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1
Financial Conflict of Interest
Brenda Cuccherini, Ph.D., MPHVHA Office of Research &
DevelopmentJanuary 2007
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Defining Conflict of Interest
“A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).”
Thompson DF: NEJM 1993;329(8): 573-576.
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Conflict: Real or Perceived
• Perceived COI: Perception may be because of misinterpretation of facts, incomplete information, poor communication, or past experiences
• Real COI: Must meet established criteria
• Both may have equal impact on the perceived validity of a study and the credibility of both the investigator and the institution
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Commitments & Divided Loyalties
• Financial
• Role– Employment– Professional– Personal
• Longstanding disagreements
• Other
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Situational Conflicts of Interest:Real or Perceived
• Functioning as an investigator/collaborator
• Membership on committees
• Roles– Health care provider– Supervisory– Administrative– Mentor/student
• Beneficiary of services
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Federal Regulations
• Established general principles that apply to Federal employees– Executive Order 12674– 5 CFR Part 2635 & others
• Defined 14 general principles• Established penalties for failure to comply
– Civil and criminal penalties – Employment related discipline (removal or
suspension)
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Federal Regulations (Cont.)
• Established the Office of Government Ethics (OGE)
• Designated Agency Ethics Official (DAEO) – Requires agency to appoint a DAEO– DAEO: source of official advise– Location: DAEO is in OGC
• Allows Agencies to develop supplemental regulations with the concurrence and co-signature of OGE
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General Principles of Conduct
• Two core concepts underlying the 14 principles:– Employees shall not use public office for private gain– Employees shall act impartially and not give
preferential treatment to any private organization or individual
• Additionally, employees must strive to avoid any action that would create the appearance that they are violating the law or ethical standards
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Why a VHA COI Policy
• Misadventures: real or perceived– Death of Jesse Gelsinger -- PI: founder of a
biotechnology firm set up to take gene therapy from laboratory to marketplace
– NIH scientists’ arrangements with outside interests
• COI negatively impacts research
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Why a VHA COI Policy (Cont.)
• To preserve trust– Public Service is a public trust – COIs undermine trust & prudent
stewardship of public resources
• To define VHA’s minimal requirements
• To serve as basis for facility policies and SOPs
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Current Draft of FCOI Policy
• Type of Conflict: financial
• Scope: VA investigators and Collaborators with ≥ 5% effort
• FCOI disclosure: filed before 1st protocol submission
• FCOI committee: reviews disclosure
• Possible significant FCOI: referral to Regional Counsel for review and action
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Current Draft of FCOI Policy (Cont.)
• If no significant FCOI: if additional safeguards needed • FCOI committee communicates to:
– IRB, IACUC, & R&D committee
• Who imposes safeguards: any of the committees• Possible safeguards:
– Informing subjects– Removing investigator– Disapproving the research
• Next disclosure filing: when FCOI changes – Additional FCOIs – Management of FCOIs– Elimination of FCOIs
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The Disclosure
• Requests information about the investigator, spouse and dependent children– Income other then Federal or university salaries that
exceed an aggregate of $10,000 in the last 12 months– Patents, copyrights, royalties, business concerns
related to the research being conducted– Position as an officer, director, trustee, general
partner, or owner of an equity interest in publicly and/or non-publicly traded companies that do business in an area related to the investigator’s research
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The Disclosure Form
• Designed for ease of completion• Defines who must fill it out• Gives reminders:
– Significant FCOI referred to Regional Counsel– Penalties for violating ethics rules or policy
• Section 1: – 7 “yes” or “no” questions– Certification that the information is correct & complete
• Section 2:– Requests information for all “yes” questions
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Status of Draft Policy
• Policy published December 2005
• Rescinded February 2006– OGC: may need OMB approval of disclosure
form
• OMB: may need to publish as a regulation– NIH had just published as a draft interim final
regulation
• Multiple reasons behind OMB’s suggestion
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OMB Suggestions
• Strongly suggested VA proceed through notice and comment rulemaking– Publish in Federal Register– 30-60 day comment period– Review comments & incorporate applicable
suggestions– Publish final rule
• Reasons for OMB suggestion– Policy may have an impact on private sector entities – Collecting information on non-VA employees
(spouses, children)
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But Then…
• OGE consulted:– Does collection of the information represent
supplemental regulations?
• OGE approved disclosure form
• OGC (VA General Counsel) reviews necessity for publication as regulations
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Another Player in the Arena
• Under Secretary for Health charged National Center for Clinical Ethics (NCCE) to develop a VHA COI policy
• To be based on NCCE recommendations– “Compensation to Health Care Professionals
from the Pharmaceutical Industry” February 2006
• Draft policy by Spring 2007
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Impact on Research FCOI Policy
• ORD invited to be member of NCCE’s task force
• Major questions on the scope of the VHA policy:– Address primarily compensated relationships – Separate policies for clinicians and
researchers
• Possible goal:– One VHA policy encompassing clinical care
and research
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What now?
• Work with NCCE’s new COI task force• Remind all investigators and research staff
that other Federal statutes & regulations still apply
• Identify web-based training programs • Research review committees continue to
be alert to situations that may violate the 14 ethics principles
• ORD continue process of “rule making”
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Remember…
"There are many ways of going forward, but only one way of standing still."
Franklin D. Roosevelt
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A wise man's question contains half the answer.
Solomon Iban Gabirol
Poet & Philosopher
1021 to 1058