Guidelines for Management of Potential Conflicts of Interest with Health Care Industry*
Introduction
* For purposes of these guidelines, “industry” refers to any proprietary entity that produces healthcare and medical goods and services, scientific products used for research or educational purposes and the representatives of such entities. “Industry” includes all healthcare vendors producing and marketing drugs, devices, nutritional products and other medical products or services.
Updated: 01/06/2025
Introduction
The University of Illinois College of Medicine (UI COM) developed the following guidelines to manage interactions between the healthcare industry and our faculty, staff, residents, and students. Various relevant sources were reviewed and incorporated. These guidelines pertain to all faculty, staff, residents, and students of UI COM, except for faculty with unpaid/courtesy appointments.
Objectives
The College recognizes that interactions between the healthcare industry and faculty, staff, residents, and students are multi-layered and complex. No set of rules or policies can cover or anticipate all situations. Therefore, each situation should be managed with the aim of ensuring that our educational curriculum, research, and patient care decisions are independent of industry influence and still allow appropriate opportunities for faculty staff, residents, and students to interact with industry to foster collaborations in a creative, scientific, and conflict-free environment. In summary, each interaction should be managed to:
- Prevent healthcare industry from exercising influence over how faculty, staff, residents, and students practice medicine and treat patients, especially when such practice or treatment is delivered under the auspices of the UI COM or UI Health;
- Prevent healthcare industry from influencing how faculty, staff, residents, and students conduct research;
- Prevent healthcare industry from influencing the content of the curriculum of the UI COM;
- Prevent quid pro quo arrangements
- Eliminate the actual or apparent endorsement by the UI COM of any commercial healthcare product, service, or for-profit
A. Compensation or Gifts
- Faculty, staff, residents, or students and those family members living in their household with them, are restricted from soliciting or accepting gifts of any sort from prohibited sources. Prohibited sources are people or businesses that do business or seek to do business with the University. In most instances, but not all, prohibited sources are healthcare industry Individuals should be aware of and comply with applicable policies, such as the:
- Individuals may not accept compensation, including reimbursement for expenses associated with attending a CME or other activity in which the attendee has no other role. Reasonable honoraria and payment of expenses may be provided for speakers at accredited educational meetings, consistent with guidelines developed by the Accreditation Council for Continuing Medical Education (ACCME) and University policy.
- No gifts or compensation may be accepted in exchange for listening to a sales talk or similar presentation for a commercial interest that produces or distributes healthcare goods and services, or scientific products used for research or educational
- Meals and other gifts or donations funded directly by industry may not be provided at any UI COM location, including any site where UIC educational or social activities occur. Healthcare industry representatives and other industry representatives may provide unrestricted funds to Departments, Divisions, or Programs for educational programs. The funds will be managed according to the Standards for Commercial Support of the ACCME and University policy.
- No gifts may be accepted in exchange for modifying patient care, such as prescribing a specific medication. Support for research and educational programs must be provided without influence on clinical decision making.
- Free samples, supplies or equipment designated for an individual are considered a gift and are prohibited. Healthcare industry representatives may donate products to a department or division when the intent is for evaluation or education regarding the product, if the University invites the donation, and if there is a formal evaluation process. Sample donations are restricted to the amount necessary to complete the Other policies related to the management of samples must comply with the specific policies and procedures of each hospital or health system Faculty must abide by the policies developed at the clinical sites in which they practice.
B. Industry Support for Educational Programs
- Commercial support for educational programs must be free of actual or perceived conflict of interest.
- All educational programs within UI COM must abide by the Standards for Commercial Support established by the ACCME. This requirement applies to all undergraduate, graduate and continuing medical education programs regardless of whether continuing medical education credit is offered.
- All funds provided by industry or an industry representative to support educational programs must be given to the University as an unrestricted gift. The funds can be provided to the Department, Division, or Program but cannot be given to an individual faculty member, staff, resident, or student. This requirement applies to all funds for meals or refreshments, speaker honoraria, or any other expense related to an educational program and includes noon conference, grand rounds, and lectures at all UIC sites. Funds that are provided by educational groups or other entities that act as “intermediaries” for industry must also be provided as unrestricted gifts.
- No gifts may be accepted in exchange for listening to a lecture or presentation by a representative of a commercial entity that produces healthcare or medical goods and services, or scientific products used for research or educational purposes.
- Healthcare industry representatives may provide educational activities on a UI COM site only if they are requested to do so by the department head or their Participants in an educational program may not be required to attend any educational session in which industry representatives disseminate information about their products or services except when such services are provided as part of a contract for in-service or other training as part of an executed purchase decision.
- The content of all educational programs will be determined by UI COM faculty and, when appropriate, the COM CME office. Industry sponsors of educational programs may not determine the content or selection of speakers for educational
- These requirements do not apply to meetings governed by ACCME Standards or meetings of professional societies and other professional organizations that may receive partial industry support. Individuals who actively participate in meetings or conferences that are supported in whole or in part by industry, including lecturing, organizing the meeting, or moderating sessions should abide by the following requirements.
- Financial support should be fully disclosed by the meeting
- The content of the meeting or session should be determined by the If the sponsor dictates the content of a session or talk, the faculty speaker must clearly delineate what information is so dictated.
