Human Subjects Protection in Health Services Research: A Researcher Perspective

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Human Subjects Protection in Health Services
Research A Researcher Perspective

• Lisa V. Rubenstein, MD, MSPH
• HSRD, 2/07

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A Fundamental Implementation Researcher Dilemma
Multiple Hats

• Researcher
• Knowledge expert
• Clinical consultant
• Police (IRB)
• Firefighter (Disasters)
• And others

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The Researcher Hat

• The one you cant take off

• Many potential conflicts exist, e.g.
• Responsibility for research success vs.
  responsibility for following guidance
• Applying expertise vs. autonomy of stakeholders
• Not all of these conflicts are handled by IRB
  compliance

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Managing Hats is About Applying Ethics

• Basic Principles (Belmont)
• Respect for persons
• Beneficence
• Justice
• Key Methods (Helsinki)
• Systematic building on prior knowledge
• Review by independent, outside groups

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Other Ethical Considerations for VA Researchers

• Taxpayers paid for our salaries and our research
  projects
• We owe them our best work
• Our job is to use data to improve care for
  veterans
• Veterans first

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Helsinki Review by Independent Outside Groups

• This means dialogue with, for example
• IRBs (patients as individuals)
• Privacy officers (patients as groups)
• Information technology officers (data safety)
• Clinical managers (e.g., COS, CMO) (stakeholder
  and resource perspectives)
• QUERIs (knowledge review)
• HSRD leadership (policy and SOPs)

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Ethical Dilemmas for Regulators, IRBs

• Fear and wish to keep us safe may cause decisions
  that , e.g.
• Reduce research quality (beneficence)
• Cause unnecessary, harmful documentation
  (beneficence)
• Reduce research for subgroups (justice)
• Stifle true dialogue (respect review)
• IRBs can become isolated and they need our
  participation and consultation

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Active, Thoughtful Dialogue is Necessary

• If research is to remain a positive force,
  researchers, regulators, and stakeholders must
  take the harder path

Research
IRB
Research
IRB
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Implementation Research (IR) Examples

• IR aims to learn how to implement evidence in
  routine practice
• Clinical/research partnerships
• Researcher roles as
• Knowledge experts
• Clinical management consultants
• Evaluators

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Implementation Researchers as Knowledge Experts

• Problems
• Knowledge is complex
• Unexpected consequences can occur

• Potential Solutions
• External input through
• Guidelines
• Expert panels
• Respected organizations
• Monitor outcomes (HSR DSMB)

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Researchers as Clinical Management Consultants

• Problems
• Privacy issues are different
• Responsibility issues are different

• Potential Solutions
• Clinical QI Review IRB plus privacy officers,
  Chiefs of Staff, QI
• Memorandums of Understanding identifying clinical
  roles/responsibilities

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Implementation Researchers as Evaluators

• Problems
• Clinical data often used for implementation and
  evaluation
• Decisions made by clinical decision-makers may
  have research implications
• Clinical settings may desire quick access to
  results

• Potential Solutions
• Ongoing steering committee representing QI, IRB,
  and relevant stakeholders

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Multiple Hats Conflicts of Interest

• Conflicts are part of daily life
• Cannot be escaped
• Can only be managed
• Management of conflict requires recognition of
  its effects on our own vision

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Hats We Dont Want to Wear
Game-Player
Criminal
Royalty
Fireperson
Cowboy
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HSRD Conflict of Interest Management Goals

• Aim for researchers who engage in
• Self-awareness
• Self-evaluation
• Effective ethical dialogue with experts, peers
  and stakeholders

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