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Once the investigator has calculated the total annual ED, this information must be added to the protocol and consent documents along with specific approved language regarding associated risk based on the dose range in which the total calculated ED falls (< 0.3 rem vs. > 0.3 rem and < 5 rem for adults vs. > 5 rem for adults with different approved language for pediatric participants)  Investigators are responsible for ensuring that the appropriate radiation risk language is included in the consent. Consent language can be found within our consent library on the IRBO website.

These changes apply to all initial reviews submitted to the NIH IRB after May 15, 2020 unless the protocol has already been submitted for RSC review prior to that date. For protocols that are currently approved by the NIH IRB, the PI should update the protocol and the risk language in the consent at the time of the next planned amendment to include the total ED for all radiation.

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