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for joining us. >>My name is Laura Heisler.you
I'm an intellectual property
Research Foundation, and also manprogram developer for themni
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
As a UW Medical School alumnus community and the UW campus.
prolific inventor of medical and faculty member, he was a
Dr. Gilson was also an electronics and instruments.
company that grew into today's entrepreneur and founded a
a leading manufacturer of analytical instruments,
headquartered in Madison. *In 2002, Dr. Gilson left WARF
a significant gift intended to
between the university and the promote the exchange of ideas
He often recollected that as Madison business community.
the regular and informal a young entrepreneur, he valued
have with a wide range of colleagues in the cafeteria of
the university's hospital.
connections and dialogue between It is in the spirit of creating
community that we host these the university and the business
entrepreneurship and sessions to encourage
and dialogue. I'd like to start by welcomingn*
two very special guests, and
Dr. Gilson's son, Bob, and his embarrassing them.
us this evening. daughter, Molly, who are joining
events. Thank you for joining us this
evening.
would have enjoyed and We hope they feel their father
honor. appreciated these events in his
garnered a large degree of *This evening's topic has
who told us they planned to interest amoattend.l reporters,
And in case you're wondering
the room, hi, mom, tonight's about the cameras in the back of
Wisconsin Public Television. program is being filmed by
evening is titled, "Conflict of Interest: When Faculty Start
Their Own Companies." We're fortunate to have with
us a group of UW-Madison
sides of this important issue. panelists with experience on all
though, I'd like to take a Before I introduce this panel,
for tonight's topic. moment to provide some context
just a couple of slides to give Ayou 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
These tabulate the number of and 2005.
created nationally coming out of start-up companies, per year,
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
the past few years. cWhen you think about this, you
think of hundreds of faculty
companies based on their own members who have wanted to start
continuing to act as university technoloprofessors.he while
We'll think about that more as
*Let's take a look at another we go through this evening.
This is a beautiful graphic done statistic.
has actually captured, this is by someone at UC-Davis, and
the Madison area. Not all of them started by UWn
faculty, but many of them.
lines going through them, those In all indicate University ofrk
Wisconsin start-ups.
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.
another decade. They span the gamut from lifes
science technologies, to
to engineering and information physical science technologies,
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
UW campus, you can see that the trend also here has done nothing
but go in one direction, which
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.
with some of our panelists And we'll be talking about that
*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
attending lab meetings at scientificompanies. boards,
How are they doing this?
tonight's panel. And that's the subject of
the key people that we need. So with us, I think we have all*
Distinguished Counsel at the To my left, Kathy Irwin,
She has been at UW since 1983. University of Wisconsin.
UW-Madison. And prior to coming to Wisconsin
in the position she has now, she
Legislature. worked at the Wisconsin
grants, contracts, intellectual Kaproperty law, conflict ofch
interest, and scientific
Welcome, Kathy. Next to Kathy, and her partner*
in the dynamic duo of conflict
is Professor Brian Fox, who is of interest management at the UW
Interest Committee. thHe is also a Marvin Johnsonof
professor of biochemistry at
And notably, he is a lead investigator at the UW Center
for Eukaryotic Structural Genetics.
*And then we have our two
representatives. faculty entrepreneur
Professor of Biomolecular Professor JChemistry.g, Emeritus
He has received numerous awards,
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
out of nuclei, and how cells molecules are transported in and
Jim is an author of more than 130 peer reviewed articles, and
an inventor on more than
many of them owned by a company that he helped found,
Third Wave Technologies.
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
Nick received his Bachelor's of Engineering from the University
of Adelaide, in Australia, and
from MIT. hHe then went to Harvard before
going to UC-Davis as an assistant professor, and has
been at UW since 1998.
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
the substance of the issues surrounding conflict of interest
at UW, what governs them and how
conflicts. the university manages those
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,
Great. can everybody hear me?
Irwin. As Laurie indicated, I'm Kathy
interest for more years than I And I've been doing conflict of
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.
of interest expert." So I have become, "the conflict
probably one of the more I can tell you that it is
terms of the law because there difficult areas to deal with in
I'd also like to say that in the isn't any real surety.
here at the university, I've time that I've been doing this
astronomical growth, I think, in seen a definite, just
of conflicts, why they're good, theand how to manage them.ding
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
interest. defAnd there were times when, of
frankly, the university didn't
We kind of made up the rules as know howe went along. them.
