Protocols and Amendments
Prior to the use of animals on a research project, the research protocol must be approved by the Institutional Animal Care and Use Committee (IACUC). New protocol submissions and protocol amendments must be submitted to the IACUC using eSirius 3G.
After the Principal Investigator submits the new protocol or amendment, the IACUC Office reviews the submission for completeness and notifies the Principal Investigator if any additional data/information is needed.
When the submission is complete, the IACUC Office provides each IACUC member with a list of proposed research projects needing review, with a brief description of the proposed animal activities, information on the species, and pain category.
The IACUC has two (2) business days to review the proposed activities. Any Committee member may request a complete copy of the protocol or amendment and a request full committee review of a research project.
Protocols: The protocol is sent to a veterinary reviewer and a (designated) primary reviewer assigned by the IACUC Chair. This primary reviewer is an IACUC member with appropriate expertise.
The primary reviewer is also charged with conducting a side-by-side comparison of the protocol to the Principal Investigator’s PHS funded grants, if applicable, and reporting any discrepancies.
Amendments: The IACUC Chair assigns each amendment to a (designated) primary reviewer. The protocol may also be sent to a veterinary reviewer, depending upon the nature of the amendment.
Protocols and amendments may undergo two types of review: Full Committee Review and Designated Member Review.
The IACUC has two (2) business days to review the proposed activities and a request full committee review of a research project. After the two days has expired, and if there has been no request for full committee review, the IACUC Chair will determine whether or not the protocol or amendment is eligible for Designated Member Review.
Full Committee Review
If full committee review is requested for a protocol, approval may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote by a quorum.
- Prior to review by the full committee, the IACUC Chair assigns the protocol or amendment to a primary reviewer.
- Concerns, if any, raised by the primary reviewer are routed through the IACUC Office to the Principal Investigator, who returns their responses to the IACUC Office.
- The protocol or amendment is reviewed by the full IACUC at the monthly Committee meeting.
- The full IACUC can approve or request revisions to the submission. If the IACUC requires modifications to secure approval, the IACUC can vote for the protocol or amendment to be reviewed by the full Committee or a named designated reviewer.
- Alternatively, a quorum of the IACUC can vote to withhold approval of the protocol or amendment. in cases where the IACUC has voted to withhold approval, the Principal Investigator is notified of reasons for this action and is provided a recommended course of action.
- If chemical, radiation, or biological hazards are identified, additional review is required by Research Laboratory & Safety Services (RLSS).
Designated Member Review
If a full committee review of a protocol or amendment is not requested, the IACUC Chair designates one qualified member of the IACUC to conduct the review (Designated Member Reviewer). All voting members of the IACUC are eligible to be a Designated Member Reviewer (DMR).
The DMR has the following options:
- Approve the protocol or amendment, if satisfied that approval criteria are met.
- Request revisions to the protocol or amendment to secure approval, if outstanding issues are present.
- Request a full committee review (FCR), if further review of the protocol or amendment is warranted.
Principal Investigator Notification
Protocol Approval: The Principal Investigator and other contacts listed in the protocol will receive an email notification from eSirius 3G confirming that the protocol is approved. The IACUC Approval Letter is attached to eSirius and includes the approval notification, expiration dates, and federal grant numbers, if applicable. This approval letter is the documentation that is provided to funding agencies as proof that the IACUC has reviewed and approved the animal work outlined in the proposal.
Amendment Approval: The Principal Investigator and other contacts listed in the protocol will receive an email notification from eSirius 3G confirming that the amendment has been approved.
The approval date is the date that either the full committee or the designated reviewer approved the protocol or amendment.
Note that the IACUC’s approval dates for your protocols may not coincide with funding periods.
Annual and Continuing Review
The USDA requires annual review of animal protocols by the IACUC. The USDA stipulates that these renewals must be done no less than annually. The Continuing Review serves as the mechanism by which the IACUC performs annual review of protocols with USDA regulated species that have a three-year approval.
For all species, the Continuing Review also serves as a mechanism for post-approval monitoring of IACUC protocols.
Protocols may undergo two types of annual or continuing review: Full Committee Review and Designated Member Review.
- The IACUC Office notifies the IACUC Committee of submission of the Continuing Review submission.
- IACUC members may call for a Full Committee Review (FCR) of the Continuing Review.
- In the absence of a call for FCR, the IACUC Chair designates a Designated Member Reviewer (DMR). The DMR is responsible for reviewing and approving the Continuing Review and supporting documents, such as wildlife permits, if any, to ensure compliance with the approved protocol.
- If identified by the DMR, the IACUC is notified of any non-compliance and/or adverse events or unanticipated outcomes via the appropriate procedures.
- If the DMR cannot approve the Continuing Review with or without modification, it is referred to FCR for review.
Protocols with an approved Continuing Review continue with no interruption.
Protocol expiration notices are sent to the Principal Investigator by the IACUC Office approximately three (3) months prior to the expiration date.
Work described in the protocol may not be continued past the approved dates unless a protocol renewal is already in place.
Renewals (De Novo Reviews)
The protocol renewal (De Novo review) should be started well in advance of the actual expiry date of your current protocol. On average, a new protocol takes 30-45 days from the date of submission to final approval. Please note that an amendment cannot be started once a protocol is in the renewal stage.
As per the Animal Welfare Act and the NIH Office of Laboratory Animal Welfare (OLAW), protocols are approved for a maximum of three (3) years. It is not possible for the IACUC to extend the protocol beyond the original three (3) years, so you must submit a renewal prior to expiration of your current protocol. If not, the animals will be unavailable for use (see SOP 107: Protocol Expiration with Animals Present on the Protocol for addition information).
If you do not intend to continue the protocol, any animals still on the protocols must either be euthanized or transferred to another active protocol, if appropriate. Complete the De Novo Review page in eSirius 3G to indicate animal disposition for expiring protocols.
The review process is the same for that of a new protocol, with the exception that the Progress Report section in eSirius. See SOP 121: Submitting a De Novo Review (Renewal) for additional information on the submission process.