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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.

To understand these criteria more fully, you may want to review the videotape, Balancing Society's Mandates, which explains these criteria during an actual review of a research proposal. Reproduction of a portion of this videotape, strictly for educational and nonprofit-making purposes, is provided with the permission of the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services.

[You may access the video file by clicking on its title. The video requires the software RealMedia Player. If you do not have this software, you may download RealPlayer free from the internet. Click on RealMedia Player and follow the instructions to download and install the software.]


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