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Kara Gavin, M.S.
Department of Communication
(and non-voting member of the U-M Institutional Conflict of Interest Committee)
Communicating Conflicts of Interest
Why is this
important?
• Our university works to improve
knowledge flow between U-M and the
“outside world”
• At the same time, we must uphold the
trust that the public places in us as a
public university, and protect the
reputations of our faculty as experts in
their field
• Communicators play a pivotal role in
both efforts!
Your role:
• Know what Conflict of Interest (COI)
is, for individuals and our institution
• Know how to find out if a topic you’re
communicating about involves COI
• Be transparent: Include
recommended COI language
in what you create.
It can be as simple as a phrase!
If we don’t…
What is conflict of interest?
Member of U-M
faculty/staff
Interest in
outside
company
or other
entity
Role in
invention
or project
(research,
clinical,
education)
COI
For individuals:
“Personal”
COI
What is conflict of interest?
U-M as an
institution,
or a top
U-M leader
Financial stake,
major gift or
leadership role in
company/entity
Invention,
research project
ICOI
For U-M as
an institution:
“Institutional”
COI
What makes it a “conflict”?
• When someone’s interest in an outside company or entity
could directly & significantly affect, or be affected by, the way
they do their U-M job
• For instance: How they design an experiment, conduct a research study,
describe research findings, address a certain topic with students or
trainees, or decide on treatments for their patients.
• Or, when U-M’s interest, or a top leader’s interest, in an
outside entity could affect how U-M conducts its business.
Why does COI matter?
Most of the time, it has to do with money –
or the potential to make money later.
Sometimes, it has to do with power
that a person has over another’s career.
Perception = Reality
Even if a person with a COI acts honorably in all cases,
we must guard against the perception that they COULD
easily act dishonorably to benefit themselves,
or the company or entity they’re involved with.
But a COI is not…
• Something to be ashamed of or hide
• Something that makes a person with a COI or a COI
management plan “bad” or “in trouble”
• Something we should shy away from mentioning
• At the least, it shows we work to keep undue influence out of our operations
• At its best, it help us show how U-M helps the world by partnering with
outside entities, while working to uphold the trust placed in us
What’s required?
• Faculty & staff must disclose outside interests that relate to their
role in research, education or clinical care to their supervisor
• Do this electronically at least once a year, and if things change
• Does not include U-M retirement plans & mutual funds
• If a person’s outside interest relates to research, they must also
disclose it to the appropriate committee (MEDCOI or UMOR COI)
• Disclosures via M-Inform, U-M’s electronic system
After disclosure, COI’s can be managed
• Management plans:
Specific actions that faculty/staff with COIs,
or their units, must take or are prohibited
from taking
• Goal: Keep the COI from biasing research,
affecting the training of students or the
careers of junior faculty, or affecting the
safety of patients or research participants
Plans may require COI disclosures in research papers, research consent forms,
presentation slides, CME, pre-lecture announcements, and publicity materials.
U-M communicators who create
stories, videos, websites and other
content about work covered by a COI
or ICOI management plan must work
with faculty & COI staff to follow the
plan’s requirements!
Med: medcoi-office@umich.edu
Institutional: coi.support@umich.edu
Give me an example!
Z looks promising, so
Company X funds U-M
Dr. Y to lead a clinical
trial, to see if Product Z
works on Disease D.
Doctor B may not be
involved in the trial, per
his COI management
plan.
U-M Scientist A &
Dr. B do research and
make Discovery C.
It seems promising in
animal tests for use in
patients with Disease D.
A
B
C
U-M files for a patent
on Discovery C; A&B
are named inventors.
U-M licenses the
discovery to
Company X, which
develops Product Z.
X C
COI
If the clinical trial shows
that Z works, and
Company X gets FDA
approval to sell Product
Z, then U-M, Scientist A
& Dr. B stand to receive
royalties from the sale
of Product Z to treat
patients. But Dr. Y
doesn’t.
