University of Cincinnati College of Medicine

University of Cincinnati College of Medicine Policy Policy and Guidelines for Industry Relationships Policy and Guidelines for Industry Relationships FAQ Date Updated Page 5/14/2008 2 -- 8 NB: The Institute on Medicine as a Profession has added the following to this document: 1. The page numbers in red for ease of navigation 2. The yellow highlighting to indicate the referenced policy language

POLICY AND GUIDELINES FOR INDUSTRY RELATIONSHIPS UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE I. Purpose This policy establishes guidelines for interactions with companies engaged in the manufacture or sale of diagnostic or therapeutic drugs, devices or services for research, education or clinical care. It applies to all personnel, which includes faculty, staff, students, and trainees of the University of Cincinnati College Of Medicine as defined subsequently (see IV.A.). Interactions with industry occur in a variety of contexts. These interactions can be positive and important for promoting the educational, clinical and research missions of the College of Medicine. These interactions must adhere to the highest ethical standards and must not create conflicts of interest that could endanger patient safety, research integrity, the integrity of our education and training programs, and the reputation of the College of Medicine or its personnel. II. Statement of Policy It is the policy of the University of Cincinnati College of Medicine that 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. III. Scope of Policy This policy applies to all academic and administrative units of the College of Medicine, and to all College of Medicine personnel. This policy is divided into three sections 1) Industry Interactions Occurring in the Context of Research and Scholarly Activity; 2) Industry Interactions Occurring in the Context of Clinical Training and Patient Care; and 3) Industry Interactions in the Form of Consulting, Collateral Employment and Entrepreneurial Affairs/Technology Transfer. This policy is intended to supplement the requirements of the applicable University of Cincinnati Board Rules, including Rule 10-17-03 ( Employee Responsibilities ); 10-17-08 ( Policy on Conflicts of Interest in the Conduct of Research at the University of Cincinnati ); 30-21-02 ( Policy on Collateral Employment for Faculty Members and Librarians ); 30-21-03 ( Collateral Employment Policy for All Employees (Excluding Faculty Members and Librarians ), and 10-17-09 ( Employee Financial Interests in Companies That are Commercializing University Discoveries, Inventions or Patents ). IV. Definitions As used herein, the following terms have the indicated meaning:

A. Personnel refers to all faculty, staff, and trainees of the University of Cincinnati College of Medicine. Trainees include students, residents, and fellows. B. Industry refers to firms or vendors engaged in the manufacture or sale of diagnostic or therapeutic drugs, devices, supplies, or services for research, education or clinical care. C. Gifts or Compensation refers to anything of value provided by or on behalf of Industry, including but not limited to food, beverages, pharmaceutical or device samples, or travel related expenses. Gifts and Compensation shall not include pharmaceutical samples which are provided in keeping with a written Departmental Policy which ensure the absence of inappropriate influence by Industry in connection with such distribution. V. Industry Interactions Occurring in the Context of Research and Scholarly Activity A. Conflict of Interest Disclosures for Research 1. All Personnel who participate in the design, conduct, analysis or reporting of research shall comply with the provisions of University Rule 10-17-08, entitled Policy on Conflicts of Interest in the Conduct of Research at the University of Cincinnati. 2. All Personnel who participate in the design, conduct, analysis or reporting of human subjects research shall also comply with University Institutional Review Board Policy IV.02 Investigator Conflict of Interest in Human Subjects Research B. Professional Publications and Presentations 1. Publications which are supported by and/or include contributions from industry author(s) shall strictly comply with Authorship Guidelines Faculty University of Cincinnati College of Medicine (May 13, 2004) as amended from time to time. 2. In professional presentations and publications, individuals must disclose their personal financial interests and financial support from industry in accordance with policies promulgated by the International Committee of Medical Journal Editors (http://www.icmje.org/). VI. Industry Interactions Occurring in the Context of Clinical Training and Patient Care

