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Protocol Submission Guidelines
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.
Submissions and scanned signature pages should be sent electronically to: email@example.com (MS Word format only).
Completing a protocol form
- All questions on the protocol form (the AEP) must be answered completely and an attempt made to answer in lay language.
- Investigators must follow the instructions written in each section.
- All required signatures must be obtained prior to approval.
- AALAS training requirements must be completed prior to approval.
- Investigators are strongly encouraged to contact a veterinarian at the Harvard Center for Comparative Medicine (HCCM, 617-432-2315) for guidance on specific animal procedures.
- While writing the protocol, take time to consider the operational requirements associated with the specific procedures/terms laid out in the protocol to ensure that there are sufficient resources and appropriate staffing/coverage to fulfill the terms of the protocol. Once the protocol is approved, all of the specific elements and timelines for animal procedures, monitoring and care must be met as described. Any work found to be conducted that is not described in the protocol or the lack of activity which is described in the protocol is considered to be off-protocol and therefore non-compliant with the protocol. The institution is obligated to report incidences of non-compliance to regulatory agencies and/or funding agencies.
Every animal experimentation protocol (AEP) must include a flowchart that outlines the details of the experimental procedures to be conducted, from which the experience of the study animals can be discerned from enrollment to endpoints. Animals that are subject to more than one procedure must be so noted, along with the order of procedures and the temporal relationship between them, to help reviewers understand the experience of animals subject to multiple procedures. The protocol flowchart must be a stand-alone document such that it can be printed and kept with the animal’s medical record. From looking at the flowchart a lay person should be able to understand what is happening to the animals involved in the depicted study (what, when, how, and to which animal). Similarly, the protocol flowchart should be a guide to all members of the research team such that they can quickly refer to the current approved version of the flowchart to confirm which procedures may be conducted under the terms of the approved protocol. The protocol flowchart is considered to be a component of the animal protocol. Care must be taken to ensure that all of the elements included in the protocol application are captured accurately and appropriately within the flowchart.
Protocol amendments require a revised protocol flowchart in order to place any new activity or time point into the scheme. The amended flowchart must reflect the overall flow of experimental procedures in the protocol while highlighting the changes proposed in the amendment.
Protocol flowcharts must be readily available for review by any member of the research team, veterinary staff, animal care staff, and inspectors reviewing your protocols.
 Any animal accounted for on the USDA Checklist is considered to be a study animal
 Note that experimental groups may be grouped, rather than depicted as individual animals, if identified as such in the flowchart
Required Elements in a Protocol Flowchart:
- Identifiers: Protocol Name, PI name, Date.
- Flow: Order and temporal relationship between the various events experienced by animals from enrollment to the endpoint: The chart should indicate whether animals will experience multiple procedures, their sequence and the intervals between them. If subsequent procedures depend on certain results, if-then or either-or statements can be helpful.
- Experimental vs. Control: Delineate procedures for experimental vs. control groups
- Numbers: Indicate number of animals being used in each arm of the study (i.e. n=8, etc. per group) with total number for study so designated (i.e. total = 100, 25/group, 4 groups). Indicate number of animals at each experimental endpoint.
- Time points and Intervals between events: Indicate time points for each procedure noted in flowchart. If there are gaps between procedures (e.g. arrival and surgery, or surgery and euthanasia) the chart should state the interval or range of possible intervals between procedures.
- Exceptions: Exceptions from standards of care (e.g. special diet or medications or toxins administered), and care that is specific to the experimental process, must be noted.
- Routine, standard care for animals need not be mentioned (e.g. routine animal husbandry).
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. The relevant protocol sections are in parentheses.
Identification of the species and the approximate number of animals to be used (Section A1);
Rationale for involving animals (Section A2a), and for the appropriateness of the species and numbers used (Section A2b);
A complete description of the proposed use of animals (Sections B2 and others);
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 (Sections J and Q);
A description of any euthanasia method to be used (Section E).
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, spelling errors, COMS/PIBC numbers, addition of other content that does not affect ant veterinary related information), the administrative comments will be sent in 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 the submission will email the document back to both the PI and the listed contact person with comments if any response or modification(s) are required. Initial veterinary reviews will be performed within 10 business days of submission to the Veterinarian. Any modifications resulting from the vet review must be sent back to the reviewing veterinarian for a follow-up review. Objections to a particular vet recommendation, due to experimental or other reasons, should be addressed within the document for IACUC review. Acceptance of veterinary suggestions does not ensure IACUC approval, as other reviewers may have other issues. The vet staff will send the reviewed document with comments and the PI’s responses to those suggestions/comments to the IACUC office, as well as any pending vet concerns. The Animal Research Studies Officer will make this version available to the IACUC as soon as available. The IACUC review method (DMR or FCR) that will be followed will be determined subsequent to the veterinary review, as described below.
IACUC Review Process
Only two protocol review methods fulfill USDA and PHS requirements—designated member review and full committee review.
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.
The Animal Research Studies Officer will distribute the veterinary-reviewed version of the submission to the IACUC Committee, 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 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 from the PI following DMR or FCR, 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 document, 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 during the review process. Once approval is granted, the Animal Research Studies Officer will notify the investigators.
If you have questions, please send an email to the IACUC office at: IACUC@hms.harvard.edu.