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In pursuit of its mission as a public institution of higher education, the University of Cincinnati College of Medicine seeks excellence in the quality of its research, in the teaching and education it provides to its students, and to improve the health of the public through the delivery of effective and efficient clinical care. The success of the College of Medicine (COM) depends upon the integrity of its members and the public’s confidence in it. This shared mission requires that faculty, students, trainees, and staff in the COM interact with representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (hereinafter “Industry”), in a manner that advances the use of the best available evidence so that medical advancements and new technologies become broadly and appropriately available. Interactions with Industry occur in a variety of contexts, including marketing of new pharmaceutical products, medical devices, and hospital and research and supplies on-site, on-site training of newly purchased devices, the development of new devices, educational support of medical students and trainees, and continuing medical education. Faculty and/or trainees may also participate in interactions with Industry off campus and in scholarly publications in a variety of circumstances including consulting activities of various sorts. While the interaction with Industry can be beneficial, and are important for promoting the educational, clinical and research missions of the COM and for translating knowledge and expertise from the faculty to society and the community, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise patient safety, negative socialization of students and trainees, bias research results, and diminish confidence and respect among patients, the general public and regulatory officials. Because provision of financial support or gifts, even in modest amounts, can exert subtle but measurable impact on recipients’ behavior, the COM has adopted the following policy to govern the interactions between Industry and COM personnel.
It is the policy of the University of Cincinnati College of Medicine that clinical decision-making, education, and research activities be free from influence created by improper financial relationships with, or gifts provided by, Industry. For purposes of this policy, “Industry” is defined as any person or any public, private or not-for-profit entity that is not directly affiliated with the University of Cincinnati and that is engaged in the pharmaceutical, medical device, and biotechnology industries, and their representatives. Interactions with Industry should be conducted in such a manner so as to identify and address conflicts of interest and to comply with relevant provisions of University Policy and applicable law. This policy cannot address every conceivable manner of industry interactions with COM personnel. Questions regarding a particular relationship or gift should be directed to the academic unit’s supervisor, the Industry Interactions Committee (IIC), or Senior Associate Dean for Faculty Affairs and Development. The following specific limitations and guidelines are directed to certain specific types of interactions with Industry.
This policy applies to all academic and administrative units of the College of Medicine, and to all College of Medicine personnel.
This policy is intended to supplement the requirements of the applicable University of Cincinnati Board Rules and policies, including:
This policy is inclusive of the following interactions:
Conflict of Interest: Occurs when a COM personnel’s obligation(s) to COM are, could be, or appear to be compromised by the external activities or agreements undertaken by the personnel, or those undertaken by an immediate family member. Actual or potential conflicts of interest may take many forms, but frequently involve a tangible benefit to the personnel from an outside source, financial or otherwise, which may, or may appear to, influence the personnel’s professional actions. A conflict may also arise if a COM personnel engages in activities with another organization that may compete with similar activities at UC COM.
Gift: Anything of any value including money, goods and services given directly to COM personnel, or to his/her family, or to UC COM, by an industry that does or seeks to do business with the University of Cincinnati or any of its affiliates. Gifts do not include items of value that are provided as a bona fide component of a sanctioned transaction or activity.
Immediate Family: The COM personnel’s spouse, birth or adoptive parent, child, or sibling; stepparent, stepchild, stepbrother or stepsister; father-in-law, mother-in-law, son-in-law, daughter-in-law, brother- in-law, or sister-in-law; grandparent or grandchild; and spouse of a grandparent or grandchild.
Industry: Any person or any public, private or not-for-profit entity that is not directly affiliated with the University of Cincinnati and that is engaged in the pharmaceutical, medical device, and biotechnology industries, and their representatives.
Outside Activity: Includes collateral employment and activities (employment or service) outside of the university or within the university that is outside the scope of the individual’s normal employment.
Outside Activity Report: A web-based system for preparing, reviewing, and approving collateral employment, conflict of commitment and conflict of interest.
Personnel: Refers to all faculty, staff, and trainees of the University of Cincinnati College of Medicine. “Trainees” include post-doctoral, graduate, undergraduate and medical students.
Because outside activities available to COM personnel are many and varied, no policy statement or procedures document can address all possibilities. It is therefore the obligation of each faculty and staff member to:
All faculty and staff must receive approval from their direct supervisor (Department Chairperson, Center Director, Section Chief, etc.) and respective Dean prior to engaging in collateral employment or outside activities (University Board Rules 30-21-02 and 30-21-03).
COM personnel conducting affairs on behalf of the university, including hiring and procurement, must do so in a manner that is objective, ethical, and has integrity. This includes individuals who use a Purchasing Card (P-Card) for the purpose of procuring goods or services for the University of Cincinnati or one of its associated organizations.
