UW School of Medicine Policy on Potential Financial ... · PDF fileUW School of Medicine...

UW School of Medicine Policy on Potential Financial Conflicts

of Interest with Commercial or Non-profit Entities

I. Purpose

The UW School of Medicine (SoM) requires that its faculty avoid, or disclose and address, perceived or real conflicts of interest between their responsibilities as faculty of the SoM and their activities with outside commercial or non-profit entities. This policy will guide SoM faculty in their interactions with these entities so that they may continue to contribute to the mission of UW Medicine in a manner that ensures that the School and the faculty avoid real or perceived conflicts of interest. There are five core concepts upon which the faculty interaction aspects of this policy are based: (1) disclosure; (2) a general prohibition on gifts; (3) the requirement that outside compensation be at fair market value; (4) the requirement for pre-approval of outside compensation; and (5) the avoidance of the appearance of conflicts of interest, as well as actual conflicts.

UW Medicine encourages appropriate relationships between SoM faculty and industry and non-profit organizations in so far as those relationships advance the mission ofUW Medicine and help UW Medicine fulfill its community obligations. The purpose of this policy is to discourage interactions and relationships with commercial or non-profit entities if those interactions and relationships would align the faculty member toward the goals of a commercial or non-profit entity and away from the mission ofUW Medicine, its students and/or its patients. This policy is not meant to discourage collaboration with commercial or non-profit entities if those interactions have the safeguards outlined in this policy. This policy also is informed by the emerging national consensus on potential conflict of interest and the emerging research on the impmiant role played by unconscious influences as well. 1

A significant component of this policy is disclosure of potential conflicts of interest, including disclosure of outside compensation. While disclosure alone is not sufficient to address all potential conflicts, the purpose of this disclosure is to enable faculty and leadership to avoid situations in which potential conflicts may adversely affect the patients, research subjects, students, trainees, or employees of UW Medicine. This policy also imposes limitations on the relationship between outside commercial and non-profit entities and SoM faculty in the areas of suppmi for educational events, gifts, and travel or meetings funded by outside commercial or non-profit entities.

Sections II and III ofthis policy, which address conflicts of interests for individual faculty, apply to the following faculty ofthe School of Medicine: Acting, Regular, Research and Clinical faculty (except that it does not apply to Clinical faculty who are

1 See The Scientific Basis oflnfluence and Reciprocity: A Symposium, June 12, 2007 (http:/ /www.aamc.org/reciprocity) .

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not paid by the SoM, University of Washington Physicians (UWP), Children's University Medical Group (CUMG), or an SoM affiliate) and Teaching Associates ("SaM faculty" for purposes of this document).2 This policy applies to these individuals regardless of institutional affiliation or institutional site. This policy applies to activities whether they occur on the UW campus or elsewhere. We encourage all faculty not otherwise covered above to be aware of this policy and follow the intent and guidelines of the policy.3

Section IV ofthis policy applies to the SoM and its various depmiments and offices, and provides policy guidance related to the avoidance of conflicts of interest with industry at the institutional level.

There are a number of existing policies and procedures of the University of Washington, UW Medicine and affiliated institutions that apply to activities in this area. The purpose of this policy is not to replace those existing requirements, but rather to supplement and refine them to deal with the academic, clinical, research, and regulatory environment of the SoM. To the extent these existing policies and procedures provide less stringent requirements to protect against conflicts of interest, the more stringent requirements of this policy shall apply. A list of pe1iinent policies is found at the end of this policy in Appendix A.

II. Prohibited or Allowable Faculty Compensation/Relationships with Commercial or Non-profit Entities

A. Gifts

Washington State law and the University's existing Conflict of Interest Policy impose significant limitations on the ability of UW SaM faculty members to accept or receive gifts. A gift is considered anything of economic value given to the faculty member for which the faculty member does not provide a service or other value in return. Gifts do not include such things as presents from family members of the faculty, gifts exchanged among co-workers, and ce11ain other limited exceptions. (RCW 42.52.010, http://apps.leg.wa.gov/RCW /default.aspx?cite=42.52.0 1 0)

For example, UW faculty may not receive, accept, take, seek, or solicit, directly or indirectly, anything of economic value as a gift, gratuity, or favor from a person if it could be reasonably expected that the gift, gratuity, or favor would influence the vote, action, or judgment of the officer or employee, or be considered as pm1 of a reward for action or inaction. (RCW 42.52.140, http://apps.leg.wa.gov/RCW/default.aspx?cite=42.52.140)

2 "Affiliate" for purposes ofthe applicability of this policy includes Seattle Children's Hospital ("Seattle Children's"), the Fred Hutchinson Cancer Research Center ("FHCRC"), the Veteran's Administration ("VA"), the Puget Sound Blood Center, and the Howard Hughes Medical Institute. 3 Unpaid clinical faculty are also prohibited from using their faculty title in cmmection with participation on a speakers bureau or in any endorsement of commercial products. See sections 11. D. 3. and 4.

