9UNP0131SD_Warren Gilson _WordPress

- Good evening, and thank you for joining us. My name is Laura Heisler. I'm an intellectual property manager at the Wisconsin Alumni Research Foundation, and also program developer for the Morgridge Institute for Research. It is a pleasure to be involved in the Gilson Seminar Series. This series was launched in 2004, following a gift from the late Dr. Warren Gilson. Warren Gilson played a strong role in the Madison business community and the UW campus. As a UW Medical School alumnus and faculty member, he was a prolific inventor of medical electronics and instruments. Dr. 

Gilson was also an entrepreneur and founded a company that grew into today's Gilson, Inc., a leading manufacturer of analytical instruments, headquartered in Madison. 

In 2002, Dr. Gilson left WARF a significant gift intended to promote the exchange of ideas between the university and the Madison business community. He often recollected that as a young entrepreneur, he valued the regular and informal conversations he was able to have with a wide range of colleagues in the cafeteria of the university's hospital. It is in the spirit of creating connections and dialogue between the university and the business community that we host these sessions to encourage entrepreneurship and interdisciplinary collaboration and dialogue. 

I'd like to start by welcoming two very special guests, and embarrassing them. Dr. Gilson's son, Bob, and his daughter, Molly, who are joining us this evening. And who often attend these events. 

Thank you for joining us this evening. We hope they feel their father would have enjoyed and appreciated these events in his honor. 

This evening's topic has garnered a large degree of interest among local reporters, who told us they planned to attend. And in case you're wondering about the cameras in the back of the room, hi, mom, tonight's program is being filmed by Wisconsin Public Television. 

Our panel discussion this evening is titled, "Conflict of Interest: When Faculty Start Their Own Companies." We're fortunate to have with us a group of UW-Madison panelists with experience on all sides of this important issue. Before I introduce this panel, though, I'd like to take a moment to provide some context for tonight's topic. 

And to do that, I want to show just a couple of slides to give you a flavor for the situation that we're talking about. These figures come from the Association of University Technology Managers, and cover the ten-year period between 1996 and 2005. These tabulate the number of start-up companies, per year, created nationally coming out of universities. 

It's a dramatic tendency to see that numbers have more than doubled in the period between 1996 and 2005. This doesn't even begin to capture what's been going on in the past few years. When you think about this, you think of hundreds of faculty members who have wanted to start companies based on their own technologies, all the while continuing to act as university professors. We'll think about that more as we go through this evening. 

Let's take a look at another statistic. This is a beautiful graphic done by someone at UC-Davis, and has actually captured, this is all the high-tech companies in the Madison area. Not all of them started by UW faculty, but many of them. In fact, the ones with the dark lines going through them, those all indicate University of Wisconsin start-ups. And you can see, very fittingly, it's hard to see very much on this, but very fittingly in the middle, I'll try and point this out. Right here, Gilson, Inc., 

1957. Very appropriate for this evening's presentation. 

And you can also see that these technology companies span the gamut and have continued to do that over the decades. Each concentric line indicates another decade. They span the gamut from life science technologies, to physical science technologies, to engineering and information technology. And that trend has continued. If we zero in a little bit more on specifically, faculty-driven start-ups, just taking an eye on the ones that really come from technologies that started on the UW campus, you can see that the trend also here has done nothing but go in one direction, which is up. And you can see also that the number of faculty that are actually starting companies based on licensing their own technologies back from WARF has dramatically increased in the past 20 years. And we'll be talking about that with some of our panelists tonight. 

But think about it. 

This is here, in this graphic alone, it's over 100 University of Wisconsin professors who have started companies all the while continuing to run labs, mentor students, receive federal grants, teach courses. And during that time, they're having involvement in their companies, some of them being inventors on patents that belong to the companies, serving on scientific advisory boards, attending lab meetings at companies. How are they doing this? And that's the subject of tonight's panel. 

So with us, I think we have all the key people that we need. To my left, Kathy Irwin, Distinguished Counsel at the University of Wisconsin. She has been at UW since 1983. Kathy is a multiple graduate of UW-Madison. And prior to coming to Wisconsin in the position she has now, she worked at the Wisconsin Legislature. Kathy specializes in research grants, contracts, intellectual property law, conflict of interest, and scientific misconduct regulations. 

Welcome, Kathy. 

