Conflicts of Interest at Duke: Identification, Disclosure, Management

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2. Agenda. Overview of Administrative Conflict of Interest Current Climate: Industry Trends

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Conflicts of Interest at Duke: Identification, Disclosure, Management

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1. Conflicts of Interest at Duke: Identification, Disclosure, Management Joan M Podleski Director, Duke IECP

2. 2 Agenda Overview of Administrative Conflict of Interest Current Climate: Industry Trends & Regulatory Environment Key Points of Policy Responsibilities Related Policies: Nepotism & Procurement Examples and FAQs Questions

3. 3 Administrative COI Policy Approved by Duke Board of Trustees May 2008 Affects officers, directors, and any individual with administrative responsibilities Policy addresses: financial conflicts, conflicts of commitment, and conflicts that may be presented by the employment of or business relationship with a relative (nepotism) Introduce as raising awareness of conflict of interest and responsibilities Remove first bullet point for PDC—if have questions contact Mark CantrellIntroduce as raising awareness of conflict of interest and responsibilities Remove first bullet point for PDC—if have questions contact Mark Cantrell

4. 4 Scope of Policy Administrators who: Are involved in decisions or serve in a position to influence, recommend, or make purchases Hire employees Offer expert advice, or influence or manage vendor relationships AND the family of those administrators

5. 5 Issues Addressed in Policy Potential Conflicts of Interest Ownership or employment by a vendor doing business with Duke Acceptance of gifts from vendors or potential vendors Consulting relationships with a vendor doing business with Duke when the administrator can influence decisions or recommendations related to that business

6. 6 Issues Addressed in Policy Conflict of Commitment Membership on boards or advisory boards that take time away from work to the extent that full-time job obligations are not met Employment by another entity that is part-time, but that interferes with meeting the administrator’s full-time job obligations to duke Aggregate time spent in outside activities that interfere with the performance of Duke obligations

7. 7 Current Climate Industry trends Increased governmental focus on transparency and accountability Office of Inspector General reviewing how federal funding agencies are monitoring for COI Pending legislation (Sunshine Act) Research programs shut down due to apparent conflicts Applicability to non-medical research becoming more common

8. 8 Industry Trends – AAMC Task Force Report on Industry Funding of Medical Education Establish policies governing interactions between drug and device industry reps and clinicians Recommend Elimination of: Gifts Free samples (manage through centralized process) Pharmaceutical rep visits in patient areas Faculty involvement in industry-sponsored speakers’ bureaus Ghostwriting Review quicklyReview quickly

9. 9 COI Policy Key Points Clarity of compliance and disclosure responsibilities for those in administrative roles COI reporting form: Declaring relationships Definition and guidance on conflict of interest, conflict of commitment, nepotism Definition and clarification on “material gifts” Creation of FAQs to provide guidance

10. 10 Compliance and disclosure for those in administrative roles Guidance to review staff disclosures of relationships Oversight of any COI management plans put in place Reinforces confidentiality obligations Responsibilities: How will this affect me?

11. 11 Procurement Issues

12. 12 Responsibilities: How will this affect me? Product Review Committee members Sign disclosure form Reaffirm COI status at each meeting Disclosure responsibilities If COI exists, participant not involved in decision making Strict confidentiality regarding information discussed in meetings Product Requesters Sign disclosure form

13. 13 Vendor Review Meetings Codicil to meeting documents: “As part of the work of this team, you will have access to pricing and other vendor information. Materials and pricing provided by vendors should not be shared outside the team nor should such information be made available or communicated in any way to anyone outside Duke. It is important that you maintain the highest level of confidentiality regarding this process and any information you receive. Disclosure of information outside the team may result in disciplinary action, up to and including termination of your employment at Duke.” Concurrent with the Conflict of Interest process, we are reinforcing confidentiality Concurrent with the Conflict of Interest process, we are reinforcing confidentiality

14. 14 Examples

15. 15 Examples Are individuals covered by this Policy permitted to accept any gifts, or are all gifts banned? The policy prohibits the acceptance of material gifts, favors, or hospitality that might influence or appear to influence their decision making or compromise their judgment in actions. “Material” is defined to be anything having a fair market value of $25 or more.

