Frequently Asked Questions
- Background
- General Policy Information
- External Relationships Disclosure Form
- Gifts
- Meals
- Educational Scholarships, Visiting Professorships, and Stipends
- Equipment, Supplies, Resources, or Programming
- Drug Samples
- Training Assistance
- Consulting Expertise
- Speakers Bureaus
- Travel
- Industry Displays
- Continuing Medical Education (CME)
Q: Why is UI Health Care implementing a new policy now?
A: 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. UI Health Care established a task force charged with developing recommendations for a new policy. In addition, in May 2008, the auditor for the Board of Regents released a report recommending UI Health Care strengthen its conflict of interest/conflict of commitment policy.
Q: How was the new policy developed at UI Health Care?
A: During a lengthy process, a more than 40-member task force met to review the previous policy, examine and consider policies at other institutions considered best practices, and solicit/receive input across the enterprise. The task force then helped craft a draft of the policy, and it was distributed broadly throughout UI Health Care for review and comment. Through routine meetings, e-mail correspondence, open forums, and other venues, input from dozens of faculty and staff was solicited and received. Many of the suggestions and changes were incorporated into the final policy.
Q: Are other academic medical centers changing their conflict of interest/commitment policies to be more stringent?
A: Yes. Widespread national attention on the issue has prompted many academic medical centers to strengthen their policies. Here are some examples:
- The University of Pittsburgh
- Stanford University
- Boston University
- Duke University
- University of Michigan Hospitals and Health Centers
Q. When is the new policy effective?
A. Implementation planning--working through questions and specific circumstances--started on January 1, 2009. The policy went into effect on July 1, 2009.
Q. What will happen to contracts now in place and that will not expire until after July 1, 2009?
A. If the contract will expire during the course of Calendar Year 2009, then it may run to conclusion. If the contract date extends beyond December 31, 2009, then it should be renegotiated in accordance with the provisions of the new UI Health Care policy.
Q. What will happen to salary payments for staff who are employed to provide services related to the contract?
A. In most cases, staff salaries related to contracts and grants are paid by UI Health Care (College of Medicine, UI Hospitals and Clinics or UI Physicians), although these staff are employed conditionally as long as the grant or contract is available to fund their positions. The salary costs are "pass throughs" of actual cost to the vendor/granting agency. Such payments may continue. All such arrangements will be reviewed over the first six months of 2009 to assure there are no conflicts or potential perceived conflicts.
Q. What is the process for disclosure?
A. All faculty and staff will be required to complete an online External Relationships Disclosure form annually as part of the overall Compliance process, and as new relationships occur. The form is now available and must be completed by September 1. Several broadcast emails will be sent to those affected by the policy, with directions on accessing the form.
Q. Will the policy be updated?
A. The policy, while final, is anticipated to be reviewed and, where necessary, amended on an annual basis.
External Relationships Disclosure Form
Q. How do I complete the External Relationships Disclosure Form?
A.
- Go to the online External Relationships Disclosure form.
- Log in with your HealthCareID and password.
- Read the instructions on the screen and complete the form. All UI Health Care employees must submit a completed form, regardless of whether they have any relationships to disclose.
Q. I am sure that I have completed a disclosure form before as part of my employment at UI Health Care. Why is nothing listed under "Existing Disclosure Forms?"
A. You would not have completed a disclosure form for the UI Health Care Conflict of Interest/Conflict of Commitment policy before July 1, 2009, because that is when the policy and the requirement to disclose went into effect. Nothing will be listed under "Existing Disclosure Forms" until you complete the form once. Please click "New Blank Disclosure" and complete the form. After you have completed and submitted this form, it will then show up under "Existing Disclosure Forms" for you to update next year or as new relationships occur.
This disclosure process does not replace the disclosure process that is also required by Conflict of Interest in Research, CME, or the Provost's Office. The UI Health Care Conflict of Interest disclosure process is a separate database, so any information you completed for the other requiring bodies (if they apply to you) does not show up in this database at this time.
Q. Is there any evidence that gifts from industry really influence physician behavior?
A. Social sciences research has shown that gifts, promotions, etc. influence behavior. View a list of references and resources on the topic.
Q. Do I need to throw away before July 1st any pens, post-it note pads, etc. received previously from vendors?
A. Yes.
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?
A. Accepting the textbooks as a free gift would be prohibited under the policy. Publishers may make a donation via an unrestricted grant submitted through the UI Foundation, and the department may choose to use the money to buy specific textbooks.
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?
A. 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?
A. No.
Educational Scholarships, Visiting Professorships, and Stipends
Q. Can industry-sponsored courses for fellows continue under the new policy?
A. There are a couple of options to receive Industry support for educational activities. It can be provided in the form of an unrestricted educational grant submitted through the UI Foundation. The monies must go directly into an educational account and not directly to individuals, divisions, or departments.
