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Is Institutional Review Board (IRB) approval required?

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Is Institutional Review Board (IRB) approval required?

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This is a question that needs to be evaluated by the consortium members. Each institution IRB has its own criteria and requirements. Many non research setting do not require IRB approval. None was needed in phase I because of the way surveys were collected. In our past experience with multi site testing requiring access to patient health records (admissions, discharge, diagnosis), even when IRB approval is obtained by the national team each site had to get local IRB approval for the survey protocols proposed. It would make sense for each school to review the survey protocols used in phase I with their local IRBs and for the consortium to consider this input in designing an approach for phase II.

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