Research Compliance and Integrity University of South Alabama AD 240Mobile, AL 36688 Ph: (251) 341-4913daniellemiller@southalabama.edu
IACUC Submission and Review
Before beginning work with vertebrates in research or teaching, an animal protocol
must be submitted and reviewed by the IACUC. The University of South Alabama uses
an electronic system to submit and review IACUC protocols, amendments, etc. All submissions,
regardless of type, are handled through the IRBNet electronic management system. *If you are working with rDNA or biohazardous materials in animals, an IBC protocol
should be submitted simultaneously with the IACUC protocol.
The Principal Investigator (PI), as defined in the USDA Animal Welfare Regulations
(AWR), is “an employee of a research facility, or other person associated with a research facility,
responsible for a proposal to conduct research and for the design and implementation
of research involving animals.” At USA, the PI must be an employee of USA with an academic appointment and assigned
research space. PIs are responsible for ensuring adherence to approved IACUC proposals
(or protocols), compliance with IACUC policies and procedures, as well as federal
regulations governing the humane care and use of animals. The PI is responsible for
all aspects of their research projects, including the actions of protocol personnel.
Federal laws require a committee review of all proposed activities related to the
use of live or dead vertebrate animals in research or teaching.
IACUC approval must be obtained under the following circumstances before initiating
activities and teaching:
The use of live vertebrate animals (including mammals, birds, fish, amphibians, and
reptiles).
Animals are purchased or euthanized for the sole purpose of obtaining tissues.
Animals that are purchased or euthanized for the sole purpose of being bait for animals
in a study.
Field studies where the research alters or influences the animal (s) activities studied,
such as capturing (tagging and banding), blood sampling, and entry into a body cavity
or removal of a body part.
If the activity does not change or affect the animals' activity and there is no interference.
New animal tissues from another investigator. If sharing remaining tissues from another
investigator, the Investigator must be listed as additional personnel on the sharing
PIs protocol.
Commercially purchased tissues or fluids obtained as a byproduct (slaughterhouse,
meat market, etc.). Note: A memorandum addressed to the IACUC is REQUIRED. See the Commercial Tissues guideline for details.
Dead animals not killed for research, teaching, or testing purposes.
Pre-hatched chicken eggs.
Field studies conducted on free-living wild animals in their natural habitat that
do not harm the animals under study, that do not involve an invasive procedure or
materially alter the behavior of animals under study. Refer to the IACUC: Field Study Guidelines for details.
*Note: It is recommended that investigators check with the IACUC Administrator to
ensure a protocol is not necessary.
*Note: If you click on one of the PDF forms and you get a message that states: “Please wait…If this message is not eventually replaced by the proper contents of the
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Be sure you do not have a pop-up window asking you to open the document with a different
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Protocol Process Overview
All protocols receive a pre-review by the IACUC office and a veterinarian review to
ensure all animal care and use abides by PHS, USDA requirements, AAALAC guidelines,
and institutional standards. For protocol submission deadlines, refer to the IACUC Calendar for additional details.
Protocol Pre-Review the IACUC administrator serves as a conduit between the reviewers and committee before
and after the IACUC review. Pre-Review or Administrative Review focuses on the required
training of personnel, enrollment in the OHP, grammatical and typographical errors,
and animal numbers. After administrative review, any comments/suggestions are emailed
to the Principal Investigator.
VAS Review
Web Services
Congruency Review (VAS) If the research involves using live vertebrate animals, NIH Federal Policy requires
that the researcher follow specific procedures in the grant's Vertebrate Animal Section
(VAS). The VAS is evaluated against the IACUC protocol to ensure that the required
elements are addressed. The congruency review is done during the protocol pre-review
process. For more information on the VAS, please see the Vertebrate Animal Section (VAS) below.
Veterinary Pre-Review
Veterinary Pre-Review
Veterinary Pre-Review the IACUC office will forward new protocols to the Attending Veterinarian before
to Full Committee Review (FCR). The A.V. reviews the protocol and covers information
such as minimizing pain & distress, analgesics, use of pharmaceutical-grade drugs,
surgery, physical restraint, etc. The A.V. pre-review does not guarantee Approval.
This process gives the researcher time to adequately address the parts of the protocol
in question.
