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The Washington University in St. Louis (WU) IRB has determined that storage and analysis of de-identified data does not constitute human subjects research as defined under federal regulations [45 CFR 46.102 and 21 CFR 56.102] and does not require IRB approval.

Below are links to the information that should help most everyone determine if an IRB is required at their institution. If you have questions, please email us at

Frequently Asked Questions:

  • Is individual patient consent required for providers to enter data into the registry? No, the registry has been determined “not human subjects research” under US Federal Guidelines at WU. 

  • Do I need to get approval from my local IRB in the USA? U.S. entities generally recognize our existing IRB approvals, and you should not need additional approvals. However, some academic institutions may have special requirements. Most local IRB reviews and determinations have been made quickly, often within a few hours.

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