Z©
FDA
Language you can use:
Story about a paper by A & B’s team that describes Discovery C:
“U-M has applied for a patent on Discovery C, with A and B as co-patent holders, and
licensed it to Company X. A & B may one day benefit financially if it proves successful.”
Clinical trial recruitment materials: “People with Disease D may be eligible for this
trial, which will test experimental treatment Z that was discovered at U-M and is being
developed by Company X under a license of U-M’s patent. The study will be led by
Doctor Y, who has no financial interest in Z or X.”
Social media post about Z’s FDA approval:
“Great news! Drug Z, discovered at U-M, has received FDA approval to treat Disease
D. The discovery of Z by U-M’s A & B led to its development by Company X, including
a clinical trial led by Dr. Y. Patients at Michigan Medicine may soon have access to Z.”
Give me another example!
Company L,
with A & B
as paid
consultants,
develops
Product Z, and
funds a study
of it elsewhere.
Z
U-M engineer A & Dr. B
do research & make
Discovery C.
They create an
algorithm to improve
detection of Disease D.
A
B
C
U-M files for a
patent on
Discovery C; A&B
are named
inventors. U-M
licenses Discovery
C to A & B’s new
startup, Company
L.
L
COI
U-M business
investment fund
F gives
Company L
seed funds, and
gets a partial
stake in the
company in
return.
ICOI
F
If the study shows
that it works, and
Company L begins to
sell Product Z, U-M
and A & B stand to
receive both
royalties & profits
from sale of their
company stakes.
Z©
Language you can use:
Story about Discovery C, before F invests funds:
“U-M has licensed Discovery C to U-M startup Company L, launched by A and B.
A and B serve as paid consultants to Company L.”
Investment announcement:
“U-M’s Fund F has invested in several companies started by U-M entrepreneurs. This
includes Company L, started by A and B, based on their research. In exchange for
this investment, U-M will receive equity in Company L.”
Product goes on the market: “A diagnostic tool developed at U-M is now available
to help diagnose Disease D. It’s being brought to market by Company L, started by
co-discoverers A and B, and supported in part by U-M’s Fund F. Michigan Medicine is
evaluating clinical use of it under an independent decision-making process.”
Give me another example!
U-M Leader X serves on the board of Company
Y, and is paid for that service.
Leader X oversees a unit of U-M.
Dr. Z, who is on faculty in that unit but doesn’t
have tenure, gets a research grant from
Company Y to study one of its experimental
products in a clinical trial.
This creates an Institutional COI because of
Leader X’s role with Company Y.
Before the clinical trial can begin, an ICOI plan
must be implemented. It makes sure that Dr. Z
and the project team, and her department chair,
all know of Leader X’s ICOI, and what to do if
they have a concern.
Company Y Board
Z
X
ICOI
Z team
member
Language you can use:
Communications about Dr. Z’s results from the trial of
Company Y’s experimental product:
“The study led by Dr. Z was funded by Company Y. Although U-M’s
Leader X is a member of Company Y’s board, Leader X was not
involved in the research or any decisions regarding it.”
How do I know if there’s a COI?
Ask key questions when planning communications:
Was this developed/invented at U-M?
If yes…
• By whom? Has the invention been filed with Innovation Partnerships
(previously known as Tech Transfer)?
• Has a patent been filed? Which individuals are on the patent application?
Is there a company involved?
If yes…
• Did they license the technology from U-M or express interest?
• Did they fund the research before, or are they funding it now?
• Do you have a relationship with the company
(founder, equity stake, consultant, leadership)?
How else could I know?
• Look for disclosures in slides & papers, and in research study
consent forms
• Check the ICOI spreadsheet for company names that should
trigger ICOI disclosures & language: http://michmed.org/JbkG0
• Ask COI staff if you’re uncertain or to get recommended language!
medcoi-office@umich.edu coi.support@umich.edu
Planning communications about a faculty member on a topic not related to
their COI? No disclosure is needed!
