1. CONFLICT OF INTEREST REPORTING ANGIE SOLOMON - MARCH 2016 Research Integrity Office

2. WHY IS REPORTING IMPORTANT?  For the protection of human subjects  For the protection of our faculty, staff and institution  Because of Federal regulations and requirements  To maintain the public’s trust  For Complete Transparency

3. Senators scrutinize physician conflicts Study: Transparency lacking in Biomedical Literature Opinion: Problems with Hidden COI Conflict of Interest: Gateway to Corruption Doctors scrutinized for potential conflicts of interest Conflict of Interest issues being probed What kind of research can we trust? HHS tightens COI rules Academic-Industry Conflict of Interest Growing

4. WHAT IS CONFLICT OF INTEREST? Duke definition: A conflict of interest exists when a primary interest or responsibility is (unduly) affected by a secondary interest or responsibility or has the potential to be affected. PHS FCOI definition: Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. Key elements:  Direct and significant (D&S)  Design, conduct, and reporting (DCR)

5. CONFLICT OF COMMITMENT Broadly defined, a potential conflict of commitment encompasses situations in which an employee’s external relationships or activities may, or may appear to interfere or compete with the University’s mission, or with the staff member’s ability or willingness to perform his or her job responsibilities.

6. WHY USE THE WORD POTENTIAL?  Because a lot depends on the circumstances.  For example, if an employee discloses an external tie and steps are taken to remove the chance of bias (e.g. removing the employee from certain decisions), the potential conflict has been managed.  Another example, a Duke employee accepts a gift from someone outside Duke and then makes what he/she claims was an unbiased decision about using the services of that person’s company. But the appearance of bias, regardless of anything else, create a potential COI.

7. RESEARCH VS. ADMINISTRATIVE COI Research COI is about potential bias and protecting human subjects. Administrative COI is mostly about potential bias in purchasing and hiring decisions and conflicts of commitment.

8. Researchers  Call issued 3.8.16  @4800 people required  Deadline 4.30.16  Federal grant funds not released until form received.  All equity relationships; All Intellectual property; and All relationships >$5K must be disclosed. Administrators  Call issued 1.11.16  @1700 people required  Deadline was 3.9.16  All equity relationships; All Intellectual property; and All relationships >$5K must be disclosed.  Mainly looking for overlaps between Duke job and outside relationships DISCLOSING CONFLICTS OF INTEREST Why do I have to fill out this form, my co-worker didn’t have to?

9. RESEARCHERS VS. ADMINISTRATIVE RESEARCH Regular rank faculty Individuals involved in the design, conduct, or reporting of research Individuals involved in clinical care Covered Officials Subcontractors and Subrecipients that do not fall under their own PHS- compliant policy ADMINISTRATIVE Certain Administrators – e.g. Business managers, all staff in certain areas such as Compliance, and staff identified by their department. Individuals involved in clinical care (not involved in research) Covered Officials

10. ANNUAL DISCLOSURE FORM Significant changes in financial relationships should be reported within 30 days of the change. Departmental metrics are impacted by completion of coi forms! There are escalation procedures to collect forms to ensure compliance and they vary depending upon Research or Administrative guidelines.

11. GUIDELINES FOR RESEARCH OR ADMINISTRATIVE In terms of COI, maintain separation between your Duke responsibilities and your work with external companies. However, you should disclose the outside relationship when applicable. Examples of when to disclose:  When in discussions of competitors of the entity.  Any time your objectivity could be called into question by not disclosing the information. When in doubt……Ask…..and, where applicable, ……disclose!

12. USE OF DUKE RESOURCES  Except as authorized, faculty & staff may make only incidental use of University resources for purposes unrelated to missions of the University.  Includes but not limited to facilities, personnel, students, equipment, and confidential information.

13. GIFTS  Accepting gifts from industry is not allowed.  Dinners with non-CME talks are considered a gift.  Individuals may purchase the dinner and attend  Gifts of educational materials are generally allowed.  Open dinners at national meetings are generally allowed.  The Office of Audit, Risk and Compliance is a great resource for gift questions. 684-2475

14. ADMINISTRATIVE COI REVIEWS  Provide guidance to administrators and departmental supervisors related to COI.  Evaluate and manage sources of potential bias.  Evaluate whether the outside relationship might lead to personal inurement.

