III Getting Started: Building the IRB Protocol

Ensure the IRB has adequate information to complete its review expediently by addressing these topics in the protocol. Check that the content of the protocol is consistent with all other materials, especially the consent documents. The IRB frequently asks for corrections of inconsistencies such as number of subjects to be enrolled, number of study groups, or dosages.

Completeness of the Presentation
Ethical Considerations
Study Design and Statistics
Subject Selection
Subject Recruitment and Incentives
Privacy & Confidentiality
Other Resources
Literature Cited


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