Official U-M, state and federal policies:
https://michmed.org/9AbxY
Medical School policies:
https://michmed.org/VJMX3
ALSO:
Ask Innovation Partnerships
(innovationpartnerships@umich.edu)
for proper language about the status of
any patent/license/FDA approval!

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Communicating Conflict of Interest 2024.pptx

  • 1. Kara Gavin, M.S. Department of Communication (and non-voting member of the U-M Institutional Conflict of Interest Committee) Communicating Conflicts of Interest
  • 2. Why is this important? • Our university works to improve knowledge flow between U-M and the “outside world” • At the same time, we must uphold the trust that the public places in us as a public university, and protect the reputations of our faculty as experts in their field • Communicators play a pivotal role in both efforts!
  • 3. Your role: • Know what Conflict of Interest (COI) is, for individuals and our institution • Know how to find out if a topic you’re communicating about involves COI • Be transparent: Include recommended COI language in what you create. It can be as simple as a phrase!
  • 5. What is conflict of interest? Member of U-M faculty/staff Interest in outside company or other entity Role in invention or project (research, clinical, education) COI For individuals: “Personal” COI
  • 6. What is conflict of interest? U-M as an institution, or a top U-M leader Financial stake, major gift or leadership role in company/entity Invention, research project ICOI For U-M as an institution: “Institutional” COI
  • 7. What makes it a “conflict”? • When someone’s interest in an outside company or entity could directly & significantly affect, or be affected by, the way they do their U-M job • For instance: How they design an experiment, conduct a research study, describe research findings, address a certain topic with students or trainees, or decide on treatments for their patients. • Or, when U-M’s interest, or a top leader’s interest, in an outside entity could affect how U-M conducts its business.
  • 8. Why does COI matter? Most of the time, it has to do with money – or the potential to make money later. Sometimes, it has to do with power that a person has over another’s career.
  • 9. Perception = Reality Even if a person with a COI acts honorably in all cases, we must guard against the perception that they COULD easily act dishonorably to benefit themselves, or the company or entity they’re involved with.
  • 10. But a COI is not… • Something to be ashamed of or hide • Something that makes a person with a COI or a COI management plan “bad” or “in trouble” • Something we should shy away from mentioning • At the least, it shows we work to keep undue influence out of our operations • At its best, it help us show how U-M helps the world by partnering with outside entities, while working to uphold the trust placed in us
  • 11. What’s required? • Faculty & staff must disclose outside interests that relate to their role in research, education or clinical care to their supervisor • Do this electronically at least once a year, and if things change • Does not include U-M retirement plans & mutual funds • If a person’s outside interest relates to research, they must also disclose it to the appropriate committee (MEDCOI or UMOR COI) • Disclosures via M-Inform, U-M’s electronic system
  • 12. After disclosure, COI’s can be managed • Management plans: Specific actions that faculty/staff with COIs, or their units, must take or are prohibited from taking • Goal: Keep the COI from biasing research, affecting the training of students or the careers of junior faculty, or affecting the safety of patients or research participants Plans may require COI disclosures in research papers, research consent forms, presentation slides, CME, pre-lecture announcements, and publicity materials.
  • 13. U-M communicators who create stories, videos, websites and other content about work covered by a COI or ICOI management plan must work with faculty & COI staff to follow the plan’s requirements! Med: medcoi-office@umich.edu Institutional: coi.support@umich.edu
  • 14. Give me an example! Z looks promising, so Company X funds U-M Dr. Y to lead a clinical trial, to see if Product Z works on Disease D. Doctor B may not be involved in the trial, per his COI management plan. U-M Scientist A & Dr. B do research and make Discovery C. It seems promising in animal tests for use in patients with Disease D. A B C U-M files for a patent on Discovery C; A&B are named inventors. U-M licenses the discovery to Company X, which develops Product Z. X C COI If the clinical trial shows that Z works, and Company X gets FDA approval to sell Product Z, then U-M, Scientist A & Dr. B stand to receive royalties from the sale of Product Z to treat patients. But Dr. Y doesn’t. Z© FDA
  • 15. Language you can use: Story about a paper by A & B’s team that describes Discovery C: “U-M has applied for a patent on Discovery C, with A and B as co-patent holders, and licensed it to Company X. A & B may one day benefit financially if it proves successful.” Clinical trial recruitment materials: “People with Disease D may be eligible for this trial, which will test experimental treatment Z that was discovered at U-M and is being developed by Company X under a license of U-M’s patent. The study will be led by Doctor Y, who has no financial interest in Z or X.” Social media post about Z’s FDA approval: “Great news! Drug Z, discovered at U-M, has received FDA approval to treat Disease D. The discovery of Z by U-M’s A & B led to its development by Company X, including a clinical trial led by Dr. Y. Patients at Michigan Medicine may soon have access to Z.”
  • 16. Give me another example! Company L, with A & B as paid consultants, develops Product Z, and funds a study of it elsewhere. Z U-M engineer A & Dr. B do research & make Discovery C. They create an algorithm to improve detection of Disease D. A B C U-M files for a patent on Discovery C; A&B are named inventors. U-M licenses Discovery C to A & B’s new startup, Company L. L COI U-M business investment fund F gives Company L seed funds, and gets a partial stake in the company in return. ICOI F If the study shows that it works, and Company L begins to sell Product Z, U-M and A & B stand to receive both royalties & profits from sale of their company stakes. Z©
  • 17. Language you can use: Story about Discovery C, before F invests funds: “U-M has licensed Discovery C to U-M startup Company L, launched by A and B. A and B serve as paid consultants to Company L.” Investment announcement: “U-M’s Fund F has invested in several companies started by U-M entrepreneurs. This includes Company L, started by A and B, based on their research. In exchange for this investment, U-M will receive equity in Company L.” Product goes on the market: “A diagnostic tool developed at U-M is now available to help diagnose Disease D. It’s being brought to market by Company L, started by co-discoverers A and B, and supported in part by U-M’s Fund F. Michigan Medicine is evaluating clinical use of it under an independent decision-making process.”
  • 18. Give me another example! U-M Leader X serves on the board of Company Y, and is paid for that service. Leader X oversees a unit of U-M. Dr. Z, who is on faculty in that unit but doesn’t have tenure, gets a research grant from Company Y to study one of its experimental products in a clinical trial. This creates an Institutional COI because of Leader X’s role with Company Y. Before the clinical trial can begin, an ICOI plan must be implemented. It makes sure that Dr. Z and the project team, and her department chair, all know of Leader X’s ICOI, and what to do if they have a concern. Company Y Board Z X ICOI Z team member
  • 19. Language you can use: Communications about Dr. Z’s results from the trial of Company Y’s experimental product: “The study led by Dr. Z was funded by Company Y. Although U-M’s Leader X is a member of Company Y’s board, Leader X was not involved in the research or any decisions regarding it.”
  • 20. How do I know if there’s a COI? Ask key questions when planning communications: Was this developed/invented at U-M? If yes… • By whom? Has the invention been filed with Innovation Partnerships (previously known as Tech Transfer)? • Has a patent been filed? Which individuals are on the patent application? Is there a company involved? If yes… • Did they license the technology from U-M or express interest? • Did they fund the research before, or are they funding it now? • Do you have a relationship with the company (founder, equity stake, consultant, leadership)?
  • 21. How else could I know? • Look for disclosures in slides & papers, and in research study consent forms • Check the ICOI spreadsheet for company names that should trigger ICOI disclosures & language: http://michmed.org/JbkG0 • Ask COI staff if you’re uncertain or to get recommended language! medcoi-office@umich.edu coi.support@umich.edu Planning communications about a faculty member on a topic not related to their COI? No disclosure is needed!
  • 22. Official U-M, state and federal policies: https://michmed.org/9AbxY Medical School policies: https://michmed.org/VJMX3
  • 23. ALSO: Ask Innovation Partnerships (innovationpartnerships@umich.edu) for proper language about the status of any patent/license/FDA approval!