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In addition, as a general rule no UW faculty may accept gifts in connection with their activities and responsibilities as faculty where the value of any gifts received from any one entity, individual or group of related individuals exceeds fifty dollars in any fiscal year. Faculty members who are involved in the acquisition of goods or services may not, with limited exceptions, accept any gifts regardless of dollar value from those who seek to provide the goods or services to the University (RCW 42.52.150, http://apps.leg.wa.gov/RCW/default.aspx?cite=42.52.150). Gifts received from patients can be accepted but these gifts are governed by the foregoing limitations and exclusions.

Gifts in excess of fifty dollars in value and/or gifts related to the faculty members' University work may be accepted by the University or an affiliate consistent with the policies and procedures of the institution on accepting and administering gifts. For the University of Washington, see:

Employee Responsibilities and Employee Conflict of Interest, Executive Order No. 32, http://www.washington.edu/admin/rules/policies/PO/E032.html Grants Information Memorandum 34 http ://www.washington.edu/research/osp/gim/girn34.html and Gift Processing Guidelines https :// devar. washington. edu/ departments/ gpal AdminPoli cy. asp

Even though Washington State law and University policy do not prohibit all gifts as described above, SoMfaculty are prohibitedfi·om accepting any form of personal gift fi'om commercial entities and non-profit entities created and supported by commercial entities, or their representatives, including promotional items such as pens or pads, pharmaceutical samples for personal and family use, ente1iainn1ent or recreational opportunities, cash or cash equivalents, and business courtesies such as food and beverages.

B. Food and Beverages

Food and beverages provided by commercial entities or non-profit entities created and suppmied by commercial entities are not pennitted at UWMC, HMC, the SoM, and South Lake Union or at off-campus events held by UWMC, HMC, or the SoM or any of its faculty.

In off-campus events not sponsored by UW Medicine, its component entities, or its faculty, there are cetiain limited circumstances in which faculty, including those responsible for the acquisition of goods and services, are allowed to accept and consume food and beverages provided by others. In general, faculty may accept food or beverages that are incidentally provided at an event that is considered pmi of the job duties of the faculty member. Food and beverages may also be accepted and consumed at events sponsored by civic, charitable, specialty or job-related professional organizations, governmental, or community organizations. In other situations, faculty members should

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refrain from accepting gifts of food and beverages from commercial or non-profit entities created and supported by commercial entities.

C. Consulting With Commercial or Non-profit Entities

Consulting is appropriate where faculty provide real value and receive reasonable compensation. It is the policy of the SoM that a faculty member should accept only fair market compensation for specific, legitimate services provided by him or her to the commercial or non-profit entity in question. Payment should be commensurate with the amount of time and effort spent on these activities. The terms ofthe arrangements, services provided and compensation should be set fmih in writing. In addition, the faculty member must follow the University Outside Professional Work Policy (see below). If there are questions, faculty members are encouraged to consult with their immediate depmimental supervisor (i.e. chair, division chief or service chief), depmiment director or administrator, and/or hospital medical director.4

D. Speeches, Meetings, and Travel Funded by Commercial or Non-profit Entities

1. Activities on Behql{o[Non-proflt Organizations. Universities, and Government Agencies

Under the University's existing Outside Professional Work Policy, faculty are encouraged to pmiicipate in the work of non-profit professional associations and societies, to contribute their expertise to scholarly, editorial, and advisory bodies, and to serve on public commissions or boards of philanthropic organizations. Faculty are also encouraged to accept invitations by non-profit organizations, colleges and universities, and govemmental agencies for purposes of presenting guest lectures, delivering papers, serving on review panels, and participating on accreditation activities.

These involvements are characterized as University and community service, not as outside consulting, and prior approval is not required (provided, if they involve time away from the University, approval for travel away from the University should be sought from the appropriate supervisor). Such activities should be repmied annually using the Annual Repoti of Outside Activities (see below).

In such instances of University and conununity service, it is not uncommon for a faculty member to receive some fmm of honoraria (money or a thing of value) for such activities. Under existing University policy, faculty are specifically authorized to accept honoraria for these activities, except that faculty are not permitted to accept honoraria in situations where the person, company, or organization offering the honoraria wants to sell goods or services to the University, and the SoM faculty member is in a position to influence the University's decision to acquire that type of good or service. (University of Washington

4 There are additional laws and regulations that apply to arrangements involving health care related entities . Faculty should be aware of these laws and restrictions, and should consult with their own personal advisors as appropriate whenever this type of consulting is occurring.

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Policy Directory, Executive Order No.43, http://www.washington.edu/admin/rules/policies/PO/E043.html )

2. Speeches, Articles, or Appearances on Behal[ o( Commercial or Non-Pro fit Entities When compensation, including payment for travel and lodging, is offered to a faculty member by a commercial entity or a non-profit entity for a speech, appearance, atiicle or similar activity that is not part of the faculty member's University work, the compensation may still be accepted, provided the payment is commensurate with time and effmi as described above under Section C. dealing with consultation and provided that advance permission for the work is obtained pursuant to the University Outside Professional Work Policy, and provided the activity is not otherwise restricted as described below.

