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109.6b Organization Policy on Continuing Review of Approved Research
The Organization requires JHM IRB continuing review of approved human subjects research where required by applicable federal regulations. The JHM IRBs 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). Principal Investigators (PIs) are responsible for submitting continuing review applications containing sufficient information to allow the IRBs to determine whether the research may continue, should be modified, or should be terminated.
In determining how often continuing review should occur, the JHM IRBs will consider the risks posed by the study intervention, what type of data and safety monitoring is provided for, 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, 2018. Since the protocol will expire on February 1, 2019, the IRB must complete its continuing review no later than that date minus one day—January 31, 2019. This applies to studies receiving either convened or expedited review.* Once the period of approval is established, it will be communicated to the investigator in writing in the approval notification.
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. Verification may be required if the IRB finds inconsistency with data submitted from previous years, determines there is a history of non-compliance with continuing review requirements, or believes unapproved 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.
Where continuing review is required, approval to conduct the research automatically expires if a continuing review application is not submitted for IRB review prior to the expiration date. In limited circumstances, the IRBs may permit continued study activity where the PI has submitted the continuing review application prior to the expiration date, but the IRB’s approval for continuation does not occur before that date (see Policy No. 109.7).
The IRBs have the authority to monitor the data produced by the study, the consent process, and the research itself through either the compliance monitoring program of the OHSR or independent consultants.
If the IRBs determine that significant new findings regarding the research might affect participants’ willingness to continue taking part in the research, the IRBs have the authority to require provision of such information to participants. This may include requiring re-consent of the subjects.
For studies where continuing review is not required by regulation the IRB may determine continuing review is required provided the rationale for this determination is documented as part of the IRB review process.
Additionally, as an alternative to continuing review, where continuing review is not required by regulation, the IRBs have the authority to require that a progress report be submitted to the JHM IRB. A progress report is an institutionally required study update that must be submitted to the JHM IRB at a designated interval. The purpose of the progress report is to ensure the study is being conducted in a compliant manner and there are no issues with the conduct of the research that would prevent continued approval. Progress reports may be required at intervals of one, two or three years from the date of initial approval. The interval will be communicated in the approval notice.
(* Approval or acknowledgment of exempt research, non-human subjects research, and research for which the IRB has determined no progress report or continuing review is required may be extended in the eIRB system at three-year intervals.)