16. 16 Examples An example of a prohibited gift is accepting tickets to sporting events, concerts, plays, and similar events; accepting merchandise of greater than $25 in value.

17. 17 Examples Are vendors still able to provide lunch during a lunch and learn session when they are providing training on a new product that is being implemented? Vendors may provide nominal lunches such as pizza or sandwiches.

18. 18 Examples What about visiting vendors’ facilities? May vendors pay for site visits? No. With regard to visits to vendor facilities, if the department administrator in consultation with Procurement determines that it is in the best interest of Duke, then Duke will pay the travel expenses.

19. 19 Examples What if I am participating on a vendor-sponsored user group? May a vendor pay my travel expenses? No. If your participation on a user group has been approved by your immediate supervisor as being in the best interest of Duke, then Duke will pay the expenses. Under the assumption that the supervisor has okayed presentation at seminar and participation on a vendor-sponsored user groupUnder the assumption that the supervisor has okayed presentation at seminar and participation on a vendor-sponsored user group

20. 20 Examples When a vendor sponsors a seminar, may they pay for my time and travel to the seminar? If you will be presenting on a topic unrelated to the vendor’s product or service, the vendor may pay for your expenses but not your time. If the presentation is related to the vendor’s product or service, the vendor may NOT pay any of the expenses. Under the assumption that the supervisor has okayed presentation at seminar and participation on a vendor-sponsored user groupUnder the assumption that the supervisor has okayed presentation at seminar and participation on a vendor-sponsored user group

21. 21 Examples May I attend a seminar which is sponsored by a vendor that is offered free to all participants? Yes. Because the vendor is paying for all participants, this would not be a violation of the Conflict of Interest policy. On-site meals that are part of the event may be included. Example. Vendor wants to pay for breakfast during round tables (nominal value) Cannot be discussing vendor’s productExample. Vendor wants to pay for breakfast during round tables (nominal value) Cannot be discussing vendor’s product

22. 22 Examples May I provide consulting on my personal time or is this a conflict of commitment or conflict of interest? This situation could be a conflict of interest or commitment. In order to comply with the Policy, you should take the following steps: Not on Duke’s time—during PTO or time offNot on Duke’s time—during PTO or time off

23. 23 Examples, cont. Next Steps: Notify your manager Complete a revised Disclosure Form for review Manager must consider if responsibility conflicts with Duke position and propose a management plan if appropriate Employee cannot use Duke’s name, materials or other Duke staff members to perform outside responsibilities Employee must perform Duke obligations, e.g., be available for coverage or overtime requirements with no special considerations Employee cannot use information gained at Duke Employee should identify any vendor funding for supervisor to consider in management process Manager must oversee the management plan agreed upon by the COI review committee and the employee Not on Duke’s time—during PTO or time offNot on Duke’s time—during PTO or time off

24. 24 COI Policy Summary COI Policy requires individuals with administrative responsibilities to exercise their best care, skill, and judgment for the benefit of Duke “Individuals shall not accept any material gifts, favors, or hospitality that might influence their decision making or compromise their judgment in actions affecting the University.” If an employee has a relationship with a vendor representative, it could be interpreted as a conflict of interest in influencing product decision making or it may be seen as Duke sponsoring a particular product. For effort reporting—talk to ComplianceFor effort reporting—talk to Compliance

25. 25 COI Policy Summary Policy covers financial conflicts, conflicts of commitment and nepotism Policy requires disclosure of all outside relationships as defined in the policy and fully answer all questions on the COI Disclosure Form Disclosures will be reviewed to determine if there is a conflict that needs to be managed or eliminated Compliance is required with this and all Duke policies For effort reporting—talk to ComplianceFor effort reporting—talk to Compliance

26. 26 Questions For questions regarding Conflict of Interest, please contact: [email protected] Office of Internal Audits at 613-7630 Duke Procurement at 681-5900 Compliance concerns can be reported to the Duke Institutional Ethics & Compliance Office at 919-613-7691 or to [email protected] Issues can be reported anonymously to the Duke Compliance & Fraud Hotline at 1-800-849-9793.

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