tor, against, and abstaining; the basis for requiring changes in or disapproving the research; and a summary of the discussion of controverted issues and their resolution. OHRP recommends that the recusal of IRB members because of a conflicting interest also be documented when recording votes on IRB actions.

In order to document the continued existence of a quorum, the following examples demonstrate one acceptable format for documenting in the minutes the votes on actions taken by the IRB on research projects undergoing initial or continuing review:

OSP staff will develop IRB meeting minutes in draft form within three working days following an IRB meeting. Draft minutes will be sent to the IRB Chair for initial review. After initial review, the minutes will be distributed via email to all IRB members for 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.