If there will be continuing education credits offered at the event, another option is to follow the processes and procedures outlined by the CME Office in the Carver College of Medicine. The CME Office can be reached at 319-335-8599. Their web site is at: http://www.medicine.uiowa.edu/cme/index.html
Q. What is the process for submitting an unrestricted grant through the UI Foundation?
A. If you know the UI Foundation Development Officer (DO) who is assigned to your department, you should speak with that DO. If you do not know which of the Foundation's DOs is liaison to your area, you may inquire with Greg Lamb, Assistant Vice President, Corporate and Foundation Relations. His email is gregory-lamb@uiowa.edu and phone is 319-467-3804. By submitting it through the UI Foundation, you do not also need to submit it to the VPMA/Conflict of Interest Office for approval.
Equipment, Supplies, Resources, or Programming
Q. What about accepting donations of equipment from a vendor?
A. A written Letter of Agreement must accompany gifts of equipment and materials from industry to clarify the intention and to document that no quid quo pro is expected. The agreement must be approved by the VPMA/Conflict of Interest Office. Use the provided Letter of Agreement template.
Q. May we continue to accept measuring devices we use in the clinic from the company that makes the devices? We do have a contract with the company.
A. 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.
Q. Can we have American Cancer Society brochures available in the UI Community Medical Services (UICMS) clinics?
A. Yes, if they have been reviewed and approved by the UICMS.
Q. Does the policy affect free drug samples for low-income patients?
A. While industry-supplied drug samples and vouchers may not be accepted or distributed to patients at UI Health Care, faculty and staff are permitted to help patients in applying for drug assistance programs sponsored by pharmaceutical companies.
Q. 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?
A. Yes.
Q. Does the new policy allow attendance at computer user groups where industry provides food and door prizes?
A. Attendance at user groups is allowed if there is a contract in place with the company, specifying that the user groups will occur, and that food/meals will be provided. The door prizes, however, would not be allowed.
Q. May a physician travel to and attend a training course at a vendor's expense?
A. It would be prohibited under the policy for a physician to attend the training course at a vendor's expense, unless the training is for something that the department has already purchased, and this training is part of the purchase agreement. The vendor may donate funds through an unrestricted grant to the UI Foundation, and if the department chooses to send the physician to the course with this money, that would be allowed.
Q. a. Does the new policy prohibit me from being a paid consultant for a pharmaceutical company?
b. May I continue to serve on a data safety monitoring board for a pharmaceutical company?
A. 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:
- There must be a time-limited contract in place that outlines specific deliverables, tasks, responsibilities, and compensation that is consistent with the expertise provided.
- The contract should be approved by the department DEO, and then forwarded to the VPMA/Conflict of Interest Office for approval.
- The relationship must be reported on the External Relationships Disclosure form.
Q. Where should I send a new consulting agreement so it can be reviewed and approved in accordance with the Conflict of Interest policy?
A. Besides submitting it to your Departmental Executive Officer, the agreement should also be forwarded to the VPMA/Conflict of Interest Office at coi@healthcare.uiowa.edu
Q. Does the policy prohibit participation in speakers bureaus?
A. Speakers bureaus are typically speaking events where physicians give presentations based largely or entirely on material provided 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. May I take an honorarium for giving lectures?
A. Faculty, staff, and trainees may accept honoraria from academic institutions and professional associations, and the relationship must be disclosed. Honoraria may not be accepted directly from industry, however.
Q. If the contract includes provisions for faculty or staff travel and expenses related to conduct of the contract, is that acceptable?
A. 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. Can research investigators accept an invitation to attend an investigators' meeting for an industry-sponsored clinical trial?
A. Attendance at the investigators' meeting is allowed; however, any travel expenses (transportation, lodging, meals, etc.) must not be paid by the industry sponsor unless there is a contract in place for the trial that states the investigator's expenses to the meeting will be paid by the sponsor.
Q. May a UI Health Care employee travel at the company's expense to evaluate a product that the department is considering purchasing?
A. No, travel to evaluate a product before purchasing it cannot be made at the company's expense. 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.
Q. Does the ban on industry displays in patient areas of UI Hospitals and Clinics include off-site facilities, e.g., North Liberty Family Care Center or the future Institute for Orthopaedics, Sports Medicine and Rehabilitation?
A. Yes.
Q. 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, there are usually industry displays outside the meeting area, but no vendors are present in the meeting room. Is this allowed under the policy?
A. 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 would also be allowed.
Continuing Medical Education (CME)
Q. The policy states that "all CME activities sponsored by the Carver College of Medicine must be in compliance with ACCME regulations, requirements, standards, and guidelines." Where do I find the ACCME requirements and standards?
A. These are the links: