Yale Psychiatry Grand Rounds: September 16, 2022

September 16, 2022

Information

Presentation, Provost's Committee on Conflict of Interest at Yale

Edward L. Snyder, MD, FACP, Committee Chair; Jill Pagliuca, Committee Member

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00:00They will be Jill.
00:15Oh, I think we lost Stephanie.
00:23Let's see. We'll give her
00:25a minute to come back on.
00:40Say.
00:54Hmm.
01:05OK, so you were just introduced
01:07and we lost you, right,
01:09with Jill and we didn't get her last name in.
01:13OK. So anyway, sorry about that.
01:15So I'd like to also.
01:20OK, so you've lost me really early.
01:22OK, that's not good.
01:25So names, this is Jill.
01:28Luca, who's the director of the Conflict
01:31of Interest Office and we have Ed Snyder,
01:34who's a professor of laboratory
01:36medicine and a long standing
01:38member of the committee.
01:39So with this, I'll turn it
01:40over to the two of you to present.
01:42Thank you. Thank you.
01:44OK, well, thank you very much.
01:46Can you guys hear me? Yes, OK.
01:49Well, thank you very much.
01:50It's a pleasure to be here.
01:52We welcome the opportunity.
01:54I'm Ed Snyder.
01:55I'm was director of the Blood Bank at
01:57Yale for many years and I'm still there,
02:00but also currently direct
02:02the blood Bank at Bridgeport.
02:04And I've been a privilege
02:06to be on the COI committee.
02:08It's changed quite a bit over the years.
02:10And the purpose of this talk
02:11is to give you some idea of how
02:14this the committee functions.
02:16So it's not quite as much of a
02:18black box as it might have been.
02:19And also at the end,
02:20we've got a bunch of vignettes
02:23briefly to describe situations that
02:25are conflicts of interest or not,
02:27that may relate to many of you
02:29in the audience,
02:30and to sort of engender some discussion,
02:32which we're going to leave a
02:34bunch of time for at the end.
02:36And Jill and I will do A tag
02:38team kind of approach to do this.
02:40So for disclosures,
02:41I do run the three phase three clinical
02:44trials for the serious Corporation
02:47for Red Cell related issues and
02:50I'm also on the Board of Human Ethics,
02:52but I don't get it personal
02:54on our area or equity.
02:56As you'll see that you can't run a
02:58clinical trial and get equity from the
03:00company that you're doing the trial for,
03:02we'll talk about that and Jill has
03:04no external financial interest.
03:06Next slide please.
03:08So the conflict of Interest Committee is
03:10appointed by an advisory to the Provost.
03:13I've been sharing.
03:14I've had the honor of being
03:15chair for the last,
03:16I guess four or five years,
03:18I guess maybe more.
03:20We meet once a month every month
03:23through the summers and the winters and.
03:27We have about 20 two members of the committee
03:32and of which 16 are voting 6 or not.
03:35There's an equal group of men and women.
03:39The majority of the of the members are from
03:42the medical school faculty that are voting.
03:45We have a couple from the Faculty
03:47of Arts and Sciences and we have
03:50a variety of administrators,
03:52representatives of the Provost
03:53office and and so forth.
03:55We have quite an eclectic.
03:56Group as you'll see in one
03:58of the coming up slides,
04:00next slide.
04:01So the the charge is to advise
04:03the university leadership on
04:06implementing the COI policy.
04:09And this policy is designed to
04:11protect the faculty so that as well
04:14as is to protect the institution.
04:16And that seems to work pretty well.
04:19There are sometimes when things
04:21get a bit difficult because the
04:24faculty at Yale are all very
04:26bright and they're very creative,
04:28and they're all kinds of
04:30relationships that develop.
04:31And we try to be nimble to work
04:33with the groups and to make sure
04:36that university policy is applied,
04:38yet the faculty are given the
04:39freedom to do what
04:40they need to do.
04:41That's why they came here.
04:42So sometimes it's a little
04:44easier than others.
04:45So we just hope that
04:46everyone understands that.
04:47Our intention is to be helpful
04:49to to the faculty as well as
04:51to protect the institution.
04:56The review we review faculty requests
04:58to serve on boards of directors.
05:01Whether it's for profit or not,
05:03it doesn't matter.
05:04We review those all those requests.
05:06We determine whether significant financial
05:09interests presented with the disclosure,
05:13if there is a one existing with
05:15disclosures that the university faculty
05:18are required to to submit, and if so,
05:22how such conflict should be managed,
05:23reduced or eliminated.
05:25You can see we left afterward ignored.
05:28We don't have that option.
05:29If there's a conflict of interest,
05:31we need to manage it, to ameliorate it,
05:34reduce it or eliminate it.
05:36And there are a variety of ways we do it,
05:38which we'll talk about.
05:40We do an activities review to see if
05:43the significant financial interest.
05:44Has the potential to affect non research,
05:48the academic teaching or clinical
05:51administrative responsibilities and we
05:53also do order we call transactional
05:55reviews whether we determine if
05:57the significant financial interest
05:59directly and significantly affects.
06:01And these are the three buzzwords design,
06:03conduct and reporting.
06:05Which can relate to whether you get
06:08consent on something or whether you
06:11actually evaluate the data, et cetera.
