Wednesday, December 02, 2009

Dr. Wise's NIKE appointment may violate ethical policies of the UW School of Medicine.


Phyllis Wise. UW Provost, has recently announced that she has accepted a position on the Board of NIKE.

Cross Posted to AAUP/UW list-serv.

Her decision to do this raises many concerns, especially in an era where teh UW is under great finaciakl challenge. Among these concerns, there are questions about how someone as busy as a University Provost can accept a board position at a major corporation, about the seemliness of her accepting the addition of about $200,000 to her nearly $600.000 salary, and about conflicts of interest arising because NIKE is a major vendor as well as supporter of the UW Athletics Department.



As a Professor in the Medical School, however, I see additional issues because Dr. Wise is also a Professor of Physiology in the same School of Medicine. Our SOM administration has recently enacted ethics rules in response to national concerns about the ethics of interactions of medical school faculty with industry. These rules governaing Dr. Wise and my self are far more stringent than the rules of the UW Faculty Code.

I have abstracted the policies from UWSoM websites and listed 14 questions arising from these policies that should be addressed to Dr. Wise.

Actions Required of SOM Faculty:

Subject to certain limited exceptions, all regular faculty and university employees within the School of Medicine who desire to engage in outside work for compensation are required to obtain prior written approval from the University using the Request for Approval of Outside Professional Work for Compensation form (formerly 1460), an interactive PDF document. Detailed instructions for completing the form are found on the first page of the file.

>>>1. Has Dr. Wise filed this form? Is it available in the public domain (NOTE: quoted from text below: '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. '?

As required by the UW Medicine Policy for Faculty on Potential Financial Conflicts of Interest with Commercial or Nonprofit Entities, if the outside work requiring prior approval includes compensation that has monetary value, that value should be disclosed on a supplement to the request for approval.

>>>2. This implies that her total recompense from NIKE must be disclosed publicly. Is that the case and has she made these numbers available prior to approval?

Both the request and the supplement are submitted first to the department chair. After review, the department forwards both forms to the Office 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.

>>>3. Were these procedures followed? Did the Dean's office sign of on this agreement? (NOTE: as discussed below, the Dean is also supposed to review the level of pay to determine if it is fair market value.)
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 approval. 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 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. ....

All UW investigators participating in research involving UW facilities or resources or patients receiving care at the UW are subject to GIM 10, the UW's Significant Financial Interest Disclosure Policy. As part of GIM 10, if any investigator has a significant financial interest related to the research, it must be indicated on the eGC1 and the interest must be disclosed using the Significant Financial Interest Disclosure Form (Exhibit 1 to UW's GIM 10).
>>>4. Has NIKE agreed to the disclosures required by form 1461 and Policy GIM 10. Has NIKE agreed to public disclosure? 

Conflict of Interest Policies Underlying the SOM Required Actions, Excerpted
NOTE: I have underlined some text for relevance. Deletions from UWSoM textrs are marked by '...'

The definition of a significant financial interest is different for clinical trials, which has a zero threshold. In addition, the UW Human Subjects Review Committee Application has specific questions regarding investigator financial interests.
>>> 5.Dr. Wise's office has direct responsibilities for clinical trials, including human subjects approval. Does this mean she must exempt her office from all clinical trials relevant to NIKE's interests? Given the complexity of the UW oversight and compliance effort, what policies would make this possible?
I. Purpose

It is the policy of UW Medicine that School of Medicine (SoM) 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 interaction with these entities so that they may continue to contribute to the mission of UW Medicine in a manner that ensures the faculty avoid real or perceived conflicts of interest. There are five core concepts upon which this policy is 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 conflict, as well as actual conflict.


>>>6. Again has Dr. Wise submitted her request to determine if it is at fair market value?

This policy applies to the following faculty of the School of Medicine: Acting, Regular, Research and Clinical faculty.... It 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.
.......

.......

II. Prohibited or Allowable 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 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 certain 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 part 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.

....


Even though Washington State law and University policy do not prohibit all gifts as described above, it is the policy of UW Medicine to prohibit SoM faculty 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

.....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 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.

