A social work student desires to comprehend the experiences of children of incarcerated parents. She will have a(n)informed consent (21 CFR 50.25) IRB review.
The records reviewed should include the complete documents obtained from the clinical investigator, such as the protocol, the investigator's brochure, a model consent document and any advertising intended to be seen or heard by future study subjects.
An IRB must complete continuing review of research at intervals suitable to the degree of risk, but not less than once per year.
An IRB must demand that informed consent documents comply with the needed elements of informed consent (21 CFR 50.25), but cannot require additional criteria.
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