1. CONFLICT OF INTEREST REPORTING & UPDATES
Research Integrity Office
Angie Solomon
February 8, 2017

2. Thoughts for today:
Medical research is often driven by two primary aims:
the development of knowledge and the scientific process and
the development and commercialization of new products and therapies to treat medical conditions. Both underscore a “greater” goal—to improve the health and wellbeing of individuals.
Commercialization of new products can serve yet another goal— to generate financial gain for the organizations and individuals involved in that process.

3. Investments in and financial donations from commercial research sponsors can be important sources of funding for academic and nonprofit organizations.¹
But, when the Institution or individuals at the institution have a financial interest in the research sponsor, or in the outcome of research itself, that interest could impact objectivity and research integrity. Financial interests may also impact the institution’s role in protecting the safety and welfare of human subjects.²
Ass’n of Am. Med. Colleges, Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research, Oct. 2002, p. 1 [hereinafter Task Force Part II Report].2
Id.

4. Conflicts of interest have the potential to threaten the integrity of a university's scholarship, research, instruction, evaluation, and administration. To ensure that its reputation and research programs are not compromised by even an appearance of inattention to this matter, Duke University has policies in place - consistent with federal guidelines - that require the reporting and management of the potential conflicts of interest of its faculty, administrators, and certain staff members.

5. 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)

6. 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)
(IP) Duke treats royalties as income regardless of whether they come through the institution or not.

7. What about IP?
Consult with OLV and RIO early so we can help manage the process.
Consult with OLV and RIO early so we can help manage the process.

8. 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)

9. Why Is This So 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

10. Disclosure of Conflicts of Interest
Disclosures can come from:
Annual COI Disclosure Forms
Self reports
Departmental requests
IRB requests
Senior Administration Requests
Open Payments Database
Other

11. General management strategies
Low Level ($5K - $25.001K) – 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

12. Management cont… 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

13. Other considerations HSR no more than minimal risk
HSR > minimal risk
Animal study
Royalties >$25K
Tool rule
Exempt study (IRB)
Management strategies:
DSMB/DSMBplus
Non-conflicted PI/clinical PI
Data blinding (or something that produces objectivity and transparency)
External IRB
Other

14. Rebuttable Presumption
This is a general rule that prohibits a conflicted investigator against serving as the principal investigator in human subjects research, except when there are “compelling circumstances.”
Examples of compelling circumstances:
Research to further develop an early stage discovery may require the insights, knowledge, perseverance, laboratory resources, or special patient populations of the discoverer.
The best interests and or safety of patient-subjects may justify involvement of the conflicted investigator.

15. 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.

16. 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.

17. 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.

18. Disclosing conflicts of interest
Researchers
Call to be issued
Deadline
Federal grant funds not released until form received.
All equity relationships; All Intellectual property; and All relationships >$5K must be disclosed.
Administrators
Call issued
Deadline
All equity relationships; All Intellectual property; and All relationships >$5K must be disclosed.
Mainly looking for overlaps between Duke job and outside relationships

19. Researchers vs. 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
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

20. Personal vs. Institutional
When an individual has a financial relationship that might (or could be perceived to) lead to bias in research.
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

21. 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.

22. 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.
Crossing either the $5K or $25K, or changing equity or IP positions qualifies as significant.

23. 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!

24. 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.
an example is that someone with a start-up should not use Duke letterhead, and should not use their Duke address. Technically you shouldn’t use your Duke computer for non-Duke work.  Hence, they should use a G-mail account or equivalent for any non Duke business.

25. 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,

26. 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.

27. What about consulting?
Duke (OCRC) doesn’t review or sign private faculty consulting agreements.
Faculty are certainly allowed to consult, but the University considers that to be a private endeavor between the faculty member and the company. The University, thus, views consulting agreements as personal, private agreements between the consultant and the company, and does not review, approve, or disapprove these agreements.  We suggest that faculty consult a competent private attorney for legal advice on the terms. Sometimes a company will ask for a University signature on a consulting agreement. We will not do that but can provide a brief explanation of the University’s position* if necessary. 
Provided by Gavin Foltz - OCRC

28. Here are some things to consider:
a)   It is up to the faculty member to comply with applicable University policies, such as those on consulting, conflicts of interest, and intellectual property.
b)   Consulting is typically limited to 44 days per year.
c)    University facilities and other University resources may not be used for consulting.
d)   Research in Duke facilities must be done under a research agreement with the University, and not under a consulting agreement.
e)    A consulting agreement cannot obligate intellectual property that belongs to Duke (which is anything arising from research done at Duke).
f)    Be cautious of any provisions, such as confidentiality, IP, or non-compete, that might restrict what you do, or wish to do, in your activities as a Duke faculty member, including your research at Duke.
g)    A faculty member may not receive both research funds and greater than $5K per year consulting income from the same company without a Conflict Management Plan being developed with  the Research Integrity Office.
h)   Equity holdings in a company from which one receives research support is a complex issue and should be discussed with the Research Integrity Office.
i)     Be aware of any potential conflicts with other obligations you may have.

29. Consulting agreements typically have broad confidentiality and intellectual property provisions. One needs to take care that those are targeted only to what is done in the consulting, and don't reach out to restrict other activities of the faculty member. If the consulting is in the same area as a faculty member’s research or other activities at Duke, he or she may want to consider a provision like what follows to be sure the company’s rights under the consulting agreement don’t reach into his or her Duke activities.
*Company acknowledges that the Consultant is a member of the faculty of Duke University and is subject to Duke University’s policies, including policies concerning consulting, conflicts of interest, and intellectual property. Company  acknowledges and agrees that nothing in this Agreement shall affect the Consultant’s obligations to, or research on behalf of, Duke University, including, without limitation, obligations relating to intellectual property developed in whole or in part by the Consultant in connection with such research.  This Agreement shall not be taken to grant Company any rights in unpublished data or other research results developed at Duke University.
Provided by Gavin Foltz

30. 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:
Caution: It is generally not a good idea to meet with investment advisors – the risk of disclosing confidential information is too high (insider trading).

31. 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.

32. Other PHS requirements
Sponsored travel must be reported:
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.

33. 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.

34. What is Open Payments? Physician Sunshine Act – Open Payments
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 data will be available in June of 2017.

35. Does Duke review this data?
YES we do!
As we receive updates from CMS, the communications department sends a mass 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).

36. 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.

37. 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 s 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.

38. Conflict of Interest Committee Charge
The School of Medicine (SOM)/ School of Nursing (SON) Conflict of Interest (COI) Committee is charged with the protection of the integrity of Duke’s research and educational missions, as well as the integrity of the organization and the individual.
Governed by the SOM/SON COI policy related to research
Review/manage COI for SOM/SON
Advise on Institutional Conflict of Interest (ICOI)
Other activities as appropriate

39. Vice Dean for Clinical Research
RIO Org Chart
Mark Stacy, MD
Vice Dean for Clinical Research
Geeta Swamy, MD
Associate Dean, Regulatory Oversight & Research Initiatives
Greg Samsa, PhD
School of Medicine
and
Institutional Conflict of Interest Committee Chair
Angela Solomon
Administrative Manager, RIO
Susan Brooks
Admin Coordinator, RIO
Angel Walker
Program Coordinator, RIO
Tamera Gentry
Admin Coordinator, RIO

40. Contact Information
Angel Walker
Program Coordinator
Tammy Gentry
Administrative Coordinator
Susan S. Brooks
Angie Solomon
Administrative Manager
Greg Samsa, PhD
Chair, COI Committee