Forms & Submission

IACUC-related forms and instructions on how to submit IACUC protocols are found on this page.

Which forms should I use?

I will be working with animals in research at the Harvard Longwood Campus. I need to create an IACUC protocol.

All research involving animals requires IACUC review and approval. Animal research proposals (i.e. IACUC protocols) are submitted in the eIACUC system. See the "Forms & Instructions" section below for details on how to submit a new protocol.

The IACUC protocol must identify a Principal Investigator (PI). They and the persons working with the animals described on the IACUC protocol must adhere to all relevant institutional policies (see Wiki page). Examples include:

If you are joining a lab, familiarize yourself with all of its approved IACUC protocols. Animal activities, or any aspect of an animal activity not described on an IACUC protocol cannot be pursued without the committee's approval. This includes administrative details, such as the location (i.e. room) where you may perform the work. Depending on the scope of the new activity, modify an existing IACUC protocol or submit a new, separate IACUC protocol for the committee to review and approve. Furthermore, be sure your name is listed on the IACUC protocol before you may begin the animal work as described. The onboarding checklist outlines the requirements for newcomers.

I need to make a modification to an approved IACUC protocol or renew an IACUC protocol in anticipation of its expiration.

Changes to approved IACUC protocols (i.e. amendments) are submitted in the eIACUC system. See the "Forms & Instructions" section below for details. This includes administrative details, such as changes to the list of personnel allowed to perform the animal work approved on the IACUC protocol (i.e. personnel additions) and changes to funding that supports the animal work (i.e. grant additions). These requests may also be submitted as amendments.

Renewals to approved IACUC protocols (i.e. annual renewals or three-year renewals) are also submitted in the eIACUC system. See the "Forms & Instructions" section below for details. Please keep in mind that once it is approved by the IACUC, the three-year renewal will supersede the previous protocol.

My lab receives federal funds for animal work taking place at another institution.

Use the Ceded Review Request Form whenever your federally-funded grants awarded to HMS/HSPH/HSDM are associated with IACUC protocols from other institutions.

Use the Custom Antibody Production Form when contracting custom antibody production. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e. not purchased off-the-shelf). 

My lab receives funds to support the animal work on campus.

Requests to add awards that directly fund animal work (i.e. animal procurement, husbandry per diems, equipment, and supplies) are submitted in the eIACUC system. See the "Forms & Instructions" section below for details on how to submit grant additions as part of an amendment, new protocol, or renewal submission.

While the requirement for congruency review only applies to PHS-, DHHS-, NSF-, and NASA-supported research, non-federal awards may still need to be added to an IACUC protocol.

The NIH Grants Policy Statement 4.1.1.2 does not apply to fellowships or training grants that do not directly fund animal research, and therefore, they should not be added to an IACUC protocol. Instead, if requested, provide the PI's IACUC approval letter that references the award directly supporting the animal research described on the fellowship application.

I will import animals tissues or excretions.

Use the Ex Vivo Tissue Import Form to notify the animal care program regarding the importation of animal tissues, fluids, or cadavers.

The use of deceased animals or parts of animals does not require IACUC approval; however, the lab or institution donating tissue must have IACUC approval for any activity involved with (1) euthanizing animals for the explicit purpose of obtaining or using their tissues or other materials, or (2) project-specific antemortem manipulation of animals prior to euthanasia.

I would like to report an unanticipated, negative experimental outcome or accident that resulted in harm to an animal.

Use the Adverse Event Report Form to notify the animal care and use program of any event that jeopardizes the health or well-being of animals. This includes natural disasters, accidents, and mechanical failures.

E-IACUC

Accessing E-IACUC

Submit or update animal research proposals to be conducted at the Harvard Longwood Campus in the eIACUC protocol management system (HarvardKey required).

If you are new to Harvard, it may take a few days for your account to feed into eIACUC. If you are still unable to log in 3 business days after receiving your Harvard University ID (HUID), then contact the Office of the IACUC.

Affiliates, typically non-Harvard employees without HUIDs, will need to request for a person of interest (POI) role. Contact the office to begin this process. Individuals will need to provide personal information, such as legal name, date of birth, description of the duties/roles to be performed on the Harvard Longwood Campus, and if applicable name of the building to which access is needed (i.e. core facilities, on-campus lab space, or vivaria).

E-IACUC Support

Learn how to navigate the protocol management system.
Learn how to create new IACUC protocols.
Learn how to renew IACUC protocols.
Learn how to request changes to approved IACUC protocols.
Learn how to submit annual updates to approved IACUC protocols.
Learn how to address errors in eIACUC that may prohibit submission.

