conflict of interest opportunities abound n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Conflict of Interest – opportunities abound PowerPoint Presentation
Download Presentation
Conflict of Interest – opportunities abound

Loading in 2 Seconds...

play fullscreen
1 / 25

Conflict of Interest – opportunities abound - PowerPoint PPT Presentation


  • 73 Views
  • Uploaded on

Conflict of Interest – opportunities abound. John Slattery, Ph.D. Vice Dean for Research and Graduate Education School of Medicine. More than theoretical…. Risk Was Known as FDA OKd Fatal Drug Study

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Conflict of Interest – opportunities abound' - briar


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
conflict of interest opportunities abound

Conflict of Interest – opportunities abound

John Slattery, Ph.D.

Vice Dean for Research and Graduate Education

School of Medicine

slide2

More than theoretical…

Risk Was Known as FDA OKd Fatal Drug Study

New documents show Warner-Lambert trivialized liver toxicity of diabetes pill Rezulin while seeking federal approval. Inside help from senior regulators is trumpeted in company memos.

Los Angeles Times March 11, 2001

Standing up to industry: As corporations increasingly hold their purse strings, many researchers feel pressed to deliver favorable results

-- Baltimore Sun June 26, 2001

Drug testing under ethics microscope

USA Today August 7, 2000

  • The Scientist, May 28, 2001
    • When Corporations Pay for Research:
    • UCSF researcher disputes trial results from drug company

Standing up to industry: As corporations increasingly hold their purse strings, many researchers feel pressed to deliver favorable results

-- Baltimore Sun June 26, 2001

slide3

Overview: Four Key Points

Conflicts of interest are omnipresent.

Conflicts of interest are not unethical per se.

Managing conflicts of financial interest is part of research design process.

Disclosure of interests promotes the public character of science and is the first step towards management of COI.

the source of conflict
The Source of Conflict
  • Professional responsibility
    • To act in the interest of the client without regard to self interest
  • Personal gain
    • Is a result of the work we are doing
    • Comes in many ways
      • University salary
      • Forms of professional recognition
      • Companies or other interest
      • Equity, consulting income, etc.
slide5

“Traditional” Obvious COI’s

  • Self-dealing
  • Acting in dual roles that conflict
    • Ghostwriting, an academic accepting authorship of an article written by a company or company’s agent
  • Accepting gifts and personal benefits
  • Influence peddling
  • Personal use of another’s property
  • Personal use of another’s confidential information
  • Conflicting outside employment
  • “Revolving doors”
slide6

Defining “Conflicts of Financial Interest”

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

concerns
Concerns
  • Our actions are not always deliberate
    • Avoid or manage conflicts
  • Sometimes they are
    • Avoid or manage conflicts
  • When they are, actual scientific misconduct is likely to have taken place
    • Falsification, fabrication (distortion) of the research record
issues
Issues
  • Perceptions and appearances of COI play a major role
    • Public trust, confidence and support
    • Political factors
    • Press attention
  • Avoid risks of
    • Governmental audits and investigations
    • Civil liabilities
    • Damaging publicity
  • Higher standards of conduct in order to protect
    • Research integrity
    • Human subjects
the appearance of a conflict
The Appearance of a Conflict
  • Why it is important -
    • When something goes wrong and there is a COI, it will be named as the cause
    • Can destroy the value of the research
    • Erodes public support – financial or participation
    • Avoidance of legal liability
whose financial interests are of concern
Investigators, including students, postdocs and others

Staff in key roles

Immediate family members of these individuals

(e.g., spouse, children, siblings, parent, grandparents)

Institution (including IRB members, officials)

Whose Financial Interests are of Concern?
what financial interests of individuals are relevant
Salary, honoraria, consulting fees or other payments from sponsors.

Stock, stock options, or other ownership interests.

Intellectual property rights.

Royalties from the University for work in the field of inquiry.

