In every review other than an expedited review, one or more experienced primary reviewers, designated by the chairperson, shall conduct an in-depth examination of the Application and Protocol Form, all required and other attachments submitted by the investigator, and any additional documents submitted by the investigator at the request of the primary reviewer(s). These materials shall fully disclose any risks to subjects or others and any risks of noncompliance.
The primary reviewer(s) shall then write memos to the IRB summarizing the proposed research and appraising the risks involved. The memos shall contain a recommendation that the IRB approve the research, disapprove the research, or approve the research provided that certain modifications are made in the protocol or in the proposed informed consent process.
The reviewer memos, the Application and Protocol Form, the proposed informed consent document, and any other documents specified by the primary reviewer, shall then be submitted to all IRB members at least five business days prior to a regular monthly or specially scheduled IRB meeting.
At such an IRB meeting, at which a majority of the IRB members are present, including at least one member whose primary concerns are in nonscientific areas (an IRB quorum), the IRB shall fully consider the proposed research and the recommendation of the primary reviewers. Proposed research shall be approved by a majority vote of the IRB quorum. Should the quorum fail during the meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures, or absence of a nonscientist member) the IRB shall not take further action or votes unless the quorum is restored.
The deliberation, action and vote on each proposed research by the IRB quorum shall be recorded in the meeting minutes. The recorded vote shall include the number of members voting for, against, and abstaining, in this fashion: Total = 10; Vote: For - 9, Opposed - 0, Abstained - 1.