Policy Recommendations from the Task Force on Industry Conflict of Interest in the Clinical Setting February 23, 2009

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1 Policy Recommendations from the Task Force on Industry Conflict of Interest in the Clinical Setting February 23, 2009 Charge In November, 2008, the UWMF, UWHC and UWSMPH created a Task Force on Industry Conflict of Interest in the Clinical Setting to address relationships with industry education, research, marketing, and receipt of gifts that might influence interactions between health care providers and their patients, and well as medical decision making. This task force was asked to: Study the Joint Conflict of Interest Principles (initially developed by UW Healthcare Entities: Principles, Version 8, ) and recommend modifications that reflect the best current thinking of the UWMF, UWHC and UWSMPH and our national professional organizations. Translate these principles into actionable policies and procedures to guide behavior of faculty, staff and students of the UW Healthcare Entities. Recommend specific governance and infrastructure necessary to oversee the implementation, evolution and cooperation with these policies and procedures. Critically examine the elements of industry-provider relationships vulnerable to COI that are uniquely relevant to those who participate in patient care, including industrysponsored speaker s bureaus, individual and institutional acceptance of educational gifts, and disclosure to patients of financial and research relationships with industry. The policy recommendations that follow serve to (1) maintain the highest possible standards of professionalism; (2) avoid or appropriately manage any conflicts of interest with industry; (3) maintain the trust and confidence of patients and the community at large; and (4) maintain the integrity of our evidence-based healthcare delivery system. The goals of the UW Healthcare Entities are summarized by the Association of American Medical Colleges: the overarching goal for both academic medicine and industry must be to maintain productive relationships in research, education, and patient care that contribute to the health of the public and sustain the public s trust. 1 Currently, each of the UW Healthcare Entities has a distinct set of policies addressing conflict of interest. Given the shared mission of the UW Healthcare Entities and the national trend to address this complex set of issues we propose these policy recommendations as a basis to formulate consistent policies to address conflict of interest across the UW Health entities. Background Professionalism, a core value of the UWMF, forms the basis for the provision of health care. The esteemed and privileged position held by physicians and other health care providers in society is dependent on the strength of the fiduciary relationship between 1 Industry Funding of Medical Education, Report of an AAMC Task Force to the AAMC Executive Council (2008), 31. 1

2 providers and their patients. Promoting the values and behaviors associated with professionalism for both current and future generations of healthcare providers is a primary responsibility of an academic health center. All health care providers must ensure that the process by which they make clinical decisions is transparent, ethical, free of undue economic influence, and reflects the highest professional standards. Patients deserve and expect well-informed, objective health care decision-making based on their best interests. Even the appearance of a conflict of interest may undermine patients confidence in our work and our respected role in society as health care providers. Interactions with employees, representatives, and vendors of pharmaceutical, medical device, and medical testing companies ( industry ) are routine aspects of modern health care, especially in an academic health center where research and education are core missions. Although health care providers and the health care industry share some common interests, industry s need to create financial reward for investors leads to conflicting incentives. Relationships between health care providers and industry must be scrutinized to determine if they conform to our own ideals and to the public s expectation of un-biased decision making. Conflicts, once identified, must be managed to protect the patientdoctor relationship. Sometimes, the only possible solution is to eliminate the relationship with industry. However, there are instances when the conflict can be eliminated or minimized by ensuring that there is concordance between the goals of health care providers and industry, that these goals meet the mission of the UW Healthcare Entities, and are clearly in the best interests of our patients. Much of the current work to eliminate or appropriately disclose conflicts of interest between the pharmaceutical industry and healthcare providers was prompted by a 2006 publication in the Journal of the American Medical Association: Health Industry Practices that Create Conflicts of Interest 2. This publication has inspired numerous healthcare organizations, particularly academic health centers, to review their policies which address industry-provider conflict of interest. The Task Force recognizes that the effect of industry on all aspects of medicine is pervasive and is not limited to the direct interactions of health care providers with industry. Industry has a profound effect on all levels of education from pre-doctoral training through post graduate education (including continuing medical education), the design and conduct of research (including the research agenda), and direct to consumer marketing. Comprehensive management of these issues is as critical to the long-term success of the UW Health Care Entities and the United States healthcare system, as are the management issues addressed in this document. In the absence of national standards to govern the interactions between industry and all aspects of the health care system including research, education, and patient care the ability to manage conflict of interest at any single institution will be limited. Therefore, the Task Force recommends that UW Health assume a leadership role for the implementation of rational, evidence-based, and constructive conflict of interest strategy both regionally and nationally. In addition, the Task Force recommends that the UW Healthcare Entities establish a comprehensive educational program addressing all of the items in this document, including their rationale and the UW Health policies that are adopted. UW 2 Brennan TA, Rothman DJ, Blank L, et al. Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers. JAMA, 2006; 295:

