Protocol Submission Guidelines
PIs are encouraged to send any new protocols and amendments as soon as the PI completes a reasonable draft. Three-year renewals are due to the IACUC no later than 60 days prior to their expiration date in case the protocol needs to be re-reviewed at a subsequent full committee meeting. Otherwise there is risk of research interruption if any required modifications are not satisfactorily addressed prior to the protocol expiration date. Early submission helps ensure that there is no lapse in approval and that research continues uninterrupted.
Accessing protocol forms
Current forms and supplemental information can be found on our Forms page.
Every animal experimentation protocol (AEP) must include a flowchart. Click here for detailed guidelines and flowchart examples.
Grant and Protocol Congruence
According to PHS Policy on Humane Care and Use of Laboratory Animals, the information in the protocol must specifically correspond to the information outlined in any grant application citing this protocol approval in these five areas:
Identification of the species and the approximate number of animals to be used
Rationale for involving animals, and for the appropriateness of the species and numbers used
A complete description of the proposed use of animals
A description of the procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research (Section Q), and that analgesia, anesthetic and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals
A description of any euthanasia method to be used
Protocol & Amendment Review Process
All submissions will first be reviewed by one of the Research Officers (ROs). The RO will review the form for completeness and request clarification on items the veterinary or IACUC reviewers may want more information about.
The veterinarian has a duty to advise both the IACUC and the PI on matters relating to veterinary care and use of laboratory animals.
Upon completion of the Administrative Review, the RO will pass the submission to the Veterinary Review Coordinator, who will assign a veterinarian to review the submission. Initial veterinary reviews will be performed within 5 business days. The veterinarian may recommend changes, which lab must address by responding to comments under the Reviewer Notes tab and modifying the protocol when appropriate. Modifications resulting from the vet review must be returned to the reviewing veterinarian for a follow-up review.
Objections to a particular vet recommendation, due to experimental or other reasons, should be addressed by responding to the Reviewer Note. Acceptance of veterinary suggestions does not ensure IACUC approval, as other reviewers may have other concerns.
IACUC Review Process
Once all comments have been addressed to the satisfaction of the reviewing veterinarian, the RO will send the protocol to the IACUC to determine whether it will be reviewed by Designated Member Review (DMR) or Full Committee Review (FCR).
DMR and FCR are the only protocol review methods that fulfill USDA and PHS requirements.
The RO will distribute the protocol to the IACUC, giving all members an opportunity to request FCR. If no requests for FCR are made within 48 hours (24 hours for emergency submissions), the IACUC Chair will delegate 1-2 committee members to review the submission. The assigned reviewer(s) will may approve the protocol, request modifications, or request that it is sent for FCR.
If a member of the IACUC requests FCR, the document will be reviewed at the next available IACUC meeting.
The RO will distribute the protocol to the IACUC (no later than nine business days before the meeting) for review during a convened meeting of a quorum of the IACUC members, and with a formal vote. After the meeting, the RO will relay the IACUC’s recommendations (approval, a request for modifications, or withholding of approval) to the PI and contact person.
If modifications are required from the PI following DMR or FCR, the RO will return the protocol to the PI. Modification requests can be found under the “Reviewer Notes” tab of the protocol workspace or within the SmartForm itself. The PI must address the reviewers’ comments by editing the protocol and/or replying to the Reviewer Notes and resubmit to the OOTI.
A designated committee member will review the responses and may choose to approve the protocol, request further modifications, or send the revisions to the next full committee meeting. A veterinarian may be consulted during the review process.
Once approval is granted, the RO will notify the investigator and contact person.
If you have questions, please send an email to the IACUC office at: IACUC@hms.harvard.edu.