06:13So it's a pretty broad brush that we use
06:17and it's not just something we invented.
06:20These are things that are used by a
06:22variety of funding agencies, the NIH.
06:25The National Science Foundation and others.
06:29And it varies among institutions.
06:31Some institutions are much stricter
06:33than Yale might be, for example.
06:35Others might be more LAX.
06:38So we are concerned about whether it
06:40affects directly and significantly design,
06:42conduct and reporting or or could
06:44the research have a direct and
06:46significant effect on the objectivity
06:48of the investigator's next slide?
06:52So the university policy states a
06:54conflicts exists when an individual
06:57has a significant financial interest.
06:59That's what SFI stands for.
07:01Should I didn't define that that
07:03could directly or significantly affect
07:05his university activities generally,
07:07this is when the external interest has
07:09incentive to our to the individuals conduct,
07:12his or her conduct,
07:14and whether there's an opportunity,
07:16which you'll see in a couple of slides.
07:18We'll show you how we put that into
07:20into effect. Next slide, please.
07:22So if you the,
07:26the concern for conflict of interest
07:28heightens in the medical school when
07:30there are human subjects involved
07:32in the research.
07:33So if you're,
07:34you know,
07:35in the Department of Anthropology and
07:37they want to give you a large amount
07:39of money to go on a trip or to do
07:42some lecturing that's different than
07:43it would be in the medical school.
07:45If you're asked to do a study and
07:47you're involved in recruiting patients
07:49and putting them into clinical trials,
07:51very, very different.
07:53What we have is a general.
07:56It's not an official policy but it's
07:58sort of the guidelines we follow that
08:01if you are getting personal remuneration.
08:03Personal remuneration excess of
08:05$10,000 that we do not allow you to
08:09do clinical trials for that company.
08:12Now,
08:12there are mitigating circumstances
08:14which you're seeing here.
08:16And why was $10,000 chosen?
08:18They had to be drawn somewhere.
08:20Some places have 5000 NIH,
08:23you need to report it 5000.
08:24Other places have larger amounts.
08:26Them institutions don't allow any
08:29financial personal remuneration.
08:32So there's a we have 10,000
08:34and if that's the case,
08:36if you're getting over $10,000 and
08:38you are involved in the design,
08:40conduct or reporting of
08:41research that you will,
08:43you have a management plan that
08:45usually gives you a choice of capping
08:47at 10K for that year or giving up.
08:50The research and faculty that I have
08:52talked to do both depending on who
08:54they are and what the situation is.
08:57And the conflict of interest
08:59involves yourself,
09:00your spouse and any dependent children.
09:02So if you are working for a company
09:05doing research and your wife works for
09:07that company and gets or your husband
09:09works for that company and gets $30,000,
09:12that has an impact on your
09:14conflict of interest reporting.
09:16So we'll make some of this clear.
09:18The the IT seems kind of Byzantine,
09:20but we're here to help and
09:22to to try to explain.
09:24So what you see here are a bunch
09:27of mitigating factors including
09:28if it's a multi centered study,
09:31remember we talked about the design conduct.
09:33Reporting.
09:33So what is the opportunity that someone has?
09:36If you're doing a study that
09:38has 50 patients in it and 40 of
09:40them are from Yale and you're
09:42getting money from the company,
09:44that's much more likely you'll have an
09:46impact on that than if it's a multicenter
09:49study being conducted at 75 institutions,
09:52multinational multi nationally and you're
09:55recruiting for patients that even if you
09:58completely were doing the wrong thing,
10:01you still probably wouldn't
10:02be able to affect.
10:03The outcome of the study,
10:04because it's such a minimal impact.
10:06So we look at whether it's a multi centered.
10:08We did look at whether Yale
10:10is a coordinating site,
10:11if there's less percent 5,
10:12less than 5% enrollment, if you're,
10:15if there's involvement in study design,
10:16collection, reporting consent,
10:18if there's an independent DSMB.
10:20All of these things go into the
10:21committee's evaluation of whether
10:23there's a conflict of interest.
10:25So it's not just black and white,
10:28there's lots of Shades of Grey that
10:30we consider and other factors as
10:32well such as if the individuals.
10:34Expertise is unique and there's a good
10:37reason why certain situations should occur.
10:40If the research is in an early stage,
10:42if it's in the best interest of patients
10:45who would directly benefit from involvement,
10:47all of these things we consider.
10:49We really do try to to look at
10:51all possible mitigating factors.
10:53Next slide, please.
10:54And there are other things we consider.
10:56If there are increased risks,
10:58if the research compares or value enhances
11:02investigators intellectual property,
11:04there's the opportunity for conflict.
11:05At least the appearance and
11:07optics are critical.
11:08We don't want anyone in the
11:10faculty to be the poster child
11:12on the Yale Daily News someday.
11:15We are.
11:15We try to work with individuals
11:18to ensure that they're complying
11:20with the university policy,
11:21and we understand what what
11:23the investigators needs are.
11:24If there are multiple SF's with the entity,
11:27if the investigator has intellectual
11:29property license to the sponsor,
11:31if their students or trainees involved,
11:34we've had some situations where faculty.
11:36Have been.
11:38Having students work on their projects,
11:40they're getting some money from
11:42companies and the faculty members
11:43on the students Thesis committee.
