Frequently Asked Questions
All animal experimentation protocol submission forms are available on our "forms" page. You may contact the Animal Studies Research Officers by emailing IACUC@hms.harvard.edu for consultation about completing the form. You should also check with HCCM about facilities where your animals will be held.
AEPS should be submitted to email@example.com.
Upon receipt an administrative review will be performed by one of the Animal Studies Research Officers IACUC office administrative review yields significant changes which are pertinent to veterinary review, the PI will be asked to revise the document prior to sending for veterinary review. If the administrative review yields minor changes (i.e. typos, COMS/PIBC numbers, etc.) the administrative comments will be sent within the document, to the vet, and the PI will be asked to revise the document per the administrative review comments at the same time the veterinary revisions are requested.
The veterinarian has a duty to advise both the IACUC and the PI on matters relating to veterinary care and use of laboratory animals. The veterinarian assigned to review will email (currently and until the implementation of an eProtocol system) the document back to the PI and listed contact with comments requiring a response or modification. Compliance with the requested change or a response satisfactory to the veterinarian or eventually satisfactory to the IACUC is required for IACUC approval. Initial veterinary reviews will be performed within 10 business days of submission to the Veterinarian. In order to qualify for IACUC review the PI responses must be approved by the veterinarian. Acceptance of veterinary suggestions does not ensure IACUC approval, as members may have other issues. The vet staff will send the reviewed document with comments and PI responses to those suggestions/comments to the IACUC office. In order to facilitate IACUC review, the Animal Research Studies Officer will make this version available to the IACUC reviewers, for full committee review, as soon as available but no later than 2 weeks before the full committee meeting.
IACUC Review Process
Only two protocol review methods fulfill USDA and PHS requirements—full committee and designated member.
The Animal Research Studies Officer will distribute the veterinary-reviewed version of the submission to the IACUC Committee for review during a convened meeting of a quorum of the IACUC members, and with a formal vote. After the meeting, the Animal Research Studies Officer will relay the IACUC’s recommendations (approval, a requirement for modifications (to secure approval), or withholding of approval) to the PI and any contacts listed in the “contact field” of the submission’s cover page.
If modifications are required, the Animal Research Studies Officer will send an email letter identifying the changes or clarifications requested by the Committee. The PI must submit a point-by-point response to the request for modifications as well as a revised final protocol, within three weeks of receiving the email. 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 prior to approval. Once approval is granted, the Animal Research Studies Officer will notify the investigators as described above.
The Animal Research Studies Officer will distribute the veterinary-reviewed version of the submission to the IACUC Committee giving all members an opportunity to request a full committee review of the document. If there is no such request within a given timeline, the IACUC Chair will then delegate a Committee member(s) as the reviewer(s) of that submission. The assigned Committee reviewer(s) will review the submission and may either approve it, request modifications in order to secure approval, or request that it is sent for full committee review. If a member of the IACUC requests full committee review (FCR), the document will be reviewed at the next available IACUC meeting.
Please complete an addition of personnel form and return it to the IACUC office via email or fax (617-432-3169). Any personnel added to a protocol must first take the required AALAS courses. Also, additional personnel must be registered in the occupational health program through HCCM.
4. How do I increase the number of animals approved on my protocol or make any changes to my protocol?
Any changes to the approved protocol must be submitted as amendments for IACUC approval. IACUC approval of these changes must be finalized before they may be implemented.
If you have an additional award for which you will be using an approved protocol as the protocol of record for that award, you must verify that all animal procedures outlined in the grant are described in the protocol. You will need to complete the New Grant IACUC Template Form and submit the appropriate supporting documents as outlined on the form (eg: the Vertebrate and Methods sections of the grant).
The IACUC is required by PHS policy to confirm that the protocol and grant are congruent in five areas: animal species and approximate numbers of animals to be used, rationale and appropriateness of the species and number, proposed animal use, procedures to minimize pain and distress, and method of euthanasia.
Once confirmed, the IACUC office will send you a letter with the new grant added under the approved protocol. The letter will include the protocol title, number and approval date, the funding agency and grant number and may be sent to the funding agency as official notification of animal protocol approval.
In general, an amendment to a protocol involves refinements to procedures or experimental methods that address or help define the goals or aims described on the original protocol. If your research is headed in a new direction or includes many new procedures and animal species, it is advisable to submit a new protocol. If you have received a new grant, you may add the grant and new procedures and/or animals to the protocol if the new grant is within the general scientific goals described in the protocol. If the new grant addresses a different scientific question, you should submit a new protocol to be linked to the specific new grant.
Veterinarians can be reached by calling the Harvard Center for Comparative Medicine (HCCM) at 617-432-1288 or by going to the HCCM secure website and looking under “About HCCM /Vet Staff”. Contact information for the veterinary staff is also posted in the animal facilities.
No. IACUCs do not have authority to administratively extend approval beyond three years. When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy (see NOT-OD-05-034).
Our OLAW Assurance number is: A3431-01, which is to be used with all Federal grants.
Yes. Pre-reviews are performed by the IACUC staff or veterinary staff on a per-request basis. Researchers should be aware that if they would like a protocol pre-reviewed, they should give the veterinarian or IACUC staff ample time to do the pre-review. The IACUC staff handles 60-70 submissions per month.
11. When is an amendment needed? What if I am only changing transgenic mice or treats to animals for enrichment, etc.?
Examples of changes considered to require an amendment include, but are not limited to changes:
- in procedures
- in the species or in approximate number of animals used
- in anesthetic agent(s) or the use or withholding of analgesics or administration of any other agents
- in the method of euthanasia
- in the duration, frequency, or number of procedures performed on an animal and
- to procedures or strains/species listed on a new grant that are not yet approved in your IACUC protocol
Please contact the IACUC office: firstname.lastname@example.org
In addition, if you wish to move your animals to a different facility, please notify HCCM by completing the appropriate transfer form found on their website. Do not move the animals yourself.
The use of dead animals or parts of animals is not covered by the PHS Policy unless the activity involves (1) euthanizing animals for the purpose of obtaining or using their tissues or other materials, or (2) project-specific ante-mortem manipulation of animals prior to euthanizing them. If either circumstance is applicable to the acquisition of dead animals, body parts or tissues, prior IACUC protocol review and approval are required. Thus, if animals are euthanized on an approved protocol and as described in an approved IACUC protocol, dead tissues can then be used for research and do not require an additional IACUC approval.