Understanding and Managing Conflicts of Interest in Research

1. Understanding and Managing Conflicts of Interest in Research Malcolm R. (Mac) Parks, Ph.D. Assoc. Vice Provost for Research University of Washington May, 2002

2. Consider these headlines… Risk Was Known as FDA OKd Fatal Drug Study New documents show Warner-Lambert trivialized liver toxicity of diabetes pill Rezulin while seeking federal approval. Inside help from senior regulators is trumpeted in company memos. Los Angeles Times March 11, 2001 Standing up to industry: As corporations increasingly hold their purse strings, many researchers feel pressed to deliver favorable results -- Baltimore Sun June 26, 2001 Drug testing under ethics microscope USA Today August 7, 2000 • The Scientist, May 28, 2001 • When Corporations Pay for Research: • UCSF researcher disputes trial results from drug company Standing up to industry: As corporations increasingly hold their purse strings, many researchers feel pressed to deliver favorable results -- Baltimore Sun June 26, 2001

3. Focus on conflicts of financial interest… “A potential financial conflict of interest occurs when there is the possibility, from the perspective of an independent observer, that an individual’s private, financial interests, or his or her family’s interests, may influences the individual’s professional actions, decision, or their judgment in pursuing research .” Council on Governmental Relations, 2002 Does this happen where you work?

4. Learning Objectives… • Identify and define conflicts of financial interest in research. • Understand the process of disclosure and management. • Apply tools for managing conflicts of financial interest. …and we want to do all this in terms of real cases.

5. Two most important points…. • Managing conflicts of financial interest is part of the research design process. • Disclosure of interests promotes the public character of science.

6. Two most important steps... • Disclosure of interests by all involved parties. • Thoughtful application of problem-solving tools.

7. Whose financial interests? • Investigators, including students • Staff • Family members

8. What financial interests? • Salary, honoraria, consulting fees or other payments from sponsors. • Stock, stock options, or other ownership interests. • Intellectual property rights. • Royalties from the University for work in the field of inquiry.

9. Where do potential conflicts of financial interest arise? • Consulting. • Licensing of University technologies. • Research (esp. research involving human subjects). • Purchasing / procurement • Mentoring.

10. Let’s get down to cases... What should be disclosed? What financial interests need to be managed? What are the options for managing these interests?

11. Scenario 1: Dr. McGrath & Big River • Issues… • Is the seminar presentation and discussion a straightforward scientific exchange among peers similar to a presentation at a professional meeting? • Does the presentation constitute a “disclosure” of information to the company? • Should Dr. McGrath consider what information is disclosed at this type of meeting? • Facts… • PI as consultant • Federal funding • Company has immediate financial interest in topic • PI shares unpublished research.

12. Management strategies… • University may want to a nondisclosure agreement with Big River in order to protect any patentable invention that might have been disclosed during the initial visit to the company. • McGrath needs to inform company of his obligations under the Bayh-Dole Act (i.e. University owns intellectual property created through federal funding). • McGrath should discuss his consulting relationships with the University prior to presenting seminars or workshops for private industry.

13. Scenario 2: Big River includes Dr. McGrath • Issues… • What does the nondisclosure agreement cover? To whom does it apply? • Is it appropriate to restrict McGrath’s discoveries to Big River? • What are NSF and DOE’s rights to the discoveries? The University’s? • Will the grad student be free to publish or to use work for dissertation? • What responsibilities does Big River have to protect McGrath’s work? • Is McGrath signing as an individual or as a representative of the University? • Facts… • Larger private consulting agreement • McGrath signs for self and University • McGrath agrees to disclose only to Big River • Big River claims intellectual property • McGrath dedicates student and University resources to complementary project.

14. Management strategies and issues… • Most universities will require disclosure of the consulting relationship. • The University is likely to request renegotiation of the nondisclosure agreement. Eliminating language that prevents disclosure to University and federal sponsors. • The consulting agreement should not assign IP broadly. The agreement should acknowledge that the University has dominant rights. • Publication issues should be addressed. • Consulting relationships should not involve students or University resources. • Faculty can not sign agreements on behalf of the University.

15. Scenario 3: McGrath, Big River, & FastFill • Facts… • Big River draws broadly on intellectual property developed by Dr. McGrath, students, & Big River engineers. • Big River finances start-up company-- FastFill • McGrath becomes co-founder & chair of company advisory board. • FastFill awards McGrath lab research grant. • McGrath retains faculty roles and responsibilities. • Issues… • Have Dr. McGrath’s commitments to the company made it too difficult to fulfill his University responsibilities? • Is it appropriate for the company to trade on Dr. McGrath’s role in the University? • Is technology development compromised by an inability to sort out intellectual property rights? • Do McGrath’s company roles create a conflict of financial interest if he becomes PI on the grant? • Does the research agreement obligate intellectual property and student effort?

16. Management strategies and issues… • University may require McGrath to either withdraw from roles in FastFill or take a leave of absence while he works with the company. • The University is going to claim ownership of intellectual property developed in grant and then pursue licensing to company. • McGrath will be required to disclose financial relationships to students and co-workers at University. • University may appoint oversight group for research. • Consulting relationships should not involve students or University resources. • Publication restrictions, if any, will be eliminated.

17. Principles and Practices for Managing Financial Conflicts of Interest... …based on UW example Research integrity is paramount: Researchers are not allowed to perform the primary data analysis unmonitored on projects in which they hold a financial interest. The University generally does not accept industry-sponsored clinical trials involving technologies that the University has licensed to the sponsor.

18. Public scrutiny and access must be protected: All research data and results must be available for review by scientists who have no financial interest of any kind. No publication restrictions on the results of industry-sponsored research. Researchers having a financial interest must disclose the amount and nature of that interest as part of the University's GIM-10 process. Researchers having a financial interest must disclose that interest tothose organizing presentations of their work and to publishers.

19. Human subjects and students must be protected: • Researchers having a financial interest are not allowed to participate in the informed consent process in studies involving human subjects. • Human subject review committees are informed of researchers' financial interests and are empowered to inform subjects of those interests. • The University safeguards and protects students' academic activities from commercial exploitation.

20. Start-up companies warrant additional attention: • No researcher should receive funding for a clinical trial from a start-up company in which he or she holds equity. • No researcher should receive funding for a clinical trial from a start-up company in which he or she serves as a board member or in another direct management position.

21. Licensing activities spur additional review: • Researchers having a financial interest are not allowed to participate in negotiating the terms and conditions of contracts or licenses involving the University. • Researcher involvement in industry-sponsored research is re-reviewed if that research leads to licensing negotiations. • Special oversight committees are appointed in cases involving intellectual property, student researchers, and the potential for inappropriate use of state property.

22. Additional reminders: • Consulting relationships that distort the responsibilities to the University as the primary employer should be avoided. • Don’t enter agreements that limit publication. • Do not use students or university facilities in consulting activities. • Keep a separate record of unique information or intellectual property discussed in consultations. • Refrain from creating the impression that the University has sanctioned an outside activities unless you have explicit approval to do so.

23. Summary… Handling conflicts of interest is not about who’s good or bad. It is about making design and staff decisions that protect and enhance the credibility of your research. Self-management is the first, best step. It’s a team thing– we all have a role to play.