August 2010

The Organization requires IRB continuing review of approved research.  IRBs delegated responsibility for continuing review are authorized to conduct the process in accord with federal regulations using either (1) an expedited review process (see Policy No. 110.1) or (2) a convened review process (see Policy No. 111.1).Continuing review applications may contain proposed changes in the approved research.  The review process for continuing review applications with proposed changes must be conducted in accord with federal regulations using either (1) an expedited review process (see Policy No. 110.1) or (2) a convened review process (see Policy No. 111.1).

It is the policy of the Organization that a PI must submit a continuing review application before IRB approval expires.  The application must contain information to allow the IRB to determine the research may continue, should be modified, or should be terminated.

IRB approval of research automatically expires at the end of the designated approval period determined at the initial review or any subsequent review.  This continuing review process is mandatory. In determining how often this review should occur, the JHM IRB will consider the risks posed by the study intervention, what type of data and safety monitoring is provided in the protocol, and any other factors which affect the health and welfare of the study participants. IRBs may approve research for a defined time period of not more than one year minus one day, or for a limited number of subjects.  Thus, the IRB will calculate the approval period for research per the following example:

A protocol is reviewed and approved (or approved with administrative changes) on February 1, 2007.  Since the protocol will expire on February 1, 2008, the IRB must complete its continuing review no later than that date minus one day—January 31, 2008.  This applies to protocols receiving either convened or expedited review.

As part of the continuing review process, information submitted by the investigator may involve discrepancies or may not be able to be verified by the IRB.  In such cases, the IRB may request verification of information from sources other than the investigators.  The IRB may contact the Department or Division Chair for assistance in obtaining such verification.  For projects that involve ICTR-CRU funding, the IRB may contact the ICTR-CRU for assistance in obtaining such verification. For projects that involve medical procedures, the IRB may contact Institutional Officials in the JHM Hospitals for verification of information. Verification may be required if the IRB finds inconsistency with data submitted from previous years, determines there is a history of serious non-compliance where continuing review requirements, or  believes material changes have occurred since the last IRB approval of a protocol.  The IRB may also request verification for any other cause or may request verification without cause.

Approval automatically expires if a continuing review application is not submitted for IRB review.  The IRBs have the authority to allow continued participation of subjects in research for which IRB approval has lapsed while the continuing review process occurs if there is an overriding safety concern or ethical issues that indicates it is in the best interest of the participants to continue. In such cases where participants may continue in the research, data analysis must stop until the IRB completes the review process. The IRBs do not have the authority to allow new enrollment during the continuing review process.

The IRBs have the authority to monitor the data produced by the study, the consent process, and the research itself through either the IRB office or using independent consultants.  Once the period of approval is established, it will be communicated to the investigator in writing in the approval notification. 

The IRBs may determine that significant new findings regarding the research might relate to participants willingness to continue taking part in the research. In such cases the IRB has the authority to require provision of such information to participants.