All other studies that cannot be reviewed and approved at an EXEMPT or EXPEDITED level must be reviewed by a convened meeting of the IRB (so-called “Full Board review”). For such reviews, each member of the IRB must have the appropriate amount of time available to review all relevant information needed for an effective review in accordance with federal regulations. Thus, a Full Board review requires additional time and resources for review.
As with other categories, a Full Board review is initially conducted by an ORC staff member and then verified by the IRB Chair who then presents the pre-reviewed protocol to the Board at a convened meeting. In addition, Board members receive a copy of all relevant protocol materials (synopsis, consent forms, associated recruiting materials, questionnaires, case report forms, etc.) well before the convened meeting in order for them to pre-review materials for a more efficient use of time at the meeting.
Although not required, it is recommended that investigators contact the ORC well before submitting a protocol for full Board review. If time is available, the ORC staff can provide a “pre-review” of the protocol to identify any issues or concerns that might come up during a Board meeting, especially with complex, unusual or higher risk research projects. Again, this assistance is often helpful to new investigators, or researchers expanding into a new area, but is only effective if enough advance time is provided.
Investigators seeking Full Board review complete and sign an IRB Application Form, and attach all appropriate documents relevant to that particular protocol (see Application for specific guidance and instructions) well in time for review at the next meeting. IRB meeting schedule and deadline dates are listed elsewhere on this website.
In all cases, whether a project may be thought of as Exempt, Expedited or Full Board category, investigators are advised to contact an ORC staff member, or consult with the website, for guidance and assistance in developing protocols for submission and review.
This page was last modified on May 25, 2016