A. Site Access by Industry Representatives Industry representatives other than service personnel are not permitted on the premises of the College of Medicine except for specific appointments with faculty or authorized staff members. Presence at other times must be approved. Approvals may be granted on a per visit basis or as a standing appointment for a specified period of time at the discretion of the faculty member, his or her division or department. B. Affiliated Training Sites Policies Policies established by affiliated training sites which regulate access of Industry to such sites shall be honored to the extent that such policies may impose additional restrictions or limitations on site access by sales and marketing representatives. C. Gifts or Compensation It is expected that no form of Gift or Compensation from Industry will be accepted by Personnel of the University of Cincinnati College of Medicine under any circumstances, except as reasonable compensation for bona fide services. Individuals must consciously and actively divorce clinical care decisions from any perceived or actual benefits expected from Industry. It is unacceptable and unlawful for patient care decisions to be influenced by the possibility of personal financial gain. Examples of circumstances involving Gifts and Compensation that are unacceptable under this Policy include, but are not limited to, the following: Individuals may not accept Gifts or Compensation 1. for prescribing or for changing a patient's prescription to a specific medication. 2. for recommending or utilizing a specific diagnostic or therapeutic device. 3. for listening to a sales talk by an Industry representative. 4. while attending a CME or other activity or conference (that is, if the individual is not providing bona fide services at the event). 5. provision of scholarships and other educational funds directly to students and trainees D. Industry Support for Unique Educational or Training Opportunities Industry support for Unique Educational or Training Opportunities must be specifically for the purpose of education and must comply with all of the following provisions:

1. The student or trainee to receive such support must not be selected by the industry providing the support. 2. The funds are approved by the department, program, or division responsible for the student or trainee; 3. The department, program or division has determined that the funded conference or program has educational merit; and 4. The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a "quid pro quo." 5. The name of the College of Medicine or the attendee s affiliation with the College of Medicine may not be used to imply endorsement of a product or service by the College. E. Support for Educational Activities 1. All continuing medical education events sponsored by or accredited by the University of Cincinnati College of Medicine must be compliant with ACCME Standards for Commercial Support whether or not CME credit is awarded. The Standards may be found at www.accme.org. 2. Educational grants that are compliant with the ACCME Standards may be received from Industry but must be administered by departments or divisions of the College of Medicine and not by individual faculty. 3. Meals or other types of food and beverages directly funded by Industry may not be provided at educational events sponsored by or accredited by the University of Cincinnati College of Medicine. 4. Gifts other than educational material approved by the faculty director of the educational event may not be provided at educational events sponsored or accredited by the University of Cincinnati College of Medicine. 5. Faculty and medical staff should evaluate carefully their own participation in or attendance at meetings and conferences that are fully or partially sponsored or run by Industry because of the potential for conflict of interest. Meetings and conferences supported in part or in whole by Industry should follow these guidelines: a. Financial support by Industry is fully disclosed by the meeting sponsor. b. The educational content promotes scientific and educational activities and discourse.

6. The name of the University of Cincinnati or its College of Medicine may not be used in a way which suggests commercial endorsement. The use of the name of the University or the College of Medicine in connection with non-university of Cincinnati-Sponsored events is limited to the identification of the participating University of Cincinnati individual by his or her title and affiliation. 7. It is recognized that industry sponsored literature and models are utilized for teaching purposes in our clinical and education programs because of their benefit to patients. Information provided by unbiased sources is preferred. However, industry sponsored literature and models may be utilized with the following provisions intended to minimize marketing and advertising influence: a. The materials are used solely for education. b. The clinician decides when they are utilized, not the industry representative. c. The materials are not overtly promotional in nature. d. The educational literature and models must not be displayed publicly in a manner intended for the purpose of product promotion. F. Training of Students, Trainees, and Staff Regarding Potential Conflict of Interest in Interactions with Industry The University of Cincinnati of College of Medicine shall make available training regarding potential conflicts of interest in interactions with Industry to all faculty, students, residents, trainees and staff. VII. Industry Interactions in the Form of Consulting, Collateral Employment and Entrepreneurial Affairs/Technology Transfer A. Faculty members and staff of the College of Medicine may engage in collateral employment with Industry, including work of a consulting nature, provided information regarding such employment is made known in advance to the individual s department head and the Dean of the College of Medicine and provided said department head and Dean agree that the collateral employment: 1. Does not interfere with nor is inconsistent with the performance of the individual s university duties; and 2. Does not raise questions of conflict of interest in connection with other interests or work in which the individual or the College is involved.

B. Reporting of collateral employment shall be made in accordance with University Rule 30-21-02 ( Policy on Collateral Employment for Faculty Members and Librarians ) and 30-21-03 ( Collateral Employment Policy for All Employees (Excluding Faculty Members and Librarians) ) on University of Cincinnati forms provided for that purpose. Any proposed collateral employment may be subject to the development of an acceptable conflict management plan or other mechanism designed to ensure that such collateral employment will comport with the requirements of this Policy. C. Any College of Medicine employee who intends to become involved with a Technology Development Company as that term is defined in University Board Rule 10-17-09, entitled Employee Financial Interests in Private Companies that are Commercializing University Discoveries, Inventions or Patents is expected to comply with the provisions of that Rule, including the development and approval of a conflict management plan for approval by the Office of Research. VIII. Monitoring and Enforcement A. Enforcement of this policy shall be the responsibility of the academic unit head and dean or staff supervisor, as the case may be. Violations of the policy may subject the individual in violation of the Policy to discipline in accordance with standard policies of the University of Cincinnati and the College of Medicine. B. The College of Medicine shall establish an Industry Interactions Committee which shall be charged with oversight of this policy, coordinating training and education under the policy, communicating with outside entities as required by the policy, and providing support to the College of Medicine for interpretation of the policy. The Committee shall report to the Dean, College of Medicine not less than annually. Date Adopted January 10, 2008 Date Revision Adopted May 14, 2008 Signature

1/6/12 University of Cincinnati - College of Medicine University of Cincinnati, College of Medicine About Us Frequently Asked Questions Gifts, Meals, and Products Q. Why preclude meals? Do they really affect patient care decisions? A. Medical professionals have an obligation to avoid real or perceived influences which are potentially harmful to patients. The UC College of Medicine stresses this obligation by implementing the Policy and Guidelines for Industry Relationships. Research specific to industry gifts to physicians has suggested the following: Even token gifts, such as pens, engender a sense of obligation on the part of the recipient Receiving gifts is associated with positive physicians attitudes toward pharma representatives (Brotzman et al.) Physicians who request additions to drug formularies are more likely to have accepted free meals or travel funds (Chren et al.) The rate of prescriptions by physicians increases substantially after they see representatives (Lurie et al.), attend company-supported symposia (Orlowski et al.) or accept samples (Peay; Cleary) Thus it has been shown that such gifts, including meals provided by Industry, can influence the decision-making process. Our goal is to provide our patients with the best, most objective care. This is why we have chosen to eliminate such incentives. Q. In the past, one of our pharma reps provided lunch for our meetings. Is this still allowed under the new policy? A. As discussed above the main thrust of our policy is to eliminate incentives from pharma. These incentives include meals, and consequently no meals may be provided to any UC College of Medicine personnel, including all faculty, staff, students, residents and fellows. Q. I understand that we no longer allow pharmaceutical sponsors to purchase meals on campus, but what about using funds that are derived from industry for research and education? A. The policy allows pharmaceutical, device and biotech companies to fund departments or divisions or the CME office (although not to individual faculty members) in support of their educational activities and programs by means of an unrestricted grant (which does not involve a quid pro quo ). Q. Isn't there a big loophole in the policy if a company can support education to a department and the department can turn around and use that money for the same purpose? A. It may seem that way, but there is no loophole. Let's look at the difference. Prior to implementing this policy industry reps provided meals for talks, may have directed the subject of the talk and the speaker, and were at the event with promotional materials. They may have discussed their products with participants. This essentially makes it a company marketing event. Under the new policy, when educational events take place they are free of company intervention or direction. If food is provided it is provided by the department. And while the department may have received funds from a company that has products in that area, these funds are spent at the department's discretion. Most importantly, no one will feel any obligation to any company. With or without industry support and with or without food incentives, educational events will continue at the College of Medicine. Q. Can an Industry representative take a doctor out to lunch or dinner for a business purpose? A. No. The policy prohibits restaurant meals with industry reps because of the implied quid pro quo that is present in such situations. We suggest, instead, that industry reps be invited to meet with University of Cincinnati faculty or medical staff in accordance with the site access provisions of this policy. During these interactions, no gifts may be accepted by University of Cincinnati representatives, except as reasonable compensation for bona fide services offered. Q. Does the policy affect free samples for needy patients? A. Yes and no. Under certain circumstances, free samples may be important source of pharmaceuticals for needy patients. Therefore, they may be accepted by individual departments only in keeping with a department specific policy, which ensures the absence of inappropriate influence by industry in connection with such distribution. Site Access by Sales and Marketing Representatives Q. Under the policy are sales and marketing reps allowed on the UC or affiliated campuses? A. Industry representatives other than service personnel are not permitted on the premises of the College of Medicine except for specific appointments with faculty or authorized staff members. Presence at all times must be approved. Approvals may be granted at the discretion of the faculty member or his/her division or department. The access rules of the policy do not apply to premises of our affiliates, which typically have their own policies governing site access by Industry representatives. www.med.uc.edu/aboutus/deansoffice/ /FrequentlyAskedQuestions.aspx 1/3

1/6/12 University of Cincinnati - College of Medicine Continuing Medical Education Q. Can pharmaceutical companies and device manufacturers continue to support our CME programs? A. Commercial entities, such as pharmaceutical companies and device manufacturers may support CME activities as long as the support is given with the knowledge and permission of the CME Office and the CME activities are conducted in compliance with the American College on Continuing Medical Education (ACCME) Standards for Commercial Support and the other requirements of Section VI(E) of the Policy. Q. Can commercial supporters (i.e., pharmaceutical companies and device manufacturers) pay the expenses of attendees at our CME events? A. No. Commercial supporters are not permitted to pay (directly or indirectly) registration costs, travel, or other educational event-related expenses. Q. If a potential speaker has a relationship with a commercial entity, are we permitted to use him or her as a speaker at our CME courses? A. Disclosing a relationship with a commercial entity does not automatically exclude an individual from speaking at a CME event. However, if the potential speaker is planning to discuss therapies or therapeutic agents that may be related to the companies for which there is a relationship, the potential conflict of interest must be examined and managed. This typically means that the CME Office will direct a review of the content of the presentation to ensure that the presentation is evidence-based and does not present a biased view of products or therapies, in accordance with the ACCME Standards for Commercial Support. Q. Can course directors include an honorarium or other reimbursement for the time it takes to organize a CME event? A. Yes. The Policy permits reasonable compensation provided for bona fide services. When the CME event budget is developed, all costs associated with developing and implementing the event should be itemized. That includes the effort of course directors, coordinators, staff, and others who are devoting time to the event. These costs should be reasonable and verifiable. The University of Cincinnati CME Office can assist with all questions concerning CME events. Industry Funding for Education Q. I have been invited by a pharmaceutical company to give a talk to community physicians. Am I allowed to do this? A. University policy allows faculty to consult and such talks would be considered consulting activities and are permissible. In instances in which UCCOM faculty and staff do participate in such talks, they should follow the guidelines below, which represent in part, Section VI. E. 5., and VII A of the policy: Financial support by industry is fully disclosed by the meeting sponsor. The educational content promotes scientific and educational activities and discourse. The consulting does not interfere with nor is inconsistent with the performance of the individual s university duties. Reporting of collateral employment shall be made in accordance with University Rule 30-21-02 and 30-21-03. Q. Is it still allowable for our department to receive grants from industry for scholarships or other educational funds for students and trainees? A. Yes. However, according to section VI. D. of the policy, industry support of students and trainees must be specifically for the purpose of education and must comply with all of the following provisions: The student or trainee to receive such support must not be selected by the industry providing the support. The funds are approved by the department, program, or division responsible for the student or trainee; The department, program or division has determined that the funded conference or program has educational merit; and The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a "quid pro quo." Q. How does the policy apply to educational models and literature from Industry? May these materials be accepted from Industry? A. Yes, Industry sponsored literature and models may be utilized with the following provisions intended to minimize marketing and advertising influence: The materials are used solely for education The clinician decides when they are utilized, not the industry representative The materials are not overtly promotional in nature The educational literature and models must not be displayed publicly in a manner intended for the purpose of product promotion Scope of the Policy Q. How will this policy affect community physicians who are volunteer faculty members, giving their time to instruct residents/medical students at private offices? A. Under section IV, A of the policy, COM Personnel refers to all faculty, staff, and trainees of the University of Cincinnati College of Medicine. While this policy does not directly apply to volunteer clinical faculty who are not compensated by the University of Cincinnati, all individuals affiliated with the College of Medicine are encouraged to adhere to its principles. Under the policy, COM Trainees including students, residents, and fellows are expected to abide by the policy guidelines while participating with volunteer preceptors. Trainees should not be placed in a position of undue influence by Industry during their participation. www.med.uc.edu/aboutus/deansoffice/ /FrequentlyAskedQuestions.aspx 2/3

1/6/12 University of Cincinnati - College of Medicine www.med.uc.edu/aboutus/deansoffice/ /FrequentlyAskedQuestions.aspx 3/3