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IRB Basics and Specific Topics

Levels of Review

There are 3 levels of IRB review.

A PI may request a level of review, but the IRB Chair or Vice-Chair makes the decision. 

(1)  Exempt Review

(2)  Expedited Review

(3)  Full Review

 
Informed Consent Process

Informed Consent is the knowing consent of an individual or his/her legally authorized representative which is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. Informed consent is not just a form or signature, but a process of information exchange that includes:

  • subject recruitment materials
  • verbal instructions
  • written materials
  • questions/answer session
  • agreement documented by signature

Checklist of Required Elements:  Review this list to make sure your consent form is complete.

Waivers:  Review this printout to see if your study is eligible for a Waiver of Informed Consent or Waiver of Documentation of Informed consent

Template:  Letter for Waiver of Written Documentation:  Download this template to create your letter for an anonymous survey.

 
HIPAA and Research  

HIPAA = Health Insurance Portability & Accountability Act

 
Additional IRB Basics
 
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