continue the project, the IRB should complete continuing review for the project as soon as possible. Investigators may resume the human subject research activity once continuing review and approval by the IRB has occurred. The IRB should document why the lapse in IRB approval occurred, and, if appropriate, any corrective actions that the investigator, institution, or IRB is taking to prevent any such lapse of approval of the project from occurring again in the future.

When IRB approval of an ongoing research project lapses and the IRB subsequently approves continuation of the project, the IRB may approve the project for one year and establish a new anniversary date for the expiration date of subsequent approval periods, or the IRB may approve the project for a period of less than one year so as to retain the original anniversary date on which prior approval periods expired.

When continuing review of a research project does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. Such expiration of IRB approval is not considered to be a suspension or termination of IRB approval. 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