Conflicts of Interest, GIM-10 & State Ethics Act November 4, - - PowerPoint PPT Presentation

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

Conflicts of Interest, GIM-10 & State Ethics Act

2

• 1. Conflict of Interest
• 2. GIM 10
• 3. Outside Work &

UW Medicine COI Policy

• 4. State Ethics Act

Today’s Topics

3

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

What is a Conflict of Interest?

4

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

Federal Research Standard

5

• 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

Common Financial Interests

6

• 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

UW Significant Financial Interest Disclosure Policy (GIM 10)

7

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

• f interest of research investigators

8

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

9

• 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.)

Typical SFI’s

10

• 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;

• r (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

• f SFI); new regulations and/or guidance anticipated by end of 2009.

UW Definition of “Significant Financial Interest”

11

GIM 10 Process Flowchart

12

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

13

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

14

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

15

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/

16

• 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

Outside Work Summary

17

• 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

2005 State Ethics Act Changes

• Background

Background -

18

• 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

• therwise 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

2005 State Ethics Act Changes

• Effect

Effect -

19

• 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

2005 State Ethics Act Changes

• Implementation

Implementation -

20

• 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.

Limitations to Keep in Mind

21

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