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Protocol Requirements

Inquiry, Application, Amendment, and Continuing Review

Submission Procedures

Not Human Subjects Research/Exempt

Initial Application 

Review, Decisions, Notification

Amendments

Continuing Review/Renewal

Submission Procedures

Not Human Subjects Research/ Exempt

An instructor may be performing a human subjects investigation as part of a classroom exercise or an investigator may believe that his or her human subject protocol qualifies as exempt under one of the statutory exemptions found at 45 CFR 46 101.  In these cases, the instructor or investigator is asked to submit an Inquiry Regarding Human Subject Study by using the IRB Online Submission and Review System. Submission of the application and IRB review will allow the IRB to determine whether or not the investigator will need to submit a full protocol application for IRB review. 

If an investigator knows that the human subjects study does not qualify as exempt, he or she should submit a full application, as follows:

A. Initial Application Procedure

All investigators must submit a completed protocol application and an Institute-compliant Informed Consent Document prior to the deadline. As of Winter 2015, all IRB applications must be submitted using the IRB Online Submission and Review System, which can be found under the Academic Services section at access.caltech.edu for qualified Caltech investigators. Any questions or concerns regarding access to the application and the online submission process should be directed to the IRB Administrator (irb@caltech.edu). Investigators are encouraged to read pertinent background information also available on the IRB website, and to contact the IRB administrator with questions, prior to submitting a protocol application.  Deadlines for receipt of materials in order to be considered at an upcoming IRB meeting will be posted on the IRB website.

B. Review, Decisions and Notification

When received, the IRB Chair will determine whether a protocol qualifies as expedited, requires full committee review, is exempt or is not human subjects research.  If a protocol is exempt or not human subjects research, the PI will be notified in writing and IRB consideration will be complete.  If the protocol requires expedited or full committee review, the PI will be notified when the review is complete.  If the protocol contains FDA-regulated research, the PI will be notified and asked to submit supplemental materials.

All applications requiring review will be assessed by the Chair (in the case of expedited protocols) or (for full review) during scheduled committee meetings. Allow as much time as possible for the review process. After review, the principal investigator will receive notice that the protocol has been approved, disapproved or requires modification.

If approved, the principal investigator will also be told whether future Continuing Review will be on an annual or more frequent basis.

C. Amendments

Request to make modifications to an existing approved protocol shall be submitted and approved by the IRB before any deviations from the approved protocol are implemented.  

Applications for Amendment should be created and submitted using the online IRB Submission and Review System.  Applications for Amendment may be eligible for expedited review.

After review of the application for Amendment by the IRB, the principal investigator will receive notice that the amendment to the protocol has been approved, disapproved or requires modification.

D. Continuing Review/ Renewal

All proposals are reviewed at least annually, and renewed up to three times. The principal investigator is required to submit an Annual Renewal Application, an updated Informed Consent document, and current copies of partner institution's IRB approvals or reliance agreement (if applicable) using the online IRB Submission and Review System. After four renewals, the principal investigator will need to submit a de novo application. The IRB may waive this requirement in exceptional circumstances.

After review of the application, Informed Consent and Other documents by the IRB, the principal investigator will receive notice that the protocol has been renewed, disapproved or requires modification. 

QUESTIONS?

Please direct any questions to the IRB Administrator (626) 395-4699 email: irb@caltech.edu