Frequently Asked Questions: Conflict of Interest

UI Health Care updated its Conflict of Interest/Conflict of Commitment policy in response to several factors including a desire to have strong ethical standards and the recent "Patient Protection and Affordable Care Act" signed into law March 23, 2010. This federal law contains the "Physician Payment Sunshine Provision" that requires drug and medical device manufacturers to publicly report gifts and payments given to physicians and teaching hospital personnel beginning September, 2014.

A 40-member task force led the effort to create the new policy, benchmarking with other institutions, considering best practices, and soliciting input from faculty and staff across UI Health Care.

Yes. Widespread national attention on the issue has prompted many academic medical centers to strengthen their policies. Here are some examples:

• Stanford University
• Duke University
• Johns Hopkins School of Medicine
• University of Wisconsin Hospitals and Clinics

The policy went into effect on July 1, 2009. A revised version is effective April 29, 2016.

Yes. The policy was most recently revised in 2016 and became effective April 29, 2016. A Summary of Changes document lists the policy revisions. The policy will be reviewed every year and will be amended as necessary.

The Act requires that manufacturers of pharmaceutical/biologic products or medical devices that provide a payment or other transfer of value to a physician or hospital report the information to the Centers for Medicare and Medicaid Services (CMS). The information is collected annually by CMS and made publicly available.

Manufacturers began data collection on August 1, 2013 and reported it to CMS on March 31, 2014. CMS released the information on a public web site on September 30, 2014. The information will be updated annually.

1. CMS web site:
   Applicable Manufacturers and GPOs
   Physicians and Teaching Hospitals
    
2. CMS general online posting:
   CMS National Physician Payment Transparency Program OPEN PAYMENTS
    
3. Links from Policy and Medicine:
   Quick Reference Guide
   Top 50 Things to Know About the Final Sunshine Act Regulations
   Final Sunshine Rule and Continuing Medical Education (CME)
   Payments Related to Research and Delayed Publication
   Reporting Requirements
   45-Day Review Period and Penalties
   Cost and Regulatory Impact Analysis
   Nature of Payment Categories
   Final Sunshine Act Regulations: Definitions

UI Health Care faculty and staff who meet the eligibility requirements for disclosure (see below) will be required to complete an online disclosure each year and update the disclosure as new or changed outside financial relationships occur. All UI Health Care employees who meet the requirements must submit a certification through the eCOI system annually. Those who have no outside financial relationships to disclose will only submit the certification. Those who do have outside financial relationships to disclose must also submit a Disclosure Report for each relationship.

All UI Health Care employees working 50 percent time or more in a classification identified below, and trainees, must complete an annual disclosure/certification at least once per year:

• Faculty
• Professional and Scientific Staff
• SEIU Staff
• Merit Exempt Staff

Log in to the electronic system, called eCOI, at https://ecoi.uiowa.edu to complete your disclosure

• Contracts or letters of agreement to upload on the eCOI form for consulting relationships
• Tax records from the previous calendar year may be helpful, as you will be asked how much compensation you received from the entity, including travel expenses, income from dividends or the sale of stock, and income from licensing or royalties
• If you are involved in research (non-PHS or PHS-funded), in addition to the above, you will be asked about the value of stock ownership in the entity for both you and your family members (spouse, domestic partner, or dependent children) as well as compensation your family members received from the entity
• If you are involved in any PHS-funded research, in addition to the above, you must report the total number of days and destination of any sponsored or reimbursed travel
• The disclosure requirements for the UI policy on Conflict of Commitment and Conflict of Interest in the Workplace may require other information, depending on your employment status (e.g., faculty, etc.)

Log onto eCOI at https://ecoi.uiowa.edu. You must use your HawkID to log on, not your HealthCareID. When you are logged on, you can click the "Help" hyperlink on the right side of the screen. There you will be able to click on the "User Guide" hyperlink. This document will take you through the disclosure. If you need assistance in completing your disclosure or have any questions, contact the Conflict of Interest Office at 1-319-384-5252 or email [email protected].
 

You may update your disclosure at any time, but you should update it within 30 days of a new or changed outside financial interest. You will only certify once per year, during the annual disclosure period. New UI Health Care employees must submit the disclosure within the first month of employment, and then during the annual disclosure period thereafter.