Next to Kathy, and her partner in the dynamic duo of conflict of interest management at the UW is Professor Brian Fox, who is the chair of the UW Conflict of Interest Committee. He is also a Marvin Johnson professor of biochemistry at UW-Madison. And notably, he is a lead investigator at the UW Center for Eukaryotic Structural Genetics. 

And then we have our two faculty entrepreneur representatives. Professor Jim Dahlberg, Emeritus Professor of Biomolecular Chemistry. He has received numerous awards, including membership in the National Academy of Sciences. Jim is a pioneer in a number of molecular studies involving the health of cells. And his work has shown how molecules are transported in and out of nuclei, and how cells follow genetic instructions. Jim is an author of more than 130 peer reviewed articles, and an inventor on more than 25 issued U.S. patents, many of them owned by a company that he helped found, Third Wave Technologies. 

And Jim is going to tell us about some of his seminal activities in getting conflict of interest activities going at UW-Madison. 

And finally, we have Nick Abbott, who's Sobota Professor of Chemical and Biological Engineering at UW. Nick received his Bachelor's of Engineering from the University of Adelaide, in Australia, and his PhD in Chemical Engineering from MIT. He then went to Harvard before going to UC-Davis as an assistant professor, and has been at UW since 1998. Nick's research focuses on looking at investigations involving cellular interactions at interfaces, particularly involving a liquid crystal, a matrix. He is the co-founder of Platypus Technologies, and is also a prolific inventor and collaborator on campus. 

So I think we're going to get things started by having Kathy and Brian give us an overview of the substance of the issues surrounding conflict of interest at UW, what governs them and how the university manages those conflicts. We'll then move into hearing from our faculty entrepreneurs, and how they've managed in their own experience to deal with conflict of interest. Then we'll open it up for questions from you. 
- Kathleen Irwin: Excuse me, can everybody hear me? 

Great. As Laurie indicated, I'm Kathy Irwin. And I've been doing conflict of interest for more years than I would like to admit to. And frankly, I think the only reason I'm doing it is that when the first one walked in the door, I was so young and green I wasn't smart enough to jump out of the window, like all the other attorneys in our office. So I have become, "the conflict of interest expert." I can tell you that it is probably one of the more difficult areas to deal with in terms of the law because there isn't any real surety. I'd also like to say that in the time that I've been doing this here at the university, I've seen a definite, just astronomical growth, I think, in the university's understanding of conflicts, why they're good, and how to manage them. 

So hopefully, when you hear Jim talk about some of the early days, I can tell you that I think we have come a far piece. Faculty start-ups, almost by definition, create a conflict of interest. And there were times when, frankly, the university didn't know how to deal with them. 

We kind of made up the rules as we went along. One of the things that I specifically remember was a very, very fine young professor in the College of Engineering, as a matter of fact, who concluded that he could not remain at the university and take technology that he felt very strongly should be commercialized out, because at that time, in the early stages, we really didn't have a method for managing the conflict that occurs when you have a faculty entrepreneur. That was a terrible waste of a really good young professor. I can remember it made a very deep impression on me that we really needed to figure out some way so that we could allow the commercialization, the entrepreneurship that needs to occur, to drive, essentially, our technology out into the real world. In order to do that, we have to figure out some way to allow that to happen without saying to faculty, well, here's your choice. You can either go out or you can stay in. 

The area with conflict of interest, and one of the reasons that it's really difficult to deal with is that it sets up a tension between two very important, but very competing policies. The university has, for a long time, encouraged outside activity. One of the near and dear held concepts is the Wisconsin Idea, which says that the boundaries of the university should be the boundaries of the state. And I think, nowadays, you could say the nation, the world, and for certain places, the universe. 

So that's a very real and important mission of the university, to encourage this outside activity. And yet, at the same time, it's clear that the primary responsibility of faculty and staff has to remain to their university duties. I gave some thought as to why there was all the concern about conflict of interest and managing it. 

I think one of the things that struck me is that it's important to maintain the public confidence in the objectivity of our research. University research in the U.S., has probably received an unprecedented support from our government. And part of that reason is because university research is seen as objective and untainted by outside commercial pressures. And I think that's something we really have to continue to strive to maintain, the confidence, if you will, of the public in the fact that the university and its faculty can manage these potential conflicts. 

