IRB Member Documents

IRB Member Review and Reference Documents

CHA has developed documents for its IRB Reviewers to help provide reference and facilitate documentation of review.

The reference documents are tools designed to assist Reviewers, but they may also provide insight for researchers as they draft and develop study projects and protocols. The documents contain embedded links and references, which may also serve as general education resources.

The information in the documents below – both the reference documents and the IRB member Reviewer forms – help make the IRB review process more transparent; enabling researchers to see and know the same information and criteria by which each study will be evaluated.

Reference documents for IRB members

• Not Human Research reference
• Quality Improvement versus Research guidance
• Categories of Exemption Reference (Revised Common Rule)
• Categories of Expedited Review reference
• Expedited Amendment Review & Approval reference
• Informed Consent and Consent Waivers reference (Revised Common Rule)
• Minors in Research reference
• Parent/Guardian Permission and Minor Assent reference

IRB member Reviewer forms

• New Exempt or Not Research Review Form
• New Expedited Study Review Form
• Expedited Amendment Review Form
• Expedited Continuing Review (CR) Review Form
• Minors Checklist/Review Form for New Exempt/Expedited Studies
• Minors Checklist/Review form for Greater Than Minimal Risk Studies

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