IACUC Submission and Review

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.

• Undergraduates
• Graduate Students
• Research assistants or associates
• Non-faculty

The above positions can be listed as additional key personnel on the protocol.

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.
• Teaching protocols

• Invertebrates (insects, snails, cephalopods, crabs, etc.)
• 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.
• Commercially available, off-the-shelf antibodies and custom antibodies. See the SOP IACUC Review and Approval of Outside Sources of Animal Samples
• 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.

Checklist for Submitting a New Project to the USA IACUC

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• 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.
  
  
• 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 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.
  
  
• 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 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.
  
  
• 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 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 (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 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 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 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 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.