Conflicts of Interest, GIM-10 & State Ethics Act November 4, 2009 ITHS Clinical Research Education Series Jeff Cheek, Ph.D. Karen Elledge Assoc. Vice Provost – Res. Compliance/Ops. Director of Regulatory Guidance Office of Research School of Medicine jcheek@u.washington.edu kelledge@u.washington.edu (206) 543-6619 (206) 616-3954
Today’s Topics 1. Conflict of Interest 2. GIM 10 3. Outside Work & UW Medicine COI Policy 4. State Ethics Act 2
What is a Conflict of Interest? The simultaneous existence of conflicting primary and secondary “ interests ” • Interest – anything that is capable of influencing actions, decisions or judgments • Conflict – occurs when a secondary interest is adverse to the primary interest (duty) Potential conflicts of interest occur in all human processes and are not inherently “bad” if they are appropriately managed 3
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.” - Public Health Service 4
Common Financial Interests • Money – cash, salary, fees, royalties, honoraria; any monetary right or obligation (both 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 5
UW Significant Financial Interest Disclosure Policy (GIM 10) • Applies to all research (sponsored and unsponsored) and 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 6
GIM 10 Purpose: Ensure no research or tech transfer activities at UW are adversely affected by outside financial interests of persons involved in those activities GIM 10 Policy complies with PHS and NSF requirements for policy pertaining to financial conflicts of interest of research investigators 7
GIM 10 Disclosure: Prior to participating in research or tech transfer activity, anyone having a significant financial interest related to the activity must disclose details Can occur: when research proposal submitted to OSP; when application submitted to HSD; when SFI arises during the course of research; or prior to concluding technology licensing transaction 8
Typical SFI’s • 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 license transactions) • Imputed interests (spouse, etc.) 9
UW Definition of “Significant Financial Interest” 1. For a Clinical Trial, any Financial Interest. 2. 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. 3. 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 currently revising guidelines (and perhaps definitions of SFI); new regulations and/or guidance anticipated by end of 2009. 10
GIM 10 Process Flowchart 11
University Outside Professional Work Policy Pre-approval required (chair, dean, provost) • Subject to pre-approval, faculty may engage in outside work for • compensation Policy (and accompanying form) requires disclosure of days and • nature of work, not compensation Approval for up to 13 days per quarter • Annual report listing all outside professional activities, whether or • not compensated, must be filed 12
UW Medicine Conflict of Interest Policy May 2009 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 13
UW Medicine Conflict of Interest Policy Applies to Following SOM Faculty: Acting, Regular, Research Faculty Clinical Faculty paid by SOM or close affiliate (UWP, CUMG, Seattle Children’s, FHCRC, VA, PSBC, and HHMI) Teaching Associates 14
UW Medicine Conflict of Interest Policy Consulting and Other Outside Work: Still permitted with prior approval SOM Supplement requires disclosure of amount of compensation Amount cannot exceed fair market value for services performed Forms are available at UW Medicine website: http://uwmedicine.washington.edu/Global/Policies/ 15
Outside Work Summary • UW policy supports approved outside work • De minimis use of UW resources permitted • Advance approval required • Form not required for some non-profit work • Requests involving potential conflicts of interest are scrutinized • SoM Supplement form required 16
2005 State Ethics Act Changes - Background - Background - - Ethics Act first passed in 1995 Broad prohibitions against financial interests, gifts, private use of state resources, assisting others in state transactions, revolving doors (State Ethics Board unfriendly to cost reimbursement and de minimis uses) 1996 amendment – safe harbor for managing researcher financial interests consistent with NIH/NSF standards UW adopted GIM 10 to satisfy NIH/NSF requirements and fit within ethics act safe harbor 17
2005 State Ethics Act Changes - Effect - Effect - - Alternate compliance system for “University Research Employees” at state universities (research faculty/employees engaged in research/tech transfer – not other employees) 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 Adherence to no less than federal PHS (NIH) standard Liberalization of permitted de minimis uses Authorization of reasonable reimbursement for private uses 18
2005 State Ethics Act Changes - Implementation - Implementation - - Modification and development of administrative processes to ensure compliance with ethics act • GIM 10 – for financial interests (consulting, gifts, etc.) • Outside work approval process • Liberalization of permitted de minimis activities Governor approved proposed UW policies in early 2007 UW formally adopted revised policies in 2007 See Office of Research FAQ’s 19
Limitations to Keep in Mind 1. Faculty who own 50% or more of a company may be required to take a whole or partial leave to do work for it. 2. Faculty member cannot be an investigator in a clinical trial involving faculty member’s invention or product. 3. The UW will not conduct a clinical trial of a UW invention or for a company in which it has a substantial equity position. 4. 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). 5. UW intellectual property cannot be transferred through consulting or other “backdoor” methods. 20
Go to our Websites: http://www.washington.edu/research/about.html http://uwmedicine.washington.edu/Research/Regulatory-Guidance/Pages/default.aspx 2005 Ethics Act Information: http://www.washington.edu/research/ethics.html http://www.washington.edu/research/ethics_faq.html 21
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