Why do I need a protocol?

The WashU IACUC is responsible for oversight of the animal care and use program as described in the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide). All live vertebrate animal research must be approved by the IACUC before any work may be done. The IACUC protocol is a detailed description of the proposed use of animals prepared by the researcher for IACUC review and approval. The review ensures procedures are consistent with WashU policies, ethical standards of animal use, and support animal welfare. Activities involving animals in research, testing, and teaching can begin only after they have been reviewed and approved by the IACUC.

Starting the Protocol Process

A protocol is required when any live vertebrate animal is produced for or used in research, testing, or teaching. Federal regulations require IACUC review all projects involving the use of live vertebrate animals. This is required if funding is through WashU, or if the animal is housed at this institution. If a WashU investigator is working at another institution and is not utilizing funds procured or managed through WashU, animal use only requires approval by the other institution’s IACUC. If you are unsure whether or not your research would require a protocol, consult our “Determine if a protocol is necessary” guidance document.

In order to access Animal Care and Use IACUC policies and guidance, the LAMPS Researcher User Manual, and the LAMPS protocol website, you must first obtain a WUSTL key from your department business administrator.

Initial submissions of protocols or amendments must be made by the principal investigator. After the initial submissions, any person listed on the protocol with edit access can submit revisions.

If you need help or have questions utilizing the LAMPS system or writing portions of your protocol please contact:

Meredith Moore
Director, Institutional Animal Care and Use Committee
Phone: 314.747.0373
Email: moore577@wustl.edu
Offices: Institutional Animal Care and Use Committee (IACUC)
Office of Research Integrity & Ethics (ORIE)

Allison Overmyer
Manager, Institutional Animal Care and Use Committee
Phone: 314.362.3229
Email:allisonovermyer@wustl.edu
Office: Institutional Animal Care and Use Committee (IACUC)

The Protocol Review Process

The IACUC must perform a comprehensive review at initial submission and at each 3-year renewal. The review process has multiple cycles designed to meet regulatory requirements and streamline review as much as possible.

Round 1 – IACUC Office/DCM Veterinary Pre-Review

All protocols are first reviewed by the IACUC office team for completeness. A veterinarian will also review and comment on the protocol for appropriate animal use, drug doses, housing and enrichment, etc. The team will make comments and return the protocol to you for modifications as necessary. The reviewers will make comments and return the protocol to you for modifications as necessary until it is complete prior to being assigned to IACUC committee members.

Round 2 – IACUC Committee Review

Following the initial Pre- Review, protocols are assigned to a small group of primary reviewers. The reviewers will make comments and return the protocol to you for modifications as necessary until it is ready for approval. During this stage of review, all committee members will have access to the submission and the authority to request additional review. The protocol may be reviewed by one of the following processes:

Designated Member Review (DMR): Most protocols are reviewed by one or two members of the IACUC via Designated Member Review (DMR). This process is completed over email and will take a minimum of 10 days to complete. The DMR reviewers will make comments and the protocol will be returned to you for modifications as many times as necessary until the reviewers are satisfied. To protect the integrity of review, the identity of the DMR reviewers assigned to your protocol is kept confidential. Comments will be sent to you by the IACUC office staff.
Full Committee Review: Certain procedures and protocols subject to additional oversight may require Full Committee (FCR) at a convened monthly IACUC meeting. Common protocol activities that fall in this category are procedures with unrelieved pain or distress; multiple survival surgeries in sensitive species, or protocols involving a principal investigator who is new to the WashU IACUC. Any IACUC member or member of the DCM veterinary staff may call for Full Committee Review (FCR) of any submission at any time. Once a call for FCR has been made, the submission must be reviewed at a convened IACUC meeting unless the referral is retracted by the requestor. The IACUC meets the fourth Tuesday of every month.

The Protocol Amendment Process

Amendments are pre-reviewed by administrative staff, then reviewed via one of the three methods listed below. Amendments can be submitted at any time and must be approved before the work described in the amendment may begin. The LAMPS system can only process one amendment at a time. For a complete list outlining the specific criteria for each form of review, consult the Review Processes for Protocol Amendments guidance.

Administrative Review

Certain minor protocol changes (ie. funding, non-covered species personnel etc.) may be reviewed and approved administratively by the IACUC office staff. Amendments are approved after verification that all training and occupational health requirements are completed.

Veterinary Verification and Consultation (VVC)

Specific significant changes that do not unduly impact animal welfare or alter study objectives may be handled administratively in consultation with a DCM veterinarian. The veterinarian is not conducting Designated Member Review, but is serving as a subject matter expert to verify that the proposed change is consistent with all applicable IACUC approved policies and is appropriate for the species. Examples of eligible changes include anesthesia agents, analgesics, or euthanasia methods.

Designated Member Review (DMR) and Full Committee Review (FCR)

Significant experiment related protocol changes, including addition of satellite housing, species, surgery, hazards, SOP exemptions, and changes to the Principal Investigator, will be reviewed by DMR or FCR.