- The speaker must provide a fair and balanced
- The speaker must make clear that the comments and content reflect the individual views of the speaker and not the University of Illinois, UI COM or the Department.
- Faculty, trainees, students and staff should carefully evaluate whether it is appropriate to participate in off-campus meetings or conferences that are fully or partially sponsored by industry because of the high potential for real or perceived conflict of interest.
C. Provision of Scholarships or Other Educational Funds for Students and Trainees
- Industry support for students and resident participation in education programs must be free of any real or perceived conflict of All educational gifts or support of educational programs must be specifically for the purposes of education and must comply with the following requirements:
- UI COM, Department, Division, or Program must select the student(s) or resident(s) for participation;
- The funds must be provided to the Department, Division, or Program and not directly to the student or resident;
- The Department, Division, or Program must determine that the education conference or program has educational merit;
- There is no implicit or explicit expectation that the participant must provide something in return for participating in the educational program
- This provision does not apply to regional, national or international merit- based awards that will be considered on a case-by-case
D. Disclosure of Relationships with Industry
- Faculty and staff must disclose all Outside Activities in accordance with UIC and University of Illinois The specific disclosure obligation and method is dependent on the activity. The place of disclosure currently is according to university policy.
- In UIC Research COI, Covered Individuals must complete an annual Disclosure Profile update disclosing and seeking approval for Outside Activities. This requires retrospective and prospective disclosure of external activities. Proposed new Outside Activities require Unit Executive Office (UEO) review and approval prior to engaging in Outside Activities. Additional disclosure is required and necessary whenever a substantial change in external activities occurs or when required by granting agencies.
- COI training is required for new Covered Individuals and is completed within the UIC Research COI application as part of the Disclosure Profile update. COI training must be completed every 4 years; however, researchers may require more frequent COI re-training to comply with federal sponsor
- The University Policy on Conflicts of Commitment and Interest is available at: COCI Policy 2024 – EVPAA, and includes related policies: Financial Conflicts of Interest in Research – EVPAA, and Organizational Conflicts of Interest – EVPAA
- All publications must comply with the guidelines of the International Committee of Medical Journal Editors.
- Covered individuals must complete situation specific disclosures of potential conflicts of interest when required (e.g. procurement, IRB applications, grant proposals).
- All continuing medical educational activities must be disclosed and resolved as defined by the Office of Continuing Medical Education and the ACCME.
- Faculty must disclose a potential conflict of interest when lecturing/teaching about a related topic in the medical school curriculum.
- Faculty or staff who serve as consultants, members of a speaker’s bureau, have an equity interest in or another relationship with industry for which they receive personal compensation or other support must recuse themselves from deliberations or decision making regarding the selection of products or services to be provided to the hospital or health system, or UI COM (e.g., selection of drugs to be added to the formulary) by the company. While requests for formulary inclusion of medications can be made by conflicted faculty, these conflicts must be disclosed at the time of the requests. Faculty with such ties to industry shall not participate in decisions regarding the purchase of related items, drugs, procedures in their department unless specifically requested to do so by the purchasing unit and after full disclosure of the faculty member’s industry relationship. Under all circumstances the financial relationship must be disclosed and any conflicts resolved prior to participation in any decision making.
- Faculty and staff are prohibited from publishing articles that are substantially or completely “ghost” written by industry representatives. Faculty and staff who publish articles with industry representatives must participate in the preparation of the manuscript and shall be listed as authors or otherwise appropriately cited for their contribution. The financial interest of all authors shall be disclosed in accordance with the standards of the journal.
- Faculty with financial relationships with industry must ensure that the responsibilities to the company do not affect or appear to affect the ability to properly supervise and educate students, residents, and other trainees, nor influence employment decisions for faculty and All such relationships must be disclosed particularly during educational or research activities pertinent to the industry relationship and resolved as defined by ACCME.
E. Access by Sales and Marketing Representatives to Faculty, Staff, Residents, and Students
- Faculty, staff, residents, and students at each UI COM clinical site must abide by the policies and procedures for each site (Chicago, Peoria and Rockford) with regard to meeting with industry representatives. In general, representatives are permitted in non- patient care areas by appointment Company representatives are not permitted in any patient care areas except to provide scheduled and approved in-service training on devices and other equipment for which there is an executed University contract for these services. Involvement of students and residents in such meetings should occur only for educational purposes and only under supervision of a faculty member.
F. CME
For all CME activities, UI COM follows the Accreditation Council for Continuing Medical Education (ACCME) standards available on their website.
G. Definition of Significant Financial Interest
The current definitions are the same as those used by NIH and are:
$5,000 expected in next 12 months for you and your spouse and dependent children aggregated OR any equity for you and your spouse and dependent children regardless of value. Royalties paid through the university are excluded.
Because this threshold may change, please refer to the following websites to see the most current definition:
H. Relationship to Other University Policies
These guidelines supplement University policies on Conflict of Interest. Faculty and staff should familiarize themselves with those policies and reporting obligations. If these guidelines and University policies conflict, then the more restrictive of the two will apply. Questions about the policies should be discussed with the department head and/or administrative staff.
Other University Resources: