cc
Christianson. I'm director of licensing at
Wisconsin Alumni Research Foundation, or WARF.
The Gilson Series was launched
the late Dr. Warren Gilson. Warren Gilson played a strongm
role in the Madison business
As a UW Medical School alum and cofaculty member, he was as.
prolific inventor of medical
Dr. Gilson was also an electronics and instruments.
He founded a company that grew entrepreneur.
a leading manufacturer of analytical instruments located
in Middleton. In 2002, Dr. Gilson left WARF a
significant gift intended to
between the university and promote the exchange of ideas
He often recollected that as a Wisconsin businesses.
the regular and informal young entrepreneur, he valued
cafeteria of UW Hospital. He was able to have a wide range
of discussions with colleagues
and the business community, as within the university community
together. theIt is in this spirit ofems
creating connections in dialogue
business community that WARF between the university and the
to encourage entrepreneurship and interdisciplinary
collaborations. I'd like to welcome and thank a
very special guest, Dr. Gilson's
evening. son, Bob, who is joining us this
He often attends these events. Thanks, Bob.
would've enjoyed and appreciated We hope that your father
In case you're wondering about these events named in his honor.
remarks, even though we're a the cameras and my formal
this room, we're being filmed nice group tonight.ds here in
This program is being filmed by Wisconsin Public Television.
Tonight, we host Dean Paul
And now, it'll become even more apparent why I'm reading.
Paul received a BS in Physics and Math and a PhD in
Nuclearphysics from the University of Notre Dame.
That same year, he joined the University of Wisconsin as a
research associate. And in 1975, he was appointed to
the faculty of the Department of
Following the creation of the Department of Medical Physics in
1981, he served as chair from 1987 through 1998.
He holds and appointment as professor in the departments of
Medical Physics, Radiology, Human Oncology, Engineering
Physics, and Physics. In 1999, DeLuca assumed the
role of Associate Dean for
in the UW School of Medicine Research, and Graduate Studies
And his administrative role was expanded in 2001 with his
appointment as Vice-Dean. Dean DeLuca is an
internationally recognized
radiation effects on humans. expert in high-energy particle
international commission on Hradiation units ande
measurements, and currently serves as vice chairman.
He is also a member and chair of
international security division of U-Committee at Los Alamos.
Other national and international
society affiliations include the associations and professional
Physicists in Medicine, American Physical Society,
Health Physic Society, National Council on Radiation Protection
and Measurements, Council on
and Standards and Institute Ionizing Rof Physics.asurements
Please join me in welcoming Dean Paul DeLuca.
( applause )
Craig could have been much more succinct by merely saying this
guy's older than dirt, and he's a resident geek.
( laughter )
startled by the membership of I'm the audience. bit
I had anticipated that this would be more of the general
community, as opposed to people that are deeply experienced in
clinical trial research.
very familiar with it ignore So I hope those of you that are
Secondly, I'd kind of like to spend a little time, and you'll
notice it right away. I'll give you my personal
opinion and interpretation of things, not necessarily, in some
cases, what the standard policy is.
And what you'll see right away
constitutionalist with respect is that I tend to be a strict
I'm here tonight to talk about to this kind of activity.
trials. And what I'm going to try and do
is give you a little bit of a national perspective on this,
and where it's going. Then I'm going to try and bore
in on local perspective as to how this is managed.
And then I'm going to talk
case example. sWe'll try and protect theal
innocent as best we can in that case.
So I was not alone in my
I had some very distinct help from Steve Harsy, who's sitting
in the audience, and from Tracy Cabot.