In general, you do not have to disclose activities that are not related to your University of Iowa responsibilities unless the time devoted to them interferes with your obligations as a University employee.

No, these do not need to be disclosed.

No. By disclosing your outside financial interests, you are fulfilling the requirements of the Conflict of Interest/Commitment policy. In some cases, no further action will be taken. In other cases, you might receive a Management Plan from the Conflict of Interest office, although that too may not represent a conflict. Management Plans are in place to prevent and/or manage a potential conflict or the appearance of a conflict.

"UI resources" includes time, funding, facilities, equipment, intellectual property, personnel, materials, or information/data that would not be available to the general public and that you would not be free to disclose to other members of the larger scientific community by publication or presentation. Any consulting agreement that requires you to use UI resources, other than incidental use of phone/email/computer, should be restructured as an agreement with the UI for your services as a UI employee.

Call the COI office at 1-319-384-5252, or e-mail [email protected].

Research shows that gifts and promotion items do influence behavior. View a list of references and resources on the topic.

Accepting free textbooks that contain promotional pages or logos is prohibited under the policy. Departments may accept gifts of textbooks, medical journals, or educational devices to be used in skills labs if they do not contain promotional pages or logos. Publishers may also donate an unrestricted grant submitted to the department, division, or through the UI Center for Advancement, and the department may choose to use the money to buy specific textbooks.

No. Accepting even small gifts under the Iowa Gift Law limit is not allowed.

No you may not.

Yes, if the event or meal is open to all attendees. In such cases, the meal is viewed to be 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. Meals, snacks, or refreshments at UI Health Care events related to industry are allowed only when purchased through a UI Health Care department, division, or UI Center for Advancement account.

No.

No, as a UI Health Care employee, you may not.

Industry support for educational activities can be provided in the form of unrestricted educational grants submitted to the department, division, or through the UI Center for Advancement. The monies must not go directly to individuals.

If continuing medical education (CME) credits will be offered at a UI Health Care event, you must follow the processes and procedures outlined by the CME Division in the Carver College of Medicine.

If you know the UI Center for Advancement Development Officer (DO) assigned to your department, you should speak with that DO. If you do not know who the DO is, you may contact Greg Lamb, Assistant Vice President, Corporate and Center for Advancement Relations at [email protected] or call 1-319-467-3804.

A written Letter of Agreement must accompany gifts from industry of equipment and materials to clarify the intention and to document that no quid pro quo is expected. The agreement must be approved by the VPMA/Conflict of Interest Office. Use the provided Letter of Agreement template.

If the measuring devices are part of the purchase agreement, you may accept and use them. If they're separate and provided free, you may not.

Yes, if they have been reviewed and approved by the UICMS.

Yes, if that is how the department chooses to use the money. You must also follow the University of Iowa Hospitals & Clinics Vendor Policy (e.g., industry displays are not allowed in UIHC patient care areas). In addition, the vendor cannot offer free trinkets, food, or giveaways.

While industry-supplied drug samples and vouchers may not be accepted or distributed to UI Health Care patients, faculty and staff can help patients apply for drug assistance programs sponsored by pharmaceutical companies.

Yes.

No, this is not allowed as it has the potential to influence prescribing behavior. The company can donate an unrestricted educational grant to the department, division, or UI Center for Advancement account and the department may choose to purchase particular drugs.

Attendance at user groups is allowed if there is a contract in place with the company specifying that the user groups will occur and food/meals will be provided. However, door prizes are not allowed.

Only if the training is for equipment the department has already purchased and the purchase agreement includes training provision. Or, the vendor may donate funds through an unrestricted grant to the UI Center for Advancement or to a department or division account, and if the department chooses to send the physician to the course with this money, that is allowed.

Faculty, staff, and trainees who provide training and/or educational presentations for industry, Medical Education Companies (MECCs), or similar commercial enterprises, must comply with the requirements for consulting agreements. Presentations or training in which the primary purpose is to promote company products is prohibited.

