Therefore, such expirations of IRB approval do not need to be reported. However, if the IRB notes a pattern of non-compliance with the requirements for continuing review (for example, an investigator repeatedly or deliberately neglects to submit materials for continuing review in a timely fashion), the IRB should determine whether such a pattern represents serious or continuing noncompliance that needs to be reported to appropriate institutional officials, agencies supporting the research, and/or OHRP.

For a full continuing review, an IRB member makes a motion, another member seconds the motion, and then the convened IRB votes for, against, or abstains from one of the following five actions:

APPROVED. IRB approval indicates the IRB has concluded that the research meets the federal criteria for approval. OSP staff process the approval, and the researcher is provided with an approval letter and, if applicable and practicable, stamped informed consent/assent documents.

MINOR REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. This decision indicates that the IRB has approved the protocol pending submission of minor revisions and that the IRB has given the primary reviewer the authority to approve the minor revisions. OSP staff generates an email requesting revisions and returns the submission to the investigator. The investigator responds to the IRB's suggested revisions, making relevant changes in the application and re-submits to the OSP. OSP staff then provides the revised application to the primary reviewer.

TABLED. This decision indicates that the IRB withholds approval pending submission of major revisions and additional information. OSP staff drafts a letter and returns the submission to the investigator, outlining the reasons for tabling the protocol, and includes a description of the revisions or clarifications requested.

DISAPPROVED. OSP staff generates a letter describing the reasons for disapproving the protocol and provides it to the researcher. A study is not approved if the IRB has enough information to make the necessary determinations of approval but believes the continuation of research does meet the criteria for approval.

OSP staff will include in the letter approving the continuation of a project the beginning and end date of approval. During the convened meeting, the IRB determines the approval period as appropriate to the degree of risk but not less frequently than once per year for research retaining full Board review status. The date when a protocol is approved by the full Board, or by the primary reviewer following the completion of requested minor revisions to a protocol, determines the latest permissible date of approval and, therefore, the latest permissible date for the next continuing review.