Two of the people who work in my
Steve, in particular, works right at the interface between
faculty and conflict of interest
committee, and probably spends and conflict of interest
So let's get down to it. 20% or 30% of his time on that.
recent American Association of This is a quote taken from a
force on financial conflict of Medical College report on a task
Now the interesting thing, interest in clinical research.
form that's available on the that's now available in draft
authors of that is the current Web, and one of the principal
Robert Golden, who in fact dean of the Medical School,
thing. drafted a fair piece of this
the first few points become clear, "opportunities to profit
from research may affect, or
judgments about what subjects to appear to affect, a researcher's
provided to subjects, even enroll, the clinical care
Well, probably the key word is the proper use of subjects."
appear to affect," because I that parenthetical phrase, "or
institution, and they wouldn't think everyone at this
accepts the first premise, be here very long otherwise, who
profit from the research, isn't going to be able to do that for
very long.
problem reduces to the So in many cases, the entire
and the perception of those appappearance of activities.es,
That doesn't remove us from having to deal with those
issues, but it does change the
The other point to keep in mind is that this is not dramatically
different than you would have if
example, not involving human you were doing NIH research, for
All right? subjects.
for these grants. FThey're very successfuld
in pursuing those grants. It advances their career.
They get promoted.
Their prestige in the field They getincreases.creases.
So they're not free of conflict of interest.
It's a personal conflict of interest, but it's not obvious
that it's any less of a conflict
doing human subjects research. of interest than in for example,
are involved. ThThat's why we have a specialts
attention to this particular
Here's another quote from that problem.
"Financial interests also threaten scientific integrity
when they foster real or
data collection and analysis, adverse event reporting, or the,
presentation or publication of research findings."
This is another example, which
first statement. is somewhat distinct from the
point in just a minute or two. I'm going to elaborate on this
have this again, the "apparent Also, I call your attention, we
So again, we have this biases," okay.
we have to deal with. pThe NIH sponsors vast amountsat
of clinical trials. Why are they seemingly less
subjective to difficulties, with
interest? It's largely because there's nof
financial relationship, other than the grant or contract
between the agency and the
It's when it's this distinct faculty member.
company, or even more complicated, when the faculty is
directly involved in it that we run into a conflict of interest
that's directly involved. Now, this statement, which is
toward the end of the introduction of that particular
report, "At the same time, a
industry and academia is principled partnership between
medical progress..." essential if we are to preserve
clock back and look at the If you kind of wind the
taken place in care of patients, principal discoveries that have
diseases, invariably, private companies were involved in that.
And their relationship, very
or with the institution, had a often with the faculty founders
research. For example, here at Wisconsin,
I'm deeply familiar with several
One example, a prime example, is digital subtraction
angiography.
or two faculty members in the That wasmedical school.ed by one
And working very closely with General Electric Medical Systems
Division and Phillips, for
out, make that as comprehensive as it is, and then promulgate
that throughout the industry. So it is the standard of care in
cardiovascular diagnosis. Even today, DSA is still the
standard of care. So there was a very distinct
relationship between several of our faculty and several major
companies.
individuals had a potential conflict of interest between
those things. Yet, had we not done that, it's
not clear how long it would've
Another example, bone been befodensitometry. popular.
Bone densitometry is one of the most common screening exams done
for example nowadays. The degradation and bone loss is
a severe complication.
work that we see on campus is focused on rectifying some ofD
these problems. Well, the medical imaging that
was involved in that bone densitometry created a
corporation, Luna Radiation,
wholly by General Electric. Faculty were deeply involved in
that process. And not having them involved in
that process very likely
densitometry being delayed or otherwise put off for who knows
how long, certainly potentially decades.
So there's a great benefit to this.
The more recent example I think is tomotherapy.
That is, you may not be wildly
tomotherapy. familiar with the impact of
company. I'm sure you've heard of the
that device is virtually But in fact, that company and
radiation oncology. reThe penetration of that of
instrument into the treatment market has gone from essentially
zero five years ago, to probably
but much higher penetration in, 2if you will, lesser developeds,
countries, because when they buy
gear. So they're essentially ramping
up their clinical care programs.
back of this technology. And they're doing that on the
relationship between one or two Thifaculty members and whatht
ultimately became a company,
So society is benefiting Tomotherapy.
activities. The problem is how do we manage
these activities in a principled
There's lots of people who have their finger in the pie.
These are just some of the
are really deeply involved in athe whole business of clinicalh
trials and conflicts of interest.