Regarding external interests and activities, the following actions by COM personnel are prohibited:
Regarding external interests and activities and the design, conduct, reporting of research or scholarly activity, the following actions by COM personnel are prohibited:
Gifts to COM Personnel
The COM recognizes that the acceptance of gifts, even in modest amounts, can exert influence on the recipients’ behavior. COM personnel must avoid even the appearance that their professional decisions might be influenced by any perceived or actual benefits from Industry. Accordingly, COM personnel may not accept any personal gifts from industry under any circumstances. Examples of gifts include:
Gifts to COM
Gifts that directly support the mission of UC COM, (e.g., samples for evaluation, contributions towards seminars or other internal conferences, items of educational value such as books), may not be donated directly to COM personnel under any circumstances, but may be donated to UC COM, subject to the following:
Educational materials may be gifted by Industry to the COM for use by COM personnel and students provided such materials are preapproved in advance by the Dean of the COM or designee and have no branding beyond a logo on the cover or device. Such materials must not be distributed directly by Industry to individual COM personnel.
Gifts containing industry brands and/or logos such as clocks, pens, post-it pads, posters, etc. are marketing tools and should not be displayed in clinical and teaching areas. Anatomic models or charts that are deemed important for patient education and/or the COM educational mission are permitted, but non-branded versions are preferred. Industry sponsored literature, models, and research samples may be utilized with the following provisions intended to minimize marketing and advertising influence:
COM personnel may not accept on-site meals or any other gifts of food for themselves or others if sponsored, catered, or provided directly by Industry unless such meals are explicitly permitted by this policy.
Industry funding for meals or in-kind contributions of food or beverages may not be accepted by COM personnel or for COM meetings, retreats or social events without approval from the COM Industry Interactions Committee. Meals related to investigator meetings where participation is necessary for the
investigator and his or her study staff to receive the appropriate training and experience to conduct the study are permitted.
COM personnel who choose to accept meals during their outside professional activities must be cognizant of the UC research-related conflict of interest policies and procedures and, if appropriate, it is their responsibility to report the monetary value of meals funded by Industry via the OAR system. For licensed providers, the value of such meals may be reported under the Physician Payment Sunshine Act (http://www.cms.gov/regulations-and-guidance/legislation/national-physician-payment-transparency- program/index.html).
COM personnel may serve as consultants to industry; such relationships can lead to research, innovation and improvements in medical and surgical products, and can ultimately promote advances in patient care and in the research enterprise. Such consulting relationships must not: (a) interfere with University duties; (b) compromise professional ethics; (c) have elements that may be construed by the government as an illegal kickback; or (d) be used as a vehicle for direct payment to faculty aimed at convincing them to use an industry company’s products.
Outside consulting relationships with industry paid directly to COM personnel are permitted under the following conditions:
Outside employment, consulting activities, and financial interests of COM personnel may be disallowed if they result in conflicts with the employee’s duties, responsibilities, and obligations to the COM as set forth in University of Cincinnati’s regulations and policies. It is the responsibility of the COM personnel to ensure that no consulting or employment agreement that he or she enters into violates any University of Cincinnati regulations and policies as well as state and federal laws.
COM personnel may serve as speakers to present information relevant to Industry’s products. Such speaking opportunities may serve to provide necessary scientific and educational information to the medical and health care provider community. COM personnel may spend time and effort apart from their assigned COM duties in preparing for such presentations, and compensation by Industry may be offered.
COM personnel are permitted to speak on behalf of Industry but this must be conducted as an approved outside activity. The COM personnel must disclose the activity via the OAR system prior to engaging in
the outside activity. Approval may be dependent upon whether the COM personnel is meeting his or her Departmental assignments and expectations. Speaking engagements will be permitted for one year (12 months) renewable terms.
Payment to the COM personnel must be commensurate with the tasks performed considering the COM personnel’s specialty, expertise, experience, and regional/national/international reputation. Speaking relationships must not function as de facto gifts from Industry or marketing of Industry products. Faculty are prohibited from receiving a retainer or other similar payments simply for being a member of a speakers’ bureau. Any payments for involvement with a speaker’s bureau must be in relation to actually performing a service as a speaker, lecturer, etc. Faculty are prohibited from participating in and receiving an honorarium for an Industry sponsored speaker’s bureau event when the goal of the activity is marketing of the vendor’s products.
Any gathering where information is presented must be primarily dedicated to informing healthcare professionals about a product or treatment, providing scientific information, and promoting educational discourse on the topic presented. The venue must be conducive to informational communication and any meals must (a) be reasonable as judged by local standards; (b) not be part of an entertainment or recreational event; and (c) be provided in a manner conducive to informational communication. A COM personnel’s spouse or other guest in a meal accompanying an informational presentation made by or on behalf of Industry is not appropriate.
The COM personnel must retain full control of the educational content and ensure the ethical and scientific integrity of the information he or she presents. The content of the presentation should be produced by or fully vetted by the COM personnel for scientific accuracy. The COM reserves the right to review all content for appropriateness.
If an Industry engagement requires that use of Industry prepared presentation materials on drug products, then the materials must follow pharmaceutical guidelines and present information on the FDA-approved use of the drug product and may not promote the off-label use of a drug product.
Speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.
The COM shall not sponsor or host any Industry speaker’s bureau activities.
