Link: University of Iowa

Frequently Asked Questions

Background and General Policy Information

Q: Why did UI Health Care implement this policy?

A: 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, 2013.

Q: How was the new policy developed at UI Health Care?

A: 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.

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:

Q. When was the policy effective?

A. The policy went into effect on July 1, 2009. A revised version is effective July 1, 2010.

Q. Has the policy changed since last July?

A. Yes. The policy was revised in March, 2010, effective July 1, 2010. A Summary of Changes document lists major policy revisions. The policy will be reviewed every year and will be amended as necessary.

Disclosure Process

Q. What is the disclosure compliance process?

A. UI Health Care faculty and staff who meet the eligibility requirements for disclosure (see below) will be required to complete an online External Relationships Disclosure Form each year and update the disclosure as new relationships occur.

Q. Who is required to submit the disclosure form?

A. All UI Health Care employees working 50 percent time or more in a classification identified below must complete the External Relationships Disclosure Form at least once a year:

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

Q. Is there a new form this year?

A. Yes. The new online disclosure form for 2010-2011 will be available July 1 and must be completed by all eligible UI Health Care employees by September 1, regardless of whether or not they have any relationships to disclose.

Q. How do I complete the External Relationships Disclosure Form?

A.

  1. On the Conflict of Interest web site, click on the link in the yellow box on the right side of the screen
  2. Log in with your HealthCareID and password
  3. Read the instructions on the screen and complete the form
  4. For your convenience, click here to download and print the directions

Q. I completed the External Relationships Disclosure Form last year. Why do I have to complete a disclosure form again?

A. To fulfill the requirement for 2010-2011, you need to verify the information you submitted for 2009-2010 (or add/edit as necessary), and you also need to disclose outside relationships for July 1, 2010 to June 30, 2011. The External Relationships Disclosure Form includes separate sections and questions for each time period.

Q. Do I still have to fill out separate disclosure forms required by the Continuing Medical Education (CME) Division, the Provost's Office, and Conflict of Interest in Research?

A. That depends. This year, completing the External Relationships Disclosure Form will fulfill the disclosure requirement for both the UI Health Care Conflict of Interest/Commitment policy and for Continuing Medical Education (CME), if CME requirements apply to you. This disclosure process does not, however, replace the disclosure process also required by Conflict of Interest in Research or the Provost's Office. You must disclose separately for those entities if they apply to you.

Q. How much time do I have to update the External Relationships Disclosure Form after a relationship changes or I enter into a new relationship?

A. You may update the form at any time, but you should update within 30 days of a new or changed relationship.

Q. Do I have to disclose non-professional activities?

A. In general, you do not need to disclose non-professional activities unless the time devoted to them interferes with your obligations as a University employee.

Q. If I have an appointment with both UI Health Care and at the VA Hospital, does the income from the VA need to be disclosed?

A. No, your income from the VA does not need to be disclosed.

Q. What activities do not need to be disclosed?

A. The following activities generally do not require disclosure:

  1. Holding office in, or undertaking an editorial office or duties for a scholarly journal, academic press, or professional organization
  2. Serving as a referee for a scholarly journal or an academic press
  3. Serving on a professional review board or peer review bodies (non-industry, e.g. NIH study section)
  4. Attending or presenting at events sponsored by professional organizations or academic institutions, such as professional meetings, workshops, colloquia, symposia, seminars, or training programs
  5. Visiting other sites in connection with accreditation, audits, sponsored project reviews, or like activities
  6. Non-professional activities, unless the time interferes with your obligations as a University employee

Q. How do I access the public disclosure database and what disclosure information is shown to the public?

A. Go to the Conflict of Interest web site and click the “View UI Health Care Faculty and Staff Disclosures” link on the right side of the screen. Or, click “Show Public View of My Disclosures” on the Instructions page of the External Relationships Disclosure Form. Information shown to the public includes the entity name, amount of compensation, and the type of relationship. If an employee has no outside relationships to disclose, a statement to that effect will appear under his/her name.

Q. Is there a threshold for the dollar amount that must be disclosed?

A. No. Any amount over zero should be disclosed.

Q. I am co-founder of a company, but I do not have any income from this relationship yet. Do I have to disclose it?

A. No, unless it presents a conflict of commitment. Upon receiving any financial gain from the relationship, you must disclose it.

Q. Do I have to disclose stock ownership?

A. Income from stocks and options related to industry as defined under the Conflict of Interest policy must be disclosed. Income from mutual funds does not have to be disclosed.