The Public Health Service, the
Association, the state of AAMC, thWisconsin. Medical
But probably what should be at
Our management of public the top is public perception.
articulate publicly how carefully this kind of work is
being done is seminal to any
If we're not able to do that, we're not going to have much
success.
this properly, even if there has Every time we have failed to do
that perception is available to the public it's not completely
above board, we run into severe perception problems that can be
really extremely negative.
several examples of that on And we havcampus.rtunately,
Let me talk a little about
of interest. research misconduct and conflict
we have two activities that Conflinteract such that the when
professional judgment in one may
the other. or may seem to be influenced by
conflict of interest situation. You could have this situation
arise in several different
One that I'm not going to talk contexts.
conflict of interest, because in about is the clinical practice
entirely by the University of Wisconsin Medical Foundation and
the hospital. There's another conflict of
interest that we have yet to
That's the institutional wrap our arms around.
That's the relationship between the institution and external
agencies that could put the institution in a conflicted
opinion.
very deep relationship with General Electric Medical Systems
Division. Management of that in an above
board public way is really an institutional management of it.
It does not get down to individuals.
It's not an individual or trial related conflict of interest,
but is rather an institutional
The university's policies in conflict of interest.
We haven't put anything in this area are just evolving.
to put something in place fairly place, but we're going to have
So then we get into research quickly.
really governed by UW Policy. coThis is something that theis
university has dealt with in a
way. very comprehensive and proactive
along here, a few minutes And I'talking about that.s we go
In any case, let's diverge a
research misconduct and the relationship between that and
conflict of interest. Research misconduct, and this
is a quote I've actually taken
School's Web site, which I think from the Harvard Medical
material on this. They define research misconduct
as a "fabrication,
other practices that seriously falsification, plagiarism, or
commonly accepted within the deviate from those that are
proposing, conducting or scholarly community for
This is exclusive of --. reporting research."
might argue that if someone behaves in a manner that's free
of research misconduct, why do
interest, okay. And in many ways, a clinical
conflict reduces to an
member is either committing misconduct or is committing
malpractice.
fact that if someone is not committing any form of research
misconduct, and is not
in fact be very well managing cotheir conflict of interest.may
It's really a question of how deeply does the institution
reach into that area. That is the crux of the matter,
at least for me.
forms of research misconduct. We had one about a year and a
half or two years ago at the
outright fabrication of scientific information that wasm
published in the peer review
used to pursue further and more NIH funding, which was obtained.
That constituted absolute fabrication of results, and was
a core violation of research
And it resulted in the dismissal misconduct principles.
member. If you looked at that case in
detail, you're actually stunned that anything would get that far
along.
been for the students in that Anlaboratory, that might have't
persisted for yet another five
That was an example of research or tenmisconduct. right.
Now, in my experience seemingly intermable at the institution,
I've only run into two instances
1972, that I've been aware of or of research misconduct since
The probability of this occurring is extraordinarily
rare. It could be argued that the
conflict of interest in a clinical environment is even
rarer.
instances of where we've had any You have very, very few
"Medical malpractice occurs when a negligent act or omission
by a doctor or other medical
or harm to a patient." professional results in damage
quite a bit above conflict of That stateinterest.es the bar
In essence, to commit malpractice, the physician has
to behave in such a way that it results in the damage or harm to
a patient because of that misbehavior.
You could easily avoid that in
but have a significant conflict the contexof interest.cal trial,
So we need to make a real clear distinction between medical
malpractice, which fortunately, is relatively rare, and conflict
of interest situations in a clinical trial, which are
relatively common.
of that as we go along. And "Conflict of interest inles
patient care occurs when a
recommendations to patients based on outside influences
rather than on standards of care."
That's really the crux of the matter in clinical conflict.
I have a clinical trial I'm doing over here and you really
don't need this, you really need
That is the crux of the matter to participate in that.
interest. Let me keep up with where I'm
going here. Now, this is kind of a flow
diagram of the university's process for managing conflict of
interest. The key to the management of
conflict of interest, and you should really say financial
conflict of interest, because there can be an academic
conflict of interest. I'll get into that in a minute.