15. RESEARCH REVIEWS Related to Conflict of Interest

16. GROUND RULES Most COI Policies are based on the PHS rules that were revised in 2011 and went into effect August 24, 2012. http://grants.nih.gov/grants/policy/coi/ The PHS regulations specifically exclude institutional COI. Duke, however, has its own Institutional COI Policy. Duke also considers royalties paid through the institution to be a possible source of COI. Duke COI policies can be found: https://medschool.duke.edu/research/ethics-integrity- compliance/research-integrity-office/coi-related-policiesfaqs

17. PERSONAL VS. INSTITUTIONAL PERSONAL When an individual has a financial relationship that might (or could be perceived to) lead to bias in research. INSTITUTIONAL When an institution, or someone who can act for the institution (e.g. dean, department chair), had a financial relationship that might lead to bias in research, or (more frequently) inadequate supervision of human subject research. Today’s discussion focuses on Personal COI

18. WHAT IS A SIGNIFICANT FINANCIAL INTEREST  = to or >$5,000/year in payment  = to or >$5,000 in equity value (publically traded company)  Any privately held equity or options  Royalty Rules:  Apply on a case-by-case basis on non-institutional payments (= to or >$5,000).  Duke treats royalties as income regardless of whether they come through the institution or not. Intellectual Property is reviewed on a case-by-case basis.

19. WHEN IS MANAGEMENT REQUIRED?  $5K and > in extramural income and research overlap identified  Private equity and research overlap identified  Public equity $5K or > and research overlap identified  IP and research overlap identified (determined case-by-case, some managed prior to licensing) ALL NIH RESEARCH OVERLAPS ARE REVIEWED TO DETERMINE REPORTING REQUIREMENTS.

20. IS ALL MANAGEMENT CREATED EQUAL? NO! Management is determined by many different factors.

21. GENERAL MANAGEMENT STRATEGIES Low Level ($5K - $24.9K) – Disclosure  Publications, presentations, grant applications, and IRB documents.  Doesn’t change the conflict.  Allows the reader/hearer/reviewer/potential research volunteer to understand that someone who could affect the outcome of the research has an interest beyond the scientific.

22. CONTINUED…. For >$25K (or any options or private equity)  Require disclosure.  Not allowed to be PI (unless approved by COIC) – because of bias concerns and inurement issues.  Not allowed to obtain informed consent for research related to the coi.  Students may need to be informed of the coi.  NIH reporting nearly always required on PHS grants. There can be other conditions assigned to the management plan.

23. MY PI HAS QUESTIONS……. Is consulting allowed?  Yes. Duke encourages its faulty to consult. Consulting should be research focused. It is a good idea to include in the contract a limitation of $25K per year so that research will not be impacted. In general, avoid marketing efforts. What about speaking?  True CME is allowed, content should be independent.  If non-CME; slides and content must be faculty prepared; must be independent; faculty member must be a recognized expert. If the company’s lawyers are suggesting changes – it’s not allowed.  For more information refer to Promotional Medical Education Policy here: https://medschool.duke.edu/research/ethics- integrity-compliance/research-integrity-office/coi-related- policiesfaqshttps://medschool.duke.edu/research/ethics- integrity-compliance/research-integrity-office/coi-related- policiesfaqs Caution: It is generally not a good idea to meet with investment advisors – the risk of disclosing confidential information is too high (insider trading).

24. WHY COI REVIEWS ARE CRITICAL  PHS regulations require that institutions manage the COI for all personnel who meet the criteria of direct and significant of the design, conduct or reporting of the project.  The NIH (or Program Officer) must be notified if there is an overlap with funding and federal research that meets the definition above.  Should we not manage and report it, then discover the COI in retrospect, we are required to create a remediation plan.  If the NIH does not accept the remediation plan, the grant money may have to be returned.

25. RIO AWARD REVIEW At Duke, when a grant is awarded (or is at JIT notification), we review the list of key personnel for any significant financial interest reported by the key personnel. The grant can be released if no overlaps are revealed. No $$$’s are supposed to be spent on a federal award until it has cleared a COI review.

26. PRIMES AND SUBS  The prime grant recipient is required to manage reporting of conflicts to the NIH. We are allowed to defer COI management to the sub (if they are PHS-compliant). Reporting is the responsibility of the prime.  If an individual has a personal contract with Duke, and the work is not being done through their PHS-compliant organization, they must complete the Duke form and be managed by our COI program.  Sub forms are required annually! My sub wants to know why they haven’t been paid?

27. OTHER PHS REQUIREMENTS  Sponsored travel must be reported: https://radapps.duke.edu/phs_travel https://radapps.duke.edu/phs_travel  Individuals funded by PHS/NIH must have training: training is part of annual compliance training.  FCOI must be made publicly available when requested.  Reporting of conflicts to eRA Commons is more detailed than in the past and is an annual requirement rather than a one time notification. Dukehealth.org has a listing of companies reported on the most recent coi form of physicians.

