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Faculty Conflicts of Interest

Some New Wrinkles on Faculty Conflicts of Interest in Research

Panel
New Wrinkles on Faculty Conflicts of Interest in Research
Paul A. Fleury, Dean of Engineering
Yale University, formerly at University of New Mexico

National Laboratory Perspective
Patricia L. Oddone, Executive Assistant to the Director
Lawrence Berkeley National Laboratory

Kumar Patel, Professor of Physics and Astronomy
University of California at Los Angeles

New Wrinkles on Faculty Conflicts of Interest in Research
by: Paul Fleury
Yale University, formerly at University of New Mexico

To set the stage for this panel discussion on faculty conflict of interest in research, I would like to emphasize the importance of this topic and why it is providing new challenges to universities. These issues will only increase in their complexity as the research engine that has fueled our technology since the Second World War will be based increasingly in research universities. The research university is a relatively new phenomenon dating back only to the early 1950s. It has proven a very wise investment intellectually, socially and economically for our country, and it is up to us to make sure that such complications arising from conflicts of interest do not jeopardize it in the future.

To begin with we must broaden the definition and understanding of issues related to conflict of interest in the conduct and support of research. The traditional theme of research ethics has centered around issues of falsification, fabrication and plagiarism, which tends to focus on individual execution and honesty of the researcher. The changing landscape for university research over the past several years has brought new complexities to the way that researchers must address ethical questions. Generally it appears that the tools required are often lacking within the university system for faculty to properly address these issues.

Much of the new challenge arises from the growing pressure for outcomes-oriented research both from funding agencies and universities themselves. This involves a thrust toward commercialization of inventions or discoveries, which involves the university, both institutionally and through individual faculty members, in the technology transfer process. Questions of intellectual property ownership, methods of rewards and incentives, etc. give rise to new aspects of faculty conflict of interest . For example, it has led to a focus on the expanded notion of "conflict of commitment" that in many instances has highlighted the difference between policies on consulting as stated in the faculty handbook on the one hand and the university's intellectual property policy on the other.

The Bayh-Dole Act of 1980 gave federally funded research inventors and their institutions rights to commercialize their advances. Together with the increasing congressional demand for accountability in research, this has expanded the focus on what I call "outcomes driven research" as an ever-larger component in the university research portfolio. Indeed, today calls for proposals not only from the mission agencies, but even from the National Science Foundation itself, often require identifying areas of likely application, industrial partners in the research and either in-kind or actual dollar matches to the federal funds supporting these grants. Consequently, the weight in the selection process to determine which projects are funded has been shifting away from scientific impact and potential for breakthrough discovery, increasingly toward potential for eventual commercial application.

As industry supported in-house research has decreased, industry has turned increasingly to universities to meet at least the front end of their R&D needs. As the United States lags behind other developed countries in its investment in civilian R&D, several studies [ including the 1997 "Endless Frontiers -Limited Resources" Report by the Council on Competitiveness] have pointed out the need to do ‘more with less' in the research and development arena. The key idea that emerges from these deliberations is that partnering is the way to go. Partnerships increasingly involve players not only from different disciplines, but from different institutions and even different types of institutions. In general, it may be a very good idea to use industry investment to help leverage taxpayer funded research, but at the same time this approach complicates the conflict of interest landscape for both faculty and students. These partnerships often involve imposition of deliverables or requirements that influence the direction of and areas in which the research is done.

Many universities are seeking additional revenues through such partnerships and through the revenues that might arise eventually from commercialization of the resulting intellectual property. Given the increased complexities of this research environment, even those faculty whose hearts are pure and whose minds are clear still find that there are too many pitfalls to navigate successfully. Consequently they face the possibility that within several years they may themselves be subjects of audits or possibly even litigation. University technology transfer offices have been formed throughout the country to manage and develop intellectual property generated by the faculty. But economics alone does not justify the magnitude of this effort. There are scarcely a dozen universities nationwide whose revenues from such activities exceed $10 million annually. Indeed, over the top 100 research universities the direct results of technology commercialization amount to only about 2 percent of their total research funding.

There are, however, other advantages such as providing avenues for faculty and students to exercise their entrepreneurial capabilities, building bridges to industry and contributing to the economic development of the region in which the university is located. While these are worthy goals of technology commercialization, unclear guidelines that presently exist in most universities for faculty behavior are causing substantial present and potential future problems. The mix of private and public funding in support of faculty research activity causes problems not only of ownership, but of potential exploitation of students and diversion of research directions into avenues which might be influenced by the prospect for financial gain on the part of the university or the faculty.

In this panel, experts from a major research university and a fundamentally oriented national laboratory will discuss these and related issues facing the university research community. We hope that the audience will participate in the discussion of the points that they raise. Let me end this preamble with a couple of suggestions for what I believe universities need to do. First they must develop a clear and fully disseminated intellectual property policy. This must contain an exploration and understanding of the consequences?many potential unintended consequences?that the policy might lead to. Second, in the case of a university affiliated technology transfer organization, the mission objective must be clearly understood by both the technology transfer group and the faculty. Whether the goal is to enhance local economic development, to maximize revenue stream for the university or to provide entrepreneurial opportunities for faculty and students, it must be made clear at the outset. Following from these general principles there should then be generated more specific rules governing the participation of faculty and even students in consulting for companies in which they may have a financial interest and for reporting potential conflicts of interest in both the case of government funded and industry funded research.

Let us now hear from our experts on the panel.

National Laboratory Perspective
by: Patricia L. Oddone
Lawrence Berkeley National Laboratory

We've heard a lot about the pressures and the rules facing researchers. I would like to focus on the responsibility of researchers funded by taxpayer dollars to spend money wisely and ethically, and what has happened in a place like the Lawrence Berkeley National Laboratory when this has not been the case. Yesterday, you heard from representatives of the Department of Energy nuclear weapons laboratories, Sandia, Livermore and Los Alamos. There are 10 other DOE national laboratories that do not work on weapons, and Berkeley is one, located on University of California land next to the Berkeley campus. We have a lot of rules and regulations, being managed by the University of California for the Department of Energy. Nevertheless, the view of our director is that right and wrong are still pretty clear. He comes from Bell Labs, as do my other two panel members, and he is troubled by what he describes as an "entitlement mentality" that comes with federal funding.

I want to describe three cases, all occurring in the past two years, to illustrate the kinds of conflicts that we deal with at Berkeley Lab. The first concerns a violation of copyright policies, the second a violation of outside business rules, and the third an example of scientific misconduct. In the first case, the Department of Energy became suspicious about a particularly successful book containing data, funded by the Department of Energy, at our lab. A researcher, who for several years had been responsible for compiling the database, had also contracted with a book publisher on the same data. Under lab policy, the copyright in such a case would be owned by the laboratory; the researcher would be entitled to 35 percent of the royalties and the laboratory would keep the rest. This is the same as for University of California policy on patents, as well as copyrights. In this case, the researcher, who was a long-time lab employee, claimed that he had created the data for the book on his own time, even though it's exactly the same thing. And, in any event, that he had been authorized by the lab to sign the contract. This was, in fact, the case for earlier editions when the book was not successful; but later, he didn't follow through.

From the start of the investigation, it was definitely adversarial. The researcher was uncooperative, refusing to supply information and speaking through an attorney. Ultimately, the laboratory did not take legal action against him because the amount of disputed royalties was smaller than we thought. There was also a statute of limitations, which meant we couldn't get royalties from back years, and there were some lab policy ambiguities that needed to be cleared up. The reaction of the researcher was one of righteous indignation and triumph. Since he got away with it, what he did was right. The lab director, nevertheless, sees it as a clear case of someone taking the government's money and profiting from it.