But the financial conflict of interest starts the process by
the faculty member disclosing completely and thoroughly any
aspect of their financial situation that could bear upon a
potential conflict of interest. That's done annually by
virtually every member of the faculty and staff.
It is reviewed comprehensively
That unit level is usually the at the unit level.
Our Dean's office, Steve Dean's office.
conflict of interest. There's a subset of those that
he pulls out of his stack that
And then we, together, review are pathose in detail.rous.
So this is done periodically on an annualized basis.
If a faculty member's financial status changes after filling out
that conflict of interest form, we revisit that situation.
This is an ongoing, centralized process.
This occurs in virtually every
That subsequently gets referred to the so-called conflict of
interest committee, which is a
committee. broad campus appointed
on that in a minute. I'll show you some of the people
That typically may result in an There minterview process. room.
The results of that may result
The management plan may be very in a matrivial. plan.
You can't do it.
you can't participate in any So your management plan is no,
that particular company or clinical trials associated with
On the other hand, there are entity.
permitted. circumstances where this is
those in a little detail as we I'm going to try and talk about
Let me give you a flavor of the review criteria.
If you go out and look on the Web, and you say, okay, DeLuca,
that's the review criteria of Wisconsin.
What is it at the University of Chicago?
What is it at Harvard?
You will find different Wcriteria depending on thes?
institutions. Where do our criteria lie in the
spectrum? I'd say more or less in the
middle. The extreme ones are quite
distinct. As far as I know, for example,
Harvard is extraordinarily
financial conflict of interest. Ours breaks out to something
like this.
Three to the right, No Review or No Management; Limited
Management; Full Management.
whether or not the process is Whaallowed to go forward.is
If it's allowed to go forward,
clinical trial is allowed to go forward, it's going to fall into
one of those three categories.
particular issue that we have to One, that there's really no
Another, where we have a circle deof middle ground, a limitedd.
management plan.
full management plan. AThese criteria are arranged,
probably by order of precedent. So compensation, if it's less
than $10,000 a year, there's no review or management;
$10,000-$20,000; greater than $20,000 a year relationship.
Notice the issue with respect to ownership interest in a
publicly traded company.
mathematical sentence. That's an "and" statement in the
$10,000 AND that must not Yoconstitute more than fivean
percent equity. If you happen to have $5,000,
and that's more than five percent equity, then you fall
outside the AND, okay.
those two terms. So it's really the product of
right, it's $20,000 OR five Notice percent equity.r to the
So the AND switches to an OR
Either one will trip the statement.
venue. discriminator in that particular
you either do or you don't. If you do, you're automatically
don't pass go, don't collect
You're immediately into at $200.
all. least a management plan, if at
there's no particular problem. No ownership interest, then
directors, external advisors, Leadesome other capacity.d of
Doesn't have to be paid, just has to be involved.
These can trigger various review
Here's a chart that kind of breaks out the disposition of
what the conflict of interest committee review might entail.
Focus on the extreme right
plan. Under the full management plan,
what the heck is going on here? What's going on is, under
special circumstances, the
participate in a clinical trial. faculty member may be allowed to
activities have to be included But all of these criteria and
And it's very intrusive, if you look at this a little bit.
For the faculty person to participate, there's a lot of
intrusion by the management plan
activities, a high level of into tscrutiny.to-day
An institution wants to be in a position of not only are they
comfortable with this research
comfortable with every aspect of going forward, they're
being managed, and that that how that research process is
minimizes the amount of rpotential for conflict ofy
interest or even perception of
These can be quite intrusive. If you go down to the bottom,
you're talking about monitoring by the chair and the Dean's
office. So we will actively get involved
in faculty, much to their disgust, in day-to-day
activities, with respect to this, even going so far as to
what are they buying, and how are they buying it, and who are
they buying it from, for
discussion. Annual report and review withe
the department chair. We take a very proactive.
Steve will arrange for he and I to meet with either department
heads or section heads. These are generally clinical
departments.
discussion about how this Andmanagement plan is goingugh
forward, and what the difficulties are associated with
it. Now, I'll keep track
of where I am here. One of the key things to keep in
mind is that if it's decided to allow this to go forward, and
there's a management plan put in
intrusive state, it can be very place, andrestrictive.in a very
I'll give you one example.
how restrictive it can be. But this gives you a flavor of
You cannot serve as Co-PI. You cannot serve as PI.
this particular research. YThis can be very hard for ain
faculty member to accept, to not
Let me give you a list of what be key personnel.
Key personnel are people who do one or more of these particular
activities, designing of
So what you're really saying to this faculty member, is because
of your financial conflict of interest, you cannot be involved
in the designing of research
This was, for example, an extremely troublesome problem.
I used the case of Tomotherapy. The faculty member was 100%
responsible for that entire product.
So when you say you want to pursue that research on campus,
and you can't in any way get
research, that is a real involved in designing the
The faculty members are not thrilled to have that particular
process put upon them.
about human subjects. That's obvious and that's not a
particularly compliance related thing.
We do that very easily. Analyzing or reporting the data
for publication.
All of these things could be Submitting manuscripts.
otherwise affected by conflict restricted, curtailed or
So it's a significant intrusion into the faculty member's life.
I frankly, as an aside, have to tell you, I really struggle with
that sometimes. You know, the risk benefit ratio
that's involved, we tend to err tremendously on the risk side
and don't look very carefully,
side. It's a huge advantage, in many
cases, to have our faculty
They very often can get pushed participate in this thing.
about the perception of this. oSo the general central campusn
policy is to err on the side of caution rather than to look
necessarily at the benefits.
accept a little higher level of I personally risk.re willing to
Exceptions to a full management plan limitation.
There can be exceptions.
some very compelling However, they really require
exceptions. cNamely, that the greater goodse
would be restricted by not
circumstances. implementing those compelling
maybe the work can't be done. Or without those, maybe the
results will not be interpreted correctly.
Without that participation, maybe that research won't go in
the correct direction at all, and we'll waste a lot of time,
energy and money and miss an
There really needs to be some compelling reasons to do this.
If the risk is greater than minimal, and I mean minimal is
close to the accident rate for
is about one part in 10,000 or driving your car to work, which
This is generally not granted as something like that.
Compelling circumstances. Nature of the clinical research;
nature of the significant financial interests.
There may be significant
are sufficiently isolated, they finmay be significant, but ifey
they're sufficiently isolated and at arm's length, maybe
that's a reason for allowing
How closely do the financial this to go forward.
research? If they're really well uncoupled
or mildly related, maybe that's compelling.
Potential for bias. Unique qualifications of the PI,
and I'll give you an example of this.
In many cases, all of these activities are compelling
circumstances that could result in a conflict of interest
committee taking a more open
an exception. But this last point is probably
the most important to keep in mind.
Full disclosure is the essence
In any kind of conflict of of reality.
provide full disclosure is interest situation, failure to
In realty, it's location, location, location.
In this kind of instance, it's
disclosure. The more you disclose, the more
comprehensive it is, the less difficulty you have.
This is the committee.
because how broad it is. And I show you this largely
recognize all the names. You wouldn't necessarily
them. This is a very broad swath of
faculty.
deeply experienced, not just in Thresearch, but in clinicalry
research. They're also experienced in
commercialization, technology transfer.
They have a very good knowledge of what the institutional
mentality and history is. They tend to execute on those.
It's chaired by Brian Fox.
Brian to spend that much time on And the fact that they can get
this committee spends a lot of it is quite shocking, because
They represent physicians, time on these issues.
social scientists. scientists, basic scientists,
expertise on this committee. There's a broad swath of faculty
faculty members on this committee are the ex-officio and
consultants.
right now. Some of those are in this room
consultants, you have individuals from Letters and
Science who are responsible for tech transfer, and the Medical
School, CALS. You have representation from the
institutional and human subjects
Pech. You have Kathy Irwin from legal
services. So the infrastructure
associated with all human subjects research is heavily
represented on this particular
They provide at least some committee.
