Other Reportable Events

There are other types of Unanticipated Problems that need to be reported to the IRB. Changes in the status of a subject are particularly important. A change is status means the subject has become pregnant, become a ward of the state or become incarcerated. Each of these events could require the IRB to make a new determination which might require full-board review. Subpart B Protections apply to subjects who are pregnant, additional Subpart D protections 45 CFR 46.409 apply to children who become wards of the state and Subpart C Protections apply to subjects who become prisoners or are incarcerated.

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