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 > Research > Human Subjects Research > NYUCD Human Subjects Protocol >  XIII. Ongoing IRB Issues

XIII. Ongoing IRB Issues

A. Purpose
Protocol Amendments
Principal Investigators cannot deviate from or change the approved protocol without the prior review and documented approval of the IRB unless the deviation is required to protect the welfare of subject(s). Deviation from IRB-approved consent documents and protocols is considered an IRB violation. Therefore, these deviations must be reported immediately to the IRB (forms provided below). Principal Investigators planning any change must submit to the IRB a request for approval of a change on the appropriate form (see below). These protocol amendments must indicate all modifications to the protocol and/or consent form since the last IRB approval. For commercially sponsored studies, Principal Investigators should obtain the sponsor's approval of the protocol as well as the IRB approval.

Annual Protocol Approvals
Principal Investigators must resubmit all clinical research protocol materials (cover document, protocol, consent, advertisement) on an annual basis to the IRB for continued approval (forms provided below). The IRB office sends renewal reminders to all Principal Investigators 2-3 months before the annual approval date. It is the Principal Investigator's responsibility to send all requisite renewal information to the IRB before the expiration date of the study. Failure to meet this deadline will force termination of the study. A continuation of a study without IRB renewal approval constitutes an IRB violation.

Protocol Closure
Principal Investigators must officially inform the IRB that the study has been terminated (forms provided below). Closure as defined by the IRB denotes that: (1) subject enrollment has ceased, (2) all subjects have either completed the protocol or have been withdrawn, and (3) all data analyses have been completed. If data analysis is continuing despite completion of data collection, then an Annual Protocol Approval must be obtained. If the study has been part of a multi-center clinical trial, if the NYUCD site has completed data collection and analysis, then the study can be closed even if data collection and analysis is ongoing at other sites or at the study sponsor.

B. Process
For protocol amendments, annual renewals, and study closures, the Principal Investigator must submit the appropriate documents to the IRB. For industry- and government-funded studies, the sponsor will require written documentation that protocol amendments and annual renewals have received IRB approval.

OSP IRB Applications
Request for Approval of an Amendment (Appendix 21). Retrieve from: The OSP IRB does not have a specific amendment form. Use the NYUSM forms or submit a letter that contains the pertinent information.

NYUSM IRB Applications
Request for Approval of an Amendment (Appendix 21). Retrieve from:

Annual Renewals and Protocol Closure:
Request for Reapproval or Study Closure (Appendix 22). Retrieve from: