IRB Guidelines

Section IX: Continuing Review of IRB-Approved Activities

The IRB has the authority to observe, or have a third party observe the consent process and the activity of any application that is approved.

Projects must be renewed annually, unless otherwise stated on the approval form. The IRB can approve studies for no more than 365 days at a time.

Depending on the degree of risk associated with a given project, the IRB may require continuing review more often than once per year.

New applications are required every five years for ongoing projects.

Annual renewal/revision procedures:

1. The Principal researcher (PI) is sent a blue form (Researcher Request Form) in the approval packet for the purpose of renewing, changing or closing projects.
2. Approximately four weeks prior to the end of the approval period, the PI will also be sent a green reminder form.
3. PI can use either the blue form or the green form to request renewals, changes or closures.
4. No action by the PI at the end of the approval period will automatically result in a closure.

Materials required for renewal:

1. Blue Researcher Request Form (to be found in the approval packet) or the green form (Reminder to Renew) sent 4-6 weeks before the expiration date , completed and signed by PI.
2. Consent form(s) for the study
3. Adverse event report if applicable.

Materials required for changes to the protocol:

1. Blue Researcher Request Form (to be found in the approval packet), completed and signed by PI.
2. A cover letter detailing the changes.
3. Consent form(s) for the study. If changed, submit revised version.
4. Any changed instruments, documents etc.
5. Any relevant authorizations, approvals, permission letters etc.

Continuing reviews:

Unless the information received during the prior approval period, or at the time of renewal, suggests that a project's review category (administrative, expedited, full committee) must be changed, the renewal materials will be reviewed in the same manner as the original application. Allow a week for the paperwork to be processed.

Failure to respond to a renewal notice:

Projects are closed by the IRB if the renewal materials are not received by the renewal date. Once the researcher receives a purple notice of closure, all activities involving human subjects must stop immediately.

Reactivating projects:

The Human Subjects Office must be contacted if and when the researcher wishes to reactivate the project. Reactivations will not be considered if more than a month has elapsed since the expiration of the approval. No human subjects research can be conducted during the lapsed period. New applications will be required after a month has lapsed.