Phil/Mbiol 7570, Fall 2007 Bryan Benham

1. Conflict of Interest and Commitment Phil/Mbiol 7570, Fall 2007 Bryan Benham 1

2. Tom publishes paper on effectiveness of drug compound A in cell populations. Theresa publishes a paper on effectiveness of drug compound B in cell populations. Also, declares that research was supported by the drug company BigDealDrugs, Inc. Evaluate

3. Why be more worried about Theresa’s publication than Tom’s? Is there a conflict of interest? What is it?

4. Outline • What is a conflict of interest? • Why should researchers care? • Types of conflict • Guidelines and Management

5. Conflict of Interest (CoI) A CoI arises when one’s personal interests have the potential to impair one’s judgment in fulfillment of one’s responsibilities. We all have multiple responsibilities that may come into conflict.

6. The ethical question: Not how to get rid of conflicts of interest, but instead how to balance and manage those conflicts of interest so that they don’t impair one’s judgment or ability to fulfill one’s responsibilities.

7. Research Interests? • Conduct and report research objectively • Conduct research in a way that preserves the integrity of the research enterprise…(RCR) • Conduct research productively, so that it adds to or advances further research

8. Of particular interest… • Research vs. Financial Interests • Individual conflicts • institutional conflicts* • Research vs. Other Commitments • Professional • Personal

9. Academic-industry collaborations are a fundamental and beneficial part of modern biomedical science. However, the increase in number and complexity of these relationships has been accompanied by concerns about financial conflicts of interest (COI).

10. Bayh-Dole Act of 1980 Universities may own intellectual property developed as a result of federally funded research • Universities and investigators share in profits from commercialization • But Congress concerned about openness and objectivity of academic research

11. Financial Conflicts of Interest • Financial interests in the results of research may inappropriately influence the design, conduct, or reporting of research. • May compromise the objectivity, integrity, and/or productivity of research • Appearances of financial conflicts also threaten public trust in the integrity of public institutions.

12. Dilemma • Financial rewards promote energy and creativity and thus promote good science • Financial rewards threaten the objectivity, integrity and productivity of the scientific process

13. National Policy • PHS guidelines published in 1995 • 42 CFR §50.600 • Association of American Medical Colleges Task Force - 2001 • Association of American Universities Report - 2001 • DHHS Guidance for Human Subject Protection - 2004

14. PHS/NSF Requirements • Investigators applying for federal funds must disclose potential financial conflicts to home institution • Home institution must ensure that conflicts are reduced, managed, or eliminated • Conflicts and management plans must be reported to agency • Disclosure required for “significant financial interests” (5% equity interest or $10,000 per year)

15. University of Utah Conflict of Interest Policy • Original policy written in mid-1990’s • Revised policy approved spring 2004 (PPM 2-30 Rev. 10) • Covers all research regardless of funding source • Defines activities that require disclosure • Defines activities that are not allowed • Establishes a process to identify, evaluate and manage individual conflicts of interest • Available at: www.admin.utah.edu/ppmanual/2/2-30.html

16. Activities that prompt a disclosure: • Submission of a new grant or contract to OSP • Submission of a new protocol to IRB • Submission of an invention disclosure to TCO • Request for signature authority on a University account

17. What information is required: If the discloser has significant financial or other interest in a business entity that is: • sponsoring the research or • whose business is substantially related to the subject of the project: • What is the business entity? • What is the nature of the financial interest? • How does the discloser propose to manage the conflict?

18. “Significant Interest” • Equity interest >$10,000 or 5% ownership • $10,000 or more income per year from the sponsor • Position as officer, director, agent or employee • DOES NOT INCLUDE • salary, royalties or other remuneration from Univ. Utah • income from seminars, lectures, teaching engagements, or service on review panels/advisory committees sponsored by public or nonprofit entities • income from mutual or pension funds

19. Activities that are Not Allowed (1) Academic freedom restrictions • sponsor interference in the scientific analysis, or with reporting of research results. • delay of academic degree by more than the time contractually allowed for publication and/or protection of intellectual property rights (up to 6 months). • confidentiality requirements that impact evaluation of a student, faculty member, or other employee. • evaluation of faculty, post-docs, staff, or students based on participation in business entities in which the evaluating employee has a significant financial or other interest.

20. Activities that are Not Allowed (2) • Solicitation or receipt of gifts • A violation of the Utah Public Employees Ethics Act • Payments, incentives or gifts, directly or indirectly, from sponsors, to employees conducting human subjects research • all funds must go into restricted research account • Negotiating an intellectual property license on behalf of the University with a business entity in which the employee has a significant financial or other interest

21. Management options: • Disclosure of the conflict in presentations and publications • Disclosure of conflict to potential human subjects • Conflicted individual prohibited from enrolling human subjects • Decision-making by a non-conflicted investigator • Blinding of data • Monitoring of the research by a non-conflicted peer, not a member of the research team. • Individual divests financial interests [rare] • Prohibit involvement of conflicted individual [rare] • Conduct research elsewhere [rare*]

22. Case 1 Project: Testing of a potent new anti-cancer drug, developed by Dr. John Smith, on persons with pancreatic cancer. Information: Dr. Smith is Chair of his department and a foremost expert in his field. He is also a stockholder in and Chairman of Board of Directors of ABC Corporation. ABC is funding this research project, for which Dr. Smith is the Principal Investigator. He is also the physician who will consent potential subjects into the project. He receives no salary support or personal remuneration from this project. Successful outcomes from the research will be of direct benefit to ABC.

23. Case 1 management 1. Disclosure of the conflict to all journals where results of the research are submitted and in all public presentations of the research. 2. Dr. Smith will disclose his conflict to all patients asked to consent to the study. (The reviewer commented: It will be difficult for anyone else to obtain informed consent because of lack of knowledge of the science.) 3. An individual without ties to ABC or subordinate to Dr. Smith will oversee the research to monitor that the conflict of interest does not influence the research or the interpretation of findings. This independent monitor will submit a statement that he/she is willing to serve in the role and has no ties to or financial benefit from ABC. The independent monitor will make a report to the Conflict of Interest Committee every 3 months.

24. Case 2 Project: Testing of a technology to measure concentration of certain chemicals in the human body Information: Dr. Ann Black is a professor in the College of Science. She has developed a new technology to measure concentrations of chemicals in the brain. She formed a startup company, 456 Corp, to develop and market the technology for diagnosis and treatment stroke. She also worked with the University’s Technology Commercialization Office to license her technology to 456 Corp. Dr. Black has a 25% equity ownership in the company, but receives no income or consulting fees. However, 456 Corp has a research agreement with the University’s Office of Sponsored Projects to conduct the project in Dr. Black’s laboratory. Several of her graduate students are supported by this project.

25. Case 2 management • The conflict of interest with 456 Corp will be disclosed to all journals where results of this research are submitted, and in all public presentations about this research. • Publication or public disclosure of the results of this research will not be delayed longer than the six months allowed by the University of Utah Technology Commercialization Office to file appropriate provisional patent applications. • Subordinates (graduate students, junior staff, etc.) will not be evaluated based on their willingness to participate, or their performance, in this project. • An individual without ties to 456 Corp or subordinate to Dr. Black will oversee the research to monitor that the conflict of interest does not influence the research or the interpretation of findings. This independent monitor will submit a statement that he/she is willing to serve in the role and has no ties to or financial benefit from 456 Corp. The independent monitor will make a report to the Conflict of Interest Committee every 3 months. • All inventions from this project will be disclosed to the Technology Commercialization Office.

26. Financial CoI Management of conflicts of interest provides protection for: • The integrity of the scientific enterprise • Investigators, research associates, students • Human subjects • The institution • The public

27. Federation of American Societies for Experimental Biology http://opa.faseb.org/pages/Advocacy/coi/guiding_principles.html

28. Guiding Principles • Investigators must conduct research activities objectively • Investigators must operate with transparency • Investigators must be accountable to all stakeholders

29. Stakeholders • Investigators • Institutions • Editors • Professional Societies • Industry • Professional Advancement • Experimental Subjects

30. Other Conflicts of Interest Conflicts of Commitment: One’s non-financial obligations conflict with one another and result in not being able to fulfill one’s obligations. Little or no regulation…

31. Peer Review? Dr. Axel receives a grant proposal to review, but notices that the proposed project has direct bearing on Dr. Axel’s own research, such that Dr. A may be tempted to use the proposed suggestions. Is there a conflict of interest?

32. Overworked? Graduate student B is expected to teach undergraduate courses and perform independent research for completion of degree. But time constraints limit the quality of both. Is there a conflict of interest?

33. Missing Prof. Professor C is a consultant for XYZ Inc. Prof. C has been spending approximately 40% of time working on XYZ project and this takes C out of the laboratory. C’s graduate students are upset that they don’t have contact with C as often as they would like. Is there a conflict of interest?

34. Having a Life Dr. D is a newly graduated Ph.D. with a new job at Big University. Dr. is also a new parent. Spending time with family and advancing in academia is important to Dr. D, but when writing a grant Dr. D can’t find time to do appropriate background research, so borrows large sections from old Professor’s grant application. Is there a conflict of interest?

35. What is your conflict of interest?