3 Health should mandate its successful completion by all physicians and health care providers in each organization. These policy recommendations require review and approval by the clinical and administrative leaders of each UW organization, and must reflect the cooperative input by legal counsel, compliance officers and the Task Force on Industry-Provider Conflict of Interest representing the University of Wisconsin Madison, the University of Wisconsin Hospitals and Clinics Authority, and the University of Wisconsin Medical Foundation, Inc. 3 3 These Principles were developed cooperatively by the following individuals: Rebecca C. Hutton, University Legal Counsel, University of Wisconsin Administrative Legal Services Michael J. Lee, Vice President of Compliance and Chief Compliance Officer, University of Wisconsin Medical Foundation, Inc. Amanda K. Reese, Associate Counsel, University of Wisconsin Medical Foundation, Inc. Claudia Jane Sanders, Vice President of Legal Services and Privacy Officer, University of Wisconsin Medical Foundation, Inc. Daniel J. Weissburg, Director of Compliance and Privacy Officer, University of Wisconsin Hospitals and Clinics Authority 3

4 Policy Recommendations 1.0 Oversight, Maintenance, Adherence to Policy This policy should apply to all physicians who practice medicine as members of UWMF. In addition, the Task Force recommends that the policy be applied to all health care providers who are employed and practice under any UW Health entity, such as nurses, physician assistants, pharmacists, etc. UWSMPH relies on a large number of physicianteachers at various sites in the state of Wisconsin who are also employed by other health systems. While respecting the sovereignty of these institutions, the Task Force recommends that UWSMPH encourage these providers to adopt these recommendations or comparable policies. Because the standards and regulation for conflict of interest with industry are evolving rapidly, UW Health policies and procedures must be regularly reviewed and modified to reflect current thinking and action in this area. Executive leadership at each of the UW Health entities will be responsible for creating the procedures that ensure adherence to these policies. 2.0 Definitions 2.1 Designated Department Personnel: A management staff individual or individuals designated by executive leadership in a UW Healthcare Entity or its academic departments for the purpose of managing Industry relationships via policies and procedures that are developed by the UW Healthcare Entity in accordance with the Task Force recommendations. 2.2 Gifts to Individuals: Anything of value for the private benefit of Staff (defined below) or their immediate family or an organization with which the Staff is associated, for which payment or services are not provided in return. This includes, but is not limited to money, property, favor, service, food, travel, and entertainment (e.g. tickets for theatrical events, sporting events, or golfing fees). 4 There is no de minimis value to a gift, so this includes items of little value such as pens, sticky notes, magnets, key chains, and laser pointers, all of which are considered gifts. 2.3 Gifts to an Institution: Anything of value given to and for the benefit of the UW Healthcare Entity which receives it, for which payment or services are not provided in return. This includes, but is not limited to, money, property, favor, service, entertainment, or travel. 2.4 Industry or Industry Representatives: Manufacturers, services, and other vendors of pharmaceutical, medical device, and medical testing companies, and their employees, representatives, agents, and vendors. 2.5 Staff: Any UW Healthcare Entity s employees, students, trainees, volunteers, and temporary staff. As noted in 1.0 above, The Task Force strongly recommends that these policies be applied to all health care providers 4 Wisc. Admin. Code, UWS8.03(1)(a) (2008). 4

