Frequently Asked Questions
21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?
Yes. The IRB should receive and review all research activities. The documents reviewed should include the complete documents received from the clinical investigator, such as the protocol, the investigator's brochure, a sample consent document, and any advertising intended to be seen or heard by prospective study subjects. Some IRBs also require the investigator to submit an institutionally developed protocol summary form. A copy of all documentation reviewed is to be maintained for at least three years after completion of the research at that institution. However, when the IRB makes changes, such as in the wording of the informed consent document, only the finally approved copy needs to be retained in the IRB records.