One of the things that I
very, very fine young professor in the College of Engineering,
as a matter of fact, who
remain at the university and concluded that he could not
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
entrepreneur. That was a terrible waste of a
really good young professor.
deep impression on me that we really needed to figure out some
way so that we could allow the
entrepreneurship that needs to commercialization, the
our technology out into the real occur, to drive, essentially,
In order to do that, we have to figure out some way to allow
that to happen without saying to
choice. You can either go out or you can
stay in.
interest, and one of the reasons *The area with conflict of
deal with is that it sets up a that it's really difficult to
important, but very competing tensionpolicies.two very
The university has, for a long
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
for certain places, the say the nauniverse. world, and
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.
there was all the concern about I gconflict of interest andhy
managing it.
struck me is that it's important I think one of the things that*
confidence in the objectivity of to maintain the public
University research in the U.S., our research.
unprecedented support from our has probably received an
And part of that reason is government.
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
I think there's also a concept* conflicts.
management of university assets, that over the prudent use and
And whether we like it or not, I including its employees.
thinks at a public institution think in general, the public
university activity is taxpayer like Wisupported.hat all
I think there's some of us that would say, "wish that it were."
Then you guys could quit
But the fact remains, you know, that it is not all supported by
public taxpayer dollars, at least, Wisconsin taxpayer
dollars.
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,
of impropriety. a*I think when Brian talks tonce
you, one of the things you're going to hear is that in a lot
of cases, it's not just that
It's managing so that even the there is truly a conflict.
there. appearance of a conflict is not
I'm not going to bore you with *Applicable law in Wisconsin,
If anybody is really interested in it, feel free to ask some
questions.
provisions. But There's both Wisconsinral
provisions and then there's also
They have some similarities in some at the federal level.
reports, that's that thing you that they both require annual
We've tried to make that a get to fill out in April.
online system. little easier by going to an
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
that conflicts had received on some somewhat unfortunate press
And so they came out with some the east coast.
condition, essentially, of regulations that are a term and
And that's where we put most of receiviour nickel.l grant.
*It applies to principal investigators and others with
substantial research
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.
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
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
be on this committee?" asked me, "How would you like to
situation right there. That was sort of a conflict
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
have met, had I not been the audience that I never would
And my life has been greatly involved in this.
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.
arranged to deal with this, given the federal and states
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
significant financial interest this investigator has some
observer to question whether the that might lead an independent
conduct, or the reporting, might design of that research, the
possibility of a personal gain, either to that individual or toe
their immediate family. So this is the operational
definition that we use to try to
*The university's perspective, as Kathy mentioned, is that we
encourage faculty and staff to
in outside activity, to interact be involved in this, to engage
share our expertise; and to wtransfer intellectual propertyo
through WARF to the private sector whenever possible.
This is part of the culture that
and be faculty at this attracts many of us to come here
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
inherently bad. There are a number of policies*
at UW that govern COI.
This is Chapter 8 of the UW System Board of Regents rules of
policy that has been developed
I think this is probably quite over quite some time.
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
engaged in human subjects about invresearch.s that are
So these are the three, kind of layers of evaluation that we try
to take for faculty activities
activities. So in order to make some sense*
of this, let me give you the
There are about 9,000 people at scthe UW who need to file anW.
annual outside activities report.
This is the scope of the initial
Our Regents' rule is that everybody gets notified about
April 1, by the chancellor, that
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
90%, within a month. high compliance rate, 85% or
we're approaching the 98% or 99% In many colleges on campus,
*With this massive amount of information, we've needed ways
to sort through and identify the
have more attention to manage individutheir conflicts.need to
So we've assigned a series of financial thresholds.
They're summarized here.
an outside activity in excess of One is that any compensation for
equity interest that exceeds $10,000 in a single year, or an
a publicly held entity. tWe recognize that any interestn
in a privately held entity has
And this also represents the inherent risk for conflict.
occurring at the UW. many faculty start-ups that are
member of a board of directors Then any leadership position,
signal to our committee that we in a cneed to have furthers that
examination.
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.
these activities represent a We need to determine whether
This is an assessment phase, and potential or actual conflict.
faculty committee. this is the major work of this
work with the individual to manage or eliminate the sources
of the conflict.
the committee makes recommendations in the form of a*
management plan.
on the administration of the And then we depend very heavily
is from to help execute these collegemanagement plans.y member
*Some of the individual
plans are that you need to obligations in these management
outside activities disclosure. complete and submit an annual
circumstances change. So this is obviously a veryf
dynamic process.
company on April 30, but you You may not have a start-up
October 15. So as part of this dynamic
updating, we need to be made
That would also include new relationships, new consulting
activity, significant changes in
related to existing financial research conflicts. that are
*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.
students and staff about the This includes discussion with
faculty member has in an outside role or the participation that a
It also needs to include activity.
