review; minutes will be discussed and approved at the next scheduled meeting. IRB meetings may be recorded. Meeting recordings will be utilized for the primary purpose of developing the minutes. Once meeting minutes are approved, meeting recordings may be erased. The Chair or OSP staff may periodically utilize the OHRP self-assessment tool to evaluate the quality of meeting minutes.

45 CFR § 46.116(d) requires that the IRB document findings when approving a consent procedure that does not include, or which alters, some or all of the required elements of informed consent, or when waiving the requirement to obtain informed consent. OHRP recommends that when approving such a waiver for research reviewed by the convened IRB, these findings be documented in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

Similarly, where HHS regulations require specific findings on the part of the IRB, such as approving a procedure that waives the requirement for obtaining a signed consent form, approving research involving pregnant women, human fetuses, or neonates, approving research involving prisoners, or approving research involving children, the IRB should ensure that findings are fully documented in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

The IRB must determine which protocols require continuing review more often than annually, as appropriate to the degree of risk. OHRP recommends that the minutes of IRB meetings clearly reflect these determinations regarding risk and approval period. OSP staff will be responsible for tracking the dates for continuing review and expiration of approval periods and periodically updating the IRB on the dates.

Following the approval of changes to a protocol either through the change in research activity approval process or continuing review, OHRP recommends that the investigator incorporate the revision into the written protocol and provide the OSP a copy of the revised protocol. This practice ensures that there is only one complete and up-to-date protocol. The revision dates should be noted on each revised page and the first page of the protocol itself. This procedure should also be used for revised and approved informed consent documents, which supersede previous one(s).

As stated in 45 CFR § 46.115(b), OSP will retain the IRB records described in section 15.1 for at least 3 years. Records relating to research reviewed by the IRB will be retained for at least 3 years after completion of the research. Records will be accessible to OSP staff, IRB members, and the designated Institutional Official. Investigators may request