Title Slide

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Research Ethics / IRB Part III IRB Eric D.
Zemper, Ph.D. Statewide Campus System Michigan
State University College of Osteopathic
Medicine Department of Physical Medicine
Rehabilitation University of Michigan
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IRB

• The Institutional Review Board (IRB)
• Purpose To see that
• Risks to research participants are minimized
• Risks are reasonable in relation to benefits
• Selection of participants is equitable
• Informed consent is obtained
• Confidentiality is adequately maintained

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IRB

• HUMAN SUBJECT
• A living individual about whom an investigator
  conducting research obtains
• Data through intervention or interaction with the
  individual,
• or (2) Identifiable private information.
• 45 CFR 46.102 (f)

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IRB
RESEARCH A systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge - 45 CFR 46.102 (d)
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IRB
You cannot proceed with study (or even contact
participants) until IRB approves your
project Informed consent is necessary from all
participants in a research project The
participants must be completely informed and
consent must be uncoerced IRB must review and
approve any changes You have to keep all IRB
forms and signed consent forms on file
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IRB

• Things you have to do
• Tell the IRB about your plan for human research
• After approval Tell the IRB about any changes
• Tell the IRB about the problems you encounter
• Tell the IRB about the progress of your research

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IRB

• Tell the IRB about your plan for human research
• Who are the potential subjects? What risks do
• they take?
• What makes the research scientifically worthy of
  
• those risks?
• Is it sufficiently funded to reach its goals?
• What is the justification for changing medical
• care?
• Who is responsible for what? Back-up plan?

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IRB

• Tell the IRB about your plan for human research
• What will be done to minimize risks?
• - Potential physiological / medical harms
• - Potential psychological / social harms
• Who, besides the researchers, are providing
• oversight?
• Is a DSMB (Data and Safety Monitoring Board)
• needed?

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IRB
After approval Tell the IRB about any
changes Apply for IRB approval BEFORE
implementing changes in a protocol or
consent EXAMPLES - Eligibility criteria -
Number of subjects to be recruited - Adding or
deleting a procedure or analysis - Adding or
changing a recruitment method (letters,
flyers, phone call) - Change in investigators or
facilities
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IRB
After approval Tell the IRB about any
changes Apply for IRB approval before
implementing changes EXCEPT when safety
protections are necessary to eliminate apparent
immediate hazards to the subject. Implement a
safety change and report IMMEDIATELY to IRB.
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IRB

• Tell the IRB about the problems you encounter
• Unanticipated Problems
• Unexpected and expected Adverse Events (check
  IRB
• policies/guidance)
• Protocol and consent deviations

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IRB

• Tell the IRB about the progress of your research
• Report progress with renewal application
  (yearly)
• Report data about recruited subjects
• Report updates, significant developments
• New information that may affect subjects
  willingness
• to participate
• Summaries of expected and unexpected adverse
• events (see IRB policies)