28. MORE ON TRAVEL REPORTING…  Travel reporting is required by the PHS for all PHS funded investigators.  Institutions must evaluate for potential biasing effect of travel.  Reporting is required of any sponsored travel with the following exceptions: universities, governments, hospitals, research institutes.  Reporting should include spouse and dependent children.

29. AGENCIES USING PHS FCOI REGULATIONS Public Health Service (PHS) Agencies (updated 9/15/2015) 1.Agency for Healthcare Research and Quality (AHRQ) 2.Agency for Toxic Substances and Disease Registry (ATSDR) 3.Centers for Disease Control and Prevention (CDC) 4.Food and Drug Administration (FDA) 5.Health Resources and Services Administration (HRSA) 6.Indian Health Service (IHS) 7.National Institutes of Health (NIH) 8.Office of Global Affairs (OG) 9.Office of the Assistant Secretary for Health (OASH) 10.Office of the Assistant Secretary for Planning and Evaluation 11.Office of the Assistant Secretary for Preparedness and Response (ASPR) 12.Office of Public Health and Science 13.Substance Abuse and Mental Health Services Administration (SAMHSA)

30. NON-PHS AGENCIES UPDATED 3/10/15 1.Alliance for Lupus Research (ALR) 2.Alpha-1 Foundation 3.American Asthma Foundation 4.American Cancer Society (ACS) 5.American Heart Association (AHA) 6.American Lung Association (ALA) 7.Arthritis Foundation (AF) 8.CurePSP 9.Juvenile Diabetes Research Foundation (JDRF) 10.Lupus Foundation of America (LFA) 11.Patient-Centered Outcomes Research Institute (PCORI) 12.Susan G. Komen for the Cure

31. WHAT’S NEW? Physician Sunshine Act – Open Payments - well sort of new…….  Section 6002 of the Patient Protection & Affordable Care Act.  Collects and displays information reported by companies to physicians and teaching hospitals.  Registered physicians and teaching hospitals can review and, if needed, dispute payments reported about them.  Collected data is displayed on a public site.  Data collected for each calendar year is published in June of the following calendar year. 2015 data will be available in June of 2016. https://www.cms.gov/openpayments/index.html

32. Does Duke review this data? YES we do! As we receive updates from CMS, the communications department sends a mass email to all Duke physicians like this one: The Open Payments system is now open. Physicians and teaching hospitals may now register in the system, so they can be prepared to review any data that may be submitted about them. The Review and Dispute period is targeted to start in April 2016 following the close of data submission. If physicians and teaching hospitals registered last year, they are not required to recertify their registration. However, if it has been over 180 days since a physician or teaching hospital has logged onto the Enterprise Identity Management System, the account has been deactivated for security purposes. If an account has been deactivated, contact the Help Desk. Beginning today, the Help Desk will have extended hours from 7:30 a.m. – 6:30 p.m. (CT).Open Payments system

33. SUMMARY OF RIO RESPONSIBILITIES  Provide guidance around coi issues.  Evaluate and manage sources of potential bias.  Protect human subjects (by limiting the role of conflicted investigators).  Evaluate whether the research could lead to personal inurement (use of institutional resources for personal gain).  Evaluate if research is consistent with our non-profit mission.  Report to outside agencies regarding coi, when appropriate.

34. HOW CAN I HELP?  Encourage timely completion of COI forms.  Remind investigators to update their COI form within 30 days of a change.  Talk to the PI before submitting a DPAF to ensure the question regarding COI is answered correctly.  Respond to and encourage prompt replies to RIO emails and requests.  Encourage investigators to contact RIO before entering into a consulting agreement with a company they receive research support from or before taking on research projects for companies they consult for.  Encourage subrecipients & subcontrators to return COI paperwork promptly.

35. CONTACT INFORMATION Angel WalkerProgram Coordinator 684-3121 Angel.walker@dm.duke.edu Tammy GentryAdministrative Coordinator 613-2163 Tamera.gentry@dm.duke.edu Susan S. BrooksAdministrative Coordinator 684-6757 Susan.s.brooks@dm.duke.edu Angie SolomonAdministrative Manager 684-1822 Angela.solomon@dm.duke.edu Ross McKinney, MD Chair, COI Committee 668-9000 Ross.mckinney@dm.duke.edu https://medschool.duke.edu/research/ethics-integrity- compliance/research-integrity-office