I think there's also a concept that over the prudent use and management of university assets, including its employees. And whether we like it or not, I think in general, the public thinks at a public institution like Wisconsin, that all university activity is taxpayer supported. I think there's some of us that would say, "wish that it were." 

Then you guys could quit writing all those grants. But the fact remains, you know, that it is not all supported by public taxpayer dollars, at least, Wisconsin taxpayer dollars. But I think that there is that perception. I think it's also true that in general, public employees are expected to maintain a higher standard, sort of like Caesar's wife. You have to be above reproach, and to avoid even the appearance of impropriety. 

I think when Brian talks to you, one of the things you're going to hear is that in a lot of cases, it's not just that there is truly a conflict. It's managing so that even the appearance of a conflict is not there. 

Applicable law in Wisconsin, I'm not going to bore you with it. If anybody is really interested in it, feel free to ask some questions. But there's state and federal provisions. 

There's both Wisconsin provisions and then there's also some at the federal level. They have some similarities in that they both require annual reports, that's that thing you get to fill out in April. We've tried to make that a little easier by going to an online system. I hope most of you find that easier. And then it requires updating if there's change. 

The federal regulations came about from NIH and NSF, our two major funding agencies here at the university, in response to some somewhat unfortunate press that conflicts had received on the east coast. And so they came out with some regulations that are a term and condition, essentially, of receiving a federal grant. And that's where we put most of our nickel. 

It applies to principal investigators and others with substantial research responsibilities. And it looks at what's known as significant financial interests of the PI or his or her spouse, or dependent children that would reasonably appear to affect the proposed research. 

A significant financial interest, which is one of the key terms, can include any sort of compensation. This would be primarily consulting, but also includes any equity interest. And virtually all faculty start-ups end up with some sort of equity or ownership interest. 

With that, I'm going to turn it over to my cohort in crime, Brian Fox, who has been a member of the Conflict of Interest Committee for as long as I've been on it, and has now been coerced into taking over as the chair. And he's a wonderful chair. 
- Brian Fox: Thank you, Kathy. I started involvement with this committee before I was promoted from assistant professor to associate. And a dear friend dean of mine asked me, "How would you like to be on this committee?" That was sort of a conflict situation right there. 
(laughter)

 So I've been involved with this now since 1998. It's been a very intellectually challenging activity. I would say I see some people in the audience that I never would have met, had I not been involved in this. And my life has been greatly enriched by that. I've been challenged, always, with the kind of creativity that's here in Wisconsin, and this desire to create and move things into the public sector. This is about how the UW has arranged to deal with this, given the federal and state regulations that are in place now for dealing with financial conflict. 

So these will be some definitions that we've worked out in this UW committee process over the years. What is a potential conflict of interest? We consider that a potential conflict of interest exists when this investigator has some significant financial interest that might lead an independent observer to question whether the design of that research, the conduct, or the reporting, might be in some way influenced by the possibility of a personal gain, either to that individual or to their immediate family. So this is the operational definition that we use to try to evaluate it. 

The university's perspective, as Kathy mentioned, is that we encourage faculty and staff to be involved in this, to engage in outside activity, to interact with the public in the state; to share our expertise; and to transfer intellectual property through WARF to the private sector whenever possible. This is part of the culture that attracts many of us to come here and be faculty at this university. So the university acknowledges, then, that conflicts of interest are common, and they frequently are unavoidable as you move forward into this complex playing field. We also acknowledge that conflicts of interest are not inherently bad. 

There are a number of policies at UW that govern COI. The first one is our UWS8. This is Chapter 8 of the UW System Board of Regents rules of policy that has been developed over quite some time. I think this is probably quite old. I think it was in the '70s that it was developed. It applies to faculty and academic staff. 

So there's also, now as you heard, there are requirements for investigators that have federal funding. Then there are also concerns about investigators that are engaged in human subjects research. So these are the three, kind of layers of evaluation that we try to take for faculty activities with outside financial activities. 

So in order to make some sense of this, let me give you the scope of what we do at the UW. There are about 9,000 people at the UW who need to file an annual outside activities report. This is the scope of the initial problem going in. Our Regents' rule is that everybody gets notified about April 1, by the chancellor, that you need to file this annual report. Then by April 30, the reports are all supposed to be filed. And we're actually getting to the point where we have very high compliance rate, 85% or 90%, within a month. In many colleges on campus, we're approaching the 98% or 99% response level. 

