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DUKE UNIVERSITY

DUKE UNIVERSITY HEALTH SYSTEM 

Office of Internal Audits

 CONFLICT OF INTEREST AND COMMITMENT POLICY FOR

OFFICERS AND EMPLOYEES WITH ADMINISTRATIVE RESPONSIBILITIES

 Frequently Asked Questions

COMPLYING WITH THE FINANCIAL CONFLICT OF INTEREST POLICY

AND OTHER ETHICAL STANDARDS

Q1.  To whom does the disclosure process apply?

A1 - The disclosure process applies to the following individuals employed by the University or Health System:

• The President, Duke senior officers, and trustees;
• Faculty members (regular and non-regular rank);
• Any individual who acts as an investigator in research. Specifically, anyone who contributes to the design, conduct, analysis, or reporting of results of research.
• Any individual paid using funds from a externally funded grant (e.g. an NIH, NSF, state, or Department of Defense grant);
• Any individual who is involved in making or advising on purchasing decisions;
• Any individual who is engaged in the selection, purchase, or prescription of medications,  devices, or services for patient care;
• Any individual involved in hiring, evaluating, and managing employees at Duke; and
• Any individual who provides expert advice or otherwise exercises independent discretion in performing his/her duties.

Q2.   As part of this policy, what am I being asked to do?

A2 - You are being asked to do two things:  First, to comply with the Financial Conflict of Interest Policy (Policy) and other ethical standards of institutional importance to the University or Health System (e.g., conflict of commitment, nepotism, and gift prohibition).  Second, to submit an annual conflict of interest disclosure form and to update your responses over the course of the year promptly after a change occurs. Examples of a reportable change include a new outside position, buying or selling equity in a business, significant new honoraria, or employing a member of your family.

 Q3.  How are family members of an employee covered?

 A3 - Family members are covered in two different ways:

• For financial conflict of interest, by federal rules the individual must report her/his own financial interests and those of any immediate family member, which is defined to include a spouse, spousal equivalent, and/or dependent children.  
• For nepotism, i.e., decisions affecting the employment of relatives, "family" is broader and includes a spouse, spousal equivalent, children, parents, brothers, sisters, step-parents, step-children, and step-brothers or sisters, and other persons living in the same household as that individual.

 Q4.  What disclosures are required?

 A4 - The disclosure form includes questions that try to identify relationships, primarily financial, that might affect your work for Duke. Examples of areas that might be affected include how you conduct research, teach, or provide patient care. Another example is the purchasing or recommending items on Duke's behalf.   While many faculty and staff do not have all of these duties, most have at least one. The disclosure form specifically requires providing information related to the following areas:

• General information about your position at Duke;
• Whether you or a family member have a financial interest (as described below) that is related to or overlaps with your responsibilities on behalf of Duke or with a company that does business with Duke;
• Whether you or a family member serve on an outside entity's board as a director, trustee, advisor, etc., or have position with fiduciary obligations, including as an president, vice-president, treasurer, secretary, or other officer position;
• Any outside work for which you received an IRS Form 1099, W-2, or K-1, except if from an institution of higher education, governmental agency (like the VA), hospital, research institute, or Duke;
• Any intermediary company that receives money on your behalf, e.g., a consulting group that receives payment for your work (in which case you will be asked to identify the original funding entity);
• Whether you employ or supervise a member of your family; and
• Lobbying activities that Duke must account for to comply with its obligations as a charitable institution.

 Q5.   What is an example of a financial interest?

 A5 - Anything of actual or potential monetary value owned by the employee or family member that is related to the employee's duties and responsibilities at Duke, including the following:

• Payments for services, including honoraria, consulting fees, lecture payments, etc. that are not excluded under the Policy (because it comes from a university, hospital, etc. See A4);
• A gift whose fair market value exceeds permissible limits;
• A right of ownership in intellectual property (copyright, patent, trademark);
• Equity ownership (stock, stock option, security, or other ownership interest); and
• Any other interest that Duke determines qualifies as a financial interest.

