for a range of problems over a five-and-a-half-year period. Despite repeated efforts and an unambiguous warning by the School of Medicine and Public Health's (SMPH) ACUC, problems recurred. When the SMPH ACUC reached an impasse in its efforts to make a decision about problems that arose in 2008, the case was taken to the All-Campus ACUC. Her privileges to conduct animal research and her research protocols were suspended by that committee on Feb. 13, 2009. The AC ACUC decided that a move to different facilities with significantly more oversight by veterinary staff should be a condition of reinstatement, as should the researcher's commitment to correcting the problems the committee attributed to her. The suspension of a principal investigator's privileges or protocol is unusual, and can be damaging not only to the research, but also to the career of the investigator. In this instance, the decision reflected the committee's effort to maintain ethical animal care and safety.

There is a dispute about whether or not Dr. Basso had sufficient information to respond effectively to the offenses for which she was suspended. She has also raised questions about the university's timely reporting of the offenses to the appropriate federal agencies. These issues remain in dispute. From my perspective, the changes made recently by the AC ACUC in the location and oversight of Dr. Basso's work should have been made earlier, but I arrive at that view from reviewing records of actions taken prior to my arrival.

Dr. Basso has argued that many of the problems in her research program were the result of inadequate veterinary care and facilities. I cannot speak authoritatively about conditions in the past or judge whether or not they affected the negative outcomes for Dr. Basso's animals. I can report that in 2004, former Chancellor John Wiley authorized the addition of significantly more veterinarians on campus, and called for greater coordination and centralization of veterinary care for research animals. The record shows that questions about responsibility for the negative outcomes in Dr. Basso's program were matters of lengthy deliberation and debate for the animal care committees. Let me emphasize again that Dr. Basso's research is sophisticated, complicated, and carries inevitable risks. In many cases of the animal deaths, committees identified multiple factors. In some cases, the committees were able to assign responsibility to factors unrelated to the work of the researcher, and in at least a couple of cases, the committees hold Dr. Basso primarily responsible.

In the summer and fall of 2009, Dr. Basso requested an independent investigation of her case, a request that Provost DeLuca declined because the federal government grants authority for decisions about research protocols and privileges to ACUCs. In this case, the AC ACUC's work on the matter was ongoing.

Last week, the AC ACUC voted to reinstate Dr. Basso's protocols, approving them on condition of fundamental changes in the extent of oversight and monitoring of Dr. Basso's research program. Every experiment will be conducted under the supervision of veterinarians. All decisions regarding the health and medical care of animals will be made by the veterinary staff. The attending veterinarian will report to the relevant animal care committee on the activity and the outcomes of Dr. Basso's research on a monthly basis, or more frequently if needed. I have been assured by the attending veterinarian for Dr. Basso's research program that there is no room for non-compliance under these conditions. Given Dr. Basso's own belief that inadequate veterinary care and facilities accounted for her problems, these changes appear to respond to perspectives on both sides of the issue. Should any problems of non-cooperation or non-compliance arise, I expect that the committee will take even stronger action.

Many of you will remember hearing or reading about the December 2009 USDA visit and report, which cited several problems in what was deemed to be a generally successful animal research program. At the time of its release, I convened a group of campus officials with whom I could discuss the report and its implications. Based on that discussion, I decided to examine in detail the entire record outlining the problems in Dr. Basso's research between 2003-2008. What I found in those records led me to ask an outside consultant to visit campus for a review of the structure and the decision-making processes of the animal care and use committees. I wanted to know from an impartial outside expert whether or not our processes were appropriate. Dr. James Fox, a noted veterinarian and director of comparative medicine at MIT, submitted his report in late January. In neither his oral nor written reports did Dr. Fox give me a reason to second-guess the overall work of the AC ACUC. As was true of the USDA report, Dr. Fox's report identifies some weaknesses in specific areas and makes recommendations for change. Last month, I gave Eric Sandgren, director of the campus animal program, and William Mellon, the institutional official, a copy of Dr. Fox's report. I asked them to work on a plan to implement changes that would improve animal care oversight. They are working under the supervision of Provost DeLuca and any resulting recommendations will be included in the changes we make to the research enterprise.

Let me end by reiterating what I said at the beginning of this statement. This is a troubling and complicated case. It will elicit strong feelings about a range of issues, if my own personal reaction is any guide. Though personal feelings are important, and can inform the views we ultimately take, my job as chancellor requires that I consider all the relevant information, complexities, and the broader context and let the deliberations of experts shape my understanding and decision making. In fact, I believe every one of us has a responsibility to educate ourselves about the complexities of the issues that concern us and to think things through carefully and thoroughly, drawing on relevant expertise. What matters at the university, is that we make good on our commitments to the ethical treatment of research animals and to the importance of independent research, not only or even primarily for the sake of individual investigators, but also for the good of society as a whole. Universities are the only institutions charged specifically with ensuring freedom of inquiry and independent research.

For more than 100 years, UW-Madison has engaged in critical and groundbreaking studies of human and animal health and well being through the use of animal models. Key findings, such as the discovery of vitamins; Warfarin; methods for extending the shelf life of donated organs for transplant; and clues to the etiology, progression and treatment of diseases such as cancer and AIDS, among others; have emerged and continue to emerge from the laboratories of our university. There is no doubt that this work is vital and our best hope for improving human and animal health. Many lives have been saved and the quality of all our lives has been improved through research using animal models.

In return for the freedom to pursue independent research, universities must be able to assure the public that freedom is coupled with responsibility. My observations since my arrival suggest that the system of accountability for research compliance and safety on campus, which has improved over time, and is certainly not broken, is still not where it needs to be. Getting it there is a goal for which I take responsibility and one I will continue to pursue aggressively.

Biddy Martin

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