Conflicts of Interest at Duke: Identification, Disclosure, Management

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Conflicts of Interest at DukeIdentification,
Disclosure, Management

• Joan M Podleski
• Director, Duke IECP

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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

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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)

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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

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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

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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
  administrators full-time job obligations to duke
• Aggregate time spent in outside activities that
  interfere with the performance of Duke
  obligations

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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

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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

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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

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Responsibilities How will this affect me?

• 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

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Procurement Issues
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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

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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.

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• Examples

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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.

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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.

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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.

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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.

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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.

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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 vendors product or service, the vendor may
  pay for your expenses but not your time.
• If the presentation is related to the vendors
  product or service, the vendor may NOT pay any of
  the expenses.

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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.

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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

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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 Dukes 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

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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.

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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

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Questions

• For questions regarding Conflict of Interest,
  please contact
• conflictofinterest_at_duke.edu
• 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 iecp_at_duke.edu. Issues can be
  reported anonymously to the Duke Compliance
  Fraud Hotline at 1-800-849-9793.