5 (including nurses, physician assistants, medical assistants, pharmacists, and lab technicians) who work under the umbrella organization of UW Health Care, including individuals with $0 and courtesy appointments, such as clinical professors working at other institutions. 2.6 UW Healthcare Entities: Collectively, the University of Wisconsin Madison Schools of Medicine & Public Health, Pharmacy, and Nursing, the University of Wisconsin Hospitals & Clinics Authority, and the University of Wisconsin Medical Foundation, Inc. 3.0 Gifts to Individuals UW Healthcare Entities prohibit Staff from accepting any personal Gifts to Individuals (defined above) from Industry. 5 A complete ban on gifts eases the burdens of compliance and decision-making, and promotes patient trust. 6 This prohibition includes gifts rendered outside of the UW Health premises. Prohibited activities that are considered gifts are defined in 2.2 above. For clarification, this includes receiving a meal or beverage paid for by industry, in any setting or venue unless it is included in the formal educational program for a professional conference or CME-accredited educational activity, or is part of contracted work described below in sections 5.2 and 5.3. The ban on gifts includes but is not limited to the following: receiving food, beverage, or any item of value at industry s expense at a professional meeting (except if part of the official program), journal club, social reception, or in a meeting exhibit hall, regardless of whether it is on-site or off-site. The ban includes expenses and travel to conferences except as part of contracted work described below in sections 5.2 and Gifts to an Institution The Task Force determined that creating policies regarding gifts to the institution for educational and research purposes were outside its charge. The Task Force recommends that each UW Healthcare Entity have effective oversight mechanisms for accepting institutional gifts. These rules should be as uniform as possible. Guiding principles for acceptance of these gifts are as follows: 4.1 Gifts to UWSMPH for research come under the oversight of UWSMPH and UW Graduate School. 4.2 Gifts for education should be made to the institution above the Departmental level (i.e., to the UWSMPH, UWMF or UWHC, not individual health care providers or their Section, Division, or Department Chairs). 4.3 Gifts for education should come under the oversight of the UW OCPD if for post-graduate training (see section 11.0 below) UWHC GME office if for residents or fellows (See section 11.0 below) UWSMPH if for students 5 Industry Funding of Medical Education, ETH-004: The Relationship of the Profession to the Health Product Industry. Wisconsin Medical Society,

6 4.4 Patient education materials may be received under the oversight of the UWHC Vendor Liaison Office (VLO). UWSMPH and UWMF clinics should use the VLO or establish an equivalent oversight process with uniform rules. 5.0 Participation in Outside Activities Funded by Industry 7 The Task Force agreed that UW Health care providers are representatives of UW even when performing outside activities. A health care provider s UW affiliation cannot be separated from his/her role as a health care provider; therefore, all outside activities related to the provision of health care are relevant interests of the UW and UWMF. Promoting excellence in patient care through teaching and education is a key component of the UW Health mission. The Wisconsin Idea encompasses knowledge dissemination by UW Health care providers. Health care providers at UW include regional, national, and international experts whose opinion and guidance are sought by health care professionals and industry, and whose expertise help promote the health and well-being of citizens of the State of Wisconsin, as well as patients outside the borders of our state. Outside activities with industry that advance science and improve public health may provide an opportunity for a concordance of interest between health care providers and industry; however it is critical that any cooperative effort does not directly promote commercial products, has a clearly defined deliverable, and does not violate another tenet of these recommendations, such as the prohibition against receiving gifts. The Task Force is concerned that interactions between health care providers and industry can undermine patient trust and threaten the integrity of the medical profession as well as our academic missions of education and research. However, the Task Force believes that these interactions, with significant restrictions and oversight, can promote public health and the advancement of medical science. A critical aspect of the Task Force Recommendations is the formation of a UW Healthcare Industry Interactions Conflict of Interest Committee (IICOIC, see section 6.0 below) to provide oversight and management of health care provider interactions with industry. The Task Force recognizes that this recommendation does not completely eliminate the conflict of interest inherent in health care provider-industry interactions, but it minimizes them by promoting educational and scientific relationships and by removing the health care provider, as much as possible, from a position of marketing an industry product or service. 5.1 Participation as an Attendee or Learner Health care providers are strongly discouraged from attending industrysponsored promotional events, such as educational programs that are not certified for CME credit, including dinner programs or educational conferences sponsored by industry.* Under limited circumstances, in which the event provides a unique learning opportunity, they may attend only if: The activity does not violate FDA guidelines for the conduct of promotional events, and 7 Participation in outside activities funded by industry is subject to the UWMF Outside Income Policy and UW Outside Activities Policies. 6

