Financial Conflict of Interest Brenda Cuccherini Ph D

Financial Conflict of Interest Brenda Cuccherini, Ph. D. , MPH VHA Office of Research & Development January 2007 1

Morality, like art, means drawing a line someplace. Oscar Wilde 2

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. 3

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 4

Commitments & Divided Loyalties • Financial • Role – Employment – Professional – Personal • Longstanding disagreements • Other 5

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 6

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) 7

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 cosignature of OGE 8

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 9

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 10

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 11

Current Draft of FCOI Policy • Type of Conflict: financial • Scope: VA investigators and Collaborators with ≥ 5% effort • FCOI disclosure: filed before 1 st protocol submission • FCOI committee: reviews disclosure • Possible significant FCOI: referral to Regional Counsel for review and action 12

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 13

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 14

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 15

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 16

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) 17

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 18

“Surprise like misfortune, never comes alone” Oliver Twist Charles Dickens 19

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 20

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 21

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” 22

Remember… "There are many ways of going forward, but only one way of standing still. " Franklin D. Roosevelt 23

Reference & Educational Material Office of Government Ethics: www. usoge. gov 24

A wise man's question contains half the answer. Solomon Iban Gabirol Poet & Philosopher 1021 to 1058 25

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