>>>7. It is common practice on boards to receive gifts from their business colleagues and participate in corporate retreats. Presumably these gifts would rarely be worth less than $50. Will Dr. Wise refuse gifts and absent herself from retreats at luxury resorts?

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 UW Medicine 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. 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.


>>>8. Did the School of Medicine determine the fair market value of Dr. Wise's services to NIKE? Who made this evaluation and what process was used?
>>>9. Were the terms of Dr. Wise's contract provided in writing and if so are they a matter of public record?
D. Speeches, Meetings, and Travel Funded by Commercial ... Entities

.....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 Handbook, Volume Four, Part V, Chapter 6, Section 7)

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.
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 Handbook policy found at: Volume Four, Part V, Chapter 6: Outside Professional Work Policy. Section 6 of this chapter, entitled “Involvement with Commercial Enterprise, Deeper than Consulting,” provides guidance for faculty on accepting board positions.


>>>10. Was Dr. Wise's contract reviewed as required above?

III. Disclosure of Compensation/Relationships with Commercial or Non-Profit Entities
A. Disclosure of Outside Compensation or Faculty Support

Which relationships require disclosure?
All faculty relationships with commercial and non-profit entities require disclosure in advance, or as part of an annual reporting obligation, or both. Disclosure is required by faculty members when they receive remuneration from a company for outside work or for inventions or discoveries made as a University employee (stock ownership, stock options, equity interests, stock warrants, royalties, consulting fees, loans from the sponsor, speaking arrangements), or hold office in or serve on the board of a company (board of directors, scientific advisory board, other office in the company) – see process for disclosure (below) for details on how to report. Faculty are encouraged to inform their division head and department chair if they are in a negotiation phase in order to receive guidance about the appropriateness of the relationship and compensation.

Annually, faculty will also need to disclose support from outside commercial and non-profit entities received by the institution for the use or benefit of the faculty. Examples include grants, endowments, equipment, materials, discretionary funds, support of office or research staff, sponsorship of trips, or other sponsorships – see process for disclosure (below) for details on how to report.
.......

Process for disclosure
Disclosure will be provided through the following mechanisms:

1) Request for Advance Approval. 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. It is the policy of UW Medicine that, if the outside work requiring prior approval includes compensation that has monetary value, the faculty must submit on a form to be developed by the Dean the estimated or proposed contracted monetary value of all compensation. The form will show the monetary value of payments, the organization providing the payment, and an indication of whether other compensation (travel, destination, lodging, etc.) was also provided. The value of these other items need not be reported.

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 School 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.

>>>11. Were the negotiations for this position reviewed with the Chair of Physiology? Again (as in 3), how was the fair market value determined?

2) 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. Faculty do so by completing the Annual Report of Outside Activities.

a. It is the policy of UW Medicine that faculty will be required to provide on the Annual Report form, or on another form determined by the Dean, the monetary value of the payments actually received, and an indication of whether other compensation (travel, lodging, etc.) was also received although the value of these other items need not be reported.


>>> 12. As above (in 1-4 above) has NIKE agreed to these disclosures? If so, under Washington State Law, aren't these open for public inspection (see below '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. '?

How will disclosure information be distributed?
Information that normally flows to the Provost’s office will continue to do so.

>>>13. Since her office is required by law to review the financial terms, how is this review isolated from Dr. Wise?

Initially, the additional COI disclosure information (including compensation levels) will be distributed to relevant leadership in UW Medicine, including: the Dean of the SoM, department chairs, division heads, hospital medical directors, and hospital executive directors.

At such time as a UW Medicine website with appropriate information and links related to this topic is developed, it is anticipated that this additional disclosure information will be placed there. Access will require a UW Net ID. 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 (including lectures to medical students and residents, seminars, conferences, and community service activities with a teaching component), faculty must directly disclose to the audience relevant potential financial conflicts. .... 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.


>>>14. Will all relevant communications from Dr. Wise and appearances by her, including any involvement in UW athletics include such disclaimers?"
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1 comment:

Anonymous said...

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