IRB Policies and Procedures
Investigators are responsible
for using the most current versions of official policies and protocol submittal forms. Please
check the IRB Forms page for the current approved version of all forms.
of Proposal Reviews By Convened IRB (Full Review)
The IRB may choose from
four different outcomes when reviewing human subjects' protocols at a convened meeting (more than minimal risk, full review protocols):
is Granted Approval
The full board chairperson,
or designee has approved this protocol, for a period not to exceed
one year. The study may commence only upon written notice of approval
from the Office of Research Compliance (ORC). While the ORC will send
a reminder notice to Principal Investigators (PIs) approximately 2 months prior to protocol expiration, the PI is responsible for conducting
research under valid protocols.
The proposed study requires
minor changes that must be rectified before final approval is granted. The proposed
study may not commence under these conditions.
Minor changes may include such things as typographical errors,
re-wording of the consent form, or clarification of
The PI is responsible for
addressing the concerns of the IRB before final approval can
be granted. Once these changes are submitted, the chair or
grant final approval if the changes are satisfactory. If the
IRB requests are not adequately addressed within 60 days, the
be administratively withdrawn and it must be resubmitted
new protocol for full IRB review. For full review protocols, the PI must attend
the IRB meeting.
This protocol is in
need of major revisions – usually needing additional
information or clarification of significant issues.
This study may
not commence until IRB approval
has been granted in writing. The ORC will notify
the PI in writing (letter or e-mail) indicating
the issues being raised.
The PI is responsible
for addressing the concerns of the IRB before
contingent or final approval can be granted.
These changes must be
submitted in writing
to the Office of Research Compliance. If the
IRB requests are not adequately addressed within
60 days, the protocol
administratively withdrawn and it must be resubmitted
as a new protocol for full IRB review.