7 5.1.2 They do not receive any remuneration or gifts in exchange for attendance or participation. This includes meals and reimbursement for expenses to attend the program, including food, travel, accommodations, or registration fees, as these are considered gifts. If a health care provider attends an industrysponsored event, they must pay all of their own expenses. *An outright ban on attendance was strongly considered, but was rejected as being unenforceable, given the multitude of promotional activities available to health care providers including those on the internet or sent via mail or . Philosophically, it is difficult to limit an individual s ability to participate in information exchange, even if it may be biased and promotional. Thus, the committee chose to strongly discourage participation and to prohibit any remuneration or gifts if a health provider chooses to attend a promotional event. 5.2 Participation as a Speaker, Author, or Teacher Health care providers are prohibited from participating as speakers, authors, or teachers in outside activities that are promotional and funded by industry, such as speaker s bureaus, speaker s training programs, and contracted educational programs. Rare exceptions may be permitted by the IICOIC for unique learning opportunities in which UW health care providers can offer teaching skills, such as FDA-required device implantation proctoring or similar programs.* Exceptions will not be granted for speaker s bureaus or equivalent activities. *The Task Force recognized that in rare circumstances, UW Health care providers may have expertise that can be used to help educate health care professionals in an industry-sponsored setting, such as when the FDA requires physicians to attend industry-sponsored preceptorships for implantation of new devices. The Task Force felt that participation of UW Health care providers as teachers in these activities may be acceptable if each of the criteria below is satisfied. On , the vote on section 5.2 was 9-2. Exceptions may be granted only when all of the requirements in below are met: The activity is reviewed and approved of by the IICOIC, in advance. The IICOIC has the authority to implement a management plan for interactions with patients The terms of these activities are described in a contract with a clear deliverable. This contract will be reviewed by the IICOIC The activity does not violate FDA guidelines for the conduct of promotional events The health care provider does not directly promote a product. Presentations must be balanced with consideration of all relevant treatment options. 7

8 5.2.5 Educational materials utilized in such activities are non-promotional, unless they serve a unique medical need or are required by the FDA (such as a product insert, user manual, or training guide). For example, health care providers should develop and use their own slides or other presentation materials with rare exceptions Reimbursement is limited to reasonable expenses only. The value of the provider s time, including compensation for salary lost, may not be considered an expense. Donating the money to charity or to UW is not an acceptable alternative to compensation. There must be no quid pro quo other than teaching. Special circumstance of health care providers promoting products they invented: The general principle that health care providers should not be paid for directly promoting commercial products still applies in this special circumstance. It may be appropriate to prohibit the inventor from promoting a marketed product to health care providers at an industry-sponsored event, but not to prohibit an inventor's other outside activities related to technology transfer and commercialization. The Task Force recognized that conflicts of interest for an inventor who provides patient care are significant and management of patient interactions for this special circumstance will have to be considered on a caseby-case basis by IICOIC. 5.3 Participation as a Consultant Health care providers may participate in non-promotional outside activities with industry, such as providing expert consultation, serving on an advisory board, serving on a research advisory committee or a data safety and monitoring board for a clinical trial, if each of the requirements below is satisfied. The Task Force recognizes that some of these activities may have promotional goals or commercial aims. Participation that disseminates knowledge or promotes medical science, technical innovation and patient care is acceptable; whereas participation in promotional activities disguised as consulting is strongly discouraged. It is not possible to identify, a priori, every possible industry interaction that a health care provider may have. The IICOIC will review these interactions on a case-by-case basis.* *Note: This recommendation does not prohibit staff, as part of their UW responsibilities, from participating as an investigator in a clinical trial and/or an industry-sponsored research agreement, These activities, may impact the formulation of management plans for interactions with patients when a company in which a health care provider has an outside interest also funds that health care provider s research or educational activities at UW. Requirements for activities are as follows: The activity is reviewed and approved of by the IICOIC, in advance. The IICOIC will approve the activity if it finds that the activity is bona fide consulting 8