3. Participation on Speakers Bureaus or Other Promotionq_l Ac_tivjJies_ SoM faculty may not present at programs designed solely or predominantly for company promotional, sales or marketing purposes even in those circumstances where the faculty retain control of the content ofthe presentation and/or any slides that may accompany the presentation. Examples of activities that are not appropriate for faculty patiicipation include: (1) any anangement or speaking engagement in activities commonly called a "speakers bureau"; (2) inclusion on a list maintained by a commercial entity for the purpose of retaining or recommending an individual as a speaker, when the individual has agreed to be included on the list; and (3) patiicipation as a speaker, panelist, presenter, or commentator in any activity or event funded, directly or indirectly, by a commercial entity, where the event is, or may be perceived to be, a promotional event for the sponsoring organization and/or its products or services. Indirect funding includes financial suppmi from a non-profit entity that is created and suppmied by commercial entity(s). The limitations of this section (D. 3) apply also to unpaid faculty when using their faculty title.

In ce1iain limited circumstances when a faculty member has unique knowledge and expe1iise required for a patiicular event or occasion, it may be pe1missible for that faculty member to appear or present on behalf of industry. Such occasions include acting on behalf of industry as a consultant or advocate before a regulatory or other governmental agency (e.g., Food and Drug Administration) or before cunent or potential investors when the matter is related to the faculty member's own innovation or unique expe1iise. Such appearances may be permitted provided that advance approval for the activity is obtained in accordance with the requirements ofthe UW Outside Professional Work Policy.

In addition to the foregoing, faculty who simply attend a CME or other instructional activity and are not organizing or presenting at the meeting should not accept compensation from companies either for attending or defraying costs related to attending the meeting. Similarly, SoM faculty should not accept compensation for simply listening to a sales pitch (e.g., detailing) by an industry representative.

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4. Endorsement o( Commercic{l Products SoM faculty may not endorse a product for the primary purpose of promoting its purchase. SoM faculty may give their opinion about commercial products when there is no promotional purpose, e.g., an inquiry from a professional colleague or professional association, a hospital vendor purchasing request, an independent product survey, or in communication of the product's role in scientific research. The limitations of this section (D. 4) also apply to unpaid faculty when using their faculty title.

E. Accepting Positions on the Boards of Commercial or Non-profit Entities

When faculty members consider accepting a position on the board of an outside commercial or non-profit entity, they should consult the relevant University policy found in the University Policy Directory, Executive Order No. 57, Outside Professional Work Policy (http://www.washington.edu/adminlrules/policies/PO/E057 .html ). Section 6 of this Executive Order, entitled "Involvement with Commercial Enterprise, Deeper than Consulting," provides guidance for faculty on accepting board positions.

III. Disc1osure of Faculty Compensation/Relationships with Commercial or Nonprofit Entities

A. Disc1osure and Reporting of Outside Compensation

I . Advance Approval Requirec( Under the University's existing Outside Professional Work Policy, faculty must obtain advance approval to engage in outside activities for remuneration. Faculty do so by completing a Request for Approval of Outside Professional Work for Compensation Form. (http://www. washington.edu/adminlrules/policies/PO/E057 .html)

a. In addition to compliance with the University Outside Professional Work Policy, SoM faculty also must submit to the Dean's office, on a supplemental form accompanying the request for approval of outside work, the following: (i) the estimated or proposed contracted monetary value of all compensation or that compensation has been waived or redirected, (ii) the organization providing the payment, (iii) an indication of whether other compensation (travel, destination, lodging, etc.) is also expected. The value of these other items need not be repmied. SoM clinical faculty who have written approval to engage in an independent clinical practice from the UW Medicine CEO, Executive VP for Medical Affairs, and Dean of the SoM are not required to submit a supplemental form related to their independent clinical practice, provided that they have received written exemption from the requirement by the Dean.

b. The request for approval of outside professional work will be reviewed within the SoM, in accordance with the existing outside work approval process, for conformance with the fair market value requirement. The SoM will establish an appropriate internal review process for situations in which there is an initial dete1mination that the fair market value standard is not met.

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2. No Advance Approval Required As described above, cetiain activities involving cetiain non-profit organizations, colleges

and universities, and governmental agencies are more appropriately characterized as University and community service, rather than as outside consulting, and do not require prior approval; provided, if they involve time away from the University, approval for travel away from the University should be sought from the appropriate supervisor. (See Section 5 of the UW Outside Professional Work Policy, http://www.washington.edu/admin/rules/policies/PO/E057.html)

3. Annual Reporting Under the existing University Outside Work Policy, faculty must also submit a summary of all outside professional work, both for remuneration and for public and community service, for the previous academic year by November 15 of each year. This includes those activities for which faculty receive honoraria as well as uncompensated University and community service. Faculty fulfill this reporting requirement by completing the Ammal Repmi of Outside Activities (http://www.washington.edu/admin/acadpers/faculty/annual repmi system.html).

4. Distribution o{ Disclosure Information

The request for approval of outside work will be submitted to the Provost's office. The supplemental cor disclosure information (including compensation levels) is not submitted to the Provost's office but may be distributed, individually or in aggregate, to relevant leadership in UW Medicine, including the UW Medicine CEO, Executive VP for Medical Affairs, and Dean of the SoM, depmiment chairs, division heads, hospital medical directors, and hospital executive directors.