11:45All of these things are are Byzantine.
11:49Issues that need to be addressed
11:51and we have ways of of of addressing
11:54them and and and pursuing.
11:56How we can protect the student and
11:58the faculty and the institution.
12:00And there are various management
12:01plan techniques.
12:02Those of you who have received management
12:04plans disclosed in the collaborators,
12:06publications, research,
12:07you know well.
12:09For example, having a disclosure slide.
12:11I spoke to 1 faculty member who told
12:13me that he couldn't use a disclosure
12:15slide on his abstract presentation
12:17because he only had 15 minutes to present.
12:19Those of you who do this work,
12:21you know it takes about.
12:233 nanoseconds to show that slide and to
12:25discuss whether you have a conflict or not.
12:27So we do have some hard and fast rules
12:30that we require and but we try to be
12:32fair and very collegial as best we can.
12:35So next slide,
12:37please.
12:37All of these things are considered,
12:39and as I mentioned,
12:40we have a lot of interactions on
12:42the committee are people from the
12:44Office of Cooperative Research,
12:45which is now the University Yale.
12:49I figure what the V stands for.
12:52Cheers. Thank you, university.
12:54Yale Ventures, you only have one hospital,
12:56has a seat at the table.
12:58Yale Medicine,
12:58the office of sponsored projects,
13:00the institutional conflict of
13:03interest where the institution has
13:05either a royalties or they get
13:08the intellectual property as an
13:11institution involving human subjects.
13:13There's a separate committee that meets
13:15the discuss that at the provincial level,
13:17the IRB, the Purchasing office of purchases,
13:20the Purchasing Office is involved.
13:23Office of General Counsel and the
13:25conflict of Interest leadership,
13:26which really involves the Provost,
13:28Provost Office,
13:28and many of the other people
13:30present at at separate meetings,
13:32all have input into the COI.
13:34And as you can see their arrows at both ends.
13:36It's a pulsating Venn diagram,
13:38if you will, which can be quite.
13:40It's good to get all this,
13:42all this input that's needed.
13:43Next slide,
13:44please.
13:45So in the responsible conduct
13:47of research we give,
13:49we try to have educational outreach
13:51and this is a good example this this
13:54particular grand rounds we give
13:56yearly lectures to postdoctoral
13:58appointees on COI and COCC.
14:00We also have been asked to
14:01talk to the MD PhD students,
14:03which we'll be doing in a few months.
14:05We've had talks at the Himont group lab,
14:08medicine surgery and we have a couple of
14:11other departments to to discuss as well,
14:13also the FAS that we've talked to the chairs.
14:16And other groups,
14:17you know as as we have been
14:19requested. So if after this is over,
14:21you know another group that might
14:23benefit from our wonderful presentation,
14:25let us know, we'd be more than happy
14:27to discuss the opportunity to do that.
14:29I believe there's another slide.
14:31OK. So I'm going to turn this
14:32over now to to Jill Peluca,
14:34who's going to give us more information
14:36on the what the COI office does and
14:39then at the end we'll have some of the
14:41vignettes and then leave it up for questions.
14:44So Jill, it's all yours.
14:46Thank you, Ed. So the conflict of
14:48Interest Office administers and
14:50implements the universities conflict
14:51of interest policy procedures and
14:53we ensure compliance with conflict
14:55of interest regulatory requirements.
14:57Our activities include overseeing
14:59the external interest disclosure
15:01process for faculty and individuals
15:04who are responsible for the design,
15:06conduct or reporting of research.
15:08We provide advice to and support
15:10the activities of the COI committee
15:13and identifying and inappropriately
15:15managing reducing.
15:16Or eliminating conflicts and we work
15:18to ensure that committee determinations
15:20comport with regulatory and institutional
15:23conflict of interest requirements.
15:26We also make sure that there is equity
15:28in how those decisions are made.
15:31We assess the external interest
15:33disclosures submitted to determine
15:35if outside significant financial
15:37interest present conflicts of interest
15:39with sponsored research projects.
15:42As Ed described,
15:43those are called transactional
15:44reviews or with the individuals.
15:46Other institutional responsibilities,
15:49the activities review side of our House,
15:52if you will.
15:54But we also communicate and monitor
15:56conflict of interest management plans.
15:58We spend quite a bit of time doing that.
16:00We educate and advise faculty and
16:03other Yale community members who
16:06are affected by and dependent on
16:08COI requirements and processes.
16:10Again,
16:11advice to COI leadership Group and
16:14the institutional conflict of Interest
16:16Committee senior leadership regarding
16:19management approaches to mitigate
16:21risks and exposures we inform university.
16:24Letters of areas of concern
16:25and emerging issues.
16:27Of course.
16:27We submit the required financial
16:30conflict of interest reports to sponsors.
16:33We respond to public requests for
16:35information concerning financial
16:36conflicts of interest.
16:38The NIH regulations require that we do so,
16:42and we network with peer institutions
16:44and national organizations to see where
16:47Yale stands with some of our requirements,
16:50processes, etc.
16:54A little bit about the.
16:58External interest disclosure requirements.
17:00At Yale, I'll start off with who
17:04the requirements apply to faculty
17:07with a greater than 50% appointment,
17:10as well as any faculty or non faculty
17:14personnel who are the magic words.
