|
> 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all subjects have either completed the protocol or have been withdrawn,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: http://research.med.nyu.edu/research-resources/important-forms-researchers
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: http://research.med.nyu.edu/research-resources/important-forms-researchers
Annual Renewals and Protocol Closure:
Request for Reapproval or Study Closure (Appendix 22).
Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers
|
