IACUC REVIEW PROCESS (rev
August 2007, February 2005, May 2003)
Federal regulations mandate a maximum
of one year for study approvals. The IACUC will send
courtesy reminders to PIs approximately 75 and 45 days before
the expiration date of an approved study to allow sufficient
time for renewal processing. Note: If renewal applications
are not renewed and approved by the expiration date, animals
will be immediately transferred to the LARC Holding Protocol
for routine care. The Principal Investigator and his/her
staff will not have access to the animals until the application
has been approved.
Types of Review
adopted formalized procedures, known as “Designated
Reviewer”, approved by the USDA and PHS. This process
allows for review of proposed activities (protocols) by less
than a full Committee.
Full Committee Review: Initial applications,
every three years thereafter, and major changes
(see below) in approved protocols are reviewed by the full
committee and require completion of the Full Committee Application.
Designated Subcommittee Review: Applications
for annual review, second and third year
after initial review and approval, are reviewed by an IACUC
subcommittee and require completion of the Annual
Application (unless a major modification to the protocol
is involved - see Types of Modifications for
Urgent Reviews: Under certain rare circumstances the IACUC Chair
may designate a reviewer for urgent reviews. The investigators
must provide compelling reasons for these types of reviews.
Tissue Collection: The IACUC Chair may designate a reviewer
Category C protocols proposing tissue collection only.
Modification Review: If the PI wishes to make
modifications to the approved
protocol during its one-year approval period, these changes
must be approved before they are initiated. Approval for
a modification does not change the existing expiration date.
Loss of Quorum: If a quorum is lost
during a convened meeting of the Full Committee due to the early departure
of one or more Committee members, the IACUC Chair may call for a vote by
the Full Committee (before any members are excused) to review the remaining
protocols on the agenda via the designated member review process.
Investigators Attending IACUC Meetings
Typically, the PI is not asked to attend the IACUC meeting
at which his/her protocol is being reviewed; a thorough
application is sufficient. On occasion, however, the IACUC
may require more information
or the PI may wish to appear to address specific problems or
questions in person, particularly when Category E studies are
involved, or in cases
such as follow-up of apparent protocol violation. Attending
a IACUC meeting can be arranged by calling the IACUC office
at 476-2197. Regardless of conversations
or oral presentations at a meeting, responses and resolutions
must always be documented in writing.
Types of Review Outcome
After IACUC review, one of the following determinations
is made for each application:
Full Approval is granted when the Committee has
no concerns about the application. The investigator is sent
a letter with a IACUC approval number, valid for one year,
and may begin the project.
Revisions Requested prior to approval is given
when the members require a written response from the investigator.
The members may ask the investigator to clarify a point, provide
or make revisions in the protocol. The investigator's response
is normally reviewed by the IACUC Chair. No approval is given
until the questions and/or
concerns of the Committee have been satisfactorily addressed
and approved by the Chair.
Returned for Additional Information prior to committee
re-review is requested when serious concerns are raised and the members
agree that additional information and/or justification is needed before
approval can be reconsidered. The investigator's response must include
a point-by-point letter addressing all concerns, as well as a revised application.
The response is then reviewed by the Full Committee.
Disapproval is given when the Committee
completely refuses to approve a protocol.
On rare occasions, the Committee may encounter major
difficulty in making an assessment and an outside reviewer
may be asked to consider the protocol.