Informed Consent Overview - Module 1m Sec 6

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Module 1 Objectives
Introduction
The Process
Basic Principles
A Brief History
What Research Must Be Reviewed
IRB Review Criteria
Quiz


IRB Review Criteria

T
he IRB uses the following criteria to review your research:
  1. Risks to the subjects are minimized.
  2. Risks to the subjects are reasonable in relation to anticipated benefits.
  3. Selection of subjects is equitable.
  4. Informed consent is:
    1. sought from each prospective participant or his or her legally authorized representative, and
    2. properly documented.
  5. Adequate preparation is taken to protect the privacy and confidentiality of subjects.
  6. Adequate provisions are made for the ongoing monitoring of the subjects' welfare.

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