Managing Conflict of Interest from a Compliance Program Perspective

1. Managing Conflict of Interest from a Compliance Program Perspective Gayle Knight — Assistant Vice President for Compliance & Consultation, The University of Texas Health Science Center at San Antonio Rory Jaffe — Executive Director Medical Services, University of California Office of the President

2. Conflict of interest: a theoretical analysis • If you are not confused, you should be

3. 50,000 foot view

4. What is a conflict of interest? • A person in a position of trust has competing professional or personal interests • A conflict of interest is a situation, not a behavior • Ill intent or improper actions not required • Conflicts are common, and often encouraged! • Bayh-Dole act: academia can patent IP resulting from federally funded research • Translational research • Conflicts, if unaddressed, can lead to disaster • Loss of trust: veracity of research, willingness of people to volunteer as subjects, institutional prestige

5. Can be broken up into several questions: • Does this person have a position of trust? • Teaching, purchasing, treating, publishing, recording research data • Does this person have a competing interest? • Is the competing interest significant (“material”)? • Is the person involved in an activity that affects the competing interest? • Does the person’s official activities have a reasonably foreseeable material effect on that interest?

6. Does this person have a competing economic interest? • Interests in business entities • Investments • Positions in the business • Interests in real property • Interests in income sources • Honoraria, fees, etc. • Interests in gift sources • Personal financial effects • Effects on assets, liabilities, income, expenses • Includes immediate family

7. Does this person have a competing non-economic interest? • Trying to make tenure • Office romance • Allegiance to another country • Trying to succeed • Excessive belief in the ultimate success of the line of research • Trying to save the world

8. Is the competing interest significant? • Study of chocolate’s effect on blood lipid profile • Investigator A: $50,000 stock investment in candy company • Investigator B: Habitual consumer of chocolate bars—secretly hopes he won’t have to give them up • Investigator C: Assistant Professor, needs a few more publications to get tenure • Research assistant D: Under fire to get more subjects enrolled • How do you draw the line when an interest is not quantifiable?

9. Is the person involved in an activity that affects the competing interest? • Study of chocolate’s effect on blood lipid profile • Investigator A: $50,000 stock investment in IBM • Investigator B: $50,000 stock investment in pharmaceutical company that manufactures lipid lowering agent • Chairman of investigator A’s department: $50,000 stock investment in candy company • President of the University: University is recipient of $5,000,000 donation from chocolate growers’ cooperative

10. Is there a reasonably foreseeable material effect on that interest? • Study of chocolate’s effect on blood lipid profile • Investigator A: $50,000 investment in drug store chain • They sell candy • They sell lipitor • Investigator B: $50,000 investment in IBM • IBM gets some income from candy machines in the employee lounges • Investigator C: $50,000 investment in candy company that does not make any chocolate items • Investigator D: $50,000 investment in candy company that only makes chocolate bars

11. What do you do? • Legal obligations • What must you do • Organizational ethics • What should you do • Recognize limitations • Management vs prohibition • Non-quantifiable issues—inability to judge • Trade-offs • Innovation and conflicts are intertwined • Malfeasance and conflicts are intertwined

12. Conflict of Interest Institutional Conflict of Interest Committee IRB Research Conflict of Interest Committee Office of Technology Ventures Disclosure on Outside Boards & Other Activities Authorized Signatures on Contract Disclosure Consulting/ Outside Employment Affiliations Annual Disclosures Grant Applications

13. Conflict of InterestWhere does the Compliance Office start? • Who is the responsible party? • Does your institution have a policy on conflict of interest? • Is there a formal training program on conflict of interest? • Does the institution have a formal monitoring plan? • Is there a formal disclosure process?

14. Conflict of InterestWhere does the Compliance Office start? • Does your institution have a Conflict of Interest Committee? • If conflicts are identified, are formal management plans developed, reviewed, and approved? • How are conflicts communicated to the IRB? • Do you have an Institutional Conflict of Interest Committee? Does the Committee consist of community members?

15. Risk Assessment ProcessConflict of Interest Risk Assessment and Monitoring Plan

16. Monitoring Plan – Conflict of Interest

17. Managing RiskandOversight by Compliance Office Poorly controlled and/or no monitoring plan Minimally-controlled with no defined monitoring plan Well-controlled with established operational monitoring plan Compliance Office may facilitate risk assessment and monitoring plan development Compliance Office assists responsible party in designing and implementing an effective monitoring plan Compliance Office reviews and/or inspects monitoring and provides assurance report to management

18. Poorly-Controlled RisksResponsibilities of Compliance Office • Inform executive management • Facilitate risk assessment process • Assist in development of a formal monitoring plan with: • Operational controls • Supervisory/monitoring controls • Oversight activities • Review policies, procedures, training for development/revisions • Assess staffing levels • Provide recommendations to executive management

19. Minimally-Controlled RisksConsultation from Compliance Office • May assist in designing and implementing an effective monitoring plan • Independently evaluate procedures and processes for improvement • Identify potential gaps in reporting and controlling conflicts • Provides continuous feedback on improvement to policies, procedures, monitoring plans, training content, reporting, etc. • Works with management until controls and processes are strong and working

20. Well-Controlled RiskAssurance Activity from Compliance • Review risk assessment and monitoring plan • Determine if controls are embedded in day-to-day operations • Review and inspect: • Policies and procedures • Monitoring of training • Accountability for all disclosures • Review of disclosures by Committee • Backlog on review of disclosures • How are conflicts reported to IRB, within institution, etc. • Management plans are developed and approved • Management plans are reviewed annually • Reporting process for non-compliance (i.e. disclosures not completed, non-attendance to training, reporting of conflicts, etc.) • Displaying action for non-compliance

21. Ongoing Compliance Office Assurance • Conduct continuous reviews, inspections and validations • Provide guidance for improvement • May need to revise policies, procedures, operational responsibilities • Ensure updates to federal rules and regulations are implemented • Change in management may impact the processes currently in place • Continuous changes in environment or at national level may impact your current approach