Faculty should also be aware that this information is considered in the public domain and could be requested by individuals or organizations outside of the University of Washington.

B. Disclosure of Potential Conflicts When Faculty are Involved in Teaching Activities

When involved in teaching activities in any setting, faculty must directly disclose to the audience relevant potential financial conflicts. Disclosure of potential financial conflicts in connection with teaching activities should include both the relationships required to be disclosed in Pari II above (i.e., outside compensation) as well as institutional gifts, grants, or other financial support from a commercial or non-profit entity to suppmi the faculty member's University work. Dissemination may be perfonned through written materials distributed prior to or at the presentations or classes, at the time of presentation through disclosure slides preceding the content of the presentation, or by a verbal statement at the beginning of the presentation. Compliance with these standards is required regardless of whether formal CME credit is awarded or not.

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C. Disclosure of Potential Conflicts When Faculty Are Involved in Research Activities

Faculty having an outside financial interest related to their University research activities should follow the disclosure requirements in Grant Information Memorandum 10, http://wvv-w.washington.edu/research/osp/gim/gimlO.html.

D. Disclosure of Potential Conflicts When Faculty Are Involved in Purchasing Activities

Faculty with clinical responsibilities should also become familiar with policies on vendor relations and integrity at work for the clinical settings in which they practice. Institutional policies may have additional requirements that apply to vendor relationships. The hospital medical director should be consulted for applicable policies. In general, vendors will not be allowed in clinical areas unless their presence is required by the practitioner for the care of a patient and the presence is completely independent of any decision to purchase or utilize a product.

Faculty must disclose any conflicts of interest, including both the relationships required to be disclosed in Section II above (i .e., outside compensation) as well as institutional gifts, grants, or other financial suppmi from a commercial or non-profit entity to suppmi the faculty member's University work, if they are responsible for making purchasing decisions or advising others on decisions to purchase or lease health care devices, phannaceuticals, implants, equipment, or other expenditures. Such faculty must also recuse themselves from any final decisions regarding purchase of goods or services that such vendors supply.

IV. School of Medicine Institutional Events or Activities

This section of the policy establishes guidelines for the institutional interaction between the SoM, its depariments, and commercial entities. All SoM activities should be conducted in a manner consistent with the mission of the School and UW Medicine, and not in primary fmiherance of a commercial entity. The SoM and its departments should receive fair market value for services provided to commercial entities and the revenue received should accrue to the benefit of the SoM or the depmiment, and not to the private benefit of any pmiicular individual(s).

The School of Medicine relies upon a variety of sources to suppmi educational, research, and clinical operations. Funds or other forms of suppmi may come to the SoM or its depmiments from commercial entities, provided institutional conflicts of interests are addressed and minimized. To this end, the SoM reviews proposals for funding from industry through the Advancement office and/or the Dean's office. Department chairs are charged by the institution with oversight of all interactions with industry, with the advice and assistance of the Dean's office. When acting on behalf of the depmiments, chairs should follow the guidelines below.

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A. Guidelines for Department Educational Events Sponsored by Industry

When the SoM and its various depmiments and offices choose to solicit corporate financial support, they should follow the guidelines established by UW Medicine Advancement. This policy is intended to provide additional direction and suppmi in minimizing conflicts of interest with commercial entities.

1. General Guidelines for Outside Support Industry support for educational activities within UW Medicine institutions or UW School of Medicine educational programs in any location is permitted only if all of the following conditions are met:

1. The suppmi is umestricted with respect to content, topic, and speaker; 2. The suppmi is limited to payment for the actual costs of the educational activity; 3. The suppmi is made at a divisional or departmental level for general educational purposes and not for individual faculty members; 4. Industry may not designate pmiicular individuals as the recipients of suppmi for travel, accommodations, books, subscriptions, meeting registration, etc.; 5. Industry representatives may attend but not pmiicipate in the educational event or pmiicipate in the event as an oppmiunity to market products; 6. Suppmi is in compliance with all applicable Accreditation Council for Graduate Medical Education (ACGME)/ Accreditation Council for Continuing Medical Education (ACCME) standards; and 7. No trinkets, gifts, promotional material, free samples, or other marketing materials are available at the educational event. Only educational materials may be distributed at an educational event.

ACCME standards can be found at the ACCME website (http://www.accme.org/) and relate to interactions with industry in terms of independence of program planning, resolution of conflicts of interest, appropriate use of commercial suppmi, management of commercial promotion, and handling potential content bias.

2. Acknowledgment o[ Support The acceptance of industry suppmi for SoM educational events must occur without the actual or apparent endorsement of a company's products or services. Written materials related to the event, and verbal announcements during the event, should include disclaimers appropriate to the circumstances, such as:

"Acceptance of commercial suppmi from a pmiicular company does not imply an endorsement of that company or its products, or a promise of future purchase of the company's products." "Use of a pmiicular vendor's equipment does not imply a preference for, or

endorsement of, that equipment, or a promise of future purchase of that equipment."

