- Potential Issues in Consulting Agreement Terms
- Expert Witness
- Open Payments
- Separate COI Policy for Industry Interactions
- Industry-Sponsored Resident Education
- Speakers’ Bureaus
University of Florida faculty owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the education, research, and scholarship missions of the institution. Outside professional activities can result in allocations of time and energies that represent conflicts of commitment. In addition, these activities can result in conflicts of interest when there is a divergence between an individual’s private interests and his or her University obligations, such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A conflict of interest depends on the situation, and not on the character or actions of the individual.
Faculty members should conduct their affairs so as to avoid conflicts of commitment and avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. Disclosure of such interests is required under University policy.
Q: Where can I find a quick overview of the eCOI system?
If you’re new to the eCOI system, the eCOI Fact Sheet can provide a brief introduction.
Q: I have older Outside Activities that were submitted on the paper forms. Will I need to import those into eCOI?
No. eCOI is on a going-forward basis only and is to be used to disclose any activity that starts on or after July 1st, 2014.
Q: “Page Cannot Display” is the only thing I see when trying to login to eCOI. Why is that?
You may not be on a computer connected to the UF network. Try VPN internet access by signing in with your Gatorlink ID and password.
Q: My Outside Activity is listed as “Pending Completion.” What does that mean?
Your Outside Activity hasn’t been certified and submitted for approval. You’ll need to either 1) continue completing your application and certify all information is correct or 2) remove the application from the eCOI system.
Q: I need to make changes to an Outside Activity that has already been approved. Can this be done?
Yes. After logging in to eCOI, click “Update/Renew” in the Actions row on your dashboard (the first page you see after logging in). You’ll then be able to change/update any information and certify and submit like you did in your initial disclosure. Please note: any changes made will route the disclosure through the approval workflow a second time.
Q: My annual certification due date is approaching. What options do I have?
- View – Review a copy of your submitted disclosure
- Update/Renew – Make corrections or update information for the coming year
- Remove – Used to remove an activity from your dashboard. An explanation will need to be given. (Note: the disclosure can still be viewed under “Manage my external activities” on the right-hand side of your dashboard once removed).
- Details – View the approval and email history of your disclosure
Q: I’m being asked to upload a document, but I don’t have anything that needs to be attached. What can I do?
Potential Issues in Consulting Agreement Terms
The following is general guidance to help UF Faculty as they engage in outside consulting. This guidance is offered to provide some helpful advice and guidelines for faculty regarding some of the key aspects of their consulting arrangements. While the University has an interest in ensuring that faculty members adhere to University policies in consulting arrangements, the consulting relationship between the consultant and the outside entity is a personal agreement to which the University is not a party. We hope you find this Guidance helpful, but it is ultimately the responsibility of the consultant to ensure that University policies are being complied with and that he or she understands and complies with the terms and conditions of the consulting arrangement. We strongly recommend that you seek review of any proposed arrangement by your personal legal and tax advisers.
General Overview. The issues outlined below are common ones University personnel have seen in the past. It is not an exhaustive list of issues that can arise. The information contained in this Guidance is not intended to constitute legal or other advice on the contractual terms between the faculty/researcher and third parties. Rather, it is intended to highlight issues that could arise in the course of a specific consulting arrangement that might be of concern or interest to the consultant.
Scope of Work. The consultant should ensure that the scope of work defined in the consulting agreement is as closely tailored to the work that the consultant expects to perform as possible. For instance, a definition of services to be performed stating “the consultant shall provide such services as may be requested by the company from time to time” or “the consultant shall provide services to the company in the area of cancer research” is too broad.
Intellectual Property Ownership. Often outside consulting agreements have a provision that requires assignment of inventions and other intellectual property to the company. Apart from a potential conflict with the University’s IP Policy, faculty should consider whether to retain ownership of the intellectual property they have created so they do not jeopardize future University research programs in which the faculty member participates. For instance, companies may seek rights to future inventions related to the consulting activity, which might interfere with the University’s ability to give rights to other companies that sponsor University research or from complying with the requirements of the Bayh-Dole Act. Faculty members should note that the University’s Intellectual Property policy requires that disclosure of all inventions conceived by the faculty member be given to the University, even if the faculty members believe the company should own such IP.
Confidentiality and Right to Publish. Typically, a company will want to disclose proprietary information to the consultant and will want assurances that this information will be kept confidential. Please be sure that you understand precisely what information is confidential, and what your obligations are to protect the information from disclosure. It would be prudent to require any information the company wants to be kept confidential to be clearly marked to indicate that it is confidential. Faculty should also ensure that they retain broad rights to publish. The company can retain the right to review so that company confidential information can be redacted or to allow for the filing of a patent prior to publication.
Indemnification (“Hold Harmless”) and Limitation of Liability. Please be aware that consulting work for a company is a private matter between the consultant and the company. As a result, the University’s general insurance coverage, which is available to faculty in the role of an employee of the University, is NOT available to cover consulting work. If the consultant believes there is potential for a claim by the company against him/her for his/her consulting work, the consultant should check his/her personal liability policies (homeowners’ policy, etc.) to see what kind of protection it may afford you in the event of such a claim. The company should be asked to indemnify (or “hold harmless”) the faculty member for any third party action or similar claim related to the consulting services. For example, if a third party feels it is injured due to the company’s product or service, and that product or service is related to the consultant’s consulting activity, it is possible that the consultant will be sued in addition to the company. An indemnification obligation by the company is an obligation to pay the consultant’s defense costs and perhaps any resulting liability in such an event. In a consulting role, the consultant will be providing advice and other services to the company that may or may not be used. The consultant will likely have little or no control over how such advice or service is incorporated into the company’s business or products. It would be advisable to include a provision in the consulting agreement that the consultant’s liability is limited to his/her [gross] negligence or willful misconduct. The agreement should expressly disclaim any liability of the consultant for any product produced by the company.
Exclusivity or Non-Compete Provisions. The consultant should be aware of any provision that attempts to restrict him/her from providing advice to other companies or organizations or that would restrict him/her from any work within the University. If there are any restrictions that limit what the consultant can do on research, the consultant should make sure he/she understands them and that they are consistent with University policy.
Tax Issues. Since the consultant is an independent consultant for the company, he/she will NOT be paid as typical employees are paid. Specifically, there will be no income tax or social security tax (FICA) withheld from the consulting fee. The consultant will receive a tax document referred to as a Form 1099 that is used to report the consultant’s income to the government. The consultant is responsible for ensuring that he/she pays any taxes that are owed on that income. In some cases, the consultant may be required to pay taxes quarterly. The consultant should consult with a tax advisor to ensure he/she understands his/her financial responsibilities for taxes.
Q: When is it appropriate for me to accept an Expert Witness request?
Physicians may, with submission of an outside activity request and receipt of prior approval, accept personal employment to provide expert review and/or testimony as witnesses in medical malpractice cases that do not involve patients who were ever treated at UF or by UF providers and that are not adverse to UF Health’s major affiliates.
Q: Can I receive compensation for being an Expert Witness?
Yes. However, because it is private, direct employment, any compensation received as a result of providing this service cannot be paid to the University or FCPA and must be paid to the physician performing the service. The physician may elect to make a gift of the money to the University of Florida Foundation if s/he wishes.
Q: What about when I am requested or subpoenaed to provide testimony about my treatment of a patient?
When a physician, by virtue of their employment with the University, has seen a patient and is requested or subpoenaed to provide testimony about their treatment of the patient (in a civil or criminal context), the patient’s observed condition and expected prognosis, the University can bill a reasonable fee for the physician’s time, the monies being deposited in FCPA. The department chair or division chief is responsible to ensure that the funds are allocated or spent in accordance with UF, COM, department and division policies. (The responsible administrator is not precluded from determining that it is appropriate to use such funds to provide UF-owned equipment to faculty, or to provide support for CME or academic conference activities.) As a general rule, UF physicians acting as “fact” witnesses may not comment on the care provided by another physician (as to standard of care of the other physician’s actions), but may offer opinions as to whether the patient’s condition is causally related to the care received.
Q: How does this law impact UF COM faculty?
Companies will now be disclosing any payments to physicians and teaching hospitals onto the Official Website for Open Payments. This information is collected on a calendar year cycle and reported once annually. Physicians and Teaching Hospitals have no reporting obligations.
Q: Why is this information being reported on me?
This information is necessary to encourage transparency of reporting financial ties; reveal the nature and extent of relationships; minimize the risk of increased health care costs.
Q: What must be reported?
Under the Sunshine Act, the following information must be reported:
- The name and address of the physician
- The amount and date of the payment
- The form of the payment, such as cash or stocks
- The nature of the payment, such as consulting fees, gifts, or entertainment expenses
Q: Can I refuse to have this information reported?
Q: How can I ensure the information being reported it accurate?
Faculty can periodically check the website to view information reported on them. According to Anita Griner, deputy group director for the Center for Program Integrity (the group implementing the program), physicians should “keep records of all these payments and transfers of value that you may receive from an applicable manufacturer, and ownership interest and payments from group purchasing organizations that you may be an owner in … so that you can then compare those records against what the applicable manufacturers or GPOs submit.”
Q: What are the steps to correct misinformation that has been reported?
Before the collected information is posted to the public website, companies, GPOs, and physicians will have 45 days to review and challenge the information. The companies will have an additional 15 days to correct the information.
