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Please write long when responding to audits

When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. Sometimes we see finding responses that say only, “Defer to the IRB,” when additional information would be helpful. Some examples — if you get a finding that an approved consent form had no yes/no option for the long term storage of samples for possible future research use, it would helpful for you to clarify whether such an option was appropriate. Maybe the subjects had to agree to this long-term storage to participate in the main study, so an opt-out would not be applicable. Or if you get a finding that something was wrong with a particular subject’s consent process or form — please let us know if that subject has undergone more than one consent process and no problem was noted with any of the other consents. Complete information may help you avoid a contingency stemming from the IRB’s review of the audit.