Yale Psychiatry Grand Rounds: September 16, 2022
September 16, 2022Information
Presentation, Provost's Committee on Conflict of Interest at Yale
Edward L. Snyder, MD, FACP, Committee Chair; Jill Pagliuca, Committee Member
ID8070
To CiteDCA Citation Guide
- 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.