UC Only Visiting Faculty Onboarding Binder 2022

NEW HIRE ONBOARDING GUIDE 2022

COLLEGE OF MEDICINE UC VISITING FACULTY

University of Cincinnati Academic Health System

College of Medicine

Facilities: • UC Health Physician Offices • University of Cincinnati Medical Center • West Chester Hospital • Daniel Drake Center for Post- Acute Care • Lindner Center of HOPE

Employee Lease

UC College of Medicine Vision: To be indispensable through excellence in education, research, and patient care.

Next Lives Here At the University of Cincinnati, we realize the impact our teaching, research and service can have on our community and the world. So, we don’t wait for change to happen. We break boundaries, boldly imagine, and create what’s Next. To us, today’s possibilities spark tomorrow’s reality. That’s why we are leading urban public universities into a new era of innovation and impact. We're about engaging people and ideas - and transforming the world. We are UC. Welcome to what's Next.

Next Lives Here is a 10-year strategic direction purposefully designed to position the University for long-term, sustained success that sets us apart. As a member of the University of Cincinnati, you play an invaluable role in the success of the university’s Strategic Direction.

Next Lives Here is comprised of three platforms and nine pathways—each of which is designed to enrich and reinforce the others. In fact, we believe the biggest breakthroughs are likely to occur at the intersections of these pathways. At the highest level, we’re striving to create a mature ecosystem for innovation, inclusion and impact.

Next Lives Here: Platforms & Pathways Explained Academic Excellence Platform A commitment to student success coupled with distinctive research and creative scholarship, teaching, and service will always be the bedrock of our mission. To accelerate student success and graduate impact-driven leaders, we must attract, invest in, and celebrate the people who comprise UC. Through the development of our faculty, staff and students and transformative curricular, scholarly, and operational excellence we will pioneer new ways of thinking, creating, and doing. Bearcat Promise Bearcat Promise seeks to proactively assist students in creating a personalized path to achieving success. Through transformative curricular, scholarly, and operational excellence, we can better serve our students and prepare them to meet the needs of our rapidly changing world. Faculty Investment Greater investment in our faculty allows us to pursue and retrain high-caliber talent whose research and teaching positively impacts student success, our region and the world. By working together in creative and strategic ways we can fuel discovery and learning that leads to social transformation. Staff Enrichment It is vital we foster a workplace environment that enables staff to contribute to UC’s success. Through investments in the personal and professional growth of our employees, we can ensure employee fulfillment, an effective organization, and quality student experience. Urban Impact Platform The well-being of our institution is inherently linked with the physical, social, and economic health of our community and city. Cincinnati, and its business, civic, education, and cultural offerings, provides an opportunity to reach beyond our campuses to lead real-world learning, problem-based research and scholarship, and creative endeavors that address the multifaceted challenges affecting individuals and communities in our increasingly urbanized society. Only through collaborations and partnerships with external counterparts can we improve the human condition and advance the institution, city, state, and world. Urban Futures Urban Futures is focused on partnering to overcome barriers and apply innovative, scalable solutions to the challenges that urbanization poses to our region. UC researchers are working with external partners to accelerate economic growth and socio-economic mobility to create a better future for all. Urban Health Urban Health is leveraging and aligning the expertise of the university with the strengths of the community to address issues related to the health and well-being of our region. Through interdisciplinary approaches we are co-creating solutions and working together to develop an inclusive, diverse, and culturally competent healthcare workforce. CPS Strong CPS Strong establishes a model to engage and empower Cincinnati Public School students. By aligning programs and services to ensure readiness, create access, and foster success, we can achieve educational transformation and positively impact the future of our university and our city. Innovation Agenda We are dedicated to pushing limits and challenging minds by providing the space and opportunity for people from diverse backgrounds to connect, imagine, and discover. The formation of new collaborations and partnerships linking UC’s talent in transformative ways—both internally and externally—provides a platform to advance and enrich experiences, ideas, and outcomes. 1819 Innovation Hub The 1819 Innovation Hub brings university talent, industry, and community together in a space free from barriers that hinder innovation—allowing ideas to be unleashed and curated. It’s a one-stop destination for the university, the city, and world beyond to co-locate, bring ideas to life, and solve today’s most complex problems. Co-op 2.0 UC invented cooperative e and expanding the reach of experiential leaning to all corners of the university. Moving forward, all UC students can be placed in learning experiences that are career-oriented, transcripted, and compensated to meet the needs of our global workforce. Inclusive Excellence Inclusive Excellence works to bring out the best in our students, faculty, and staff by valuing their unique backgrounds, experiences, and perspectives. By leading with courage and compassion and welcoming and leveraging individual contributions we can collaborate, create, innovate, and compete in a global society.

