Communicating Conflict of Interest 2024.pptx

Guide for communicators at the University of Michigan about why, when and how they should mention individual and institutional conflicts of interest related to anything they're communicating about

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!

4. If we don’t…

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: [email protected] Institutional: [email protected]

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. Z (experimental) 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! [email protected] [email protected] 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 ( [email protected] ) for proper language about the status of any patent/license/FDA approval!