Miscellaneous Forms

Forms on this page should be submitted directly to the Office of the IACUC. If you are having difficulties finding/downloading any form, then contact the office for a copy.

Animal Care & Use

Use this form to notify the IACUC of an unforeseen event that negatively impacts the welfare of research animals.

Protocol Management, Funding, and Inter-Institutional Collaboration

Use for labs receiving federal funds for animal work taking place at another institution.
Use for labs contracting external organizations to produce custom antibodies (i.e. not purchased off-the-shelf). Organizations may need to fill out a Custom Antibodies Assurance Agreement to be submitted along with the form.
Use for labs importing dead animals, body parts, or tissues.
Use for labs that are unable to update funding information through eIACUC.
A MOU must be established for collaborations between HMS and any institution not covered by the Master MOU.
Use for labs that are unable to update personnel information through eIACUC. Visitors may be eligible to submit the Short-Term Personnel Addition Form instead.
Use this form to transfer a USDA-covered animal to another IACUC protocol. Submit an Animal Summary Sheet for each animal.

Still have questions?

Contact the Office of the IACUC to schedule a one-on-one training session.

Submission Guidelines

Regarding new animal research proposals (i.e. new protocols) or changes to approved proposals (i.e. amendments), Principal Investigators (PIs) are encouraged to submit applications as soon as a reasonable draft is complete.

Renewals to ongoing animal research proposals (i.e. annual renewals or 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.

Investigators must wait for the IACUC to approve the submission before starting animal work. The PI will be notified in writing in the form of an approval letter (saved in eIACUC). Contact the Office of the IACUC for confirmation if unsure.

Flowchart Guidelines

IACUC protocols should include a flowchart outlining the experimental events for a given animal, from receipt/birth to its experimental or humane endpoint. Visit the Wiki page for examples.

Grant and Protocol Congruence

The information in the IACUC protocol must specifically correspond to the information outlined in a grant application in regards to:

  1. Species and the approximate number of animals to be used,
  2. Rationale for involving animals, and for the appropriateness of the species and numbers used,
  3. A complete description of the proposed use of animals,
  4. 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, and that analgesia, anesthetic and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals, and
  5. A description of any euthanasia method to be used.

Review Process

Administrative Review

All submissions will first be reviewed by one of the Protocol Liaisons (PLs) from the Office of the IACUC. The PL will review the proposal for completeness and request clarification on items the veterinary or IACUC reviewers may want more information about.

Ancillary Review

The PL may send the submission to additional, specialized reviewers as needed, such as chemical-, radiation-, or biosafety teams. Ancillary reviews may request modifications to the proposal or specify safety procedures to be followed.

Veterinary Review

After administrative review, the submission is reviewed by a veterinarian, who will advise the IACUC and PI on matters relating to clinical care. The lab shall address any recommended changes - respond directly to each comment, modify/edit the proposal as appropriate, and resubmit it to continue the review process. Objections to a particular veterinary recommendation, due to experimental or other reasons, should be addressed similarly. 

IACUC Review

Once all comments have been addressed to the satisfaction of the reviewing veterinarian, the PL will send the proposal to the committee 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.

Designated-member Review

The PL will distribute the proposal 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 (1) approve the proposal, (2) request modifications in order to secure approval, or (3) request that the submission is sent for FCR.

If even one member of the IACUC requests FCR, the submission will need to be reviewed at the next available convened IACUC meeting.

Full-Committee Review

The PL will distribute the submission to the IACUC for review during a convened meeting of a quorum of the IACUC members, and with a formal vote. After the meeting, the PL will relay the IACUC’s recommendations to the PI and contact person: (1) approval, (2) request for modifications to secure approval, or (3) withhold approval.

If modifications are required following either DMR or FCR, then the lab shall address any concerns - respond directly to each comment, modify/edit the proposal as appropriate, and resubmit it to continue the review process.

A designated committee member may review the response and choose to (1) approve the protocol, (2) request further modifications, or (3) send the revisions to the next full committee meeting. Once approval is granted, the PL will notify the investigator and contact person.

If you have questions, then contact the Office of the IACUC.

Approved IACUC protocols are only valid for 3 years from the initial approval date. Amendment approvals do not change the protocol's approval period. In fact, the approval period for a protocol can never be extended beyond its original expriation date. In order to continue animal work, the protocol must undergo another complete IACUC review by submitting a seperate three-year renewal application. This process will create a new IACUC protocol that supersedes the previous protocol upon approval. Animal activities in the absence of valid approval are serious and reportable violations of the PHS Policy.

Furthermore, IACUC protocols supported by the DOD are subject to additional scrutiny and must undergo continuing IACUC review each year by submitting an abbreviated annual renewal application.