Surviving IRB Approval:

1
Surviving IRB Approval

• Guidelines to Submitting Human Subjects Research
  Proposals

2
The Belmont Reports Four Principles

• Respect for persons and their autonomy
• Informed consent
• Beneficence
• Confidentiality or anonymity

3
WSUs Human Subjects Research Policy

• Researchers must complete an education program
• Access from WSU home page (or Blackboard)
• Must have score of 80
• Keep a copy of your score

4
What Does Excluded from review Mean?

• IRB permission is not needed for
• Teaching/training exercises
• Diagnostic evaluations
• Therapeutic procedures
• Clinical training

5
Okay, So Then...What Does Need Review?

• Anything not excluded is
• Exempt from full review (1 IRB member, 5 duty
  days)
• Eligible for expedited review (same as above)
• Up for full committee review (10 duty days)

6
How Do I Know Where My Study Fits?

• You can apply to be exempt from full review if
  research involves
• Educational tests without subject identification
• Surveys/interviews without subject ID

7
Others Exempt From Full Review

• Observing public behavior
• Observing behavior where privacy is expected but
  no one is identified/data is not damaging
• Studying pre-existing data without subject ID

8
How Do I Apply for Review?

• FIND IRB documents at http//www.winona.edu/grants
  /default.htm check the Forms section
• READ Attachments A-D
• Complete two copies of Attachment A

9
What Else Do I Need?

• Create consent form (Attachment B, web page)
• Attach copy of survey instrument or interview
  schedule/protocol
• Send 2 sets of everything to Nancy Peterson,
  Somsen 212A

10
Potential Red Flags

• Did I mention TYPOS?
• Not completing online test
• Missing signatures
• Missing/vague consent form
• No extra credit alternatives
• Not ensuring confidentiality
• Not submitting interview schedule or survey

11
Unusual Applications

• At-risk populations (children, elderly,
  prisoners, cognitively impaired, educationally/
  economically disadvantaged)
• Deception research
• Negative outcomes