1. Research Integrity Office (RIO) 684-3121
Orientation to the School Of Medicine/School of Nursing Conflict of Interest Committee
Research Integrity Office
(RIO)

3. 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

4. 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

5. Committee Basics Monthly meetings
3:30-5:00PM on 4th Wednesday (except holiday months)
Case reviews brought forward by RIO staff
Full review
Consent agenda/expedited reviews
Confidential Information

6. 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

7. Member Roster 12 voting members (# to increase) 3 member quorum
The SOM/SON COI Chair also serves on the Campus COI Committee (ex-officio) and COI Oversight Committee (voting)
Ex-officio representation includes: Campus COI, University Counsel, Office of Audit Risk & Compliance, OLV and IRB

8. Duties of Committee Member
Read and understand the Duke COI Policy
Review agenda prior to meeting
Discuss and vote on cases

9. Ground Rules
Most COI Policies are based on the PHS rules that were revised in 2011 and went into effect August 24, 2012.

10. Committee Members
Each Committee Member is responsible for identifying any potential conflicts of interest with individuals for whom cases are being reviewed.
Members should identify any agenda items in which they have a potential conflict at the beginning of the meeting.
If during a discussion a committee member discovers they may be in conflict, they should let the chair know and recuse themselves.
This includes, but is not limited to:
Departmental relationships, such as tenure and promotion committee memberships, supervisory situations, and other personal relationships.

11. Duke Box Documents for committee review are uploaded into Duke Box.
*Members will receive an once the documents are available. Meeting Documents and Management Plans are located in a file by meeting date.

12. 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)

13. Duke vs. PHS rules
Duke rules match the PHS rules with two notable exceptions:
We do have an institutional COI policy that may require management of human subjects research on ideas developed at Duke, even if the investigators have no personal COI
We consider royalties paid through the institution to be possible source of COI

14. What Is A Significant Financial Interest
What Is A Significant Financial Interest? (As defined by PHS regulation)
= 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.)

15. When does Duke require management?
$5K - $50K - Cautionary Memo only
>$50K and research overlap – managed with restrictions
Private equity and research overlap identified
Public equity >$50K and research overlap identified
IP and research overlap identified (determined case-by-case, some managed prior to licensing)

16. General strategies Low Level ($5K - $50K) – Cautionary Memo*
Disclosure required in 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
*regardless of research overlap.

17. Management For >$50K (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 should be informed of the coi
NIH reporting nearly always required on PHS grants

18. Other considerations HSR no more than minimal risk
HSR > minimal risk
Animal study
Royalties >$50K
Tool rule
Exempt study (IRB)
Management strategies:
DSMB/DSMBplus
Non-conflicted PI/clinical PI
Data blinding
other

20. 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.

21. IP gets optioned or licensed
Existing company
Faculty member start-up
Issue cautionary memo No No
Related Research
Related research
Issue MP
Yes
Yes

22. Consent Agenda
All management plans issued by RIO that relate to research end up on a Consent Agenda once signed by the individual.
The Consent Agenda contains specific information about each plan signed for that month’s review.

23. Case reviews
The majority of management plans fall within our general management strategies, however, it is the cases that don’t fit neatly into those categories that we bring forward for committee review.
When possible RIO asks the conflicted investigator to come before the committee to present their case.

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