Financial Conflict of Interest and Outside Work Review

1. Financial Conflict of Interestand Outside Work Review December 2, 2011 Gerberding Hall 142, University of Washington

2. Speakers Jeff Cheek, Assoc Vice Provost for Research Compliance & Operations Shelley Kostrinsky, Asst Vice Provost for Academic Personnel, Office of the Vice Provost for Academic Personnel Lauren Exnicios, Director of Regulatory Guidance, School of Medicine Dean’s Office Fiona Wills, Director, UW Center for Commercialization Technology Licensing

3. Outside Work Review for Academic Personnel Shelley KostrinskyAssistant Vice Provost for Academic PersonnelOffice of the Vice Provost for Academic Personnelskos@u.washington.edu(206) 685-6138

4. Outside Professional Work Policy • Executive Order No. 57: http://www.washington.edu/admin/rules/policies/PO/EO57.html

5. Requesting Approval of Outside Professional Work for Compensation • All academic personnel are required to use the latest form, which was revised in October 2011 • Find it on the Academic HR website: http://www.washington.edu/admin/acadpers/forms/approval_compensation.docx • Obtain approval in advance • Fill out completely; sign and date

6. Requesting Approval (cont’d) • The process for review and approval includes your chair/program director • Next step is review and approval from dean/chancellor/vice provost • The last step is review, consideration and final determination by the Office of the Provost • A “Yes” response to one or more of Questions 18-27 will trigger a more thorough review

7. Common Issues Requiring Closer Review • Employing students in your outside work • Consulting with another state entity (RCW 42.12.120) • Foreign nationals on a visa • Duplicating your duties • “Deeper involvement review”

8. Additional Items to Consider • Plan ahead; submit your form early • Must indicate the specific number of days • Don’t advertize your outside business on your UW website • Questions should be directed to your chair or program director

9. Additional Items (cont’d) • Faculty Code (Exec Order 57, Section 4) requires the filing of an annual report by November 15th of your outside activities for the previous academic year • The Office of the Provost may work with the Office of Research, School of Medicine and C4C depending on the request

10. UW Medicine Faculty Conflict of Interest Policy Lauren M. ExniciosDirector of Regulatory Guidance Business Unit, Dean’s Office, School of Medicineexnicios@uw.edu(206) 543-6047

11. UW Medicine Policy for Faculty on Potential Financial Conflicts of Interest with Commercial or Non-Profit Entities Purpose: • Ensure SOM faculty avoid, or disclose and address, perceived or real conflicts of interest between responsibilities as faculty and their outside activities • Encourage appropriate relationships between faculty and industry to extent they further mission of UW Medicine http://uwmedicine.washington.edu/Global/policies/Pages/Conflict-of-Interest-with-Commercial-or-Non-Profit-Entities.aspx

12. Applicability of SOM COI Policy Applies to SOM faculty: • With the following titles/rank: • Acting, Regular, Research and Clinical faculty (except that it does not apply to Clinical faculty who are not paid by the SoM or a close affiliate) and Teaching Associates and • With either a primary or a joint appointment in the SOM

13. Applicability of SOM COI Policy (cont’d) Generally speaking, does not apply to the following SOM faculty: 1. Adjunct 2. Affiliate, Visiting, and Emeritus (provided no salary from SOM) or 3. Faculty with an appointment in a jointly administered SOM department but without a primary or joint appointment in the SOM (e.g., some Bioengineering faculty)

14. Substantive Areas of Faculty Interaction with Outside Entities Addressed by UW Medicine Policy • Consulting and other outside work • Speeches, meetings, and travel funded by outside entities • Gifts • Food and beverage • Teaching activities • Industry support of educational events

15. Consulting and Other Outside Work • Outside work by faculty permitted with prior approval under UW Outside Work Policy • Request for approval must include amount of compensation, and amount cannot exceed fair market value for services performed on the SOM Supplement • Only for faculty whose primary appointment is in the SOM