COM personnel may participate in or attend Industry-sponsored meetings, or other off-campus meetings where Industry support is provided, as long as:
COM personnel may accept an item with an Industry logo on it in conjunction with an educational conference (e.g., tote bag, a water bottle, etc.) if:
If a COM personnel is participating as a speaker or presenter at an industry-sponsored event he or she must ensure:
Meetings with Industry regarding the potential purchase, lease or rental of equipment or services from Industry, and any meals provided at such a meeting must be in accordance with the policies of the respective purchasing department working with that COM academic unit and the laws of the State of Ohio. In general, all costs for meals, travel, lodging, etc. for these meetings should be covered by a COM department and not by Industry unless explicitly approved by a member of the purchasing department, senior administrator in the COM, or the Industry Interactions Committee.
Licensed providers should be aware of the Physician Payment Sunshine Act mandates that meals from industry, which are commonly linked to industry-sponsored lectures, must now be reported and becomes part of the public domain. https://www.cms.gov/OpenPayments/Downloads/Affordable-Care- Act-Section-6002-Final-Rule.pdf.
Industry representatives other than service personnel are not permitted on the premises of the COM except for specific appointments with COM personnel. Approvals may be granted on a per visit basis or as a standing appointment for a specific period of time.
The use of pharmaceutical samples for the purposes of clinical care should defer to the policies of the clinical entity in which the physician practices.
COM personnel should be aware of the Standards for Commercial Support established by the Accreditation Council for Continuing Medical Education (ACCME). UC Continuing Medical Education (UC- CME) is dedicated to providing continuing education for physicians and other health professionals and they have established policies and procedures that address educational programs for practicing
clinicians, including residents and Fellows. These policies are available at http://cme.uc.edu/about- us/policies/.
All educational events organized by the COM and sponsored by Industry, including those in an off- campus setting, must be fully compliant with ACCME guidelines, regardless of whether formal CME credit is awarded or not. In addition to the aforementioned ACCME Standards, educational events sponsored by Industry on the COM campus shall comply with the following provisions:
Industry Sponsorship
COM personnel are prohibited from receiving funds directly to attend any CME or other education event. Industry wishing to provide support for attendance at a specific educational event should make a donation to the COM to reduce the cost for all attendees. If Industry is interested in other support for an educational event or conference, including the purchase of food or rental of facilities, the Industry should make a monetary donation to the COM academic unit for these purposes.
In addition:
The COM Curriculum Committee shall ensure that COM medical students, graduate students, and undergraduate students are trained to understand the importance of federal, state, and institutional conflict of interest laws, rules, policies, and procedures, and how Industry promotion can influence professional judgment.
Before commencing any lectures or presentations to students and trainees, COM personnel must disclose any relationships with Industry. The requirement to inform students and trainees should address the nature of the interest including the specific company and product and how they relate to the educational topic, whether in a lecture, seminar, rounds, team-based learning or other educational format.
In community educational settings in which students or trainees might be exposed to Industry marketing or representatives, COM personnel should strive to provide and to model professional behavior.
Students and trainees should be informed of the effect that exposure to pharmaceutical and device representatives may have on their autonomy and objectivity.
COM personnel may receive industry funding in the form of scholarships, educational funds, fellowships, and reimbursement of travel through travel grants. The following guidelines must be followed:
Interaction between faculty and industry in the pursuit of scientific knowledge is appropriate and may lead to development of important new concepts. It is expected, however, that faculty who publish papers with collaborators from Industry will participate in development of the study in a meaningful way, including interpretation of data and the preparation of the final manuscript.
Physicians, researchers, and other healthcare professionals rely heavily on the information they read in journal articles and other sources of the medical literature to make diagnostic, therapeutic, and research decisions, and they should be able to trust any recommendations made reflect the research and opinions of the authors and not the hidden influence of writers hired by industry.
COM faculty, staff, students, and trainees are strictly prohibited from participating in any way in publications or professional presentations of any kind, oral or written, which have been “ghostwritten” by any party, industry or otherwise. This does not apply to transparent writing collaboration with attribution between academic and Industry investigators, medical writers, and/or technical experts.
COM personnel are encouraged to follow the International Committee of Medical Journal Editors standards for authorship and contributorship (found here: http://www.icmje.org/) which require each author to contribute and participate meaningfully in the work.
Proctoring is an assessment of skills based on observation by a credentialed individual with institutional privileges that may be used in lieu of data from a peer-review process or established criteria relating to minimal volumes of procedures performed. Therefore, proctoring is a process administered through the hospital/clinic credentialing committee to objectively monitor, regulator or oversee individual privileging
for its medical staff. Proctoring is separate from precepting, in which an instructor or teacher (a preceptor) is responsible for the actions of a learning individual and is not, in whole or part, to promote an Industry.
Physicians may proctor other faculty within our institution as well as outside of hospitals and health systems unaffiliated with University of Cincinnati or UC Health. All internal and external requests for proctoring must originate from a university or health system. Requests from Industry must be approved by the IIC. Payment to faculty for proctoring services performed outside of UC Health should be at fair market value with clear objectives outlined in writing.
The UC COM, through an Industry Interactions Committee (IIC) designated by the Dean, shall have the authority to administer this policy. The designated committee will have the following responsibilities:
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