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However, vendors or manufacturers providing supp01t for an educational event may be acknowledged and thanked for their supp01t in an appropriate fashion, such as verbally at the event, website acknowledgement, a simple sign, or in the written program .

. ~· SaM Department Solicitation o[Support When SoM departments solicit support from industry, commercial contributors should be referred to as "supp01ters" or, if they are being provided exhibit space, "exhibitors". Depmtments should consult with UW Medicine Advancement prior to sending solicitations to commercial firms and follow these guidelines which are intended to address potential conflicts of interest: solicit multiple firms; send to a broad base of potential supp01ters; do not limit to the depmtment's vendors; go beyond medical device and pharmaceutical companies for support where possible. A specific exhibitor or supp01ter should provide supp01t for the entire event not a specific segment of a program, speaker, topic, or faculty member.

:L_8_olvf Department Solicitation o(Equipment If the educational event includes equipment for demonstration or training purposes and the depmtment intends to solicit donations of the equipment to be used, then the depmtment should solicit and accept equipment donations from multiple vendors. If for practical or logistics reasons the depmtment determines that it can reasonably meet its requirements from only one or a few vendors, then the depmtment should consult with the Dean's office about the appropriate process for solicitation. After the training or demonstration, donated equipment may be returned to the donor. If the donor permits the department to retain the equipment, it must be used only for educational purposes.

5. SaM Department and Industry Joint Educational Events If SoM departments wish to collaborate with industry on the production of a joint educational event, the method of funding the event and the participation of the industry pmtner need to be carefully considered. Options may include a gift of umestricted funds to the depmtment to supp01t the event, a contract for the depmtment's services in producing all or pati of the event, or the invitation of faculty or staff to participate as speakers. If the chair of the depmtment determines that the collaboration has potential merit, the depattment should work with the Dean's office to establish a contract between the patties (when depmtments are being paid to provide educational services) or with UW Medicine Advancement to document a gift (a sum offered without expectation of services and without spending restrictions).

B. Industry Sponsored On-Site Training Events

A manufacturer may wish to contract with an SoM depmtment for particular faculty to train non-UW health care practitioners and/or industry employees on techniques for the safe and effective use of devices specific to that manufacturer, or to train on techniques not related to a pmticular device. If a chair believes such an activity has merit, the chair should contact the Dean's office to review the proposal fmther. Such further review will consider the intended target audience, the relevance of the activity to the UW Medicine mission, and the potential involvement of other UW Medicine entities. If the proposal is

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approved, the Dean's office will prepare a contract, which will provide for fair market value compensation for the training services. Revenue from the contract will accrue to the benefit of the depmiment and the other UW Medicine facilities involved in the transaction if any, rather than personally to any individual faculty who pmiicipate in delivery of the training.

C. IndustRy Sponsored Gifts, Including Gifts for Fellowships and Resident Training

In accepting gifts from commercial entities, documentation of the gift or donation should reflect that there are no deliverables required of the UW; that no restrictions are placed on the use of the funds; and should include language specifically disclaiming any expectation that the UW will use or purchase the donor's product in the future.

A faculty member associated with the gift should disclose this corporate suppmi in connection with any purchasing recommendations or decisions the faculty member makes in the future involving the donor. The intent is to establish a record that any future decision to purchase equipment from the donor is based on the merits of the donor's products and avoid any appearance that a purchase might have been in return for the gift.

In the case of commercial suppmi of fellowships, a donor may not control the selection of the fellow or the content of the cuniculum associated with any fellowship the donor supports. The selection of the recipient must be left up to the SoM and the depmiment. The donor may target a pmiicular field of study, as long as the limitation does not become an attempt to control course content. These guidelines apply whether the gift is for a clinical or a research fellowship, or whether the fellowship is accredited or not. Gifts to fund fellowships should be accepted by UW Medicine Advancement as the delegated authority to accept the gift and the Vice Dean for Graduate Medical Education.

D. Industry Sponsored Multiple Vendor Product Fairs

SOM departments are often asked to "sponsor" a company as the company seeks permission to use campus space for a product fair. In such a case, the company should bring multiple vendors to display products and services of interest to SoM faculty and staff. SoM departments should avoid "sponsoring" single vendor product fairs.

Depmiments may sponsor events with multiple vendors only if no company provides promotional items or free food and beverage. If a company chooses to provide food and beverage, it should charge a price that an objective outside observer would judge reflects the reasonable value of the food provided.

V. Whom to Contact for Further Guidance

When faculty have questions about their relationships with outside health care entities, they should consult their inm1ediate departmental supervisor (i.e. chair, division chief, or service chief), depmiment director or administrator, and/or hospital medical director.

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VI. Policy Implementation and Review

The policy will be reviewed annually and updated as appropriate. All faculty members of the UW SoM should review this policy on adoption, on joining the faculty and following any updates . Chairs and division heads are to work with their faculty to assure compliance with the requirements of this policy.

Originated by:

Reviewed by:

Revised by:

Conflict of Interest Subcommittee Mark Del Beccaro, M.D., Vice Chair for Clinical Affairs, Depmiment of Pediatrics, Chair Conflict of Interest Subcommittee (of UW Medicine Committee on Continuous Professionalism Improvement)

Continuous Professionalism Improvement Committee Carlos Pellegrini, M.D., Hemy N. Harkins Professor and Chair, Department of Surgery and Chair, UW Medicine Committee on Continuous Professionalism Improvement

Conflict of Interest Subcommittee Mark Del Beccaro, M.D., Professor, Department of Pediatrics Chair Conflict of Interest Subcommittee (of UW Medicine Committee on Continuous Professionalism Improvement)

Concurred in by: Medical School Executive Committee (MSEC)

Approved by:

p .J_(;, L---cJ ,L, II. L ~ • 2_ 0 \:,

Paul G. Ramsey, M.D. CEO, UW Medicine Executive Vice President for Medical Affairs and Dean of the School ofMedicine, University of Washington

May 5, 2009 Date Originally Approved

May 29.2013 Date Revisions Approved

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APPENDIX A

1) Washington State Ethics in Public Service Act, RCW Chapter 42.52 http://apps.leg.wa.gov/RCW/defmtlt.aspx?cite=42.52

2) Employee Responsibilities and Employee Conflict of Interest, Executive Order No. 32 http://www. washington.ed u/ admin/rules/po licies/PO/EO 3 2 .html

3) Significant Financial Interest Disclosure Policy, Grants Infmmation Memorandum 1 0 http://www. washington.ed u/research/ os p/ gim/ gim 1 0 .html

4) Outside Professional Work Policy (Academic Personnel), Executive Order No. 57 http ://wwvv. washington.edu/ admin/rules/poli cies/PO/EO 57. html

5) Annual Repmi of Outside Activities htt p://www. washington.edu/admin/acadpers/faculty/ annual report svstem.html

6) Policy Governing Acceptance of Honoraria, Executive Order No. 43 http://www. washington.ed u/ admin/rules/po li cies/PO/E04 3. html

7) Patent, Invention, and Copyright Policy, Executive Order No. 36 http://www. washington.ed u/ admin/rules/poli cies/PO/EO 3 6. ht_mj

8) ACCME Standards for Commercial Suppmi http://www.accme.org/dir docs/doc upload/68b2902a-fb73-44d1-8725-80a1504e520c uploaddocument.pdf

9) UW SoM Ghost Authorship Policy (PDF) http://depts. washington.edu/clinres/pdfs/SOMGhostAuthorshipPolicy2007. pdf

1 0) UW SoM Graduate Medical Education Vendor Interaction Policy (PDF) http ://uwmedicine.washington.edu/EDUCA TION/GRADUATE-MEDICALEDUCA TI ON/POLICIES-PROCI::DURES/Documents/GME-Vendor-InteractionPolicy. pdf

11) UW Medical Center Policy on Representatives, Health Care Industry, in the Operating Room (password protected page) https ://uwmc. uwmedi cine.org/ si tes/PoliciesProcedures/Surgi calPnP /Pages/RepO R .aspx

12) UW Medical Center Vendor Relations Policy (password protected page) https ://uwmc. uwmedicine.org/sites/PoliciesProcedures/apop/Pagesf-~0-7 .aspx

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13) UW Medical Center Ethics, Standards, and Compliance (PDF) http :1 /u wmedici ne. washington.edu/G lo bal/pol icies/Documents/UWM C-Integrityat-Work.pdf

14) HMC Policies on Vendors in Clinical Areas, Drug and Device Purchasing and Purchasing of Implant and Investigational Devices (PDF) http://uwmedicine.washington.edu/Global/policies/Documents/HMC-Policy-onVendors-in-Clinical-Areas. pdf

15) Harborview Medical Center Ethics, Compliance Standards and Code of Conduct (PDF) http://mymedicine.washington.edu/Global/policies/Documents/HMC-IntegrityAt-Work.pdf

16) Seattle Children's Hospital Policies on: a. Conflict of Interest htt p://www. seattlech il drens .org/research/ support -services/ orcltinancial-conflictof-interest -policy/

b. Vendors at Educational Events (password protected page) http ://child/policies procedures/administrative/vendor at educational events.asp

c. Vend or Presence (password protected page) http://child/policies procedures/administrative/vendor presence on prenuses.asp

d. Vendor Solicitation (password protected page) http :II child/policies procedures/ adm ini strati ve/vendor soli ci tation.asp

17) Fred Hutchinson Cancer Research Center Policies a. Conflict of Interest Policy (PDF) http ://extranet.fhcrc.org/EN/sections/general counsellpolicies/cont1ict interest 2 O.pdf

b. Policy and Guidelines for Involvement with Outside Interests (PDF) http :/ I extranet. fhcrc .org/EN/sections/ general counsel/policies/ outside interests. p df

c. FHCRC Guide for Vendors (PDF) http:/ I extranet. there. org/EN /sections/vendor guide/index.html

18) UW Medicine Advancement Policies (contact Jennifer Hazel brook) a. Fundraising (to be posted on-line 4th quarter 2012) b. Underwriting (to be posted on-line 4th quarter 2012)

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FAQ's REGARDING 2013 REVISIONS TO SoM FACULTY COl POLICY

QUESTION 1: Why am I no longer permitted to participate on an industry's speaker's bureau?

ANSWER: The CPI committee felt strongly that whenever SoM faculty present at programs designed solely or predominantly for company promotional, sales or marketing purposes, the faculty participation, even though compliant with the fair market value standard, created a real and inappropriate conflict of interest situation. The CPI subcommittee also reviewed the policies of peer medical schools across the country and found that several institutions contain a similar prohibition.

QUESTION 2: Does the prohibition on participating on a speaker's bureau apply if the speech I give is about the science relating to a disease or condition as opposed to one that directly advocates for the company's product?

ANSWER: Yes, the conflict of interest stmis with the presence ofyour name in a company's list of individuals maintained by the company ("Speakers Bureau"). The implication to the public if your name appears in that list is that you directly or indirectly "work for the company'' or/and that your role is to advance the interests of the company.

QUESTION 3: Does the prohibition on pmiicipating on a speaker's bureau apply ifl retain control of the content of the presentation and/or any slides that may accompany the pl'esentation?

ANSWER: Yes, it is in fact the willingness to participate in a Speakers Bureau - in a list maintained by a company that leads to the perception of promoting a company's product or service. This is present regardless of who is responsible for the content of the presentation.

QUESTION 4: Does the prohibition apply if the activity is not called a "speakers bureau''?

ANSWER: Yes, the prohibition applies to pmiicipation as a speaker, panelist, presenter, or commentator in any activity or event funded, directly or indirectly, by a commercial entity, where the event is, or may be perceived to be, a promotional event for the sponsoring organization and/or its products or services.

QUESTION 5: I have been invited to give a talk at a symposium that is being sponsored by a drug or device company. The symposium has received the funding and I was asked

by the symposium steering committee to participate and they will pay my travel, accommodations and an honorarium for my participation. I am not receiving money from the company. Is this allowed?

ANSWER: Under the cmTent COl policy, as long as the symposium meets the standards for a CME activity (industry does not pick the speakers, control the content, etc.), pmticipation in the symposium is permitted. The revisions to the policy do not prohibit or change this. However, you must still comply with the University's outside work policy.

QUESTION 6: I have been invited to speak at Grand Rounds by a peer institution where the invited speakers are paid directly by a pharmaceutical company for speaking, yet the company has no influence in terms of content. Is this allowed?

ANSWER: So long as the Grand Rounds meets the standards for aCME activity, and neither is, nor is perceived to be, a promotional event for a company and/or its products or services, compensation directly by the company is not prohibited. However, please be aware that such direct payment is not considered best practice, may need to be disclosed under the University rules related to conflict of interest in research (GIM 1 0), and will be publicly disclosed by the company (pharmaceutical or device manufacturer) under the soon to be implemented Physician Payment Sunshine Act.

QUESTION 7: I already have an approved (through the outside compensation process) speaking atTangement that is expected to continue through the 2013 academic year. Do I have to end this arrangement immediately?

ANSWER: If you can end the anangement without undue burden to yourself or the outside company that would be the best course. However, you are entitled to fulfill the terms of the existing a11'angement but it may not be renewed or extended.

QUESTION 8: If I am asked my opinion about a drug or device that I use in my clinical practice during a panel discussion or at a conference am I no longer allowed to give my opinion?

ANSWER: You are free to give your opinion on the effectiveness of any product or device. You may not do it as part of any program put on by the manufacturer for the intention of promotion of the product or device.

QUESTION 9: My work has led to the invention or further improvement of a product or device. Am I allowed to give my opinion of the effectiveness of that product or device?

ANSWER: In the context of your University employment, you may give your opinion if asked, for example by a UW Medicine purchasing committee, but you must disclose your financial interest in the product and recuse yourself from any purchasing decision. There may also be limited circumstances where you may appear on behalf of industry as indicated in the policy, including in situations where you have a financial interest in the product and are doing approved outside work involving that product.

QUESTION I 0: I am an unpaid clinical faculty member and teach residents in my practice at a WWAMI site. Does this policy apply to me?

ANSWER: The existing policy applies specifically to faculty employed by the University and its close affiliates. All faculty not otherwise covered are currently encouraged to follow the intent of the policy and its guidelines. However, the new prohibitions on speaker bureau participation and commercial product endorsement will apply to all (paid and unpaid) faculty.

Date of Final FAQ's May 22, 2013

UWMedicine UW SCHOOL OF MEDICINE

May 28,2013

Memorandum

TO : School of Medicine Faculty

FROM: Lauren M. Exn~--~~ Director of Regulatory Guidance School of Medicine Box 358047

SUBJECT: The Outside Work Policy and Recent Changes to the UW Medicine Policy for Faculty on Potential Financial Conflicts · of Interest with Commercial or Nonprofit Entities

The purpose of this memo is to summarize the University and School of Medicine's Outside Work Policy1 requirements for paid faculty, and to share recent changes in the School of Medicine's Financial Conflict of Interest Poliql.

A. UW /SoM Outside Work Requirements

1. Scope. Subject to certain limited exceptions, all paid faculty within the · School of Medicine who desire to engage in outside work for compensation are required to obtain prior written approval from the University on the attached Request for Approval for Outside Work form (formerly the "1460"). Please note this form was revised in May 2 013 and earLier versions should no longer be submitted. In addition to the Request for Approval for Outside Work, the UW Medicine Policy for Faculty on Potential Financial Conflicts of Interest with Commercial or Nonprofit Entities requires that a

· supplement'3 be filed with the request on which the faculty member must disclose the anticipated amount of compensation to be received from the activity.

1 http://www.washlngton.edu/admin/rules/policies/POIE057.html 2 http://www. uwmedicine.org/G Ioballpo Iicies/Pages/Conflict-of-Interest -with-Commercial-or-Non-ProfitEntities.aspx 3 http://www. uwmedicine.org/G loballpolicies/Documents/COI -Outside-Work -SOM -Supplement-Online-Form. pdf


2. Process. After completing and signing both the request and the supplement, faculty submit the forms first to· their department chair. After review, the department forwards both forms to the Director of Regulatory Guidance in the Office of the Dean for approval by the School of Medicine. Review of the supplement ends in the dean's office. Effective May 15, 2013, the Office of Research (OR) assumed the responsibility for the final review and approval of outside professional work for compensation. In conjunction with this change in process, OR launched a new webpage that describes the requirements and the approval process for outside work requests.4

3. Situations When Approval is Not Required. Certain kinds of university and community service activities do not require prior written approval even though compensation in the form of an honorarium is paid. These limited exceptions are more fully described in Section 5 of the University1s Outside . Professional Work Policy.

Approval is NOT required when: o You are not compensated in any way (including in kind, waived or

assigned compensation) for the outside work • The outside work is for nonprofit professional associations and societies e The outside work involves contributing professional expertise related to

your academic work for scholarly, editorial and advisory bodies, including governmental bodies

e The work is service on public commissions or boards of philanthropic organizations

• Outside work is at the invitation of nonprofit organizations, colleges and universities, and governmental agencies involving:

o presenting guest lectures o delivering scholarly papers o serving on review panels o participating in acc~editation activities

The above activities are not subject to limitations on outside work and do not require prior approval as such. If the activities involve travel, however, approval for travel away from the University must be sought from the appropriate supervisor. This exclusion ~oes not apply to teaching courses for

4 http://www.washington.edu/research/topics/outside-world


credit or participating in continuing education activities not under the aegis of the University of Washington; prior approval for such activities must be sought.

4. Annual Approval Required. Outside work requests are submitted on an annual basis each academic year (July 1 - June 30). Approval must be received for activity each academic year, even if the activity has been approved · in years prior. If work will span two academic years, a request must be submitted for each year. All faculty activities must also be reported annually using the online Annual Report of Outside Activities (formerly Form 1461). The report must be submitted for all activities, even those that do not require prior appro':al. It must also be submitted when there is no activity of any kind to report. For ease of reporting, faculty members are encouraged to start a report online at the beginning of the academic year and then add activities as they occur. On June 30, when the year has ended, the faculty member then finalizes and submits the report.

B. Changes to SoM Faculty Conflict of Interest Policy

The School of Medicine Policy on Potential Financial Conflicts of Interest with Commercial or Nonprofit Entities has recently been amended. There are two principal changes, and they will take effect on July 1, 2013.

1. Participation on s·peakers' Bureaus. The first change is to implement a ban on faculty participation in speakers' bureaus. Under this new provision, SoM faculty will no longer be allowed to present at programs designed solely or predominantly for company promotional, sales, or marketing purposes even in those circumstances where the facu[ty retain controL of the content of the presentation and/or any slides that may accompany the presentation. Examples of activities that are not appropriate for faculty participation include: (1) any arrangement or speaking engagement in activities commonly called a "speakers bureau"; (2) inclusion on a list maintained by a commercial entity for the purpose of retaining or recommending an individual as a speaker, when the individual has agreed to be included on the list; and (3) participation as a speaker, panelist, presenter, or commentator in any activity or event funded, directly or indirectly, by a commercial entity, where the event is, or may be perceived to be, a


promotional event for the sponsoring organization and/ or its products or service~. Indirect funding includes financial support from a non .. profit entity that is created ·and supported by commercial entity(s). Faculty who have previously approved commitments to speakers' bureaus should complete this work before July 1, 2013 and no new requests for such work will be approved.

2. Product Endorsement. The second change is to prohibit SoM faculty from endorsing a product for the primary purpose of promoting its purchase. SoM faculty may give their opinion about commercial products when there is no promotional purpose, e.g., an inquiry from a professional colleague or professional association, a hospital vendor purchasing request, an independent product survey, or in communication of the product's role in scientific research.

Questions regarding the Outside Work Policy, approval process or the changes to the UW Medicine Policy on Potential Conflicts of Interest with Commercial or Nonprofit Entities should be directed to Lauren Exnicios, Director of Regulatory Guidance. Lauren may be reached at 206.543.6047 or [email protected].

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