UW School of Medicine Policy on Potential Financial Conflicts of Interest for Commercial and Non-Profit Entities

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 of UW 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 of UW 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 important 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 support for educational events, gifts, and travel or meetings funded by outside commercial or non-profit entities.

Sections II and III of this policy, which address conflicts of interests for individual faculty, apply to the following faculty of the School of Medicine: Acting, Regular, Research and Clinical faculty (except that it does not apply to Clinical faculty who are not paid by the SoM, University of Washington Physicians (UWP), Children's University Medical Group (CUMG), or an SoM affiliate) and Teaching Associates ("SoM 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 of this policy applies to the SoM and its various departments 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 pertinent policies is found at the end of this policy in Appendix A.

¹ See The Scientific Basis of lnfluence and Reciprocity: A Symposium, June 12, 2007.

² "Affiliate" for purposes of the 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 connection with participation on a speakers bureau or in any endorsement of commercial products. See section II, D.3 and 4.

A. Gifts
Washington State law and the University's existing Conflict of Interest Policy impose significant limitations on the ability of UW SoM 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)

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)

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). 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,
Grants Information Memorandum 34
Gift Processing Guidelines

Even though Washington State law and University policy do not prohibit all gifts as described above, SoM faculty are prohibited from accepting any form of personal gift from 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, entertainment 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 supplied by commercial entities are not permitted 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 certain 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 part 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 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 of the arrangements, services provided and compensation should be set forth 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 departmental supervisor (i.e. chair, division chief or service chief), department director or administrator, and/or hospital medical director. <sup>4

4</sup>  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

D. Speeches, Meetings, and Travel Funded by Commercial or Non-profit Entities.
1. Activities on Behalf of Non-profit Organizations. Universities, and Government Agencies
Under the University's existing Outside Professional Work Policy, faculty are encouraged to participate 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 governmental 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 reported annually using the Annual Report of Outside Activities (see below).

In such instances of University and community service, it is not uncommon for a faculty member to receive some form 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 Policy Directory, Executive Order No.43)

2. Speeches, Articles, or Appearances on Behalf of Commercial or Non-Profit 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, article 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 effort 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 Promotional Activities
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 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 services. Indirect funding includes financial support from a non-profit entity that is created and supported by commercial entity(s). The limitations of this section (D.3) apply also to unpaid faculty when using their faculty title.

In certain limited circumstances when a faculty member has unique knowledge and expertise required for a particular event or occasion, it may be permissible 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 current or potential investors when the matter is related to the faculty member's own innovation or unique expertise. Such appearances may be permitted provided that advance approval for the activity is obtained in accordance with the requirements of the 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.

4. Endorsement of Commercial 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. Section 6 of this Executive Order, entitled "Involvement with Commercial Enterprise, Deeper than Consulting," provides guidance for faculty on accepting board positions.

A. Disclosure and Reporting of Outside Compensation
I. Advance Approval Required
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.

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 reported. 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 determination that the fair market value standard is not met. 

2. No Advance Approval Required
As described above, certain activities involving certain 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).

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. 

4. Distribution of 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, department 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 Part II above (i.e., outside compensation) as well as institutional gifts, grants, or other financial support from a commercial or non-profit entity to support the faculty member's University work. Dissemination may be performed 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.

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.

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 support from a commercial or non-profit entity to support 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, pharmaceuticals, 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.

This section of the policy establishes guidelines for the institutional interaction between the SoM, its departments, 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 furtherance 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 departments, and not to the private benefit of any particular individual(s). 

The School of Medicine relies upon a variety of sources to support educational, research, and clinical operations. Funds or other forms of support may come to the SoM or its departments 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 departments, chairs should follow the guidelines below. 

A. Guidelines for Department Educational Events Sponsored by Industry 
When the SoM and its various departments 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 support in minimizing conflicts of interest with commercial entities. 

l. 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 support is unrestricted with respect to content, topic, and speaker;
2. The support is limited to payment for the actual costs of the educational activity;
3. The support is made at a divisional or departmental level for general educational purposes and not for individual faculty members;
4. Industry may not designate particular individuals as the recipients of support for travel, accommodations, books, subscriptions, meeting registration, etc.;
5. Industry representatives may attend but not participate in the educational event or participate in the event as an opportunity to market products;
6. Support 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 and relate to interactions with industry in terms of independence of program planning, resolution of conflicts of interest, appropriate use of commercial support, management of commercial promotion, and handling potential content bias. 

2. Acknowledgment of Support 
The acceptance of industry support 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 support from a particular 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 particular vendor's equipment does not imply a preference for, or endorsement of, that equipment, or a promise of future purchase of that equipment." 

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

3. SoM Department Solicitation of Support 
When SoM departments solicit support from industry, commercial contributors should be referred to as "supporters" or, if they are being provided exhibit space, "exhibitors". Departments 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 supporters; do not limit to the department's vendors; go beyond medical device and pharmaceutical companies for support where possible. A specific exhibitor or supporter should provide support for the entire event not a specific segment of a program, speaker, topic, or faculty member. 

4. Department Solicitation of Equipment 
If the educational event includes equipment for demonstration or training purposes and the department intends to solicit donations of the equipment to be used, then the department should solicit and accept equipment donations from multiple vendors. If for practical or logistics reasons the department determines that it can reasonably meet its requirements from only one or a few vendors, then the department 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. SoM 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 partner need to be carefully considered. Options may include a gift of unrestricted funds to the department to support the event, a contract for the department's services in producing all or part of the event, or the invitation of faculty or staff to participate as speakers. If the chair of the department determines that the collaboration has potential merit, the department should work with the Dean's office to establish a contract between the parties (when departments 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 department 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 particular device. If a chair believes such an activity has merit, the chair should contact the Dean's office to review the proposal further. 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 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 department and the other UW Medicine facilities involved in the transaction if any, rather than personally to any individual faculty who participate 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 support 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 support of fellowships, a donor may not control the selection of the fellow or the content of the curriculum associated with any fellowship the donor supports. The selection of the recipient must be left up to the SoM and the department. The donor may target a particular 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. 

Departments 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. 

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