Let me talk about a case study. And as I said, I kind of
suppressed some of the science
protect the innocent or guilty, depending on your attitude.
Here's an example where we have a faculty person who creates
shall we say a drug.
That means this faculty person What does that mean?
intellectual property associated developed and created all the
intervention. They did all the animal work,
all the biophysical experiments.
this drug. They are the world's expert on
depth and breadth of knowledge There is no one else who has the
other than that faculty member. And the faculty member deviates
from reality. He or she goes out and forms a
private company, which licenses the intellectual property back
from the university.
part of the company. The faculty person owns all or
significant compensation from The facuthe company.eceives
The faculty person serves as
particular company. So you have the elements of a
perfect storm here. You have the world's expert, the
person who created this intellectual property, and is
fully responsible for it. It's obviously an
extraordinarily attractive
They pursue a tech transfer and it's chiseled into Bascom Hall
that we view tech transfer as a good thing.
So they behave by all the good
Formed a company, put their own money into it, stood this whole
thing up. And now we have a massive
conflict of interest. The company wants to pursue a
Phase 1 clinical trial of that
What does that mean? drug.
study. That's the first in humans
to explore toxicity and to a The purpose of that is generally
This is a very research interventional trial.
So now we have a perfect
storm occurring. financial conflict of interest
nightmare with respect to a Now clinical trial.orst
So we have lots of faculty
The faculty person is the world issexpert in all aspects.is.
If you ask anyone in North
that's the person. America or Europe, they say
It's been a major research focus They're the world expert.
It's quite clear that development of this drug and
related drugs and derivative
faculty person for the next ten drugs is goiyears.consume this
So this problem is not going to go away.
It's a problem that's been
literally, probably, the created that's going persist for
person's career at this lifetiinstitution.aculty
Frankly, the work cannot be done
knowledge. without the faculty person's
particular trial and pursue this You literally could not do this
without that faculty member first phbeing involved. research
So I'm building a case here for the strength of the perceptions,
the strength of the needs and the reason why the conflict of
interest committee would make an
Such a trial poses two conflicts accommodation on this.
One is financial. All right, that's the one we're
talking about.
non-financial academic conflict But iof interest.es a
This is not a peer reviewed federal process.
This is a particular company, a privately owned company that is
pursuing this Phase 1 study.
much less than you would get at Thethe NCI or NIH level.w is
That opens the door for all kinds of potential scientific
misconduct issues associated
important as the financial with it, but are equally as
These are issues, we know entirely have to be managed from
the first principles. Now what was the school's
response to that? Well, we did a full review and
approval necessary before the conflict of interest committee
review. In other words, this request to
pursue this particular research was thoroughly reviewed at the
dean's level, and resulted in a highly iterative process of
dialogue, probably much to the
that this takes so long to dislike of the faculty member
But given the importance of this, this took a lot of
internal review before it even
committee. went to the conflict of interest
what went to the conflict of And what I'm talking about is
a request to them to make an interest committee was there was
participation of a faculty exception in this case for
Conflict of interest committee member in this.
plan. Basically indicating the faculty
cannot participate in this
review and approval. clinical trial without the full
the company must have these Telements: ongoing management
plan and oversight by the school
committee. and the conflict of interest
level fairly dramatically, So this raises the intervention
affecting the research output. significantly interfering and
built into this management plan for the proposed clinical trial.
In other words, the conflict of interest committee reached in
and made particular provisions
clinical trial is going to take with respplace. how this
And oversight of the future protocol development is clearly
a part of this. So the next stage of this
research is on the table. This interferes with this in a
significant way.
happened? FoWell, the faculty person wast
limited to preparation of the drug.
This is the world's expert. Sure, eventually other people
will be able to prepare this
But in this case, this person is particular activity.
adequately do that. Consultation about dose levels
and timing of administration
dangerous for the subjects to not have that person comment on
those things. Otherwise, you are at the risk
of misinterpreting the clinical data.
Co-authorship on resulting
Not lead authorship, publications.
It can be a bit of a pill to co-authorship.
The faculty can not serve as a swallow.