UC Core Values

Innovation

Inclusion

Impact

Positively transforming our community and society in measurable ways. • Displays an eagerness to improve Focuses on quality results • Attains results through positive actions Is a solution seeker • Takes positive action to meet growing responsibility • Builds reliable networks before they are needed

Intentionally engaging all people and seeking the contribution of diverse ideas. • Embrace freedom and openness by working to create an environment that is safe and affirming, one that nurtures independent thinking and the free and open expression of ideas • Practice civility by extending to those we meet the same respect, cooperation and caring that we expect from others. • Enthusiastically works with all employees at all levels, capitalizing on their strengths • Actively seeks opinions and ideas from people of varied background and experiences to improve decisions.

Challenging existing practices and paradigms and discovering the unknown.

• Seeks innovative solutions

• Fosters a curiosity for innovative possibilities

• Serves as a champion of change

• Constantly strives to redefine the standard of excellence in everything we do • Creates a work environment that encourages creative thinking and innovation

• Focuses on enhancing efficiencies

• Strives to create a positive

student and employee experience

• Explores new ideas,

methodologies, different positions, and alternatives to reach outcomes

• Introduces new concepts or strategies that significantly

• Values and incorporates

contributions of people from diverse backgrounds

improve or revise the way business is done.

COLLEGE OF MEDICINE-OFFICE OF THE DEAN UNIVERSITY OF CINCINNATI ACADEMIC HEALTH CENTER PO BOX 670555 CINCINNATI OH 45267-0555 3230 EDEN AVENUE

PHONE (513) 558-7333 FAX (513) 558-3512

THE POLICY AND GUIDELINES FOR INDUSTRY RELATIONSHIPS

THIS IS TO ACKNOWLEDGE THE RECEIPT OF MY PERSONAL COPY OF THE POLICY AND GUIDELINES FOR INDUSTRY RELATIONSHIPS GIVEN TO ME AS A NEW EMPLOYEE AT THE UNIVERSITY OF CINCINNATI. YOUR SIGNATURE INDICATES THAT YOU UNDERSTAND AND AGREE TO THE RULES SET FORTH IN THIS POLICY.

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PATIENT CARE - EDUCATION - RESEARCH - COMMUNITY SERVICE AN AFFIRMATIVE ACTION/EQUAL OPPORTUNITY INSTITUTION

APPROVED BY COLLEGE OF MEDICINE COUNCIL Document Owner: CoM Sr. Associate Dean for Faculty Affairs

COLLEGE OF MEDICINE Operating Procedure/Guideline Industry Relationships

Effective Date: 4/11/2019

Category: CoM-HR

Responsible Office(s): CoM Dean

Prior Effective Date: N/A

Applicable for: CoMFaculty/Providers and Staff

Background

In pursuit of its mission as a public institution of higher education, the University of Cincinnati (UC) College of Medicine (CoM) 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 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 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 is 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, compromised patient safety, negative socialization of students and trainees, biased research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because the provision of financial support or gifts, even in modest amounts, may exert subtle but measurable impact on recipients’ behavior, the CoM has adopted the following policy to govern the interactions between Industry and CoM personnel.

Policy Statement

It is the policy of the CoM 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 UC and that is engaged in the pharmaceutical, medical device, and biotechnology industries, and their representatives acting in their official capacity. The term “Industry” does not include professional associations, not-for-profit volunteer health organizations, academic institutions or not-for-profit hospitals that are not substantially controlled by Industry and provide medical research/education-related products and services. 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.

Scope of Policy

This policy applies to all academic and administrative units of the CoM, and to all CoM personnel.

This policy is intended to supplement the requirements of the applicable UC Board Rules and policies, including:

Enabling Acts

Description

University Rule 3361:10-17-03

Conduct and ethics: Code of Conduct.

University Rule 3361:10-17-08

Conduct and ethics: Policy on conflicts of interest in the conduct of research at UC. Conduct and ethics: Employee financial interest in private companies that are commercializing university discoveries, inventions or patents. Employment: Policy on collateral employment for faculty members and librarians. Employment: Policy on collateral employment for all employees (excluding faculty and librarians). Federal agencies sponsoring research require the university to maintain this policy as a condition for receiving federal grants. The requirements embodied in this policy are applicable to all proposals and subsequent awards submitted to and accepted by these federal agencies. Conflict of interest policy and statement for the UC IRB, effective December 2010.

University Rule 3361:10-17-09

University Rule 3361:30-21-02

University Rule 3361:30-21-03

Conflict of Interest on Externally Funded Projects 1.3.2

IRB Conflict of Interest Policy

This policy is inclusive of the following interactions: 1. Gifts 2. Meals 3. Consulting Relationships 4. Industry Sponsored Speaking 5. Attendance at Industry Sponsored Events 6. Industry Representative Presence 7. Pharmaceutical Samples

8. Industry Support of Education, Including Accredited Continuing Medical Education 9. Disclosure Requirements in CoM Curriculum and Extension of Policies to Community

College of Medicine Operating Procedure/Guideline Industry Relationships, Page 2 of 12

Educational Settings 10.Industry Support for Scholarships and Funds for Trainees/Fellows 11.Ghostwriting and Honorary Authorship 12.Clinical Proctoring

Definitions

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 UC 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 UC and that is engaged in the pharmaceutical, medical device, and biotechnology industries, and their representatives acting in their official capacity. The term “Industry” does not include professional associations, not-for-profit volunteer health organizations, academic institutions or not-for-profit hospitals that are not substantially controlled by Industry and provide medical research/education-related products and services. 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 UC CoM. “Trainees” include post- doctoral, graduate, undergraduate and medical students.

Requirements for Disclosure

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: 1. Carefully consider whether a particular activity might constitute an actual or perceived

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conflict of interest or a conflict of commitment; 2. If there are questions about the appropriateness of a potential activity and whether or not it qualifies for disclosure, discuss the activity with the direct supervisor, Department Chairperson, Section Chief or Center Director, the Conflict of Interest Committee, Industry Interactions Committee, or, for faculty, the Senior Associate Dean for Faculty Affairs and Development; and 3. Disclose activities using the Outside Activities Report (OAR) system including all outside and consulting activities, before undertaking the activities. 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).

General Prohibited Activities

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 UC or one of its associated organizations. Regarding external interests and activities, the following actions by CoM personnel are prohibited: 1. Using the University name, marks, or logos for advertising purposes without prior Institutional approval; 2. Using any University address or official stationary of the University for personal or non- University business without prior approval; 3. Using University personnel, equipment, or services for personal gain without prior Institutional approval (e.g., facilities use agreement, sponsored research agreement or other appropriate contractual arrangement; or where de minimis, through the OAR approval process); 4. Using position or role to determine or influence the hiring, promotion, reappointment, evaluation, responsibilities, salary and termination status for an immediate family member; 5. Using position or role to determine or influence the selection of a vendor, in which you or your immediate family member have an interest, to provide goods or services to the University. Regarding external interests and activities and the design, conduct, reporting of research or scholarly activity, the following actions by CoM personnel are prohibited: 1. Using nonpublic research information to buy or sell stock; 2. Disclosing nonpublic research information or any other proprietary information to investment companies or other third parties for personal gain. Note: Individuals who have access to preliminary nonpublic research results related to clinical trials or other research with potential commercial value may be considered insiders for purposes of federal insider trading laws if the research is sponsored by companies with publicly traded stock.

Industry Interactions

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1. GIFTS

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 should 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: Entertainment Goods or services for personal use Travel 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: A. Gifts for research and educational purposes: Industry may support the research and educational missions of the CoM by providing unrestricted research or educational grants or gifts of the following items: books, instruments, equipment, research samples (e.g., reagents, antibodies, PCR kits, etc.) or teaching aids. Such unrestricted grant or gift funds will be placed in an appropriate UC CoM/UC Health account controlled by or accessible to the Dean of the CoM or its academic units and that is managed pursuant to UC/UC Health and or UC Foundation policies and procedures. Educational materials may be gifted by Industry to the CoM for use by CoM personnel and students provided such materials are approved by the academic unit head and have no branding beyond a logo on the cover or device. Gifts containing industry brands and/or logos such as clocks, pens, post-it pads, posters, etc. are marketing tools and must 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: 1. The materials are used solely for education or research purposes. 2. COM personnel decide when they are utilized, not the Industry representative. 3. The materials are not overtly promotional in nature. 4. The recipient of the research sample, instrument, or equipment is not subject to any implicit or explicit expectation of providing something in return for the gift, i.e., a “quid pro quo”. 5. The educational literature and models must not be displayed publicly in a manner intended for the purpose of industry or product promotion.

B. Pharmaceutical samples: CoM Personnel may not accept pharmaceutical samples for patient care or personal use except as permitted by UC Health policies or that of the

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entity in which they’re practicing. Pharmaceutical samples provided for research purposes must comply with this policy for gifts for research purposes.

C. Other gifts to UC CoM: Gifts not described above, such as support for non-CME educational events and cash donations, should be managed through the UC Foundation. Donors who want to give to the COM can work directly with the UC Foundation and the College of Medicine to discuss the various forms of which contributions are made.

2. MEALS

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).

3. CONSULTING RELATIONSHIPS

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 (like an inappropriate Stark relationship); 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: A. The relationships must be disclosed via the OAR system prior to engaging in the outside activity; and approved by both the Department Chair and Dean; and B. Any outside activity must comply with UC CoM Conflict of Commitment policies. C. CoM personnel are advised that the relationship should be described in a formal written contract which documents the specific, legitimate tasks and deliverables, and that payments for services must be commensurate with the tasks performed considering the faculty member’s specialty, expertise, experience, and regional/national/international reputation. CoM personnel are responsible for ensuring their outside consulting activities comply with all applicable local, state, and federal

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regulations.

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.

4. INDUSTRY SPONSORED SPEAKING

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 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 sole 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. Meals must be reasonable as judged by local standards and not be part of an entertainment or recreational event. 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 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.

Speakers and their materials should clearly identify the company that is sponsoring the presentation and the fact that the speaker is presenting on behalf of the company.

College of Medicine Operating Procedure/Guideline Industry Relationships, Page 7 of 12

The CoM shall not sponsor or host any Industry speaker’s bureau activities unless these are part of a CoM CME-approved event.

5. ATTENDANCE AT INDUSTRY SPONSORED EVENTS

CoM personnel may participate in or attend Industry-sponsored meetings, or other off-campus meetings where Industry support is provided, as long as: A. The activity is designed to promote evidence-based clinical care and/or advance scientific research; B. The financial support of Industry is prominently disclosed; C. Attendees do not receive gifts for attendance (attendees may be compensated for consultation services as part of their participation); D. Any meals provided are modest (i.e., the value of which is comparable to the Standard Meal allowance as specified by the United States Internal Revenue Service) and consistent with the educational or scientific purpose of the event. 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: A. The item has the name of the conference or sponsoring organization on it;

B. The item is provided by the educational conference; C. The items is provided to all conference attendees.

If a CoM personnel is participating as a speaker or presenter at an industry-sponsored event he or she must ensure: A. All lecture content is approved by the CoM personnel and reflects a balanced assessment of current knowledge, and the CoM personnel makes clear that the views expressed are the views of the speaker and not the CoM or UC Health; B. Compensation is reasonable and limited to reimbursement of reasonable travel expenses and a modest honorarium. C. Any honorarium in excess of $10,000 for a single event must be reviewed by the Industry Interactions Committee to avoid any perceived conflicts of interest. D. All honoraria must be disclosed in the OAR within 30 days of acquisition or discovery. 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.

6. INDUSTRY REPRESENTATIVE PRESENCE

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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.

7. PHARMACEUTICAL SAMPLES

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.