Participation as a paid consultant or service on a data safety monitoring board for a pharmaceutical company is allowed under the policy, keeping the following in mind:

• A time-limited contract must be in place (including contract renewals and amendments) that outlines specific deliverables, tasks, responsibilities, and compensation consistent with the expertise provided.
• The contract must be approved by the department DEO and then forwarded to the VPMA/Conflict of Interest Office for approval.
• The relationship must be disclosed on an Entity Report in the eCOI system.

Yes, you must disclose the relationship and you must follow the policy requirements for consulting agreements with industry.

Besides submitting it to your Departmental Executive Officer/manager, the agreement should also be forwarded to the VPMA/Conflict of Interest Office at [email protected]. For more information, view the Faculty/Staff Consulting Contract Approval Process.

The COI Office reviews, and revises if necessary, only those sections that are relevant for compliance with the COI policy. The COI Office does not negotiate agreements for personal work that faculty and staff do outside their University position. Learn more about the issues the COI Office reviews in an agreement.

No, the COI Office does not have template consulting agreements. You should obtain a consulting agreement from the company that has hired you as a consultant. The COI Office can provide you with a document outlining standard consulting issues that are addressed in a COI review of a contract or agreement.

Accepting the money for this activity would be considered a gift and is not allowed, unless you have a consulting agreement in place that has been reviewed in accordance with the Conflict of Interest policy.

Speakers' bureaus where physicians give presentations based largely or entirely on material provided by a pharmaceutical or medical device company give the impression that work created to further industry marketing goals is the independent work of academic medicine leaders. For this reason, participation in speakers' bureaus, as well as ghostwriting, is not allowed under the policy.

Faculty, staff, and trainees may accept honoraria from academic institutions and professional associations. These activities are allowed and generally do not require disclosure. Honoraria may not be accepted from industry except as payment for providing training and/or educational presentations when there is a contract in place between the employee and the company. The contract must be reviewed and approved by the Health Care Conflict of Interest Office prior to the activity.

Yes, paid or reimbursed travel expenses with industry are considered a financial interest with the entity. Employees who are involved with any PHS-funded research have additional requirements for disclosing travel; for more information, go to the Conflict of Interest in Research Office at https://research.uiowa.edu/coi/.

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 requiring 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.

Yes, attendance at the investigator meeting is allowed and travel expenses (transportation, lodging, meals, etc.) may be paid for by the industry sponsor.

No, travel to evaluate a product before purchasing it cannot be made at the company's expense. However, if the product is purchased, and the employee must travel to see it demonstrated, travel expenses may be paid by the company only if this is specified in the purchase agreement.

Yes, expenses incurred by founders and co-founders who meet with outside entities to bring UIRF-related companies' products and services to market may be paid. These activities advance the University's mission. Researchers will still need to disclose these relationships in the eCOI system.

Yes.

Because the support for the event comes from an unrestricted educational grant, this would be allowed. Since they are outside UI Hospitals & Clinics, the industry displays also would be allowed.

Here are links to the information:

• The ACCME website
• The specific ACCME standards

All CME activities sponsored by the UI Carver College of Medicine must comply with ACCME regulations, requirements, standards, and guidelines. Education grants for CME events must be accompanied by a Written Agreement of Commercial Support signed before the event by a representative of the College and a representative of the Company providing the Grant. For more information, contact the CME Division in the Carver College of Medicine.

The CME office will require further review of presentations to insure compliance with regulatory requirements.

Discounts are allowed if they are negotiated through the usual channels, i.e. the UI Purchasing Department. A vendor may donate laboratory consumables for evaluation purposes only by completing the Product Donation Form available from the UI Purchasing Department (scroll down to "Product Donation Forms"). Donations exceeding $5,000 (vendor list price or equivalent) must receive prior approval from UI Purchasing by completing the Product Donation Form and returning the form to the Purchasing Department before making the donation.

Yes, if the purpose is to evaluate the reagents and if the vendor completes the Product Donation Form, available from the UI Purchasing Department (scroll down to "Product Donation Forms").

If your published work was for a scholarly journal or an academic press, you are not required to disclose it. But if the published work was for a medical publishing company or a company seeking to do or doing business with University of Iowa Health Care, then you must disclose it.