17:17Again responsible for design,
17:18conduct or reporting of research.
17:20So that's regardless of percentage
17:22of appointment, rank,
17:23title if you're.
17:26On responsible for design
17:27comment reporting of research,
17:29you made the disclosure requirement criteria.
17:32We have faculty who hold administrative roles
17:34who also are required to submit disclosures,
17:37and also members of research
17:40compliance committees.
17:41The requirement is to disclose
17:45significant financial interests.
17:47A pause for a second to note that you
17:49are disclosing financial interest.
17:51You are not disclosing conflicts.
17:53I have a number of faculty who will say
17:55I don't have any conflicts to disclose.
17:57And so you're not disclosing
18:00conflicts necessarily.
18:01You're disclosing significant
18:02financial interests as defined by
18:05your particular funding sources.
18:08And if you follow along the disclosure form,
18:10you don't need to.
18:12Remember what disclosure thresholds are?
18:15The disclosure form itself will
18:17lead you through that.
18:18Fiduciary roles for outside entities
18:21qualify for disclosure and whether
18:23that's for profit or nonprofit.
18:25So that includes,
18:27as as Ed mentioned,
18:28a seat on the Board of Directors or
18:32any other type of fiduciary responsibility,
18:35officer type roles,
18:37intellectual property rights are disclosed
18:40and in terms of the timing.
18:43It's at least annually,
18:45and then the requirement is to
18:47update within 30 days of acquiring
18:51new significant financial interest,
18:53or if there's a material change to one's
18:57Yale responsibilities, for example.
19:00Appointment as a department chair,
19:02that's that would represent a change.
19:04That is a material change.
19:07And it's extremely important
19:10to keep disclosures up-to-date.
19:13We have to perform retrospective
19:18reviews for specifically for NIH
19:21funding sources and other agencies
19:24that are sponsors that apply the
19:27PHS requirements to their awards.
19:29There are negative consequences
19:31for failing to disclose timely,
19:33which include retrospective reviews, which.
19:38Create a lot of extra work
19:39for the faculty member.
19:40We have to go back and ask a series
19:42of questions about the financial
19:44interest when it was acquired,
19:46the impact on the research and.
19:49It can be a very time-consuming
19:51process for everyone involved.
19:55To help faculty ensure that
19:58their disclosures don't expire,
20:00we have a multi tier.
20:04We have multi tiered mechanisms,
20:05and some of them include automated
20:08reminders that come from the systems,
20:11either from the training management
20:14system or from the conflict
20:16of interest system itself.
20:18We pair that with manual reminders
20:21that come from the conflict.
20:24Interest office,
20:25we do have a small population of
20:27individuals who are responsible
20:29personnel on sponsored projects
20:31where they have disclosures that
20:33have expired and so we reach
20:36out to those individuals to.
20:41The CIA office directly reaches out
20:43to them to get them into compliance.
20:46We have partners in gatekeeping
20:48to ensure that the conflict of
20:51interest requirements are met.
20:52The office of Sponsored Projects,
20:54for example,
20:55confirms that all responsible
20:58personnel have non expired and
21:01the appropriate type disclosure on
21:03file prior to submitting proposals.
21:06And that's not a something Yale
21:09made-up or the conflict of Interest
21:12office decided to strong arm.
21:14It's it's a requirement for.
21:17NIH and NSF proposals office of
21:22sponsored projects also does the same
21:26gatekeeping before setting up awards,
21:28and that's regardless of funding source.
21:31And if non expired disclosures
21:33are not on file,
21:35that can lead to delays in award setup.
21:39The HRPP confirms that investigators
21:42on IRB protocols also have non
21:46expired disclosures on file with
21:49the COI office prior to reviewing
21:53IRB protocol applications.
21:55And we do have a tool that's available
21:58to Department Business Office.
22:00So individual departments have
22:02access to a case status report or
22:05they can proactively track and
22:07monitor disclosure dates types.
22:09And stacks.
22:15I'll talk a little bit about
22:17the disclosure landscaping Yale,
22:18since there are some different
22:21disclosure requirements and I know some
22:23of that can become confusing and some
22:26individuals participating on the present
22:28in the presentation today may meet
22:30more than one disclosure requirement.
22:32We have a senior administrative
22:34disclosure requirement,
22:36which is administered by the Office of
22:38the Vice President and General Counsel
22:40and they reach out to employees who make.
22:43Or influence decisions regarding auditing,
22:45purchasing, contracting,
22:46admissions, financial aid terms,
22:49and conditions of employment,
22:51fundraising, or grants administration
22:52so they reach out to those individuals.
22:56For example,
22:57a Dean of the medical school has to
23:00submit a disclosure that is reviewed
23:02through the General Counsel's
23:05office and the Vice president.
23:07I submitted disclosure through
23:09that process as well.
23:10There is a separate disclosure.
23:13Process for Yale New Haven health system.
23:15They have a separate systems
23:18Compliance operations office,
23:19and the requirement applies to their
23:22covered individuals such as officers,
23:24directors,
23:24certain key employees and medical
23:27staff members.
23:31We have a conflict of interest leadership
23:35Group and spoke to on the Nice visual
23:38that he had all of the different
23:40interactions it takes a village.
