Full Review definition and criteria

Human subjects research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. IRB-A meets and IRB-B meet bi-weekly. Applications are placed on a meeting's agenda provided they meet the scheduled submissions deadlines. Due to the volume for IRB-A and IRB-B, investigators are advised to allow a minimum of three weeks for an application to be scheduled for review at a convened meeting. A full board meeting may be canceled by the chair due to a) insufficient number of applications requiring full board review, b) University holiday, c) inability to secure a quorum, or d) other reasons as may arise that make a scheduled meeting unnecessary or otherwise inappropriate.

The New York University School of Medicine IRB uses a primary reviewer system for full board reviews. Application materials are sent to the IRB members scheduled to attend a meeting at least one week in advance of the meeting. All members attending the meeting receive the application itself, the Informed Consent Document, and other material such as advertisements or recruitment letters. One member designated by the chair as the primary reviewer for a project, also receives the complete grant application or protocol, and for investigational drug/device studies, the Investigator's Brochure.

The primary reviewer leads the discussion of each project at the full board meeting. The board determines whether the project meets the criteria for approval or whether revisions to the study design are required. The Informed Consent Document is reviewed for accuracy, clarity, and inclusion of required and optional elements of consent. At the discretion of the chair, voting may be by written ballot or a show of hands. By a majority of those present at the meeting, each project is either: (1) approved as submitted; (2) approved pending receipt of required minor revisions to study procedures, Informed Consent Document(s), or other written materials; (3) tabled pending review at a subsequent full board meeting after receipt of significant additional information or revisions, or (4) disapproved.

Written minutes of each full board meeting include: (1) attendance, (2) the number of votes to approve, table, disapprove, or abstain (without individual identification), (3) the basis for requiring changes in or disapproving the research, (4) the length of time until the next review, and (5) a summary of the discussion of controverted issues and their resolution.