Full Committee Review (FCR) new protocols are assigned a primary and secondary reviewer. The secondary reviewer
is usually the Attending Veterinarian (AV). If the Veterinarian has a conflict of
interest, the Chair or Vice-Chair is assigned to be the secondary reviewer. The protocol
is presented and discussed at a convened meeting with a majority (quorum) of the voting
members present. Following protocol discussions, the primary reviewer motions to the
committee for one of the following actions: Approve, Modifications Required (to secure approval), or Withhold Approval. A majority vote of committee members is required for the motion to pass.
DMR
Designated Member Review (after FCR)
Designated Member Review (after FCR) after initial review at a convened meeting, the DMR method is initiated. Once the
researcher responds to the Modifications Required, the revised papers are shared with
all committee members (present or not present at the meeting). The committee is then
given three (3) business days to review and request a Full Committee Review. If there
is no request for FCR within three days, then the DMR process continues. The primary
reviewer, designated by the Chair, is assigned to review the follow-up response. The
primary reviewer has the authority to approve, require modifications (to secure approval),
or Full Committee Review. DMR cannot result in disapproval.
IACUC, IBC & IRB
IACUC, IBC & IRB
IACUC and work with other committees if there is a need for review by other compliance committees, such as IRB and the
IBC. The IACUC will work with the other committees to ensure those approvals are in
place. IBC approval does not supersede or waive the independent review requirement
by other research compliance committees. Reviews between committees should be sought
simultaneously to help expedite the review and approval process. *Note: Any work begun before receiving IACUC + IBC approval violates federal law and
jeopardizes all research.
Admin Review
Administrative review
Administrative review minor changes and reviews are handled administratively by the IACUC office following
institutional standard operating procedures. For more details, see the IACUC Review and Approval of Amendments policy.
Per NIH’s Office of Laboratory Animal Welfare “If the work proposed in a grant application,
contract proposal, or cooperative agreement involves live vertebrate animals, federal
policy requires applicants and offeros to address specific criteria. The description
must be a concise description of procedures on live vertebrate animals. The VAS must include the following sections: (1) Description of Procedures (2) Minimization of
Pain and Distress (3) Justifications and (4) Method of Euthanasia. To learn more details
on the VAS, click on the links below.
The IACUC must notify the researcher by letter of its decision to approve, require
modifications, or withhold approval. Researchers are notified by letter of the IACUC
protocol review decisions within 24-48 hours following the IACUC meeting as follows:
Approval
Approval
Approval Once a project is approved by a majority vote of the members present (a quorum), the
Investigator is notified by an approval letter that their work can commence.
Modifications Required
Modifications Required
Modifications Required (to secure approval) a detailed memorandum is sent to the Investigator describing the required changes.
The Investigator must address all comments and revise the protocol accordingly. The
subsequently modified protocol is reviewed using the Designated Member Review (DMR)
process. However, if during the DMR process, a member requests FCR of the revised
protocol, the protocol is reviewed at the next convened meeting.
Withhold Approval
Withhold Approval
Withhold approval if a majority vote (a quorum) of members withholds approval, a detailed memorandum
is sent to the Investigator describing the changes required before approval can be
granted. The Investigator can address the necessary changes and resubmit the protocol
as a new submission. The protocol will be reviewed at the next convened meeting. The
DMR process would not be used in this instance.
Amendments are proposed modifications to an already approved protocol. Amendments can be minor
or significant. Minor amendments can be reviewed and approved administratively. Significant
amendments be reviewed by the DMR process or FCR process. To learn more about what
defines an amendment as minor or significant, see the IACUC Review and Approval of Amendments policy.
Annual Review
Annual Review
Annual review continued oversight of approved animal research is required by federal law, regulations,
and policies. The researcher is required to submit a Continuing Review during the
first and second years of the protocol activity. The researcher should submit the
form at least one month before the protocol’s original approval date. A 60-day and
30-day Project, Expiration Reminder email is sent from IRBNet to the researcher before
expiration.
Triennial Review
Triennial Review
Triennial review according to federal laws and regulations, animal research protocols are approved
for a maximum of three (3) years. Before the protocol expiration date, a 60-day and
30-day IRBNet Project Expiration Reminder email is sent to the researcher. The IACUC
cannot extend approval beyond three (3) years. If the protocol has expired and the
researcher plans to continue their work, a new protocol must be submitted.
Protocol Closure
Protocol Closure
Protocol Closure typically, the IACUC Administrator will reach out to the Investigator before a protocol
expires. If that doesn’t happen, the Investigator can let the protocol expire naturally
or request closure of the protocol by contacting the IACUC office. * If the Investigator still has animals on their protocol, please contact DCM before
closing the protocol.
