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Institutional Review Board

East Tennessee State University

IRB Basics and Specific Topics

There are 3 levels of IRB review:

(1)  Exempt Review

(2)  Expedited Review

(3)  Full Board Review

Informed Consent Process

Ethical research standards require an Informed Consent process prior to enrolling participants into a research study. 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 guidance document to learn about eligibility for a Waiver of Informed Consent or Waiver of Documentation of Informed consent.

There are various template consent forms available on our website under Forms and Templates.

HIPAA and Research

Health Insurance Portability & Accountability Act (HIPAA) guidance:

 

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