It is the policy of the University of Kansas Medical Center (KUMC) that interactions with industry should be conducted so as to avoid or minimize conflicts of interest and the appearance of conflicts of interest. When conflicts of interest do arise they must be addressed appropriately. All vendor representatives (representatives) are expected to abide by the Vendor Relations Policy (Policy) and applicable laws and regulations while on KUMC premises or while interacting with KUMC personnel (i.e. faculty, staff and students). All gifts (including de minimus gifts), are prohibited and may not be accepted by individual KUMC personnel from representatives.
The goals of this policy are to establish guidelines for interactions with industry representatives for KUMC personnel and to safeguard education, research and patient care against market-driven conflicts of interest. The overriding goal of this policy is to ensure that the integrity of our educational, research and clinical programs are not compromised by financial or other personal relationships with industry. Interactions with industry occur in a variety of contexts including educational and research support of KUMC personnel and marketing of new healthcare, pharmaceutical and medical device products. KUMC personnel also participate in interactions with industry off campus and in scholarly publications. Many aspects of these interactions are positive and important for promoting the educational, clinical and research missions of KUMC. KUMC fully recognizes that a healthy interaction between academia and industry is part of the mission. However, these interactions must be ethical and cannot create conflicts of interest that could endanger patient safety, sway clinical decisions contrary to the patient’s best interests, alter data integrity or the integrity and independence of our education and research programs or the reputation of the institution. As part of this policy, KUMC recognizes that ethical interactions are the responsibility of both industry and KUMC personnel.
This policy applies to all KUMC personnel and all industry representatives with whom they may come in contact. This policy incorporates the following:
1Kansas law prohibits any state employees of the executive branch and members of boards, commissions, or authorities of the executive branch from accepting or requesting meals, gifts, entertainment, and travel with a few exceptions. Personnel may accept meals, the provision of which is motivated by a personal or family relationship, or provided at events that are widely attended. An occasion is 'widely attended' when it is obvious to the person accepting the meal that the reason for providing the meal is not a pretext for exclusive or nearly exclusive access to the person. (K.S.A.46-237a)
2American Medical Association. "Statement on Gifts to Physicians from Industry." (http://www.ama-assn.org/ama/pub/category/4001.html) Opinion 8.061, “Gifts to Physicians from Industry" is intended to provide ethical guidance to physicians. Other parties involved in the healthcare sector, including the pharmaceutical, devices and medical equipment industries and related entities or business partners, should view the guidelines as indicative of standards of conduct for the medical profession. Ultimately, it is the responsibility of individual physicians to minimize conflicts of interest that may be at odds with the best interest of patients and to access the necessary information to inform medical recommendations. The guidelines apply to all forms of gifts, whether they are offered in person, through intermediaries, or through the Internet. Similarly, limitations on subsidies for educational activities should apply regardless of the setting in which, or the medium through which, the educational activity is offered.
3Accrediting Council for Continuing Medical Education. “Standards for Commercial Support” (www.accme.org) When commercial interests contribute funds and services for the development of CME activities, it is considered commercial support. Commercial support has significantly enhanced the ability of the CME enterprise to fulfill its purpose. However, commercial support has the potential to introduce commercial bias that threatens the integrity of the CME enterprise. When individual’s have financial relationships with commercial interests and are in a position to control the content of CME, there is also the potential for commercial bias. The Accreditation Council for Continuing Medical Education (ACCME) believes that CME must be free of the control of commercial interests. The ACCME believes that this independence from commercial interests will help ensure that CME is free of commercial bias.
4See Kansas Government Ethics Committee Opinions K.G.E.C. 2000-10; 2000-17; 2000-18. Stating in 2000-10 and 2000-17 State employees may accept reimbursement from an external group for the expenses associated with attendance at a conference…when the person's presence at a meeting, seminar or event serves a legitimate state purpose or interest and the person's agency authorizes or would authorize payment for such travel and expenses. Stating in 2000-18 that if an employee has been offered a gift, and not because of his/her position with the State, the state level conflict of interest laws would not prohibit that person from accepting the gift. The Commission's advisory opinions serve to interpret the laws under the Commission's jurisdiction.
5See FN 3
6See FN 4.
7Industry-Supported Scientific and Educational Activities: http://www.fda.gov/cder/guidance/isse.htm This guidance was prepared by FDA's Intra-Agency Working Group on Advertising and Promotion. This guidance represents the Agency's current thinking on industry-supported scientific and educational activities. The agency is providing this guidance to describe the agency's enforcement policy with regard to scientific and educational activities supported by industry. The guidance seeks to clarify the distinction drawn by the agency between scientific and educational activities that FDA considers nonpromotional and those that the agency considers promotional, and to provide guidance on how industry may support such activities without subjection to regulation under the labeling and advertising provisions of the act.
8International Committee of Medical Journal Editors (http://www.icmje.org). II. Ethical Considerations in the Conduct and Reporting of Research; II.A Authorship and Contributorship; II.A.1. Byline Authors: An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study… Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
Barbara F. Atkinson, M.D.
Executive Vice Chancellor
Executive Dean, School of Medicine
Paul F. Terranova, Ph.D.
Effective Date: May 6, 2008