According to CMS.gov, covered recipients and physician owners or investors may initiate disputes at any time after the 45-day review and correction period begins, but before the end of the calendar year. However, any changes resulting from disputes initiated after the 45-day review period may not be made until the next time the data are refreshed.
SEPARATE COI POLICY FOR INDUSTRY INTERACTIONS
Q: What real risk is there to the University regarding conflicts of interest?
The risks associated with failing to properly disclose and manage conflicts, if necessary, are many: the protection of human subjects may be compromised; integrity of research may be placed at risk; the public may lose trust in the University and its research; the investigator/faculty member may lose the respect of the academic community; there may be a negative impact on students’ ability to pursue research interests; research results may not be published, or may be excessively delayed; the University may lose intellectual property; inferior or more costly goods and services may be purchased; and University resources may be improperly used.
Q: Why is the College of Medicine implementing a new policy now?
A couple of factors influenced the decision to move forward with shaping a new policy. First, the issue has received increased scrutiny at the federal level, prompting many academic medical centers to revise and strengthen their policies. Second, while the University’s general conflict of interest guidelines are very comprehensive, College of Medicine leadership believes it was necessary to set forth more specific guidelines respecting the College of Medicine and its interactions with the pharmaceutical, medical device, and biotechnology industries.
Q: Are other academic medical centers changing their conflict of interest/commitment policies to be more stringent?
Yes. Widespread national attention on the issue has prompted many academic medical centers to strengthen their policies.
Q. Will the policy be updated?
Q. What is the process for disclosure?
All faculty and staff will be required to annually disclose any new or current Outside Activities as part of the overall compliance process. The form may be accessed from our electronic disclosure system, eCOI, on the homepage of this website.
Q. Is there any evidence that gifts from industry really influence physician behavior?
Social sciences research has shown that gifts, promotions, etc. influence behavior. See the “Resources” page for some interesting and provocative papers on this subject.
Q. Do I need to remove any pens, post-it note pads, etc. received previously from vendors?
Q. May we accept new or revised textbooks from publishers who wish for us to look over the book for potential adoption, or as an instructor’s copy after the book has been adopted?
Accepting the textbooks as a free gift would be prohibited under the policy. Publishers may make a donation via a restricted grant submitted through the UF Foundation, and the department may choose to use the money to buy specific textbooks. Industry may also make a gift of textbooks to the UF Foundation using the appropriate documentation.
Q. If I am attending a national meeting and a vendor hosts a noon luncheon or other similar “event” open to all attendees, may I enjoy the meal or event?
Yes, if the event or meal is open to all attendees. In such cases it is viewed as part of your registration and conference attendance. However, you may not accept additional entertainment or benefits limited to only a few attendees, such as meals, tickets for sporting events, etc.
Q. If I am out to dinner with a vendor, can the vendor pay for my meal?
Q: If a vendor gives the department a grant for use in funding educational activities, can the department use some of the money to purchase food for residents?
INDUSTRY-SPONSORED RESIDENT EDUCATION
Q. Can industry-sponsored courses for residents and fellows continue under the new policy?
Yes. There are a couple of options to receive Industry support for educational activities. Support may be provided in the form of a restricted educational grant submitted through the UF Foundation. The monies must go directly into an educational account.
If there will be continuing education credits offered at the event, follow the processes and procedures outlined by the CME Office.
Q. What is the process for submitting a restricted grant through the UF Foundation?
Please contact your UF Foundation Development Officer (DO).
Q. May a vendor purchase general reference books for our residents?
No. Please have the vendor provide a gift to your department, which should decide what educational items or events it will support with those funds. It is important to separate the vendor from the decision-making process. It is okay to announce the company’s financial support at an educational event.
Q. What about accepting donations of equipment from a vendor?
A written Letter of Agreement must accompany gifts of equipment and materials from industry to clarify the intention and to document that no quid pro quo is expected. The agreement must be approved by the Conflict of Interest Office.
Q. Does the policy prohibit participation in speakers’ bureaus?
Speakers bureaus are typically speaking events where physicians give presentations based largely or entirely on material developed by a pharmaceutical or medical device company. This gives the impression that work created to further industry marketing goals is the independent work of leaders in academic medicine. For this reason, participation in speakers bureaus, as well as other forms of ghostwriting, is not allowed under the policy.
Q. If an agreement with Industry includes provisions for faculty or staff travel and expenses related to conduct of the agreement, is that acceptable?
The practice is acceptable IF the reimbursement for travel and expenses is reasonable and is explicitly spelled out in the contract. For example, if you are invited to a meeting or to speak at an event that will require two hours at a resort location, the vendor can provide expenses for the travel days and the day you are speaking, but not for a five-day stay at the resort.
Q. I am attending a meeting of my professional society and a pharmaceutical company has offered to pay for my hotel accommodations. May I accept?