Okay, second example. A principal investigator hired someone to work four days at the lab and the fifth day on his personal business, which was being run out of the lab on lab equipment. Obviously, we didn't know this at the time of hiring. The subordinate barely spoke English and feared that he would lose his immigration status if he complained. Some years went by, but eventually, he did make a complaint, both because he wasn't getting proper credit for his published work and because the fifth day was really taking all weekend, a really terrible situation. It was found that the principal investigator had violated the lab's outside business policy relating to conflict of interest. He had failed to separate lab and private interests, competed with current and proposed lab projects and engaged in the outside business using lab resources and equipment. He admitted only violating the lab's patent agreement. In the end, the principal investigator was disciplined, but not fired, because of, again, various ambiguities in the rules, which made the lab's legal team cautious.

The most interesting case is the final one. The particulars may sound familiar, since the New York Times covered this story extensively. This is the case of a researcher who eventually left the lab following a finding of scientific misconduct. The hook for the press was the research area, which was out on the fringe, indicating that power lines may cause breast cancer. Originally, the scientific misconduct charge was brought by a demoralized graduate student, who thought that the data were being manipulated. It took years, literally, during which the lab carefully reviewed the charges, and found that the data were indeed being falsified. Both the Department of Energy and the National Cancer Institute had funded the research. I should add here that while the review was under way, the lab director received protests on behalf of the researcher, one from a prominent UC faculty member and another from a program manager in the Department of Energy, who controls the lab's funding, asking that we not stop funding the work.

After scientific misconduct was found, the lab reported this finding to the federal Office of Research Integrity, which conducted its own investigation and confirmed the finding. Both the lab and the ORI disciplined the researcher. The researcher entered into a "voluntary exclusion agreement" as part of his punishment, in which he neither admitted nor denied misconduct, but agreed not to seek government funds for a three-year period. This fact was released publicly and attracted press attention, particularly when the researcher himself began giving interviews on the subject because, of course, he felt vindicated. He didn't have to admit or deny to the change of misconduct; he just had to give up funding for three years.

After the New York Times reported this story, it wasn't too long before the drumbeat began about the government getting its money back. William Safire devoted a column to the subject and erroneously said that a whistle-blower had alerted the Office of Research Integrity, when, as I mentioned earlier, the lab had initiated its own investigation and forwarded the result to the ORI. In due course, the National Institutes of Health told the lab that it wanted its money back. We had to go to our contractor, the University of California, to cover legal costs, since one government agency can't sue another. The University's response? "You just ought to pay up." The amount was somewhere under one million dollars. Fortunately, the NIH dropped its request a few weeks later.

Clearly multiple conflicts of interest were present here. The researcher has rights. We had to do our scientific misconduct investigation very, very carefully. The DOE and the NIH funded the research. The press and the public want to know about research related to power lines and breast cancer, and members of Congress, along with the Secretary of Energy, want to know what's going on, too. The IG investigation affirmed everything that Berkeley Lab had done, and even criticized its own agency's lack of policies on scientific misconduct. Of course, what makes news is the fact that an investigation has been launched, not the later findings that confirm everything you have done.

A chilling recommendation from our point of view, however, was that all current management contracts, such as those between the Department of Energy and the University of California for Berkeley, Los Alamos, and Livermore, require the DOE to recover research funds when scientific misconduct is found. Think about the incentive here for proceeding with a lengthy inquiry into such charges. In short, the laboratory was rebuked--by the public, the press, the DOE, the NIH, and even the University of California I am embarrassed to say--certainly not praised, for persevering in this very complex case.

In all three cases, individuals flouted authority and got away with it. The primary recourse we have is to tighten the rules and the policies. In each of these, the director intended that our laboratory would find the truth and do the right thing, no matter what the pressures were against this. He believes that stronger punishment should have been given in all three cases.

The perception of the researcher, in these cases, was that he was entitled to use federal funds as he wished, and to profit personally or to enhance his program and reputation if he could. We have employment protections that can make it hard to establish right and wrong, which leads to the sense, in the view of people who are not ethical, that "it's ethical if you can get away with it." One certainly does not want to abrogate federally-funded individuals' rights, but these outcomes are not right either, and at Berkeley Lab, we're continuing to struggle with such issues. I look forward to the discussion to see how others might suggest that we handle them.

 

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