With this massive amount of information, we've needed ways to sort through and identify the individuals that really need to have more attention to manage their conflicts. So we've assigned a series of financial thresholds. They're summarized here. One is that any compensation for an outside activity in excess of $10,000 in a single year, or an equity interest that exceeds that $10,000, or 5% ownership in a publicly held entity. We recognize that any interest in a privately held entity has inherent risk for conflict. And this also represents the many faculty start-ups that are occurring at the UW. Then any leadership position, member of a board of directors in a company are thresholds that signal to our committee that we need to have further examination. 

And so the university's obligations, both through the Regents' actions and through federal regulations say that we need to maintain a list of individuals whose outside activities satisfy these defined criteria. This is some data acquisition phase. We need to determine whether these activities represent a potential or actual conflict. 

This is an assessment phase, and this is the major work of this faculty committee. And then if conflicts exist, we work with the individual to manage or eliminate the sources of the conflict. 

When we've gone to this stage, the committee makes recommendations in the form of a management plan. And then we depend very heavily on the administration of the college where the faculty member is from to help execute these management plans. 

Some of the individual obligations in these management plans are that you need to complete and submit an annual outside activities disclosure. Faculty need to revise it if circumstances change. So this is obviously a very dynamic process. You may not have a start-up company on April 30, but you certainly may have one on October 15. So as part of this dynamic updating, we need to be made aware of activities. That would also include new relationships, new consulting activity, significant changes in research activities that are related to existing financial conflicts. 

So just to summarize, the general requirements of management plans. A large part of the way that we try to manage conflict of interest is through the mechanism of disclosure. This includes discussion with students and staff about the role or the participation that a faculty member has in an outside activity. It also needs to include discussion with co-investigators, co-PIs on grants, especially where data, where experiments are being planned, or data is being evaluated that relate to this outside conflict. 

The principle I think that we hope applies here is that by allowing people to be aware of the full set of assumptions going in from everyone, which may include participating in a company that wants to commercialize something based on an experimental result. Letting everybody know and be aware of that helps to let everyone make their own decisions. Okay, what else? 

Disclosure. Disclosure, disclosure disclosure. We need to have updates. 

When UW facilities are going to be used, we need to have facilities use agreements to address some state statutes about the use of public property toward the benefit of an individual. We request that if purchases are going to be made from companies that these are negotiated by an outside party, so that there isn't some question of whether or not some federal grant monies might be used to purchase at a special price that benefits the organization. 

We also, as faculty, we like to have an annual review of this management plan with the chair, because each faculty member, then, exists within a departmental culture where there are other activities that are representative of the kinds of things that faculty do, teaching, service on committees, others, that these outside activities need to be integrated into the whole package. 

A couple of unacceptable conflicts. Restrictions on publications. We're a public university. We don't do secret research. That's something that you should, as a faculty member, you should really not ever think about going into. Failure to disclose conflicts when it's reasonably possible. This goes against the core principle that we have of how we try to begin to manage conflict. 

Disclosure. Uncompensated use of university's resources. Thesis research that's not leading to original or meritorious research. This is to protect the rights of students as they work in laboratories to do meritorious dissertation research. Investigators that are involved in assessing the efficacy of their own or competitor's products. This very obviously sets up conflicts. Investigators directing purchasing. 

So what should investigators do? We want them to become aware of COI issues. We're trying to train. 

We're learning as well. This has been an ongoing process. Adhere to institutional policies. Disclose these relationships. Consider COI implications. And as we gain more understanding about what these are and how we may manage them, I hope that investigators will be able to make better choices early on as they go into these kind of situations. Then seek advice and assistance. Kathy is always here to give advice. I'm certainly available by email or telephone at any time. There's additional information available at the grad school. 

I think that will finish up. 
- Heisler: Thank you, Brian. I think now we'll move to hearing from our two faculty entrepreneur representatives. First, Jim Dahlberg, who was at the forefront of this whole question when he helped found Third Wave Technologies in 1993. So we've asked Jim to share some of his experiences as he navigated these waters almost, well, 15 years ago. 
- Jim Dahlberg: Laura asked me to give you a little bit of history. When we started Third Wave, which was in the early 1990s, the company, Third Wave Technologies, here in Madison was founded by Lloyd Smith, Lance Fors, and myself. It was focused around a development that had been, a discovery that had been made in my lab by two very capable investigators, Victor Lyamichev and Mary Ann Brow. We discovered a particular enzymatic activity. The details aren't important here. 