9 rather than a promotional activity disguised as consulting. The IICOIC has the authority to implement a management plan for interactions with patients The terms of these activities are described in a contract with a clear deliverable for services provided at a fair market value. This contract will be reviewed by the IICOIC Remuneration of greater than $20,000 for all such activities in a single year requires a management plan for interactions with patients. A management plan for interactions with patients may be required by the IICOIC even if remuneration does not exceed the $20,000 per year threshold; however remuneration above this threshold will require an automatic management plan for interactions with patients Production of manuscripts or educational materials from these activities must be the original work of the provider without ghostwriting. Manuscripts and other materials are the responsibility of the provider and will not be reviewed by the oversight committee. 5.4 Health care providers may have an equity interest in or have a leadership role in a company; however these activities must be reported to the IICOIC and must have a management plan for interactions with patients. Stocks held in mutual funds are exempt from this policy. 5.5 Health care providers may receive royalties from sales of commercial products, however each of the following requirements must be satisfied: They may not receive royalties for commercial products used at any UW Health entity for which they would otherwise expect to receive royalties. Health care providers responsible for notifying the source of the royalty payment of this policy and identifying the UW Health entities A health care provider who receives royalties for commercial products must disclose this fact, in writing, to his patients who are presented with the option of receiving the commercial product as part of their medical care The monetary value (within $5000) of all royalties, including those from WARF, must be reported to the IICOIC A management plan for interactions with patients will be required. 6.0 Oversight of Outside Relationships with Industry Oversight of all health care provider activities discussed in section 5.0 above will be under the auspices of the IICOIC. This committee will be established by the UW Healthcare Entities and will be charged with reviewing and managing all outside interactions between industry and health care providers outlined in sections above. Health care providers with outside relationships with industry, including participation in CME programs, must file an annual report with the IICOIC. Activities of the IICOIC will include: 9

10 6.1 Review of health care provider participation in outside relationships that are promotional and funded by industry, such as those outlined in section 5.2 ( Participation as a Speaker, Author, or Teacher ), above Assure that each report includes in detail, how the policies in sections through will be satisfied, including Pre-approval of the activity (section 5.2.1) Reviewing the contract describing the terms of activities (section 5.2.2) Reviewing educational materials (section 5.2.5) Granting or denying permission to participate in such activities Instituting a management plan for interactions with patients (see sections 6.7 and 6.8, below), if it determines that additional management is needed to minimize or eliminate conflict of interest. 6.2 Review of health care provider participation in outside relationships with industry that are not promotional, such as those outlined in section 5.3 ( Participation as a Consultant ), above Assure that each report includes in detail, how the policies in sections through will be satisfied, including Pre-approval of the activity (section 5.3.1) Reviewing the contract describing the terms of activities (section 5.3.2) Reviewing levels of remuneration on an annual basis (section 5.3.3) Granting or denying permission to participate in such activities Instituting a management plan for interactions with patients (see section 6.5 below), for all providers whose remuneration exceeds $20,000 per year from all sources, or for those providers whose remuneration does not meet the $20,000 threshold but for whom the IICOIC determines that additional management is needed to minimize or eliminate conflict of interest. 6.3 Reviewing a health care provider s individual stock or stock options, leadership roles on the boards of industry entities, and licensing activities; instituting a management plan (see sections 6.7 and 6.8, below) for provider patient interactions which may be influenced by such relationships. 10

11 6.4 Health care providers will be required to annually disclose all outside income from industry to the IICOIC, including participation in CME activities. The Task Force recommends that the UW Healthcare Entities establish mechanisms, including common data bases, to harmonize outside activity reporting to avoid duplicative reporting. For example, it should be clear to the IICOIC and patients the exact types of interactions a health care provider has with industry, including the relationships in sections 5.2, 5.3, 5.4 as well as remuneration for CME activities and receipt of research, training, and educational grants. A mechanism should be established for real-time updating of reports and management plans when significant changes occur, rather than relying solely on yearly reports. Required disclosure will include:* A list of each Industry entity for which a relationship exists. The name of the company that provides the remuneration and the company that is the proximate source of remuneration should be provided. For example, if a lecture resulted in an honorarium, the company that funded the program, as well as the medical education or communications company that issued the check should be provided, if that information is available. The Task Force recognizes that some educational events are funded by multiple (>2) industry sources (such as professional society meetings) and that a proximate source may not always be identifiable. Reporting requires a good faith effort to identify the source(s) of funding. In its absence, or if there are more than 2 sources, the organization sponsoring the activity may be reported Disclosure also should include a detailed description of the type of activity (i.e. educational lecture, scientific consulting, etc.) the remuneration received (i.e. honorarium, stock, stock options, etc.) and whether the event was certified for CME credit The dollar amount or monetary value (within $1000) received in aggregate from each industry entity for outside activities. 6.5 All outside activities will be made publically available by request, as outlined below in section The IICOIC will consider income from all outside activities in its evaluations and may institute management plans for interactions with patients at its discretion. The Task Force strongly believes that disclosure is a critical aspect of conflict of interest management; however disclosure may not obviate the need for additional management. Disclosure is necessary but is not always sufficient for the management 11

12 of conflicts. Literature exists which suggests that disclosure may have a paradoxical effect of creating trust when conflicts are not managed All conflict of interest management plans for interactions with patients will include either written or verbal disclosure, at the discretion of the IICOIC.* 6.8 Depending on the degree of conflict, management plans for interaction with patients also may include one or more of the following: Corroboration by an independent colleague of any prescription or device implantation involving a product from the industry entity Appointment of a Special Oversight Committee to monitor practice patterns Transfer of patient care to another colleague Cessation or modification of the relationship with an industry entity. 7.0 Disclosure A central database of all relationships between UW health care providers and Industry will be created and updated yearly. This includes the relationships described in sections 5.2, 5.3, and 5.4 above. Disclosure will include all of the following: 7.1 UW Healthcare Entities will post signs in all of its clinics and provide notification on the UW Health website to advise patients that some faculty physicians have paid relationships with industry. Notification will invite patients to contact the UWSMPH for specific information about their physicians outside compensation, including their monetary value (within $1000). The names of those inquiring will be kept confidential. 7.2 Additional disclosure to patients and documentation of disclosure about health care provider-industry relationships may be required by the UW Healthcare Industry Interactions Oversight Committee. 8.0 Site Access by Pharmaceutical Industry Representatives 8.1 In order to respect patients, patient care areas, and work schedules, UW Healthcare Entities will limit access to their facilities by pharmaceutical Industry Representatives. Access is permitted only in non-public areas which are not designated for patient care (i.e. they may not occur in clinic space, waiting rooms, patient lounges, cafeterias, etc.). 8 Cain DM, Loewenstein G, Moore DA. The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest. Journal of Legal Studies 2005;34:

13 8.1.1 These activities occur only with the oversight of the UWHC Vendor Liaison Office (VLO). UWSMPH and UWMF clinics should use the VLO or establish an equivalent oversight process with uniform rules Meetings with pharmaceutical industry representatives may take place only by invitation from a health care provider or the UWHC Pharmacy Director (or their equivalent for non-uwhc clinics). Requests for appointments with industry representatives by health care providers should be made through the VLO Requests for appointments with health care providers by representatives should be made by the VLO. 8.2 The UWSMPH will establish policies for interactions of students with pharmaceutical industry representatives. 9.0 Site Access by Medical Device Industry Representatives There is little substantive difference between pharmaceutical industry representatives and medical device industry representatives. Access restrictions are the same, unless there is a bona fide hands-on aspect of service that cannot be performed in the absence of a patient or patient care area. Interactions with medical device industry representatives are governed by the policies in 8.0 above, except as discussed below. 9.1 UW Healthcare Entities do not allow access by medical device industry representatives to patient care areas unless all three of the following criteria are met: The representative is appropriately credentialed by the entity The visit is requested by appointment and invitation of a health care provider or Designated Department Personnel who require information on the medical device Their visit to a patient care area is of direct benefit to the patient(s) currently being treated in the patient care area, or no patients are present. 9.2 Whenever possible, meetings should occur in non-patient care areas. 9.3 These activities occur with the oversight of the UWHC VLO (or equivalent for UWSMPH and UWMF sites); however requests for the services of device representatives in the operating room or procedure suites do not require VLO approval. Note: This prohibition does not apply to individuals servicing medical devices which are already in place. For these individuals, credentialing and an existing service contract are required. 13

14 9.2 UW Healthcare Entities will require prior disclosure to, and consent by, the patient if a medical device industry representative(s) may be present during any patient care interaction. The task force recommends that the UW Healthcare surgical consent forms be altered to reflect the potential presence of industry representation so that surgeons or others doing procedures can highlight this for patients during the process of informed consent. 9.3 Medical device testing Industry representatives are considered vendors for the clinical laboratories, and are not permitted to promote their products or to meet directly with patients, health care providers or clinical laboratory staff, with the exception of the Director of the Clinical Laboratories, or their designee. 9.4 The UWSMPH will establish policies for interactions of students with medical device industry representatives Pharmaceutical Samples In response to safety concerns and financial inefficiencies caused by medication samples, as well as regulatory requirements: 10.1 All medication samples are prohibited from all UWHC and UWMF clinics and facilities. Specific exceptions are made for topical products, over-thecounter medications and other specific products for specific clinics as approved by the UWHC Pharmacy and Therapeutics Committee (or equivalent for UWMF clinics and facilities). Such exceptions will be granted only when sample medications are required for the safe initiation of therapy. Additional details regarding this policy can be found in UWHC policy The Task Force recommends that this policy be adopted by all UWSMPH clinics, with equivalent exceptions and oversight as in 10.1 above Continuing Medical Education and Continuing Professional Development 11.1 Accredited CME programs are the preferred medium for the delivery of structured educational materials and programs. The Task Force recognizes that there are conflicts of interest in the CME certification and delivery process related to industry funding, including, but not limited to, content selection, selection of speakers and content writers, honoraria payments, and promotion at CME events. Continued changes in CME policies and processes at the national level are needed to decrease the influence of industry on health care provider education. A detailed discussion of CME-related conflict of interest regarding UW Healthcare Entities which offer CME programs is beyond the scope of this document. Overriding principles regarding participation in CME activities are as follows: Health care providers should participate as learners in CME activities only if they are offered by providers accredited by the Accreditation Council for Continuing Medical Education (ACCME) or a state medical society recognized by the ACCME. 14

15 Health care providers should participate as teachers or authors in CME activities only if they are offered by providers accredited by the ACCME or a state medical society recognized by the ACCME Participation in these activities must be disclosed to the IICOIC, as in sections 6.4 and Health care providers that receive honoraria for participating as a teacher, author, or reviewer in CME activities must follow the disclosure rules set forth in the ACCME Standards for Commercial Support Industry-Sponsored Scholarships and Other Educational Funds for Trainees UW Healthcare Entities require that 11.1 All scholarships or other educational funds from Industry, including fellowships, must be given centrally to the administration of the UW Healthcare Entity receiving such scholarship or fund, above the level of the department All scholarships and other educational funds must be freely given and do not contain any quid pro quo provision of any kind The evaluation and selection of the individual recipients of such scholarship or educational funds are solely the responsibility of the UW Healthcare Entity receiving such scholarship and are based on criteria determined by the UW entity, without involvement of any kind by the Industry donor, except that the Industry donor may direct the scholarship or other educational funds to a particular specialty area The existence of a scholarship or other educational funds from an industry donor, must be disclosed in all reporting circumstances including to the UW Graduate School COI Committee, the IICOIC, and if making purchasing or formulary recommendations to any UW entity Professional Travel UW Healthcare Entities prohibit Staff from directly accepting travel funds from industry, other than for legitimate reimbursement for contractual services permitted under this policy. Otherwise, travel funds are considered gifts (see section 2.2) and are prohibited Ghostwriting UW Healthcare Entities prohibit Staff from allowing their professional presentations of any kind, oral or written, to be ghostwritten by industry representatives or by any other party. Authorship must always be assigned and acknowledged based on standard academic procedures. Authors of multicenter trials with industry sponsorship must be especially diligent 15

16 about ensuring accurate and honest reporting and interpretation of results during the production process of a publication that has had industry support Purchasing 14.1 UW Healthcare Entities require Staff with any financial interest (as defined by each UW Healthcare Entity s conflict of interest or purchasing conflict of interest policy) in any pharmaceutical or medical device Industry to disclose such financial interest according to applicable policies and to recuse him/herself from involvement in any purchasing decision relevant to the conflicting interest UW Healthcare Entities require that any Staff who possesses expertise necessary to the evaluation of any Industry product which is being purchased by a UW Healthcare Entity will disclose to those charged with the responsibility for making the decision to purchase the product, any financial interest he/she has in or with the Industry manufacturer of the product being evaluated. The Task Force on Industry Conflict of Interest in the Clinical Setting consisted of: Miroslav Backonja, MD Soren M. Bentzen, PhD Norman Fost, MD, MPH (ex-officio) Carl J. Getto, MD Azita Hamedani, MD, MPH Stephen G. Harsy, PhD Patrick E. McBride, MD, MPH George C. Mejicano, MD, MS Kenneth J. Noonan, MD Daniel K. Resnick, MD Gordon T. Ridley, MHS Margaret L. Schwarze, MD (Co-Chair) Scott R. Springman, MD James H. Stein, MD (Co-Chair) Lee C. Vermeulen, Jr., Ms, RPh The final document was approved of by a 14-0 vote. 16