Conflict of Interest F.A.Q.
- Why did UI Health Care implement this policy?
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.
- How was the new policy developed at UI Health Care?
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.
- 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. Here are some examples:
- When was the policy effective?
The policy went into effect on July 1, 2009. A revised version is effective January 1, 2013.
- Has the policy changed since last year?
Yes. The policy was most recently revised in 2012 and became effective January 1, 2013. A Summary of Changes document lists the policy revisions. The policy will be reviewed every year and will be amended as necessary.
- What is the Physician Payment Sunshine Act?
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 will be collected by CMS and made publicly available.
- When will the Sunshine Act go into effect?
Manufacturers must begin data collection on August 1, 2013 and report it to CMS by March 31, 2014. CMS will release the information on a public web site by September 30, 2014.
- Where else can I find information about the Sunshine Act?
CMS has published some Fact Sheets on their web site:
CMS general online posting:
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
- What is the disclosure process?
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 interests occur.
- Who is required to submit an annual disclosure?
All UI Health Care employees working 50 percent time or more in a classification identified below must complete an online disclosure at least once a year (even if they have no outside financial interests to disclose):
- Professional and Scientific Staff
- SEIU Staff
- Merit Exempt Staff
- What is new about the disclosure process this year?
UI Health Care employees who have submitted an annual disclosure in the past will see these changes this year:
- A new disclosure period: February 4 - April 30
- A new reporting period: disclose compensation received during calendar year 2012 and compensation anticipated for 2013
- You will have the opportunity to review the entities you disclosed last year, and then be given the option of including or not including the same entities on this year's disclosure
- A new combined electronic system that will satisfy the disclosure requirements of three University of Iowa entities (UI Health Care, Continuing Medical Education (CME), and Conflict of Interest in Research)
- Employees who are involved in research are also governed by the Conflict of Interest in Research federal regulation. For complete information, go to the Conflict of Interest in Research web site at: https://research.uiowa.edu/coi/
- Where can I find the disclosure form?
Log in to the electronic system, called eCOI, at https://ecoi.uiowa.edu to complete your disclosure.
- What information do I need to gather before I begin completing an Entity Report?
- Contracts or letters of agreements 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.
- What do I need to do to complete the disclosure?
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 384-5252 or e-mail email@example.com.
- Am I expected to update the disclosure during the year?
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.
- Do I have to disclose non-professional activities?
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.
- Do I need to disclose income/dividends from investments in IRAs and diversified mutual funds?
No, these do not need to be disclosed.
- If I disclose an outside financial interest, does this mean I am considered to have a conflict of interest?
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.
- My Management Plan says that I may not use UI resources for my outside activity, what does that mean?
"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.
- What if I don't understand or agree with something on my Management Plan?
Call the COI office at 384-5252, or e-mail firstname.lastname@example.org.
- Is there any evidence that gifts from industry really influence physician behavior?
Research shows that gifts and promotion items do influence behavior. View a list of references and resources on the topic.
- Can I accept new or revised textbooks from publishers asking me to look over the book for potential adoption, or as an instructor's copy after the book has been adopted?
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 Foundation, and the department may choose to use the money to buy specific textbooks.
- Can I accept small gifts from vendors if it is under the $3.00 Iowa Gift Law limit?
No. Accepting even small gifts under the Iowa Gift Law limit is not allowed.
- May I accept gifts or door prizes from drug or medical device companies when I am away at a conference?
No you may not.
- If I am attending a national meeting and a vendor hosts a noon luncheon or other similar "event" open to all attendees, can I participate?
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 Foundation account.
- If I am out to dinner with a vendor, can the vendor pay for my meal?
- If I am attending a vendor show at a UI Health Care event outside of the hospital, can I accept free gifts or snacks?
No, as a UI Health Care employee, you may not.
- Can industry-sponsored courses for fellows continue under the new policy?
Industry support for educational activities can be provided in the form of unrestricted educational grants submitted to the department, division, or through the UI Foundation. 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.
- What is the process for submitting an unrestricted grant through the UI Foundation?
If you know the UI Foundation 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 Foundation Relations at email@example.com or call 467-3804.
- Can donations of equipment from a vendor be accepted?
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.
- May we continue to accept measuring devices used in the clinic from the company that makes the devices? We do have a contract with the company.
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.