Q. What happens after I have submitted my External Relationships Disclosure Form?

A. The Conflict of Interest (COI) Office staff will complete an initial review of your disclosure and may call or e-mail you to clarify your answers. Based on the disclosure information, the Conflict of Interest Oversight Committee may recommend a Management Plan for your relationship(s) to the Vice President for Medical Affairs (VPMA). The COI Office will then send you the Management Plan on behalf of the VPMA. After receiving the Management Plan, you must sign it, have your DEO or manager sign it, then return one copy to the COI Office. A copy should be kept in your personnel file.

Q. If a relationship changes after I submit my disclosure, how do I update the External Relationships Disclosure Form?

A. Click here to download and print the directions.

Q. Who can I contact for technical assistance?

A. If you have trouble logging on to the External Relationships Disclosure Form, contact the UI Health Care Information Systems Help Desk at 6-0001. For questions about the policy or disclosure form, contact the Conflict of Interest Office at 384-5252 or e-mail: coi@healthcare.uiowa.edu.

Conflict of Interest/Conflict of Commitment Management Plans

Q. If I disclose a relationship on the External Relationships Disclosure form, does that mean I am considered to have a conflict of interest?

A. No. By disclosing your outside relationships, 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.

Q. What if I don't understand or agree with something on my Management Plan?

A. Call the COI office at 384-5252, or e-mail coi@healthcare.uiowa.edu.

Gifts

Q. Is there any evidence that gifts from industry really influence physician behavior?

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

Q. 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?

A. Accepting the textbooks as a free gift is prohibited under the policy. However, publishers can 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.

Q. Can I accept small gifts from vendors if it is under the $3.00 Iowa Gift Law limit?

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

Q. May I accept gifts or door prizes from drug or medical device companies when I am away at a conference?

A. No you may not.

Meals

Q. 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?

A. 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.

Q. If I am out to dinner with a vendor, can the vendor pay for my meal?

A. No.

Q. If I am attending a vendor show at a UI Health Care event outside of the hospital, can I accept free gifts or snacks?

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

Educational Scholarships, Visiting Professorships, and Stipends

Q. Can industry-sponsored courses for fellows continue under the new policy?

A. 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.

Q. What is the process for submitting an unrestricted grant through the UI Foundation?

A. 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 gregory-lamb@uiowa.edu or call 467-3804.

Equipment, Supplies, Resources, or Programming

Q. Can donations of equipment from a vendor be accepted?

A. 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.

Q. 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.

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. 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?

A. 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.

Drug Samples

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 UI Health Care patients, faculty and staff can help patients apply 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. May UI Health Care residents and fellows accept drug samples for training purposes?

A. 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.

Training Assistance

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 food/meals will be provided. However, door prizes are not allowed.

Q. May a physician travel to and attend a training course at a vendor's expense?

A. 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.

Q. May I receive payment from a medical device company to provide training on a device they manufacture?

A. 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.

Consulting Expertise

Q. 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?

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:

  • A time-limited contract must be in place 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 reported on the External Relationships Disclosure Form.

Q. I might receive payment to consult for a University of Iowa Research Foundation company. Do I have to disclose this?

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

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. May I obtain a template consulting agreement from the COI Office?

A. 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.

Q. 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?

A. 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.

Honoraria/Speakers' Bureaus/Ghostwriting

Q. Does the policy prohibit participation in speakers' bureaus?

A. 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.

Q. May I take an honorarium for giving lectures?

A. 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.

Travel

Q. Do I need to disclose activities with industry for which only my travel was paid?

A. Yes, paid or reimbursed travel expenses with industry is a financial relationship with the entity.

Q. 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?

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 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.

Q. Can research investigators accept an invitation to attend an investigator meeting for an industry-sponsored clinical trial?

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

Industry Displays

Q. 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?

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, 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?

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 also would be allowed.

Continuing Medical Education (CME)

Q. 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?

A. Here are links to the information:

Q. What specific information do we need to know about how to obtain educational grants from industry for CME events?

A. 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.

Basic Science Research in the Carver College of Medicine

Q. Are discounts or donations of lab items permissible?

A. 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.

Q. Samples of reagents are often provided to labs and that helps us determine whether or not to use them. Can we take these samples?

A. 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").

Publishing

Q. Do I need to disclose royalties or compensation for publishing works?

A. 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.