Frequently Asked Questions
A COI is a situation in which financial or other personal interests could bias, or appear to bias, an Individual’s professional judgment in research, patient care, education, or carrying out their institutional duties.
We care about conflicts of interest in order to preserve and protect the public’s trust in our faculty, our institution and our research.
An institutional COI occurs when Wake Forest Baptist has a financial stake in the outcome of a research project or its licensed technology.
A conflict of commitment is a situation in which an Individual’s outside interests may interfere or appear to interfere with the Individual’s ability to carry out his/her institutional duties.
The Policy on Conflict of Interest applies to all faculty, clinical providers, WFBH employees, students, trainees, volunteers, and employees of WFBH’s controlled affiliates. The Policy on Conflict of Commitment applies to all faculty, clinical providers, trainees, exempt WFBH employees, and exempt employees of WFBH’s controlled affiliates who owe a primary duty of loyalty and support to the Institution.
Disclosures are completed electronically via the eCOI system.
- Outside interests and activities that are related to your job at Wake Forest Baptist Health (i.e. consulting, speaking activities, advisory boards, paid editorial activities, employee, etc.)
- Financial interests in an organization related to your job at Wake Forest Baptist Health, or that does business with Wake Forest Baptist Health (i.e. equity holdings, ownership, etc.) This includes start-up companies, even if there is no current value.
- Intellectual property /license agreements related to your job at Wake Forest Baptist Health
- Fiduciary responsibilities with outside entities (i.e. board of directors, company officer, executive management, scientific advisory boards, etc.)
- Unrestricted gifts for research, educational support, equipment, supplies, etc.
- Stocks or other investments in which you have no day to day control
- Writing, membership on peer review panels
- Visiting professorships or lectureships at academic medical centers
- Federal and nonfederal study section membership
- Grant review panels
- Textbook editorships
No. You only need to report those stocks that are related to WFBH and for which you have day to day control. Mutual funds are excluded.
Yes. You are required to report all income received from applicable outside entities, regardless of the amount.
Yes. You must obtain preapproval and report this outside activity on your annual disclosure, regardless of when the activity occurs.
Conflict of Interest Management
Using guidelines developed by the Conflict of Interest Review Committee (CIRC), the COI Office reviews the outside interest to determine if management is needed.
The Conflict of Interest Review Committee, or CIRC, is made up of a diverse group of faculty members from a variety of different departments and is responsible for identifying, reviewing, and managing individual conflicts of interest in research, clinical care, and education.
A COI management plan is a process initiated by the COI Office whereby conflicts are appropriately managed, mitigated, and or eliminated.
An interim monitoring report is a formal process by which the COI Office effectively ensures that the management strategies in a COI management plan are being followed. Interim monitoring reports are completed by the conflicted individual and due by a predefined date for the life of the management plan.
A start-up company is one in which the original intellectual property originates with the faculty member and the faculty member is a founder, has a significant equity position, and often has an influential role in determining the direction of the company.
The best time to address potential conflicts of interest in a startup is during the early or preliminary phase of the plans.
Employees may not use Wake Forest Baptist Health institutional resources for personal gain or to generate personal income, and their work at a start-up must be clearly separate from their work at Wake Forest Baptist Health.
Yes. Federal regulations require any equity in a non-publicly held company to be reported to the institution.
- The Wake Forest Baptist Health employee is a company officer at the startup. He/she has a fiduciary responsibility to act in the company’s best interest, which may conflict with his/her duty to Wake Forest Baptist Health. This is a key reason that employees should never negotiate with Wake Forest Baptist Health on behalf of their startups
- An employee conducts company work on Wake Forest Baptist Health’s time or with Wake Forest Baptist Health resources (includes use of computer and Wake Forest Baptist Health e-mail)
- A Wake Forest Baptist Health employee works for a faculty member’s startup and also reports to that faculty member at Wake Forest Baptist Health
- An employee's performance at the startup has an impact on the employee’s potential for job promotion/performance evaluation at Wake Forest Baptist Health
- A mentor directs students into a project that appears to benefit the mentor's startup company
The COI Office works with the founder(s) of the startup company to develop a COI Administrative Management Plan to address and mitigate conflicts which can arise from startups.
Policies, Regulations and Training
- Financial Conflict of Interest Training is required per federal regulations for all investigators who are involved in PHS funded research. This training, which is located eCOI and takes 5-10 minutes to complete, is valid for four years.
- Conflict of Interest, Conflict of Commitment, and Industry Interaction Training is required of all WFBH faculty, leadership, key administrators, network providers, and exempt employees beginning 2019 and every three years afterwards. This training is located in HealthStream and takes less than 20 minutes to complete.
Do I have to complete Financial Conflict of Interest (FCOI) training if I took it at my last institution?
Yes. PHS regulations require training for any investigator that is new to an institution, regardless of prior training.
Yes. If WFBMC is the prime recipient of a PHS funded project, then federal regulations require us to ensure that all subcontractors are compliant with FCOI training and annual disclosures. Those institutions that do not have a compliant policy must follow ours.
Penalties for failure to comply with training requirement may include, but are not limited to:
- Ineligibility to participate in grant applications, IRB, or IACUC applications or committees
- Written admonition for placement in Individual’s employee file indicating that the individual’s good standing has come into question.
- Ineligibility to work with graduate students
- Dismissal from an educational or training program
- Performance improvement counseling
- Dismissal of employment
Do I have to complete a Travel Request if industry is paying my expenses and I’m not requesting reimbursement?
Yes. In order to comply with federal regulations, the institution must collect information about all third party paid travel. Even if the vendor is paying for all travel and meals, you are required to report the trip in Concur and receive the appropriate approval.
The Conflict of Commitment and Conflict of Interest policies can be found on the iShare site under Administrative Policies.
No, consulting can be paid or unpaid service. Individuals are required to obtain prior approval for outside commitments, whether paid or unpaid.
Yes. WFBH policy does not preclude the receipt of fair market compensation for consultation or advisory board services as long as you obtain prior approval for this activity through eCOI and report it on your Annual Disclosure.
If I am consulting with industry on weekends and during my vacation, do I need to disclose this activity?
Yes. You must obtain prior approval for this activity through eCOI as well as report it on your Annual Disclosure.
How many days am I allowed for consulting and/or other outside activities related to my institutional responsibilities?
WFBH policy does not dictate or limit a set number of days for outside consulting and other activities. The allowable number of days rests with the department chairs based upon the department needs.
How does the Sunshine Act affect me since I travel and provide consulting for a device manufacturer?
Any payments or transfers of value provided by manufacturers of drugs, devices, biological, or medical supplies to physicians and teaching hospitals will be reported by the manufacturers on the publicly-accessible and searchable database known as Open Payments.
Food, Meals and Gifts
Yes. Training study teams is an important part of the preparation for industry sponsored research programs, and providing food for participants is reasonable under the circumstances since the purpose is training for a project of mutual interest and benefit, and not for marketing.
Yes, it is perfectly appropriate for departments to provide candidates with meals. These meals, however, may not be provided by drug companies or other commercial sponsors.
The receipt of food from a patient does not represent a conflict of interest. We encourage sharing such meals among the staff. A restaurant gift card is considered a gift, however, and should be discouraged and forfeited to a charitable organization or to an institutional patient event. The COI Office can offer guidance.
Yes, meals and snacks that are incidental to an approved educational meeting are acceptable. If you have not received prior approval from the COI Office to attend, use your discretion if the education appears to be more marketing related.
No. Meals provided by vendors may only be allowed at the Medical Center if the event is certified by an accrediting body, such as the CME office; if the department has received prior approval for the meal as a part of an educational event; or if a department receives an unrestricted grant from industry for educational or professional support, then the funds may be used for the purchase of food for attendees.
Gifts from industry are permissible for items designed solely to educate patients. (e.g. educational booklets about disease, devices for practicing procedures, videos for demonstrating a procedure, etc.) If the company logo is prominent, you may want to consider covering it with a WFBMC label.
The department chair or director should make the decision on how the gift may be used or if it will be donated. Returning the gift may be viewed as insulting, but the vendor should be discouraged from gifting in the future.
These events have high value for patients, and the gifts from local vendors (e.g. haircuts, food, time etc.) do not rise to the level of conflict of interest for the institution. Such philanthropy by a local business is allowed under our policy. However, the vendors with whom we have business relationships, such as drug companies or device manufacturers, may not make direct contributions of food, services, or products to our patients, but should contact the event organizer to establish an unrestricted educational grant.
Yes. The military are exempt from the policy.
Yes, as long as support is specifically for the purpose of education and meets the following conditions:
- The department chair or section head, NOT an industry representative, selects the student or trainee
- The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a “quid pro quo”
- The funds are provided to the department and not directly to the student or trainee
- The department has determined that the funded conference or program has educational merit and has completed the approval process through the COI Office