16. Speeches, Meetings, and Travel • Honoraria, including travel and lodging, permitted for speech, appearance, article not part of University work, provided payment commensurate with time and effort and advance permission obtained • No honoraria or other compensation allowed for simply attending an industry meeting or listening to a sales pitch (detailing) • Outside entities interested in funding travel can donate travel cost to University; University can fund the travel as part of faculty member’s University duties

17. Gifts • COI Policy prohibits covered SOM faculty from accepting gifts of ANY value from commercial entities or non-profit entities created and supported by commercial entities • Prohibition includes promotional items such as pens or pads, drug samples for personal use, entertainment or recreational opportunities, cash or cash equivalents, and business courtesies such as food and beverage

18. Food and Beverages Institutional Level • Food and beverages provided by commercial entities or non-profits supported by commercial entities not permitted at UW Medicine-operated facilities • Also not permitted at non-campus events held by UW Medicine, any of its component entities, or any SOM faculty

19. Food and Beverages (cont’d) Individual Level • General rule: faculty should not accept free food or beverages provided by others (violates prohibition on gifts) • Exception where food and beverages are provided as an incidental part of an event where faculty member is attending as part of their job duties, or at events sponsored by civic, charitable, specialty, or job related professional, governmental, or community organizations

20. Teaching Activities • Faculty involved in teaching activities (lectures, seminars, conferences) must disclose relevant potential financial conflicts • Disclosure must include both outside compensation and institutional support • Disclosure can be through written materials, slides, or verbal statements as appropriate to the situation

21. Industry Support of Educational Events Industry support of educational activities permitted only if number of conditions are met, including: • The support is unrestricted with respect to content, topic, and speaker • Industry may not designate particular individuals as the recipients of support for travel, accommodations, books, subscriptions, meeting, registration, etc. • Industry representatives may attend but not participate in the educational event or participate in the event as an opportunity to market products

22. Industry Support of Educational Events (cont’d) • No trinkets, gifts, promotional material, free samples, or other marketing materials are available at the educational event; only educational materials may be distributed • Vendors or manufacturers providing support may be acknowledged in an appropriate fashion, such as verbally, with simple sign, or in written program

23. Conflicts of Interest, GIM-10&State Ethics Act Jeff Cheek, Ph.D. Associate Vice Provost for Research Compliance and OperationsOffice of Research jcheek@uw.edu (206) 543-6619

24. Federal Research Standard Conflicts of financial interest occur “whenever financial considerations may have the potential to compromise or have the appearance of compromising an investigator’s professional judgment and independence in the design, conduct, or publication of research.”- US Public Health Service Potential conflicts of interest occur in all human processes and are not inherently “bad” if they are appropriately managed

25. Common Financial Interests Money – cash, salary, fees, royalties, honoraria; any monetary obligation (creditors and debtors have monetary interests), liabilities Property – any physical asset with monetary value or burden; intellectual and intangible property Equity/ownership – stock, partnership, etc. Imputed interests – spouse, family, partnership, joint ventures, other legal relationships Bottom Line: Anything with economic value

26. UW Significant Financial Interest (SFI) Disclosure Policy (GIM 10) • Applies to all research (sponsored and unsponsored) and tech transfer license transactions • Addresses conflicts and appearances of conflicts • Goal is to prevent – • Bias in research • Harm to human subjects • Misuse of UW and state resources • Violations of state ethics act

27. UW SFI policy SFI disclosure is required prior to participating in research or tech transfer activity; anyone having a significant financial interest related to the activity must disclose details Disclosures can occur: when research proposal submitted to Office of Sponsored Programs; when application submitted to IRB; when SFI arises during the course of research; or prior to concluding technology licensing transaction

28. Most frequent examples of SFI Outside salary, honoraria, consulting fees Compensation for speaking engagements Stock, stock options, other ownership interests Intellectual property rights (patents, licenses) Invention royalties (UW distributed royalties and equity not considered SFI for tech transfer) Imputed interests (spouse, etc.)

