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1. Why is continuing review required?
2. How is the approval period set by a JHM IRB?
3. How and when should a continuing review application be submitted?
4. What action may be taken on a continuing review application?
5. What happens if approval expires before continuing review is conducted?
Research approved by a JHM IRB may continue only for the time period set by the IRB. Such time periods are controlled, in part, by the DHHS and FDA regulations for human subject research. The maximum approval period is one year minus one day. Therefore, in order to conduct research for more than one year, a continuing review process is mandatory.
The IRB may approve research for a defined time period of not more than one year minus one day. The IRB may approve a project for a period of less than one year, limit the number of study participants, or require monthly or six-month reports. The IRB approval automatically expires at the time or event set by the IRB. The IRB will consider the risks posed by the study intervention, what type of safety monitoring is provided in the protocol, and any other factors which affect the health and welfare of the study participants. The IRB review process for a continuing review application may be conducted at either a convened meeting or during an expedited review session (an expedited review process may only be conducted if the application meets all regulatory requirements that make it eligible for an expedited review.
The continuing review application should be submitted by the PI no later than 6 weeks prior to the expiration of the study. For eIRB applications, submit an FSA, "continuing review application". The application must include substantive information about the progress of the study, the number and type of participants consented since the last approval, a summary of protocol events and deviations (if any), report of subject complaints (if any), if there was significant, relevant, literature published since the last approval, and a summary of the literature. Any changes proposed along with the continuing review application should be incorporated in a "Change in Research” request. Continuing review must occur until data analysis is complete.
The JHM IRB may act on a continuing review application in one of four ways:
- The continuing review application may be approved;
- The continuing review may be approved with administrative changes that must be completed by the PI;
- The continuing review application may be tabled pending submission of clarifications or revisions; or
- The continuing review application may be disapproved.
Written notification of the action is provided to the PI. Attached to the standard approval notice is the final approved version of the consent form(s), if applicable. The protocol and consent forms are valid only for the period specified by the IRB. In cases where a continuing review application is disapproved, the IRB will provide its rationale for the action taken. The investigator may request an appearance before the IRB to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the IRB.
Approval automatically expires if a continuing review application is not submitted for IRB review. If a continuing review application is submitted and IRB review is not scheduled before the approval date expires research activity must stop until the review occurs. 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. If approval lapses, the IRBs do not have the authority to allow new enrollment while the continuing review process is conducted.