But it was something we could see had a lot of utility in the analysis of nucleic acids, either RNA or DNA, to learn about their structure, their sequence, and so forth. 

Since this was work that was done in my lab, supported by NIH, I took the invention to WARF. WARF patented it. And that was it. We've been very happy with that patent. But we also wanted to continue doing research on this project, because it was obviously very interesting, the reason that we had started in the first place. So we were sort of caught in a bind. Because on the one hand, we wanted to do a lot of basic research in the lab. But on the other hand, I could see that there was a lot of potential for developing this invention into something that could be used as a diagnostic tool. So that sort of made me consider the ins and outs of what should I be doing. 

At that point, I linked up with my two co-founders of Third Wave, Lloyd and Lance. And we did start Third Wave Technologies off-campus. It was a different location, initially, on Fish Hatchery Road. Then out at the university science park. Basically, all of the development, the applicational research was done out at Third Wave. I really didn't feel I was in a position to ask a student, or a post-doc, or somebody, to do something that could be considered just developmental refinement of a discovery that had already been made, which I didn't consider to be real science. So I immediately put up a barrier of that sort in the lab. 

But I still wanted to do research on this enzyme in my own lab. And I was concerned about the possible conflict of interest that could be perceived here. At that time, the chairman of my department had some wonderful advice for me. 

He asked me, or suggested that I go to the handbook of faculty responsibilities that the university has had. I think Brian already referred to that. It's been around for many, many years. 

Even back then, there were specific guidelines about what a faculty member should or should not do. Many of those were points that Brian already alluded to. One of which, is you cannot use university facilities for private gain. Fair enough. Second, is you can't exploit a graduate student or a student researcher to do research that would benefit me personally, in terms of something that it wouldn't be to the benefit of the student's long-term interests. That's also fair enough. These were all pretty obvious to me. 

You don't want to do these things. But I wanted to make sure that I wasn't inadvertently doing something wrong. 

The chair had a policy that I thought was great. And that is, make a paper trail. Always be sure that you keep a record of what you've done. So he and I sat down and decided what would be the best way of ensuring that we don't do something wrong. Because this is well before the kinds of committees that Brian is on now. We were just sort of playing it by ear at that time. 

So I set up an oversight committee just to oversee the research in my lab that could be construed as impacting on something that would be of interest at Third Wave. Looking back at it now, I think I was really overloaded on that committee, because it was just a committee for just one professor. 

That's me, and Third Wave. This committee included three professors, one from my department, one from chemistry and one from biochemistry, the associate dean of research of the medical school and the associate dean of research at the graduate school. So I think it was really overkill. But fortunately, all these people were very generous with their time. We met regularly, I guess once a month, or maybe every two months, or something like that. I would fill out a piece of paper saying what research has gone on in my lab since we last met, who was involved, and basically, what kinds of results we had. I'd give it to them, they could look at it. I actually gave it to them before we met. We would discuss it. Were there any conflicts, what students were involved, and so forth. 

They never came back with any suggestions that I was doing anything wrong. After Brian's committee got started, and sort of formalized the whole operation, basically the committee ceased to exist. We just didn't meet anymore because it was redundant. 

One of the points that Brian made, which I held to very adamantly, was to notify people. I think that was a key to our not doing anything wrong. Because when I notify people, I would ask myself, is this really something that that person is going to approve of. So of course, I was in close consultation with my chairman. He also sent memos to the dean of the medical school, as well as the associate dean for research. I sent memos up to Donna Shalala, who at the time, was the chancellor. 

I actually met with Donna one time. 

She gave me some great advice, which I've held to ever since, which is never do anything that you don't want to see on the front page of the newspaper tomorrow morning. And that's served me very well. Obviously, she holds to that idea, as well. 

In the past ten-plus years, I've hardly done any research in my own lab that has anything to do with this enzyme. So this issue is really a mute issue for us now. There are some experiments that we're very interested in doing. And I declare this sort of thing to the conflict of interest committee. But basically, there's very little that's going on in my lab where this is necessary. This was just a way of explaining how we got the whole system going. And I'm glad that it's in good hands right now. 