23:42So the COI leadership group is
23:45lives in the village with us.
23:48The membership consists of senior
23:50leadership from the Provost Office,
23:53representative from the General Counsel,
23:55myself and Ed's Office of
23:59Research Administration.
24:00And Office of Research Compliance.
24:03The leadership group is
24:05advisory to the Provost,
24:06and they do review cases that
24:09require provincial approval per
24:11faculty handbook requirements,
24:13for example,
24:14a request to serve on the Board of
24:17Directors or an exception to policy.
24:21They also are engaged in policy
24:23review and development and sometimes
24:25we have some very challenging cases
24:28that the COI Committee reviews,
24:31which we can escalate to or refer
24:34to the COI leadership group.
24:37There is also an institutional conflict
24:40of Interest committee appointed by
24:42the President of the University.
24:45And the purpose of that committee is
24:48to assess institutional significant
24:51external relationships of the
24:54university or and or university
24:56leaders to determine whether they pose
24:58the risk of creating institutional
25:00conflicts of interest in relation
25:02to human subjects research.
25:04So it's a limited scope.
25:06But policy and procedure directly
25:09related to financial interest that are
25:13related to human subjects research,
25:15and the committee decides on
25:17actions to eliminate or manage the
25:20institutional conflict of interest.
25:26A topic that dovetails with conflict
25:29of interest is conflict of commitment.
25:32There is a specific policy
25:35on conflict of commitment.
25:37It is Appendix D of the university
25:40policy on conflicts of interest and
25:43a conflict of commitment occurs
25:45when the commitment to external
25:48activities adversely affects the
25:51individual's capacity to meet
25:54university responsibilities.
25:55And the responsibility for reviewing,
25:57identifying and addressing conflicts
25:59of commitment is with the Dean
26:03and the relevant chair.
26:04The Faculty handbook allows outside
26:07consulting for full-time faculty
26:09one day and seven since conflict of
26:12commitment is not always a formulaic.
26:17Determination. It's it really.
26:20We rely heavily on department chairs.
26:23You know, you can have maybe five
26:25days a year, and if those are the
26:26five days a year that you're in
26:28clinic or meeting classes and not
26:29meeting those responsibilities,
26:30you could still have a conflict of
26:32commitment even though the number of
26:34days is below the allowable threshold.
26:36And we we are in the process of
26:40developing reporting for Deans and
26:42department chairs so that they
26:44can become more involved with and.
26:47Engage with their faculty about
26:49conflict of commitment issues.
26:53On the horizon, we have the enhancement of
26:58disclosure requirements and what's under
27:02consideration is the possible expansion
27:05of the population required to disclose,
27:09for example, all faculty as opposed to
27:12faculty with a greater and 50% appointment,
27:16lowering the threshold for
27:18disclosure sort of across the board.
27:22So disclosure is. Level playing field.
27:26Currently, the thresholds are tied to the
27:29funding sources and their requirements.
27:33There will be additional elements
27:35related to external activities.
27:37Unfortunately, we are looking at
27:40a more comprehensive disclosure.
27:43We're looking at more comprehensive
27:45disclosure requirements so that
27:47we can be responsive to changes
27:50in federal agency requirements.
27:51So there will be some additional elements,
27:55for example in kind support to be
27:58disclosed and additional travel
28:01disclosure requirements that.
28:03At present are are not in effect.
28:10And. Future enhancements, we would like
28:15to explore harmonizing university and
28:17the hospital disclosure mechanisms,
28:201 disclosure versus 2 separate disclosures.
28:23It sounds simple,
28:24but it's really a very challenging.
28:28Initiative the hospital
28:30has different requirements,
28:31different disclosure thresholds
28:33we don't want to impose.
28:35Requirements that we don't have to.
28:38So there's some tension with that.
28:41So for now,
28:43there are separate disclosure requirements.
28:45Another consideration is the
28:47possibility of publicly posting on
28:50Yale websites financial interests.
28:52Not so much value in amount,
28:55but the fact that these outside
28:57professional relationships exist.
29:01And we will at the end of the presentation.
29:04You know there might be some suggestions
29:06that come out of the talk that we gave today.
29:09So I called jotting those down and
29:12and listing that for future as well.
29:18So that since time permits,
29:21I think that we can delve into
29:23a little more detail and we can
29:26talk about the types of financial
29:28interests that are disclosed and
29:30that we review of course honoraria,
29:32consulting fees and any other
29:34fees for serving on for example
29:36a scientific Advisory Board,
29:38expert witness activities,
29:40financial interest can include
29:42patents and licenses,
29:43intellectual property equity
29:45and also as we discussed.
29:49Earlier fiduciary responsibilities,
29:50so things like board seats,
29:53officer roles, etcetera. And Umm,
29:57considerations are if there is a greater
30:00than $5000 significant financial interest.
30:03Again, that's the PHS,
30:05or NIH threshold for what is defined
30:08as a significant financial interest,
30:10or $10,000.
30:12If it's non PHS NIH funding,
30:16or if there are other significant
30:18financial interests such as
30:19equity in a startup company,
30:21the individuals disclosure is labeled with
30:23a transaction labeled as transactional.
30:26Give you required and we need to
30:29evaluate each sponsored project
30:31or new award against the outside
30:34financial interests.
30:35As Ed mentioned,
30:37there are special considerations
30:39for human subjects research,
30:41which may include limiting income to
30:44no more than $10,000 per calendar
30:47year if the number of mitigating
30:51circumstances do not exist and we know.
30:56That often we have individuals who
31:00have significant financial interests
31:02with with multiple entities so.
31:05Some of our faculty are prolific
31:07in their consulting engagements.
31:09And they're adhering to the one day in seven,
31:13but still have significant numbers
31:16of consulting or outside engagements.
31:20Intellectual property is not considered
31:24to be a significant financial
31:27interest by PHS or by the NSF,
31:30provided the royalties come
31:32through the home institution.
31:34And the reason for that carve out is
31:36that by dole act that encouraged the
31:39translation of new discoveries to market.
31:42So it's an inherent conflict
31:45of interest that.
31:47PHS and NSF recognize uh nevertheless.
31:54Yale's conflict of Interest
31:56Committee and the IRB.
31:57Thus, our disclosure form asks for
32:00information about intellectual property
32:02rights may take into consideration
32:04the existence of the intellectual
32:06property rights when evaluating
32:08conflicts of interest, for example,
32:11if the research evaluates the
32:14investigators intellectual property.
32:16And human subjects research that
32:19is testing or evaluating comparing
32:22the investigator's own IP can
32:24be especially worrisome and
32:26generally avoided unless they're a
32:29strong management plans in place.
32:31And we do have some of those
32:33ongoing examples.
32:36Another topic is startup companies.
32:41Faculty can and may hold equity interest in
32:43startups that license intellectual property.
32:46As a founder, you are entitled
32:48to your Founders equity.
32:50Any equity interest in the startup
32:52company is considered to be a
32:54significant financial interest.
32:55That is according to federal
32:59regulations and Yale policy.
33:01Therefore, it must be disclosed
33:04even if the options are.
33:06Founder shares are only worth the
33:08paper upon which they're written.
33:10They are still considered to be
33:12a significant financial interest
33:14and equity in startup companies.
33:17Investigators should be aware that
33:20their ability to conduct research
33:22sponsored by that same company.
33:24Especially human subjects
33:26research may be restricted.
33:28We have been able to in a number
33:30of cases to put in place management
33:32plans or as Ed pointed out,
33:34there are a number of mitigating factors
33:36that allowed us to go forward with the
33:40research with a management plan often.
33:42When it comes to basic science research,
33:45bench research,
33:46we do have faculty investigators
33:48who have equity and startup
33:50companies and research sponsored
33:52research agreements from the same,
33:55from the same entity,
33:56but again with a very strong
33:59management plan in place.
34:01Board of directors service must be
34:03improved and it must be approved
34:05in advance by the Provost Office.
34:08Because of the fiduciary obligation
34:09that comes along with the board seat,
34:12those obligations can conflict
34:14with the individuals.
34:16Yeah,
34:17responsibilities.
34:17The one tip I have is to discuss
34:21prospective board seats with startup
34:24companies or other for profit ventures.
34:27Very early on with the conflict
34:29of interest office.
34:30The approval process can take
34:32a number of weeks.
34:33I've had one that took close to two months.
34:37So it all depends.
34:38Some of them can go very quickly,
34:40some of them are more complicated.
34:43So allow plan early and allow
34:45for enough time.
34:48Gales startup policy states that
34:51a faculty member cannot serve as
34:54an officer of a startup or any
34:56other company while not on leave,
34:59and except for rare and compelling
35:03circumstances, that policy is is a.
35:09We also have what we call high value
35:12significant financial interests
35:13and that Yale, those interests
35:15are those that exceed $100,000.
35:17And they typically will prompt
35:19additional questions or asking
35:21for more detailed information,
35:23information regarding the activity,
35:26the entity, the individuals research
35:28at Yale and perhaps if they have an
35:32institutional or academic leadership role,
35:34if those high value significant
35:37financial interests could influence.
35:39Decisions that are made in that
35:42capacity and the reason for that
35:44is that there's some belief that,
35:47you know, the higher the value,
35:50the higher the incentive.
35:52So there are also philosophical
35:56conversations around,
35:57you know, high value,
36:00significant financial interest
36:01can sometimes exceed ones
36:03institutional employment value.
36:06So you know, we don't.
36:10Have a.
36:11Restriction on the amount,
36:15but we do look at the amount differently
36:18and may impose instructions if
36:19there is human subjects research.
36:26So Umm. And I think that I will turn this,
36:32the rest of the presentation back to you.
36:34OK. Thank you. One of the things
36:36that you should keep in mind,
36:38you're mentioned about the time
36:39it takes for board seats to be
36:41reviewed and some go slowly,
36:43some go quickly and it must be
36:45mentioned and some don't go at all.
36:47We have had faculty members.
36:49Come to us with a request for
36:51a board of director approval,
36:52seat seat approval for a seat as if
36:55it was a given that it would happen.
36:57And it turns out that some of
37:00them were so involved in the
37:02companies work and the work of the
37:04company was so involved in their
37:06hot their university activities.
37:08It would they were just not
37:10possible for them to coexist.
37:12And they were denied the
37:13ability to join the board,
37:14which was awkward because sometimes they
37:16had already made plane reservations
37:18for the next board meeting.
37:19Where they were going to be presented
37:21with great fanfare, so please.
37:23Listen closely about contacting us as
37:26soon as possible and don't expect that,
37:29because we have to work with multiple
37:31agencies and although we may be
37:33interested in moving it forward quickly,
37:35other agencies may not be so moved.
37:37So we try to help you and be your advocate.
37:39But with that we do have some
37:41constraints for human subjects.
37:43There's special considerations,
37:44the degree of risk some people
37:46would be more than happy to have.
37:49Special research done on them all.
37:51My doctor knows all about the special
37:53research activities and I'm getting
37:55state-of-the-art cutting edge.
37:56Others may say, are you kidding?
37:57I'm just a Guinea pig.
37:58There's no way you're coming
38:00with me unless it's been proven.
38:01So there are all kinds of things
38:03that have to be considered to protect
38:04the faculty as well as the subjects.
38:06Then the hospital doesn't get involved
38:08in some of these issues as the jail medicine.
38:11The phase of the trial,
38:12if it's phase one or two safety and
38:14efficacy versus the phase three
38:16clinical trial or phase four,
38:17which would be you know a a marketing
38:21evaluation of post approval of the FDA,
38:25whether it's a single or multiple site study,
38:28expected proportion of subjects to be
38:32accrued which goes to the ability of
38:34a single investigator to influence results.
38:36Is the randomization or blinding?
38:38Is there a data safety monitoring board?
38:40And should be conflicted
38:42investigator be involved in,
38:43you know, the activities.
38:45So next slide gives us the the
38:48start of the the case studies.
38:50What I'm going to do is just
38:52mention these in in an attempt to
38:54stimulate the interest that some
38:56of you may have for questions.
38:58So here's a situation.
39:00An MD PhD researcher receives 100,000
39:02in consulting fees from Mark Tag.
39:05The researcher prescribes
39:06martec drugs to their patient,
39:09and the researcher qualifies.
39:11Patients for the clinical trial
39:14using the drug as a comparison.
39:16And compared to other drugs,
39:19if you thought this was not
39:20a conflict of interest,
39:21you have not been listening because
39:24this is certainly a consideration
39:26for a conflict that
39:28would have to be evaluated thoroughly by
39:30the by the conflict of Interest committee.
39:33Next slide. Case two, an assistant professor,
39:37receives 4000 consulting fees
39:40from Armageddon Pharmaceuticals.
39:41The assistant professors also the Pi
39:44in a stage two clinical trial involving
39:47Armageddon where she is involved in design,
39:49conduct and reporting.
39:52This is not a conflict of interest because
39:55it's only $4000 looking at it on its face.
39:58There may be other extenuating
39:59circumstances we would need to look at,
40:01but as far as the whether it's a considered
40:03a significant financial interest,
40:05the answer would be no.
40:07Why? 9999 makes you,
40:10you know, relatively pure and
40:14$10,001.57 means that you've
40:16crossed the line. I'm sorry,
40:17the line needed to be drawn somewhere.
40:20That's why we have mitigating.
40:21Circumstances that come to play so
40:23we can try to be as this passionate
40:26and in the deciding and again
40:29we are advisory to the Provost.
40:31What we do is we say yes or no and
40:33it goes to the Provost and that
40:35office makes the final decisions.
40:37They usually want up to hear what
40:39our our points of view are and we
40:41always have guidelines but this case
40:43would not be if this was $114,000.
40:45Then we're back to slide one which
40:47I just I just talked about but it's
40:494K would be considered kosher.
40:51That's OK. Next slide.
40:53Of professors of founder of a new
40:56biotech she owns 5% or he owns 5%.
40:59Founders equity in stock.
41:01The professor also has several
41:03graduate students working in her lab
41:05on projects related to the startup.
41:07This is encumbered with conflicts
41:09of interest.
41:11It's a startup, there's equity involved,
41:13stock, and options.
41:14If the company is new and it's
41:16not on the Stock Exchange,
41:17we have no way of knowing what the what
41:19the stock may be worth because it's
41:22not listed and they're graduate students.
41:24Involved, which raises all kinds of
41:26red flags to protect the student.
41:28So you some may say,
41:29well,
41:29the student is working on this area is
41:33wonderful to help his or her career.
41:35They'll have a great inroad into
41:37an academic environment that's
41:39great for that student.
41:40What about the other two or three
41:42students in the in the same lab
41:44that aren't working as closely
41:46with the faculty member on the
41:47project who may feel that they're
41:49being excluded or the other persons
41:51being given preferential treatment?
41:53Double edged swords are alive.
41:54Well,
41:55in the conflict of interest world
41:56and we have to consider all of that,
41:58we often may have a an honest broker
42:00or a third party person that the
42:02students could go to to ask whether
42:05there's a concern and and and raise issues.
42:08So we work with people on that
42:10in that regard as well,
42:11protecting again the student,
42:12the faculty member and and the other
42:14students who may not be involved.
42:16So here's a little lightning round and
42:18then we'll open it up for questions.
42:2035% of an assistant professor
42:22salary by the Garbanzo Corporation.
42:24Is sent to the Yale Department for a
42:27phase three randomized clinical trial
42:28for which the assistant professor is the Pi.
42:31So none of the money goes as personal
42:33on Auraria to the faculty member.
42:36It goes to the university,
42:37the Dean takes the 30% or so
42:41indirect charges,
42:42and the and the grant is
42:45administered through the Yale.
42:48And let's say the it's $300,000
42:51that they're supplying.
42:52That is not a conflict of interest
42:54because it goes through the university.
42:55If it's not going as personal on area,
42:58that's fine.
42:59If it's going through the university,
43:02so this,
43:02although you might think there's
43:03a lot of
43:04money, it's over 10,000, maybe over 100,000.
43:07If it's through the university,
43:08it's acceptable. It's not a considered
43:10a conflict again on its face.
43:13The faculty member asked to sit in
43:14a not-for-profit board of a of a
43:17senior care and not-for-profit. Still,
43:19a conflict of interest has to be looked at.
43:21It usually requires very little
43:23discussion by the Committee of
43:25they're not probing for problems,
43:27but it does need to be brought
43:29up and approved by the Provost.
43:31Obviously the next one,
43:32whether it's a pharma giant joining
43:35the board, we would need to know,
43:36you know, what is the faculty
43:39members administrative activities?
43:41Are they in the middle of everyone
43:44who reports to them is working on
43:47a product made by that company?
43:48And here are the person who's the center.
43:52Node for all of this content
43:54or the faculty member.
43:57Reporting this to this person
43:59who now was sitting wants to
44:01sit on the board of this giant.
44:03That's a problem that needs
44:05to be adjudicated.
44:06Faculty is invited to join a speakers Bureau.
44:10Speakers Bureau has become anathema at Yale.
44:14The Yale New Haven Hospital has extensive
44:18retraining on speakers bureaus,
44:20and that was speakers Bureau.
44:22Doesn't mean that you're giving
44:24a clinical talk involving a
44:27company's activities.
44:28At a national meeting,
44:30it's when you have these little cozy
44:32dinners at well very high-priced
44:35restaurants where you're given slides
44:38by the company and you're basically.
44:41Trying to advertise for the companies
44:44product, those are the speakers bureaus.
44:46So you have to define what it
44:48is that you're referring to.
44:50And this is not just at Yale,
44:51this is nationally.
44:52In fact,
44:52Yale is trying to catch up to what
44:54many other institutions in my opinion,
44:56have already gone beyond.
45:00As far as the Speakers Bureau
45:02is not being acceptable,
45:04how about the faculty in the Department
45:06of Music or offered half $1,000,000
45:08to write a score for a movie?
45:10Not a conflict of interest.
45:11There's no human subjects involved.
45:13They do need to disclose.
45:15They need to disclose the 500,000,
45:17but congratulations.
45:18I hope it's a great movie and it's
45:22up to the department chair to
45:23determine if the amount of time that
45:25he or her spends writing the score
45:27becomes a conflict of commitment.
45:29But.
45:29It's not a conflict of interest,
45:31they just need to disclose it.
45:33And because human subjects aren't
45:35involved that that puts it into
45:37a different category but does
45:39need to be disclosed.
45:40And if a faculty member spends 50%
45:42of her time as an expert witness,
45:44this is conflict of commitment which the
45:46department chair would get involved in.
45:47And we don't make those adjudications
45:49and the conflict of interest committee,
45:52but we are getting more involved in
45:54assuring that that is is looked at
45:57by appropriate personnel in the.
46:00To the institution.
46:00So I think that was there another slide?
46:03I think there may be one more, yes.
46:05So COI is a situation,
46:07not a behavior nor an indictment.
46:09You do not need to walk around with a
46:11sandwich board saying I have a conflict of
46:14interest and people throw stones at you.
46:16Everyone to some degree
46:17may have an involvement.
46:18It's our job to work with you,
46:20to protect you, to protect the institution.
46:23I've said this multiple times,
46:25it is not an indictment and some
46:27people may not even be aware.
46:29It's an issue that's we're here to help.
46:31Transparency is the name of the game,
46:33no matter how many times you say it,
46:35disclosure is is the key and that's
46:38critical and certainly give us
46:40enough time to to work with you.
46:42Again, don't come to us at the last
46:43minute and expect we're going to say,
46:44oh, sure, no problem, glad to help.
46:47It may be the case,
46:48but you don't want to risk it if
46:50it's really an important issue.
46:51Disclosure of mitigation,
46:53management and elimination are
46:55the various management plans which
46:57can be fairly involved and we
46:59do work with you on that.
47:01If it's a big problem,
47:02I often call the faculty member in
47:05advance rather than have a some kind of a
47:07disturbing e-mail pop up in their inbox.
47:09We try to be as as helpful as we
47:11can and professional in our in our
47:14interactions with the faculty and please
47:16contact us if in one questions arise,
47:19the earlier the better.
47:20Jill and her staff are superb and we
47:23we try to be as helpful as we can,
47:25so I'll stop there if we have questions,
47:27hopefully from you folks,
47:29so we'll be more than happy
47:31to try to answer them.
47:32Thank you for your attention.
47:36Thank you very much.
47:37We can open it up to questions now
47:39if anyone has has one.
47:46And I'd suggest if you do
47:47you can just speak up.
47:48It's hard to monitor the. Umm.
47:52Gallery of Faces or you
47:53can put it in the chat and.