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
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
decisions. everyone make their own
*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
about the use of public property address some state statutes
individual. We request that if purchases are
going to be made from companies that these are negotiated by an
outside party, so that there
or not some federal grant monies isn't some question of whether
special price that benefits the might beorganization.hase at a
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
into the whole package. ac*A couple of unacceptablerated
conflicts.
We're a public university. Restrictions on publications.
That's something that you should, as a faculty member, you
should really not ever think
Failure to disclose conflicts when it's reasonably possible.
This goes against the core
try to begin to manage conflict. principle that we have of how we
Uncompensated use of Disclosure.
Thesis research that's not university's resources.
meritorious research. This is to protect the rights of
students as they work in
dissertation research. laboratories to do meritorious
in assessing the efficacy of Investigators that are involved
products. This very obviously sets up
conflicts.
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.
policies. Disclose these relationships.
Consider COI implications.
understanding about what these And as we gain more
I hope that investigators will are and how we may manage them,
early on as they go into these be able to make better choices
Then seek advice and assistance. kind of situations.
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.
hearing from our two faculty I think now we'll move to
First, Jim Dahlberg, who was at ethe forefront of this whole.
question when he helped found Third Wave Technologies in 1993.
So we've asked Jim to share some
navigated these waters almost, of his experiences as he
Jim Dahlberg: Laura asked me well, 15 years ago.
history. to give you a little bit of
which was in the early 1990s, Whthe company, Third Wavee,
Technologies, here in Madison was founded by Lloyd Smith,
Lance Fors, and myself. It was focused around a
development that had been, a
my lab by two very capable discovery that had been made in
and Mary Ann Brow. investigators, Victor Lyamichev
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
WARF. NIH, WARF patented it.ion to
And that was it.
patent. WBut 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
Because on the one hand, we wanted to do a lot of basic
research in the lab.
see that there was a lot of potential for developing thisd
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.
Technologies off-campus. And we did start Third Wave
initially, on Fish Hatchery It was a diRoad.nt location,
Then out at the university
Basically, all of the development, the applicational
research was done out at Third
I really didn't feel I was in a position to ask a student, or a
post-doc, or somebody, to do
considered just developmental refinement of a discovery that
had already been made, which I
science. didn't consider to be real
barrier of that sort in the lab. So I immediately put up a
research on this enzyme in my *But I stiown lab.d to do
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
responsibilities that the go touniversity has had.culty
I think Brian already referred
It's been around for many, many tyears..
*Even back then, there were
faculty member should or should specific guinot do. about what a
Many of those were points that
One of which, is you cannot use university facilities for
private gain. Fair enough.
Second, is you can't exploit a
researcher to do research that graduate student or a student
terms of something that it would benefit me personally, in
the student's long-term wouldn't binterests.enefit of
That's also fair enough.
me. TheYou don't want to do these to
things. But I wanted to make sure that I
wasn't inadvertently doing
*The chair had a policy that I thought was great.
And that is, make a paper trail.
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.
kinds of committees that Brian Because this is well before the
We were just sort of playing it by ear at that time.
*So I set up an oversight
research in my lab that could be committee just to oversee the
something that would be of construed as impacting on
Looking back at it now, I think I was really overloaded on that
committee, because it was just a
professor. committee for just one
This committee included three Tprofessors, one from mye.
department, one from chemistry
associate dean of research of anthe medical school and thehe
associate dean of research at the graduate school.
So I think it was really
But fortunately, all these overkill.
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
I'd give it to them, they could look at it.
I actually gave it to them
We would discuss it. before we met.
students were involved, and so Were there any conflicts, what
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.
because it was redundant. *One of the points that Brian
made, which I held to very
I think that was a key to our adanot doing anything wrong.ple.
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
He also sent memos to the dean consultation with my chairman.
as the associate dean for of the medresearch.ol, as well
I sent memos up to Donna
the chancellor. *I actually met with Donna one
time. She gave me some great advice,
which I've held to ever since,
you don't want to see on the which is never do anything that
tomorrow morning. And that's served me very well.
Obviously, she holds to that
*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
There are some experiments that we're very interested in doing.
And I declare this sort of thing
committee. to the conflict of interest
little that's going on in my lab But basically, there's very
This was just a way of where this is necessary.
system going. eAnd I'm glad that it's in good
hands right now.
Thanks, Jim. Thank you.
front page of the newspaper? So Nick, how do you stay off the
Nick Abbott: Okay, I'll try ( to explain that.
Yes, that's right.
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
So I think it's something that university.
surrounding community ought to the university and the
So my own history is that after* being here about five years, I
was doing some cross
biologist and veterinary disciplinary research with a
in the vet school. ophthalmologist and a virologist
of reporting biological Andinteractions involving theys
engineering of materials. In particular, liquid crystals.
And we got some very exciting results, filed patents through
WARF, and founded a company,
*I guess of the trio, of the three founders, perhaps my
position is a little bit
technology is really a different, in that the
developed in my lab. technology that was being
intellectual core activity in my It's in many respects, the
So I've had to navigate this lab.
technology development going on at Platypus, and there's
research going on in my lab at
I guess on the one hand, I think the university.
was in place at the university. ISo some aspects of this duale
lifestyle seemed relatively well
And the guidelines were reasonably clear.
*Just related to, I haven't
from Platypus to do research at receivethe university.support
There's no exchange of
There's no materials exchanged. Those sorts of tangible things
have been relatively
*The area where I feel the greatest tension relates to.
ideas.
generation of ideas is a very, You know, the process of
And understanding the sources and origins of all the stimuli
you synthesize to create
process. inventions is a complicated
felt the most tension. And so that's probably where I
in was that I would operate in Sort of the vision I had going
There would be the university and there would be Platypus.
And the exchange between the two
the licensing. would be between WARF, through
rocket ship between these two So WARF wuniverses.o be the
But that turns out to be very hard.
*It's very hard to work out
particularly when they involve where all ideas originate,
At the university, I seek discussions amongst
collaborators, and they develop ideas.
I do the same at Platypus.
there's the development of ideas So in the other universe,
And sometimes, I see potential, sort of, collision course
occurring.
tension that I felt. *That's probably the greatest
the university, I make sure I involve all the participants in
the discussions, and so,
practice of inventions. So many students from my lab are
inventors on patents filed
*I've a couple of comments, through WARF.
One of the things which Kathy amentioned 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
One of the things which I've on within their groups.
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
And I think increasingly, federal agencies are being asked
to do the same thing. So I find with increasing
frequency, our activities at the
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
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
responsibilities. *The other thing I notice isg
that this evening, we seem to have talked almost solely about
start-ups.
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
millions of dollars are being given to universities to pursue
research which is in the
organizations. interest of these large
conflicts that creates within I'the university environment.ew
( all laugh ) >> Heisler: Thank you, Nick.
That's a fitting end to your
questions. presentation, with more
audience before we let the Do we have questions from the
themselves? panelists fiYeah?t out amongst
( inaudible ) >> Fox: The question is
when students start companies,
If a student started a company what about that?
financial interest, it would and there was an outside
Irwin: Particularly if you come up under the same rules.
from federal grants. have received funding
under, the UWS8 that Brian The regulations that we operate
that applies only to faculty and mentioned, the Regents' rules,
The federal regulations applies to anybody who receives funding,
essentially, under a federal
Now that's kind of skirting your grant.
we don't have a lot of question, because the answer is
start-ups. experience dealing with student
raises quite the same level of I personally don't think it
faculty member with some sort of concern as when you have a
The issue would be whether the start-up.
on their company that they're not making satisfactory progress
to the degree.
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...
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
Fox: I think that's exactly students anright.emic staff.
There's collaboration that
member. iBut I don't think we have anyty
solely graduate student driven
That's not to say it won't activities right now.
Heisler: In back. >> Can you address what I see
as a conflict of interest?
was that academic researchers, One of the rules that was listed
are not to do comparisons of scientists, faculty, and staff,
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
two panelists, are developing that tools for research.g the
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
be an academic reason to do such different animals, but there may
compare, you know, the efficacy. a study to present this and
that? STo me, it's a very large grayon
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.
bright as any line can be in And there, the line is about as
Because of the concern over the termpossible, even if it'sest.
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
relates to your company's key personnproduct.trial that
I'm not sure that we've grappled
it's not. sI think the level of concern,en
nationwide, once you move away
animal, the vet school, you know, kind of the equivalent ofs
human subjects, only for
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.
Fox: I agree. I mean, there are several
different scenarios that you
One might be a simple, sponsored might be describing here.
provided essentially as a grant reseato the company.at is
There's no financial interest of
company other than they have a the investigator with the
may construe would be a sponsorconflict, right?ch some
But you would expect, then, the results of this study would be
published at some point, and
was sponsored by company X. So there's a form of disclosure
that comes up.
interested in is when there is What my committee would be more*
there's also these other sponsored research, but then
Being hired as a consultant simultaneously with doing the
sponsored research. Accepting stock options as part
of it.
awareness and heighten the These things, then, heighten our
conflict in the design of the experiment, reporting of the
data would occur. >> Irwin: The general concept
that drives a lot of the
interest in general is management of conflict of
You know, if you have a study that comes out, and it includes
a disclosure that one of the
a product made by a company that products that I'm evaluating is
most other scholars can take a I have an ownership interest in,
"We'll have to discount that a look and say, "Eh," you know,
So you tend to focus more on the little bit."
But I do have to say that's an human subjects area.
about, you know, the more sort area, just like Nick's question
issues. That's the new frontier that
we're starting to look at.
have solved one chunk of As we get to the point where we*
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.
comparisons in our research at I think that we do make
We put our research in the the university.
other places. cGenerally, 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
I personally would feel a bit uncomfortable about actually
doing some sort of a product
But if it's about some specific technical attribute, and it's
subjective, then I think one can
comfortable with. do >> That's why I raised it.eel
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
years ago at a university. a community much like yours
Most of the discussion has >> Heisler: Thank you.
of interest. focused on financial conflicts
about in the press is that there One of the things we hear a lot
university and saying, "What are are people looking at the
How do they spend their time?" those faculty people doing?
a point of concern, I guess, And I think time also becomes
Can you comment on how that's done, or how it's looked at?
Irwin: If you look, I tend
a quantitative analysis. to call it a qualitative and
are you spending. TThat's controlled by UWS8, the
Regents' rules. It usually is something that is
left with the dean or director
Because, indeed, while you can, people always say, "Well, how
much time can you spend," for example, consulting.
The urban legend, I've never
anyplace, but the urban legend seen it actually written
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.
things that there's no So, you know, it's one of those
that. But there have been people, for
example, at the university, particularly as they were
starting to really ramp up a
concluded that they can't continue at 100% at thee
university, and have voluntarily
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
so far. People understand that you havea
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
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.
in Boston. I was consulting for a company
couple of major epidemiologists, On the board, there were a
disease was. trying to figure out what this
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
In several instances, I was able medical students.
lead as to where the thinking to say,was in the field.hem some
So it's a two-way street in this
Irwin: I think that's an arrangement, as well.
One of the reasons for excellent point.
that does give an individual an encopportunity to see what's is
happening out away from the university, and to bring that
experience back in. >> Heisler: We have time for one
more question.
possible conflict of interest >> I that a professor--out a
( inaudible ) A little different from what
you've talked about.
ongoing relationship between That is, where there has been an
faculty member who is not an that professor and say another
And what I believe is a possible entrepreneur.
entrepreneur to the company, conflict of interest between the
interacting collegially on versus the interest in
( inaudible ) My question then is what if, for
example, I would like to ask a
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
that has no connection to the iuniversity, and just takes they
whole blue sky, if you will, and
And there's nothing left of all of the collegiality
that's been invested. >> Heisler: Who'd like
to answer that, Brian?
member, I think that's certainly >> Fox: I would say as a faculty
It doesn't really exactly translate into something that my
committee can act on because
do with the nature of human interactions and character and
trust.
pulling in someone else. In some ways, it's how you're
describe some issues about how Maybe our management plans do
price for something. you shouldn't be setting the
we're addressing what you're But I'm not quite sure that
of a dynamic personal interaction that's going on in a
collaboration.
way you've set it up. RealOne person may have the, 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
haven't addressed here conflicts of interest that we
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
That's one kind of conflict that reason.
And of course, the obvious one we have to deal with.
well. oThese are major conflicts that
can not be quantified.
if you have more than five You can't say you have to report
( laughter ) friends, or something like that.
dealt with on an individual It's somethibasis.t has to be
I think we all have to be aware of it.
It's a very important point.
note, we're going to have to >> Heisler: Thanks, and on that
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
Gilson session, which will be on want to give a plug for the next
We'll continue the theme of conflict of interest.
Paul DeLuca, from the med school, will be talking about
conflicts of interest in
So with that, let me thank our clinical trials.
Thank you very much for an panel.
( applause ) enlightening conversation.
and please do enjoy Thathe refreshments.ing,
Thank you.