IRB - PowerPoint PPT Presentation

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IRB

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IRB Fed. Mandated review all fed funded human subjects research Risks minim. & reasonable in relat. to benefits Informed consent from each subject approp. documented – PowerPoint PPT presentation

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Title: IRB


1
IRB
  • Fed. Mandated ? review all fed funded human
    subjects research
  • Risks minim. reasonable in relat. to benefits
  • Informed consent from each subject approp.
    documented
  • All Research must be approved prospectively

2
What Guides Inclusion of Human Participants?
  • Respect for Persons
  • Informed consent
  • Beneficence
  • Do no harm
  • Must benefit society
  • Justice
  • Equitable fair

3
Parameters for IRB Approval
  • Risk is probability that some harm will occur
  • Harm is some specific outcome or event w/
    magnitude level

4
How to Tell If Your Project
  • Doesnt Need IRB
  • NOT Dealing with ANY source involving people
  • Is EXEMPT OR EXPEDITED
  • Activity presents no more than minimal risk to
    subjects
  • AND
  • Protocol listed as a category in the qualifying
    regulations list
  • FULL
  • Everything else

5
Research Questions
  • Ask about influence of variables on each other
  • OR
  • Ask
  • Must be !

6
Ask about your research
  • Has this been done before?
  • Do we already know the answer?
  • Is it original?
  • Is it important?
  • Does it advance knowledge?  
  • Remember
  • A good question is within your capability as a
    researcher this semester.
  • A good question is narrow but not trivial.
  • A good question is worded clearly, grammatically,
    and unambiguously.
  • A good question is value free.
  • A good question does not have an obvious yes/no
    answer.
  • A good question can be answered.
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