- Can we have American Cancer Society brochures available in the UI Community Medical Services (UICMS) clinics?
Yes, if they have been reviewed and approved by the UICMS.
- Our department is organizing a conference that will offer nursing CEUs. May we invite vendors and charge them to display their products at the event, and then use the money to pay for refreshments?
Yes, if that is how the department chooses to use the money. You must also follow the University of Iowa Hospitals and 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.
- Does the policy affect free drug samples for low-income patients?
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.
- Does the ban on drug samples apply to off-site UI Hospitals and Clinics facilities, e.g., outreach clinics and primary care clinics across the state?
- May UI Health Care residents and fellows accept drug samples for training purposes?
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 Foundation account and the department may choose to purchase particular drugs.
- Does the new policy allow attendance at computer user groups where industry provides food and door prizes?
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.
- May a physician travel to and attend a training course at a vendor's expense?
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 Foundation 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.
- May I receive payment from a medical device company to provide training on a device they manufacture?
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.
- Does the policy prohibit me from being a paid consultant for a pharmaceutical company and/or may I serve on a data safety monitoring board for a pharmaceutical company?
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.
- I might receive payment to consult for a start-up company. Do I have to disclose this?
Yes, you must disclose the relationship and you must follow the policy requirements for consulting agreements with industry.
- Where should I send a new consulting agreement so it can be reviewed and approved in accordance with the Conflict of Interest policy?
Besides submitting it to your Departmental Executive Officer/manager, the agreement should also be forwarded to the VPMA/Conflict of Interest Office at firstname.lastname@example.org. The process for obtaining an approved consulting agreement is outlined here.
- May I obtain a template consulting agreement from the COI Office?
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.
- As a physician, I am asked to participate in online surveys geared towards improving health care. I am paid a small amount of money for this activity. Is this allowed?
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.
- Does the policy prohibit participation in speakers' bureaus?
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.
- May I take an honorarium for giving lectures?
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, however.
- Do I need to disclose activities with industry for which only my travel was paid?
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/.
- If a contract is in place between a vendor and a UIHC department, and it includes provisions for faculty or staff to travel related to conduct of the contract, 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 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.
- Can research investigators accept an invitation to attend an investigator meeting for an industry-sponsored clinical trial?
Yes, attendance at the investigator meeting is allowed and travel expenses (transportation, lodging, meals, etc.) may be paid for by the industry sponsor.
- May a UI Health Care employee travel at the company's expense to evaluate a product that the department is considering purchasing?
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.
- I am the founder of a UIRF company and, because we need to get our product/service off the ground, I am in talks with industry to try to promote and/or license it. Can industry pay for travel expenses in these instances?
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 for. These activities advance the University's mission. Researchers will still need to disclose these relationships in the eCOI system.
- Does the ban on industry displays in patient care areas of UI Hospitals and Clinics include off-site facilities, e.g., North Liberty Family Care Center or the Institute for Orthopaedics, Sports Medicine and Rehabilitation?
- We have a journal club that is held at a local hotel, and is funded by money from an unrestricted educational grant. During the event, industry displays are usually set up outside the meeting area, but no vendors are present in the meeting room. Is this allowed under the policy?
Because the support for the event comes from an unrestricted educational grant, this would be allowed. Since they are outside UI Hospitals and Clinics, the industry displays also would be allowed.
- The policy states that "all CME activities sponsored by the UI Carver College of Medicine must be in compliance with ACCME regulations, requirements, standards, and guidelines." Where do I find the ACCME requirements and standards?
Here are links to the information:
- What specific information do we need to know about how to obtain educational grants from industry for CME events?
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.
- Are discounts or donations of lab items permissible?
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.
- Samples of reagents are often provided to labs and that helps us determine whether or not to use them. Can we take these samples?
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").
- Do I need to disclose royalties or compensation for publishing works?
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.
Frequently asked questions
- Background and General Policy Information
- Physician Payment Sunshine Act
- Disclosure Process
- Conflict of Interest/Conflict of Commitment Management Plans
- Educational Scholarships, Visiting Professorships, and Stipends
- Equipment, Supplies, Resources, or Programming
- Drug Samples
- Training Assistance
- Consulting Expertise
- Honoraria/Speakers' Bureaus/Ghostwriting
- Industry Displays
- Continuing Medical Education (CME)
- Basic Science Research in the Carver College of Medicine