# Presentation: 041569

## Financial Conflict of Interest

- Brenda Cuccherini, Ph.D.,MPH
- VHA Office of Research & Development
- Fall 2006

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

## 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.

## 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

## Commitments & Divided Loyalties

- Financial
- Role
- Employment
- Professional
- Personal
- Longstanding disagreements
- Other

## 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

## 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)

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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)

## 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

-   “Surprise like misfortune, never comes alone”
- _Oliver Twist    _
- Charles Dickens

## 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

## 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

## What now?

- Work with NCCE’s new COI task force
- Remind all investigators and research staff that other Federal statutes and 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”

## Remember...

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

## Reference & Educational Material

- Office of Government Ethics: www.usoge.gov

- A wise man's question contains
- half the answer.
- Solomon Iban Gabirol
- Poet and Philosopher
- 1021-1058