 Q6.  What is not an example of a financial interest?

 A6 - The following do not constitute financial interests of concern to this policy:

 Ownership of a share or shares in a mutual fund that the individual does not directly control;

• Salary or other payment from Duke or another institute of higher education (that does not rise to the level of conflict of commitment - see A8), a branch of government, including federal, state, or local, or Duke Private Diagnostic Clinic, PLLC.

Q7.  What are some examples of a financial conflict of interest?

A7 - A financial interest that could directly and significantly affect the design, conduct or reporting of funded research, or the performance of duties and responsibilities on behalf of Duke. Some examples include:

• A financial interest that affects a purchase of items like equipment, supplies, and services.  For example, ownership by an administrator or a family member in a vendor or potential vendor that does or may do business with the University or Health System when the administrator has some control over the decision or recommendation of purchases from vendors offering the same services or products;
• A financial interest that affects what information the individual decides to include in an article or presentation; in addition to this general concern, some groups of employees such as nurses may have additional restrictions or guidance about financial interests with Duke vendors and should check with their supervisor to ensure all applicable DUHS policies are followed;
• A financial interest that affects the care provided to a patient.  For example, a decision to provide one treatment over another because the individual has a consulting contract with the company that manufactures the first treatment.

Q8.  What are some examples of a conflict of commitment?

A8 - A conflict of commitment can exist when a non-Duke obligation prevents an individual from spending the time required for his/her full-time commitment to the University or Health System.  Some examples include:

• Membership by an individual on multiple scientific advisory or corporate boards, including committees, that could take that individual away from his/her job at the University or Health System to the extent that the employee's full-time job obligations to the University or Health System are not met;
• Employment by another entity that is intended to be part-time, but that interferes with full-time duties at the University or Health System even if unrelated to the missions of Duke (i.e., part-time real estate agent or owner/manager in a start-up company).
• For faculty, the fundamental rule is that consulting should be limited to 1 day per week (a maximum of 44 days/year for full-time employees). Within the School of Medicine, this is interpreted to mean 10 hours per week.

Q9.  What are some examples of a conflict resulting from the employment of or business relationship with a family member?

A9 - A conflict for which the administrator's judgment may be impaired or may be perceived as a conflict.  Some examples include:

• Nepotism - Employing a relative when an employee has direct or indirect supervision of a family member, or where the employee can influence employment decisions affecting the employment of the family member, i.e., hiring, firing, setting hours and wages, evaluations, promotion, etc.;
• Financial Conflict of Interest - Recommending the purchase of goods or services from a company for which the family member receives direct financial benefit, including salary, commission or profit sharing.

Q10.  How are the COI disclosure forms reviewed?

A10 - The forms are reviewed initially by compliance staff who support one or more of the COI review committees to determine if there are any relationships over pre-defined thresholds, like the NIH standard of a financial interest of $5000 or more, for board memberships with for profit companies and other key issues. .  If there are not, the form will be cleared as not posing a potential or actual issue.  Sometimes, the information submitted is incomplete or needs more information, and the COI review staff will ask you to supplement or clarify your answer.  Issues that reach thresholds as possible conflicts are reviewed by staff and in many cases then evaluated by one of the four COI committees (Administrative, Duke Medicine, Campus and Institutional) to decide if a conflict requires management.  If the committee determines that management is needed, either the compliance staff or a committee member will contact you to develop a plan appropriately tailored to the conflict.  You and your supervisor will be required to sign the management plan and confirm it is still in effect each year thereafter.

Q11.  Are disclosure forms kept confidential?

A11 - Yes.  Disclosure forms are kept confidential except as required for internal administrative purposes and except as disclosure is required by law.

Q12.  Why aren't gifts being disclosed any longer?

A12 - Because few gifts are now acceptable under DU and DUHS policies, this separate question has been eliminated from the disclosure form.

Q13.  What gifts are acceptable or are they all banned? 

A13 - That depends on where you work at Duke.  Campus-based employees are prohibited from accepting material gifts, favors, or hospitality that might influence or appear to influence their decision making or compromise their judgment in actions, i.e., anything having a fair market value of $25 or more.

Duke Medicine employees and medical staff should refer to the DUHS Gifts and Courtesies Policy (see http://intranet.dukemedicine.org/compliance/default.aspx) that generally prohibits acceptance of any gifts, except patient gifts reasonable in value under certain circumstances, medical models for patient education and medication samples within outpatient clinics.   Under special circumstances, certain staff may, upon advanced approval of one's supervisor, accept gifts that are reasonable in value and are appropriate to accomplish DUHS's business objectives.

Q14.  What are examples of permissible gifts?

A14 - The following is not comprehensive, but provides examples meant to facilitate a better understanding.  For non-Duke Medicine areas, gifts that could be allowed include:

• Attending a dinner or reception at a professional society meeting or conference that is sponsored by a vendor or potential vendor and all or many attendees at the conference are invited and the vendor is not presenting;
• Accepting a dinner from a vendor for all Duke personnel celebrating the successful completion of a project in which the vendor was involved;
• Accepting a meal from a potential contributor or donor to Duke, when development activities are part of the employee's job responsibilities;
• Accepting a gift from a current or potential vendor that is unrelated to the employee's job responsibilities, e.g., for an existing personal relationship; and
• Accepting reimbursement of or having actual expenses paid by sponsor of a conference for presenting at the conference when presentation does not relate to vendor's product or services and is not developed by vendor. Such reimbursement is required to be disclosed on the annual disclosure form.

Q15.  What are examples of gifts that are not allowed?

A15 -The following gifts would not be allowed:

• Accepting a gift basket of food / wine even if you intend to share it with all the employees in that division or department;
• Accepting from a vendor representative payment for a dinner attended by the employee;
• Accepting from a vendor a gift basket of food / wine for the employee's personal use;
• Accepting from a vendor tickets to sporting events, concerts, plays and similar events;
• Accepting from a vendor merchandise, such as televisions, watches, etc.;
• Payment from a vendor of expenses to attend a conference;
• Using a vendor representative's vacation home for free or less than fair market value, (unless the vendor representative is an immediate family member and the home is used for a family gathering); and
• Accepting free clinical supplies, items or equipment that would not be in compliance with Procurement's Vendor policy.

Q16.  Does the gift prohibition include the payment of travel expenses related to vendor advisory boards?

A16 - Duke allows companies to hire faculty or employees as consultants.  Travel to consulting activities, including scientific advisory boards, may be paid by the company.  If the company is a direct vendor to Duke and the employee is asked to serve on an advisory board, the situation must be evaluated and approved by the employee's supervisor.    If it is determined that the board participation is in the best interest of Duke and its constituency, then the expenses related to that service must be paid by Duke.

Q17.    Does the gift prohibition include the payment by a vendor of travel expenses related to a site visit to review vendor's capabilities to provide goods or services to Duke?

A17 -   Yes.  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.

Q18.  How will the Policy and ethical standards be interpreted and implemented?

A18 - The Policy will be interpreted and implemented to accomplish its purposes; that is, to protect the integrity of the University and Health System and the individuals covered by the Policy.  In this regard, remember that a very important aspect of any conflict of interest policy is to prevent even the perception of a conflict, because the integrity of the University and Health System can be compromised by even the appearance of a conflict of interest.  In other words, how would the transaction or behavior in question appear to the public if it were published on the front page of the local newspaper or can the action be explained to a trustee, parent or student as in the best interests of the university?

Q19.  Who should I contact with other questions?

A19 - If you have related questions that have not been addressed here, please contact any of the following offices for assistance: