cc >> 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.