Thank you. 
- Thanks, Jim. So Nick, how do you stay off the front page of the newspaper? 
(laughter)
 
- Nick Abbott: Okay, I'll try to explain that. Yes, that's right. So perhaps I can just begin my comments by saying that I'm a relatively late arrival on the scene here. And when I was thinking of coming to the University of Wisconsin in 1998, actually one of the things which I was aware of was the history of the university in translating ideas and discoveries at the university into technologies. So that was something that was a real attraction in coming to the university. 

So I think it's something that the university and the surrounding community ought to really value. 

So my own history is that after being here about five years, I was doing some cross disciplinary research with a biologist and veterinary ophthalmologist and a virologist in the vet school. And we were looking at new ways of reporting biological interactions involving the engineering of materials. In particular, liquid crystals. And we got some very exciting results, filed patents through WARF, and founded a company, Platypus Technologies. 

I guess of the trio, of the three founders, perhaps my position is a little bit different, in that the technology is really a technology that was being developed in my lab. It's in many respects, the intellectual core activity in my lab. So I've had to navigate this situation where there's technology development going on at Platypus, and there's research going on in my lab at the university. I guess on the one hand, I think I arrived after some structure was in place at the university. So some aspects of this dual lifestyle seemed relatively well defined. 

And the guidelines were reasonably clear. 

Just related to, I haven't received any research support from Platypus to do research at the university. There's no exchange of personnel. There's no materials exchanged. Those sorts of tangible things have been relatively straightforward to abide by. 

The area where I feel the greatest tension relates to ideas. You know, the process of generation of ideas is a very, very complicated one. And understanding the sources and origins of all the stimuli you synthesize to create inventions is a complicated process. And so that's probably where I felt the most tension. Sort of the vision I had going in was that I would operate in two universes. 

There would be the university and there would be Platypus. And the exchange between the two would be between WARF, through the licensing. So WARF was going to be the rocket ship between these two universes. But that turns out to be very hard. 

It's very hard to work out where all ideas originate, particularly when they involve third parties. At the university, I seek discussions amongst collaborators, and they develop ideas. I do the same at Platypus. So in the other universe, there's the development of ideas going on. And sometimes, I see potential, sort of, collision course occurring. 

That's probably the greatest tension that I felt. 

So how I tried to resolve it at the university, I make sure I involve all the participants in the discussions, and so, conceptions and reduction to practice of inventions. So many students from my lab are inventors on patents filed through WARF. 

I've a couple of comments, actually, just about trends. One of the things which Kathy mentioned is this tension. So the university, for example, encourages outside activity. And at the same time, faculty have responsibilities, which derive from the research going on within their groups. One of the things which I've experienced is that I think increasingly, the university is being asked to account for the investment that Wisconsin makes in it, in terms of the other wealth that it generates for the state. And I think increasingly, federal agencies are being asked to do the same thing. So I find with increasing frequency, our activities at the university actually being cast in terms of the translation process occurring at Platypus. I think that the frequency with which that occurs, I think, just increases the tension between these two elements of our activity. 

NSF, when they ask you to write reports, they want to know about your translation of ideas to technology. They want to be able to report that to Congress. So I think they're really sort of upping the ante in terms of these two sort of conflicting responsibilities. 

The other thing I notice is that this evening, we seem to have talked almost solely about start-ups. And evolution in research funding is that large companies are not investing in long-term in-house research, but they are finding it cheaper to outsource their long-term research to universities. There are many examples around the country where tens of millions of dollars are being given to universities to pursue research which is in the interest of these large organizations. I'm wondering what types of new conflicts that creates within the university environment. 
(all laugh)
 
- Heisler: Thank you, Nick. 

That's a fitting end to your presentation, with more questions. Do we have questions from the audience before we let the panelists fight it out amongst themselves? Yeah? 
(inaudible)
 
- Fox: The question is when students start companies, what about that? If a student started a company and there was an outside financial interest, it would come up under the same rules. 
- Irwin: Particularly if you have received funding from federal grants. The regulations that we operate under, the UWS8 that Brian mentioned, the Regents' rules, that applies only to faculty and academic staff. The federal regulations applies to anybody who receives funding, essentially, under a federal grant. 

Now that's kind of skirting your question, because the answer is we don't have a lot of experience dealing with student start-ups. I personally don't think it raises quite the same level of concern as when you have a faculty member with some sort of start-up. The issue would be whether the student is spending so much time on their company that they're not making satisfactory progress to the degree. But that's something that the student themselves can control. 
- Fox: So the student wouldn't be the PI on the project. 
- That begs the question, are you aware of any students... 
(inaudible)
 
- Irwin: I'm trying to think, and I'm not coming up with any specific that work solely as students. There's a couple where there are students and academic staff. 