What Financial Interests of Individuals are Relevant ?
slide12

Conflict of Interest Reviews

  • GENERAL OBJECTIVES –
  • Compliance with all applicable COI requirements
  • Prevent bias in research
  • Protect human subjects
  • Protect students/ trainees
  • Comply with Washington State ethics act, including not engaging in appropriate use of UW and state resources
slide13

UW COI Reviews

  • Disclosure Thresholds
  • 100 disclosures/year (70 in SOM) – recent declines
  • Management plan (self or active)
    • Disclosure – IRB, publication, researchers
    • Protection of human subjects
    • Research integrity (data and design)
    • Open publication
    • Startup and intellectual property situations
    • Oversight
  • Coordination with IRB
  • Coordination with outside employment reviews
uw coi reviews
Disclosure thresholds

Clinical trials:

Any financial interest

Other human subjects

Financial interest exceeding $5,000

Any equity interest

Any intellectual property interest

All other

Financial interest (compensation or equity and IP interest) exceeding $10,000

Any equity interest exceeding 5% ownership of a single entity

UW COI Reviews
slide15

UW COI Process

  • GIM 10 (http://www.washington.edu/research/gcs/gim/gim10.html)
  • SFI Disclosure Form – submitted with GC-1
  • Upon informal notice of funding –
    • Initial review and recommendation by SOM’s RGE/IRO
    • Final decision/closing letter – Vice Provost for Research
    • Development of management plan
    • Use of committees in complex or policy issue cases
    • Copy of closing letter to IRB
    • 2 to 4 weeks, more if complex or involving policy issues
  • Related questions on IRB application
slide16

Management Tools

  • Modification of financial interest
  • Compliance with other processes
  • Restrictions on role in data generation
  • Safeguarding data
  • Changes to research plan
  • Other restrictions in research role
  • Limitations on recruitment/consenting
  • Changes in research agreement
  • Independent advisory board
  • Independent Co-PI’s
  • Pre-publication review of manuscripts
  • Divestiture
slide17

Management Plans

  • Disclosure – the primary requirement
  • Self-Management
    • Relies on voluntary investigator compliance
    • Appropriate for lesser interests, low-risk situations
  • Active Management
    • Continuing oversight and reporting
    • Specific measures tailored to the needs of the case
    • Attention to data generation, analysis and safeguarding
    • Human subjects protections
    • Intellectual property and startup relationships
    • Outside employment
    • Compliance with other institutional processes
slide18

Principles and Practices at the UW

  • Disclosure of Financial Interests
  • Journal editors and conference organizers
  • Other researchers
  • Staff and students
  • Sponsors
  • IRB’s
  • Human subjects
slide19

Principles and Practices at the UW

  • Protecting Human Subjects and Students
  • Restrictions on recruitment and consenting
  • IRB’s advised of financial interests and review results
  • IRB’s have independent authority
  • Protection of student academic activities from commercial exploitation
slide20

Principles and Practices at the UW

  • Research Integrity/Open Publication
  • Safeguarding data generation and analysis
  • Research data and results available for usual and customary public review
  • Only minor restrictions allowed on publication of results of industry-sponsored research
slide21

Principles and Practices at the UW

  • Startup Companies
  • Startup situations reviewed most intensively
  • Cannot be researcher on clinical trial sponsored by researcher’s startup company
  • Cannot be researcher on clinical trial sponsored by company in which researcher is a director or officer
slide22

Principles and Practices at the UW

  • Intellectual Property
  • IP situations reviewed more intensively
  • Researcher involvement in industry-sponsored research is re-reviewed if that research leads to licensing negotiations
  • Special oversight committees are regularly appointed in cases involving intellectual property, student researchers, and the potential for inappropriate use of state property
slide23

Principles and Practices at the UW

  • General Ethics
  • No participation in contract or license negotiations
  • Outside employment reporting (Form 1460)
  • No overlap with outside employment
  • Oversight for complex or higher risk situations
slide24

Licensing Activities Spur Additional Review…

  • Researchers with financial interests are not allowed to participate in negotiating the terms and conditions of contracts or licenses involving the University.
  • Researcher involvement in industry-sponsored research is re-reviewed if that research leads to licensing negotiations.
  • Special oversight committees are appointed in cases involving intellectual property, student researchers, and the potential for inappropriate use of state property.
  • University does not do clinical trials on its own technologies.
slide25

Summary…

Handling conflicts of interest is not about who’s good or bad.

It is about making design and staff decisions that protect and enhance the credibility of research.

Recognize and avoid temptations that lead to inappropriate practice or actual misconduct.

Disclosure and management are the key.

IRBs and Conflict of Interest Reviewers play, separate but related, sequential roles.