Continuing Review (Reapproval & Amendment)

7.1 - Continuing/Annual Review
7.2 - Amendments to Approved Research
7.3 - New Findings
7.4 - Adverse Events/Unanticipated Event
7.5 - Protocol Deviations
7.6 - Records Retention

7.1 Continuing/Annual Review

Expedited or Full Board Protocol Applications

Approved protocols must be periodically re-reviewed so as to allow the IRB to assess the continued participation of subjects in the research. The reapproval period is set by the IRB depending on the nature of the study and risks to the subjects, but in all cases it may not be less than once per year. It is the investigator's responsibility to submit a request for reapproval (IRB-2) to the IRB before the protocol's approval lapses. If the protocol lapses it is considered to be unapproved research; subjects may not be enrolled nor the research continued until reapproval has been granted. Protocols requiring full IRB review must be submitted 8 weeks before the lapse date. Expeditable protocols must be submitted 4 weeks before the lapse date. The Office of Research Compliance (ORC) sends reapproval reminders to investigators as a courtesy, but the investigator is always responsible for submitting the reapproval on time. The reapproval form is available online.

Research Methods Course (RMC) Protocol Applications

Approved RMC protocols also must be periodically re-reviewed. It is the course instructor's responsibility to submit a request for reapproval (IRB-8) to the IRB before the protocol's approval lapses.

7.2 Amendments to Approved Research

Any change to an approved protocol must be approved by the IRB before being implemented. This includes changes that reduce risks to subjects as well as administrative changes such as adding or removing investigators. Amendment request forms (IRB-3) are available online.

The IRB will only accept one exception to this rule, specifically where the change is necessary to eliminate apparent immediate hazards to the subjects. In such cases, the investigator must submit a report to the IRB explaining the protocol deviation.

7.3 New Findings

New findings or unexpected problems whose nature, severity and frequency are not described in the information provided to the IRB or subjects must be submitted to the IRB for consideration. Examples include, but are not limited to, unexpected complications in a subject, missteps in the study procedures or consent documentation, or breaches of confidentiality.

7.4 Adverse Events/Unanticipated Events

It is the responsibility of the Principal Investigator to assess events that occur during the course of a research protocol, and determine which of the following descriptions apply. The IRB will review reports and make a final determination, indicating agreement or disagreement with the P.I.'s assessment, and why. Please see the Adverse Event and Protocol Deviation Reporting Policy.

7.5 Protocol Deviations

A Protocol Deviation is an incident involving non-compliance with the approved protocol, but typically does not have a significant effect on the integrity of the research or on the subjects' rights, safety or welfare. Protocol Deviations are to be reported to the Institutional Review Board (IRB) using the Protocol Deviation Report, Form IRB-6. Also see the Adverse Event and Protocol Deviation Reporting Policy above at 7.4.

7.6 Records Retention

All research-related records must be retained for at least 3 years after the study has been completed. All records shall be accessible for inspection and copying by the IRB, the Office of Research Compliance and applicable federal agencies.