- Fox: I think that's exactly right. There's collaboration that involves a student and a faculty member. But I don't think we have any solely graduate student driven activities right now. That's not to say it won't happen. 
- Heisler: In back. 
- Can you address what I see as a conflict of interest? One of the rules that was listed was that academic researchers, scientists, faculty, and staff, are not to do comparisons of a device or technology -- So for example, a company could not go to a professor and say, "Here's my device, here's the competitor's device, I want you to compare the two and publish your results." That obviously would be a conflict of interest. But a great deal of the research that people do, including the two panelists, are developing tools for research. There's always a comparison to an existing tool and some use of it. 

So for example, a liquid crystal... 
(inaudible)
 Clearly, we're comparing different animals, but there may be an academic reason to do such a study to present this and compare, you know, the efficacy. So where do you draw the line on that? To me, it's a very large gray area. 
- Irwin: One of the easier lines to draw, this is a good question. One of the easier lines to draw is when you're dealing with human subjects research. And there, the line is about as bright as any line can be in terms of conflict of interest. Because of the concern over the possible, even if it's inadvertent bias, as it relates to some sort of human treatment modality. We, along with most universities, have a fairly bright line that says that if you have compensation or equity interest of a certain level, then you would not be able to be key personnel on a trial that relates to your company's product. 

I'm not sure that we've grappled successfully with the issue when it's not. I think the level of concern, nationwide, once you move away from human subjects, and perhaps animal, the vet school, you know, kind of the equivalent of human subjects, only for animals. Once you move away from that, I don't think the level of concern is as high. I don't think we would prohibit someone from doing a comparison study, other than human subjects at this point. Would you agree? 
- Fox: I agree. I mean, there are several different scenarios that you might be describing here. One might be a simple, sponsored research activity that is provided essentially as a grant to the company. There's no financial interest of the investigator with the company other than they have a sponsored research, which some may construe would be a conflict, right? But you would expect, then, the results of this study would be published at some point, and would indicate that this study was sponsored by company X. 

So there's a form of disclosure that comes up. 

What my committee would be more interested in is when there is sponsored research, but then there's also these other trappings of financial gain. Being hired as a consultant simultaneously with doing the sponsored research. Accepting stock options as part of it. These things, then, heighten our awareness and heighten the concern that there is some conflict in the design of the experiment, reporting of the data would occur. 
- Irwin: The general concept that drives a lot of the management of conflict of interest in general is disclosure. You know, if you have a study that comes out, and it includes a disclosure that one of the products that I'm evaluating is a product made by a company that I have an ownership interest in, most other scholars can take a look and say, "Eh," you know, "We'll have to discount that a little bit." So you tend to focus more on the human subjects area. But I do have to say that's an area, just like Nick's question about, you know, the more sort of institutional conflict issues. That's the new frontier that we're starting to look at. 

As we get to the point where we have solved one chunk of problems, it seems like 17 more come along. Then we get to try to figure out how to solve those. And we hope you'll bear with us while we do it. 
- Abbott: Perhaps I can just add one comment. I think that we do make comparisons in our research at the university. We put our research in the context of what's going on in other places. Generally, what we're making comparisons about are sort of technical attributes. It's not the product. 

What we're doing at the university is the underlying science. I personally would feel a bit uncomfortable about actually doing some sort of a product comparison. 

But if it's about some specific technical attribute, and it's subjective, then I think one can do that in a fashion that I feel comfortable with. 
- That's why I raised it. It seems to be a very universal kind of problem. 
(inaudible)
 And I agree, it's a conflict of interest. 
(inaudible)
 I was actually involved with a community much like yours years ago at a university. 
- Heisler: Thank you. 
- Most of the discussion has focused on financial conflicts of interest. One of the things we hear a lot about in the press is that there are people looking at the university and saying, "What are those faculty people doing? 