8. INDUSTRY SUPPORT OF EDUCATION, INCLUDING ACCREDITED CONTINUING MEDICAL EDUCATION

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 https://uc.cloud-cme.com. 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: A. Funds for educational activities shall be provided to a central fund managed by the academic unit or division administrative office and not to individuals. The CME Office manages funds for certified CME activities through accounts set up by the CoM A&F Department. Contact the CME Office to make arrangements. B. Personal gifts of any type shall not be distributed to attendees or participants before, during, or after the activity, other than educational materials set forth in the Gift policy. Any items of value (gifts or other) provided to physician participants from industry are subject to being reported as a requirement of the Physician Payments Sunshine Act (PPSA), also known as section 6002 of the Affordable Care Act (ACA) of 2010, which requires medical product manufacturers to disclose to the Centers for Medicare and Medicaid Services (CMS) any payments or other transfers of value made to physicians or teaching hospitals. https://www.cms.gov/OpenPayments/About/Resources.html Industry Sponsorship COM personnel are prohibited from receiving funds directly to attend any CME or other education event from Industry. 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. If the activity is certified for CME credits, all grant funds and written Letters of Agreement must be managed through the CME Office, as described above. Exhibitor fees can be handled directly by the sponsoring department. In addition: A. The planning and coordination of the event must remain under control of the CoM/UC

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Health academic unit. B. Donated funds must remain under the control of the CoM/UC Health academic unit. C. Appropriate recognition of the Industry supporting the event must be provided, especially when the activity is granting CME or other continuing education credit. D. At the discretion of the academic unit head, the Industry representative(s) providing support for the event: 1. May attend the event; 2. May be introduced/recognized at the event; 3. May set up a table in an area adjacent to but separate from the educational event where he or she may distribute marketing or scientific literature; 4. May not distribute any gifts, trinkets or meals, beverages, snacks, candy or other food items; 5. May not conduct any marketing or commercial activities within the room where the educational event is occurring.

9. DISCLOSURE REQUIREMENT IN COM CURRICULUM AND EXTENSION OF POLICIES TO COMMUNITY EDUCATIONAL SETTINGS

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 include a balanced review of studies purporting to show how Industry promotion can influence professional judgment. Before commencing any lectures or formal presentations to students and other trainees, CoM personnel should 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 in the course of their training, of the effect that exposure to pharmaceutical and device representatives may have on their autonomy and objectivity.

10. INDUSTRY SUPPORT FOR SCHOLARSHIPS AND FUNDS FOR TRAINEES/FELLOWS

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: A. All funds must be routed through a CoM/UC Health account in accordance with CoM or UC Health policies. Disbursement of all such funds must be approved in advance by the CoM Dean or academic unit head. B. Academic units may use monies provided by industry to pay for reasonable travel and tuition expenses for residents, students, or other trainees to attend conferences or training that have legitimate educational merit. Attendees must be selected by the department based upon merit and/or financial need, with documentation of the selection process provided to the CoM Dean upon request. The CoM Dean may

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disallow use of Industry funds at his/her discretion. C. Selection of recipients of such funds must be the sole responsibility of CoM with no involvement of Industry. Industry may elect to support a specific activity or topic of advanced training, but Industry may not select individual recipients of the fellowship. D. The recipient of the funding may not be subjected to any conditions dictated by the Industry sponsor.

11. GHOSTWRITING AND HONORARY AUTHORSHIP

Interaction between CoM personnel and industry in the pursuit of scientific knowledge is appropriate and may lead to development of important new concepts. It is expected, however, that CoM personnel who publish papers with collaborators from Industry will participate in development of the study in a meaningful way. 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 personnel 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. Ghostwriting shall mean the provision of written material that is officially credited to someone other than the writer(s) of the material. Transparent writing collaboration with attribution between academic and Industry investigators, medical writers, and/or technical experts is not ghostwriting. 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.

12. CLINICAL PROCTORING

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, regulate 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. CoM personnel 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.

Reporting and Enforcement

College of Medicine Operating Procedure/Guideline Industry Relationships, Page 11 of 12

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: 1. To advise personnel on the interpretation of this policy and to develop additional guidelines for its implementation, as necessary; 2. To refer instances of non-compliance with this policy, along with any recommended action, to the UC CoM Dean or the Dean’s designee and Chair of the Industry Interactions Committee, for final action. Any such action taken will be in accordance with applicable UC CoM and university policies and procedures. Failure to comply with any of the provisions of this policy may be subject to disciplinary action up to and including termination. To the extent required by a research sponsor, UC Office of Research in collaboration with UC CoM will notify the research sponsor of the violation and any corrective action taken or to be taken. If a research sponsor should report a case of non-compliance, by CoM personnel, UC Office of Research and UC CoM will require the CoM personnel to fulfill all reporting requirements, to the extent required by the research sponsor.

Organizational units may institute policies more, but not less, restrictive than these guidelines if desired.