The faculty person cannot recruit patients and subjects.
The faculty person can't make decisions about the
implementation of protocol. The faculty person can't
participate in summary
trial. conclusions of the clinical
falls out of this, that's fine, but that faculty person can not
participate in any way in those conclusions.
That has to be up to the other
trial. investigator involved in this
situation. This is a pretty intrusive
this together, the institution So when we try and put all of
distinct from and individual conflict of interest is quite
We haven't addressed the former, conflict of interest.
latter. andI think our management ofthe
individual conflicts of interest
My perception is that how the campus conflict of interest
committee responds is a learning
They're coming to an curve.
and what's not involved. understanding of what's involved
as a function of time. I expect that process to evolve
bumpy, to tell you the truth. This is right at the crux of the
matter. Institutional conflict of
interest is going to be quite formidable.
It's going to take a while. The University of Wisconsin has
very deep relationships with
companies. tech transfer and individual
conflicts of interest is going And avoiding institutional
There's easy stuff to do. I mean, keeping drug companies
out of our enterprise, in terms of buying lunches and putting
pens all over the place, that kind of stuff is really quite
easy to accomplish. I'm much more worried about
where the institution has a potential interest in terms of
licensing intellectual property,
with a particular entity could and reaches a broad agreement
A few buzz words that keep be a problem.
the front. cropping up and need to be at
oversight and management. PI think if I ranked those,
disclosure is absolutely at the top.
The more you disclose, the
So where are the faculty on this kind of thing?
Well, there's sort of two perceptions, sort of how the
faculty feel about this process and how society feels about this
process.
faculty feel about the process. Just( laughter )t on how the
We have the wily fox
Don't move. surrounSay nothing.ounds.
Look straight ahead.
possible difficulty with respect They're trying to avoid any
committee. to the conflict of interest
The perception of how they're Sobehaving by society is quite.
different, all right? The crazy clinical rabbits have
been very, very bad again.
highly divergent points of view is really a tremendous challenge
institutionally.
dragged in at both ends of the And unfortunately, I get
I have to manage the public perception of the problem.
And at the same time, sway the
to put them out of business. faculty that no, I'm not trying
research activities. I'm not trying to restrict their
box sufficiently carefully that I don't run into a problem ina
terms with perception.
only one, and I won't discuss I hit, there's only been oneeen
instance where I've had a real
area. prIt turned out it was not al
situation that would be particularly harmful to the
subjects, but it was a
with respect to clinical trials. completely abhorrent situation
of that that I've encountered in There's only been one instance
having to worry about these the tekinds of things.e been
So, we're talking about a small slice at the bottom of the pie.
But it's a slice that's pretty
So I'll stop babbling. important.
minutes or so. I think I've talked about 45
questions. I'd be happy to not answer any
Yeah? >> Just in general, does this
affect faculty staying at the university?
Have you heard? >> Yeah, definitely.
If you make it sufficiently difficult for faculty to
rationally pursue their research, they will definitely
find a denominator that works better.
They will find a place where
in a more fascile manner. theyNo question about it.earch
I think the biggest troublesome thing for faculty is the delays
this add. This stuff really adds delays.
To get a protocol approved, which is already an exquisitely
painful process, to now add on a
attached to that protocol doubles and triples the amount
of time to get something
I know Steve has scars that have approved.
who are just enraged that it's been welted on him by faculty
It's not like we're ignoring the taken this long.
significant complexity, which is problem, it just adds a
when, you know, quite frankly, very frustrating, especially
scientific misconduct, and we're if we're not committing
we're mostly worrying about not commperception.ractice,
This leads into my question.
opportunity costs of taking this That is, are you rooted to the
conflict of interest? Is there some way, have you
started to get some insights on what those opportunity costs
are?
therapies out to help patients. YoDelays in getting graduateg
students their degrees and out
Because that seems like one of to practice.
available to counteract the poor the weapons we have perhaps
Not widely. There are some focal incidents,
you know, it's relatively easy
But they can easily be quite to figure that out.