How do they spend their time?" And I think time also becomes a point of concern, I guess, for people who have two -- Can you comment on how that's done, or how it's looked at? 
- Irwin: If you look, I tend to call it a qualitative and a quantitative analysis. The quantitative, how much time are you spending. That's controlled by UWS8, the Regents' rules. It usually is something that is left with the dean or director of the individual. Because, indeed, while you can, people always say, "Well, how much time can you spend," for example, consulting. The urban legend, I've never seen it actually written anyplace, but the urban legend is one day a week. As I always say to people, if that one day always happens to be the day that you're supposed to be meeting your graduate seminar, at some point, somebody's going to come have a little chat with you about that. So, you know, it's one of those things that there's no quantitative way to deal with that. 

But there have been people, for example, at the university, particularly as they were starting to really ramp up a company, where they have concluded that they can't continue at 100% at the university, and have voluntarily decided to cut to 60%, or 40%, or something like that. It's another one of those things that the rules are not hard and fast. But I also have to say I don't see a major problem in this area so far. People understand that you have to meet your university obligations, I think. 
- Dahlberg: Let me just add the time spent on a company is not necessarily time taken away from the university. I've personally improved my lecturing a great deal in the past, as a result of consulting and being on scientific advisory boards. You learn a great deal on these boards. 

I remember when AIDS was just coming on the horizon. I was consulting for a company in Boston. On the board, there were a couple of major epidemiologists, trying to figure out what this disease was. 

And I could listen to them discuss it. We would have a major discussion on a weekend. We had weekend meetings at that time. Then the next week, I'd come back and I'd be lecturing to medical students. In several instances, I was able to say, you know, give them some lead as to where the thinking was in the field. So it's a two-way street in this arrangement, as well. 
- Irwin: I think that's an excellent point. One of the reasons for encouraging outside activity is that does give an individual an opportunity to see what's happening out away from the university, and to bring that experience back in. 
- Heisler: We have time for one more question. 
- I have a question about a possible conflict of interest that a professor-- 

(inaudible)
 A little different from what you've talked about. That is, where there has been an ongoing relationship between that professor and say another faculty member who is not an entrepreneur. And what I believe is a possible conflict of interest between the entrepreneur to the company, versus the interest in interacting collegially on campus, which is-- 
(inaudible)
 My question then is what if, for example, I would like to ask a favor of this colleague, who then tells me that this service or facility of a company, and asks me how much I'm willing to pay for that service. I've actually experienced that. I think a little more broadly, what happens to the collegiality due to the financial value when the company is then sold to a bigger company that has no connection to the university, and just takes the whole blue sky, if you will, and takes it over-- And there's nothing left of all of the collegiality that's been invested. 
- Heisler: Who'd like to answer that, Brian? 
- Fox: I would say as a faculty member, I think that's certainly a problem. 

It doesn't really exactly translate into something that my committee can act on because it's a bit, doesn't it have to do with the nature of human interactions and character and trust. In some ways, it's how you're pulling in someone else. Maybe our management plans do describe some issues about how you shouldn't be setting the price for something. But I'm not quite sure that we're addressing what you're describing, which is a very kind of a dynamic personal interaction that's going on in a collaboration. Really, it's also one-sided, the way you've set it up. One person may have the financial conflict, and the second is just involved in kind of an intellectual way. 
- Dahlberg: This brings up a whole other-- It opens a Pandora's Box of other kinds of conflicts that we have to consider. It's easy to quantify the conflict in terms of financial gain. But there are other kinds of motivations that can lead to conflicts of interest that we haven't addressed here whatsoever. Personal conflicts where, say somebody wants to augment one's reputation. 

You can maybe manipulate publications in such a way that it will make your reputation look that much better, even though, you know, it might hurt the student in your lab for some reason. That's one kind of conflict that we have to deal with. And of course, the obvious one of power over somebody else, as well. These are major conflicts that can not be quantified. You can't say you have to report if you have more than five friends, or something like that. 
(laughter)
 It's something that has to be dealt with on an individual basis. I think we all have to be aware of it. It's a very important point. 
- Heisler: Thanks, and on that note, we're going to have to close. 

I invite you to continue this conversation in the lobby over refreshments. I'm sure our panelists will stick around for a few more minutes. Before I thank the panel, I just want to give a plug for the next Gilson session, which will be on March 6. We'll continue the theme of conflict of interest. Paul DeLuca, from the med school, will be talking about conflicts of interest in clinical trials. So with that, let me thank our panel. Thank you very much for an enlightening conversation. 
(applause)
 Thank you for attending, and please do enjoy the refreshments. Thank you.