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Managing Conflict of Interest from a Compliance Program Perspective. Gayle Knight — Assistant Vice President for Compliance & Consultation, The University of Texas Health Science Center at San Antonio

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managing conflict of interest from a compliance program perspective

Managing Conflict of Interest from a Compliance Program Perspective

Gayle Knight — Assistant Vice President for Compliance & Consultation, The University of Texas Health Science Center at San Antonio

Rory Jaffe — Executive Director Medical Services, University of California Office of the President

conflict of interest a theoretical analysis
Conflict of interest: a theoretical analysis
  • If you are not confused, you should be
what is a conflict of interest
What is a conflict of interest?
  • A person in a position of trust has competing professional or personal interests
  • A conflict of interest is a situation, not a behavior
    • Ill intent or improper actions not required
  • Conflicts are common, and often encouraged!
    • Bayh-Dole act: academia can patent IP resulting from federally funded research
    • Translational research
  • Conflicts, if unaddressed, can lead to disaster
    • Loss of trust: veracity of research, willingness of people to volunteer as subjects, institutional prestige
can be broken up into several questions
Can be broken up into several questions:
  • Does this person have a position of trust?
    • Teaching, purchasing, treating, publishing, recording research data
  • Does this person have a competing interest?
  • Is the competing interest significant (“material”)?
  • Is the person involved in an activity that affects the competing interest?
  • Does the person’s official activities have a reasonably foreseeable material effect on that interest?
does this person have a competing economic interest
Does this person have a competing economic interest?
  • Interests in business entities
    • Investments
    • Positions in the business
  • Interests in real property
  • Interests in income sources
    • Honoraria, fees, etc.
  • Interests in gift sources
  • Personal financial effects
    • Effects on assets, liabilities, income, expenses
  • Includes immediate family
does this person have a competing non economic interest
Does this person have a competing non-economic interest?
  • Trying to make tenure
  • Office romance
  • Allegiance to another country
  • Trying to succeed
  • Excessive belief in the ultimate success of the line of research
  • Trying to save the world
is the competing interest significant
Is the competing interest significant?
  • Study of chocolate’s effect on blood lipid profile
    • Investigator A: $50,000 stock investment in candy company
    • Investigator B: Habitual consumer of chocolate bars—secretly hopes he won’t have to give them up
    • Investigator C: Assistant Professor, needs a few more publications to get tenure
    • Research assistant D: Under fire to get more subjects enrolled
  • How do you draw the line when an interest is not quantifiable?
is the person involved in an activity that affects the competing interest
Is the person involved in an activity that affects the competing interest?
  • Study of chocolate’s effect on blood lipid profile
    • Investigator A: $50,000 stock investment in IBM
    • Investigator B: $50,000 stock investment in pharmaceutical company that manufactures lipid lowering agent
    • Chairman of investigator A’s department: $50,000 stock investment in candy company
    • President of the University: University is recipient of $5,000,000 donation from chocolate growers’ cooperative
is there a reasonably foreseeable material effect on that interest
Is there a reasonably foreseeable material effect on that interest?
  • Study of chocolate’s effect on blood lipid profile
    • Investigator A: $50,000 investment in drug store chain
      • They sell candy
      • They sell lipitor
    • Investigator B: $50,000 investment in IBM
      • IBM gets some income from candy machines in the employee lounges
    • Investigator C: $50,000 investment in candy company that does not make any chocolate items
    • Investigator D: $50,000 investment in candy company that only makes chocolate bars
what do you do
What do you do?
  • Legal obligations
    • What must you do
  • Organizational ethics
    • What should you do
  • Recognize limitations
    • Management vs prohibition
    • Non-quantifiable issues—inability to judge
  • Trade-offs
    • Innovation and conflicts are intertwined
    • Malfeasance and conflicts are intertwined
conflict of interest
Conflict of Interest

Institutional

Conflict of Interest

Committee

IRB

Research

Conflict of Interest

Committee

Office of

Technology

Ventures

Disclosure on

Outside Boards & Other Activities

Authorized

Signatures

on Contract

Disclosure

Consulting/

Outside Employment

Affiliations

Annual

Disclosures

Grant

Applications

conflict of interest where does the compliance office start
Conflict of InterestWhere does the Compliance Office start?
  • Who is the responsible party?
  • Does your institution have a policy on conflict of interest?
  • Is there a formal training program on conflict of interest?
  • Does the institution have a formal monitoring plan?
  • Is there a formal disclosure process?
conflict of interest where does the compliance office start14
Conflict of InterestWhere does the Compliance Office start?
  • Does your institution have a Conflict of Interest Committee?
  • If conflicts are identified, are formal management plans developed, reviewed, and approved?
  • How are conflicts communicated to the IRB?
  • Do you have an Institutional Conflict of Interest Committee? Does the Committee consist of community members?
managing risk and oversight by compliance office
Managing RiskandOversight by Compliance Office

Poorly controlled and/or

no monitoring plan

Minimally-controlled

with no defined

monitoring plan

Well-controlled

with

established operational

monitoring plan

Compliance Office may facilitate risk assessment and monitoring plan development

Compliance Office assists responsible party in designing and implementing an effective monitoring plan

Compliance Office reviews and/or inspects monitoring and provides assurance report to management

poorly controlled risks responsibilities of compliance office
Poorly-Controlled RisksResponsibilities of Compliance Office
  • Inform executive management
  • Facilitate risk assessment process
  • Assist in development of a formal monitoring plan with:
    • Operational controls
    • Supervisory/monitoring controls
    • Oversight activities
  • Review policies, procedures, training for development/revisions
  • Assess staffing levels
  • Provide recommendations to executive management
minimally controlled risks consultation from compliance office
Minimally-Controlled RisksConsultation from Compliance Office
  • May assist in designing and implementing an effective monitoring plan
  • Independently evaluate procedures and processes for improvement
  • Identify potential gaps in reporting and controlling conflicts
  • Provides continuous feedback on improvement to policies, procedures, monitoring plans, training content, reporting, etc.
  • Works with management until controls and processes are strong and working
well controlled risk assurance activity from compliance
Well-Controlled RiskAssurance Activity from Compliance
  • Review risk assessment and monitoring plan
  • Determine if controls are embedded in day-to-day operations
  • Review and inspect:
    • Policies and procedures
    • Monitoring of training
    • Accountability for all disclosures
    • Review of disclosures by Committee
    • Backlog on review of disclosures
    • How are conflicts reported to IRB, within institution, etc.
    • Management plans are developed and approved
    • Management plans are reviewed annually
  • Reporting process for non-compliance (i.e. disclosures not completed, non-attendance to training, reporting of conflicts, etc.)
  • Displaying action for non-compliance
ongoing compliance office assurance
Ongoing Compliance Office Assurance
  • Conduct continuous reviews, inspections and validations
  • Provide guidance for improvement
  • May need to revise policies, procedures, operational responsibilities
  • Ensure updates to federal rules and regulations are implemented
  • Change in management may impact the processes currently in place
  • Continuous changes in environment or at national level may impact your current approach
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