opportunity costs. catastrophic in terms of the
reasons we work so hard on our I mean, for example, one of the
General Electric was it allowed affus to be very agile.ith
So when it becomes clear that you are agile and you can be
highly responsive when the
a big phenomenon. ciIf that particular research's
walked out the door and went
literally be millions of dollars someplace else, it would be
But you know, you're not in the business necessarily to just get
it that way.
where the faculty PI is in >> Protocols are many times
medical officer or scientific consultatiadvisor.e company
In your instance, if the faculty
company. member is founder of the
can get involved in the Whdiscussion of the clinicaler
trials, as a member of the
company? company, or as an advisor of the
the company. Where the PI is not related to
the institution not by the >> The protocol is developed by
Right, but can he participate in discussion from the company,
as a member of the company, with
the company, to discuss, the the PI, who is not a member of
No, I think that's not a institutional PI.
In other words, let me repeat situwhat I think I heard.seen.
You have a PI who's formed a
No, a faculty member from the company.
And an institutional PI, not
submitted a clinical protocol. associated with the company,
How does the faculty member, >> Right.
allowed to participate with discussions with the PI who is
submitting the protocol?
Because then they have the >> They're usually not at all.
protocol. p>> So if I was not associatedhe
with the university whatsoever, and I worked for a company,
would there be a different
company who's working with standard for faculty who had a
be a different standard than another PI on campus that would
with the company that's the sexpert with the company and nos
association with the university,
equal? or would that standard be about
be about equal. >Because the faculty member'sd
completely isolated from the
They don't have any reason to partparticipate in it.ial.
They're not part of a big acquisition.
They're not on the protocol and what they do privately is what
they do privately.
is uninvolved in that clinical But notice that faculty person
You spoke a great deal about trial, completely.
investigator faculty member and ownership in the company by the
faculty member. I wonder if you could speak to
us a little bit about support for the faculty member's
laboratory and how that might differ.
Yeah, the laboratory support, generally from the company, has
to come in in the form of some
to accept those funds. kind of contract, some agreement
about is a situation where the I think what you're talking
some substantive way with a company, and that company then
wants to support research in
laboratory. And to what degree is that
allowed.
in the form of either a Welcontract, or it's just andied
outright gift.
gift comes completely If it's unencumbered.ift, the
Remember, that's the definition of a gift.
So if the company says I'm going
research in this general area in to give $5 million to support
you use it is up to you, and we Drhave no claim and there's now
intellectual property.
The issue comes if there's a There's no issue.
A contract embodies some thing, cookay.t.
Maybe that contract embodies
additional IP that's generated. Maybe that thing has something
to do with the company's
A very common example is the resources.
have a totally unique resource, cwhich the company desperatelyy
wants to take advantage of. And the company says I will
support your research for X amount of dollars, but I would
like you to deliver the following kind of product.
That creates a conflict of
definitely requires discussion. It is not, however, forbidden.
That's a different conflict.
that area, and it occurs a lot, Theis when the company is ine in
essence, hiring the faculty member, the faculty member's
resource, which the faculty member is involved in the
company, to advance that
There are instances where we've allowed that to go on.
For example, if a faculty member
that it's unreasonable and has a totally unique resource,
to have it at that point in its irdevelopment, and the companyny
wants to compensate the university fair market value,
we've allowed that for a limited
But not in any ongoing way. There has to be some degree of
isolation.
Any other questions from the Did that get at the question?
What happens if members of audience?
involved with a protocol design, the laboratory of the PI get
You can't re-label it by for example?
It has to be clean. >> That's the disclosure part.
You can't play games like that.
And if you do, you're going to
even if it's completely above attract all tboard.ng attention,
Why risk something like that? It's just not worth it.
If the faculty member is a
allowed to see patients who are in a clinical trial at that
company, and there are separate means.
The trial is run by a separate
the company. PI who is not conflicted with
clinician who routinely sees The faculty member is a
Will he be allowed to see patients who are in the clinical
trial?
You can't do that. >> No.
Well thank you, Dean DeLuca, for >> Any other questions.
A pleasure. ( applause your good talk.
)