29. What is a “significant” financial interest? • For a Clinical Trial, any Financial Interest. • For Human Subjects Research other than a Clinical Trial (i) any Financial Interest exceeding $5,000 in value, (ii) any Equity Interest; or (iii) any Intellectual Property Interest. • For all Research other than Human Subjects Research and all Technology Transfer Transactions, (i) any Financial Interest (including a Compensation Interest, an Equity Interest and an Intellectual Property Interest) exceeding $10,000 in value, or (ii) any Equity Interest representing more than a 5% ownership in any single entity. (PHS / NSF definitions) • NOTE: PHS / NIH new regulations and definitions of SFI new regulations will apply by August 2012.

30. New DHHS Rules on Financial Conflicts of Interest (FCOI) • Institutions receiving federal funding must be in full compliance with all of the requirements by the earlier of: • August 24, 2012; or • upon making its revised institutional financial conflict of interest policy publicly accessible. • In the interim, institutions should continue to comply with the 1995 regulations.

31. Summary of Key Changes • - Lowers the minimum threshold from $10,000 to $5,000 for disclosure of payments for services or equity interest in a publicly traded company with a $0 threshold for disclosure of equity in a non-publicly traded company. • - Requires investigators to disclose all significant financial interests related to their institutional responsibilities (rather than only those related to the Public Health Service (PHS)-funded research) during the 12 month period preceding the disclosure (rather than following the disclosure).

32. Summary of Key Changes Increases the institution’s responsibilities regarding identifying significant financial interests related to PHS-funded research; managing financial conflicts of interests; and ensuring sub-recipient compliance. Requires institutions to provide a financial conflict of interest report to NIH containing the details of any investigator’s financial conflict of interest (rather than just reporting the existence of a conflict of interest) AND the details of the institution’s plan for managing the conflict prior to the expenditure of funds.

33. Summary of Key Changes Requires public transparency by either publicly accessible website or written response to any requestor within 5 business days of request for institution’s financial conflict of interest policies and certain information regarding any key personnel whose significant financial interests are related to PHS-funded research. Requires investigators to complete training prior to engaging in research related to any PHS-funded grant or contract. Re-training required every 4 years.

34. 2005 State Ethics Act Changes • Alternate compliance system for “University Research Employees” at state universities (i.e., research faculty and certain staff engaged in research or tech transfer activities related to their research – no other UW personnel) • Universities allowed to adopt administrative processes, with the approval of the Governor, that apply in place of obligations otherwise imposed by Ethics Act • Ethics board retains authority to enforce violations of alternative compliance system (i.e., individual liability) • Liberalization of permitted de minimis uses • See our FAQs on Office of Research website: • www.washington.edu/research/main.php?page=stateEthicsAct

35. Limitations to keep in mind • Faculty who own 50% or more of a company may be required to take a whole or partial leave to do work for it. • In general, faculty cannot be an investigator(s) in a clinical trial involving their invention or product. • Except under rare and compelling circumstances, UW will not conduct a clinical trial of a UW invention or for a company in which it has a substantial equity position. • Except for allowed de minimis uses, UW resources and facilities can only be used to support a company through established processes (sponsored research, contracts, etc). • UW intellectual property cannot be transferred through consulting or other “backdoor” methods.

36. Scenario 1 • Dr. Sarah Bellum (School of Medicine faculty) provided a series of lectures for Pfizer, Inc. in 2010, for which she was compensated $1,500. She would like to participate in a clinical trial sponsored by Pfizer as a co-investigator starting in 2011. • Does Dr. Bellum have SFI for this trial? • What concerns might be raised by her participation? • What controls should be in place to mitigate these concerns?

37. Scenario 2 • Dr. Frank Lee Vulgar (College of Engineering) has a 50% equity holding in a startup company, for which he has no management or operational role. He proposes to have the company sponsor research via a subcontract with the UW so that he can use University equipment and facilities for the project. • He would also like to have one of his graduate students work on the project funded by his startup company as part of the student’s thesis project. • Any additional concerns about the subcontract between the startup company and the University?

38. Scenario 3 • Dr. Anita Asprin (College of Education) has just been awarded a grant from the Dept. of Education to develop a new curriculum for high school science teachers. She would like to hire her husband (who is not a UW employee) as a consultant on the project, as he has critical expertise in this area, and they have collaborated on previous projects. • Does Dr. Asprin have SFI? • Are there any other concerns to be addressed?