Avoiding Pitfalls as you go through CUHSR

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Avoiding Pitfalls as you go through CUHSR

• Ross Fink, PhD
• Chairperson, CUHSR
• August 2008

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IRBs - A Brief History

• 1966 National Institutes for Health Policy for
  Protection of Human Subjects formalized the
  ethical review process and established the IRB as
  a fundamental component
• 1974 DHEW raised the policy to regulatory
  status
• 1991 19 federal agencies adopted the Common
  federal policies Common Rule
• Estimated that there are gt4000 IRBs (2002)

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Mission of the IRB

• To review research applications and monitor
  ongoing studies to determine that the conduct of
  research meets certain standards. In most
  situations IRB approval of research will require
  a commitment to obtaining voluntary and informed
  consent to participate in research and a study
  design that minimizes risks to research
  participants

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Definitions

• A human subject is a living individual about
  whom an investigator obtains either (1) data
  through intervention or interaction with the
  individual, or (2) identifiable private
  information 45CFR46.102(f)
• Research - A systematic investigation designed to
  develop or contribute to generalizable knowledge
  45CFR46.102(d)

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Ethics of Research

• Belmont Report
• Beneficence
• Respect for persons
• Justice
• Common Rule (1991) 19 Agencies
• 45 CFR 46
• FDA 21 CFR Part 50 56
• Also
• Health Insurance Portability Accountability Act
  (HIPAA)
• Family Educational Rights and Privacy Act (FERPA)
  

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Bradleys IRB - CUHSR

• Who 11 appointed members
• What get / stay informed to apply regulations
  to human subjects research / evaluate proposals
• When meet monthly as needed during academic
  year
• How Policies and Procedures (updated 12/06 to
  include evidence of ethical training)

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Why is this important?

• Federal government says if you receive federal
  research dollars, you follow their rulesBU has a
  Federal Wide Assurance that is a promise we know
  and will follow the regulations
• Consequences of not following them loss of
  federal funding to the institution and shut down
  of all research efforts

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Reasons Proposals are Not Approved When First
Submitted

• No ethics certificate (students / faculty)
• Missing signatures of faculty advisor/department
  chair
• Incomplete application
• Purpose is missing or not clear
• Methods are incomplete or not clear
• Incomplete consent or invitation
• Instruments / questionnaires / measures are not
  attached and /or are described inadequately
• Include advertisements
• Questions / interventions might cause harm
  without safeguards

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When in doubt

• Call /e-Mail CUHSR member
• Faculty Handbook pp.145-159
• http//cuhsr.bradley.edu/
• http//citiprograms.org/

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Questions?

• ... Answers!