- General Information
A protocol for animal care and use is a form which the IACUC has developed for adequately reviewing requests for animal care and use. Any projects which involve animal activities must have an approved animal care and use protocol in place prior to the initiation of the project. One protocol may be used for all animal procedures in a grant as long as all procedures are specified in the protocol form. One protocol may be used if more than one species is required for the project as long as the protocol specifies the procedures to be performed on which animals and the number of each species to be used. Wildlife animals must be included if the exhibition of their normal species-specific behavior is compromised. This includes any animal that has been trapped or penned inside its normal range. Intentional herding of animals in an open range is also considered intruding on their species-specific behavior.
The IACUC also requires a protocol to be submitted for all covered activities in which an investigator is involved at off-campus sites, such as other institutions, in the field, or in other countries. This includes projects where the University investigator is not the awardee of the grant. In general, any activity where an investigator is acting as an agent of the University or the investigator could be listed as an author on published work requires prior IACUC approval. The Campus Veterinarian may be consulted to determine if a protocol should be submitted. The IACUC will review protocols for invertebrate animal use upon the request of an investigator. Routine submission of protocols for invertebrate animals is not required.
Each funding agency sets its own requirements for when a request for funding must have IACUC approval - at submission, before review, before release of funding, or no review requirement. It is the investigator's responsibility to ensure compliance with the funding agency's requirements. Writing "Pending" in the space for IACUC approval on grant application forms may or may not be acceptable. In all cases where live animals are used, the University requires an animal care and use protocol be approved prior to receipt of funding or initiation of a project.
Protocols are effective for one year from the original approval date. A protocol may be renewed with annual updates for a total duration of three years (two annual updates). ORA will make every effort to send annual renewal notices and three year expiration notices to all investigators approximately two months prior to expiration of the protocol. However, it is the investigators responsibility to monitor protocols and maintain compliance. Procedures must not be performed on any project which has expired until an appropriate renewal has been completed and approved by the IACUC.
Some projects may require longer than three years to complete. A new protocol form must be submitted for approval under a new protocol number. The first page of the protocol includes a space to indicate the protocol number of the previously approved project. This section must be completed, with the addition of any proposed changes to the previously approved protocol. All protocol forms must be signed by the principal investigator, (electronic signatures are acceptable for all but FDA regulated protocols). This signature establishes the investigator as the legally responsible individual under the AWA and University policy. It also binds the investigator in an agreement to comply with all University policies regarding animal care and use. This includes but is not limited to:
- compliance with all policies of the IACUC and any animal facilities used,
- completion of any training requirements set forth by the IACUC, and
- responsibility for the actions of all individuals who are named in the protocol as co-investigators or workers on the project as it relates the well-being of the animals used.
It is the investigator's responsibility to ensure that all personnel working with live or dead animals are adequately trained in the procedures to be performed as specified in the protocol. Failure to comply with any University policy regarding animal care and use may result in immediate loss of animal care and use approval, denial of access to facilities, and notification of funding agencies of withdrawal of approval for animal care and use.
- The Protocol Review Process
A copy of the current protocol form may be obtained from the ORA website. A detailed explanation for completing the form is included with the protocol. The protocol form must be fully completed in written type format and signed by the principal investigator before it will be accepted for review. The instruction section, and the surgery form if no surgeries are to be performed, should not be submitted with the completed protocol for review.
The facility manager at the desired housing site should always be contacted for space and animal availability during the desired project period, as well as for current pricing information. IACUC approval does not ensure availability of animals, housing or per diem rates. Any special requirements of the project must be worked out with the facility manager and the campus veterinarian prior to implementing the project. A copy of the IACUC policy and procedures manual for each facility may be obtained from the manager of the facility. Any deviations from the IACUC approved procedures of the facility must be specified in the protocol. The campus veterinarian may be contacted for assistance in selection of anesthetics, analgesics, euthanasia methods, or other aspects of completing the protocol form.
The IACUC meets monthly, normally in the week following the second Tuesday in the month. The exact day and time vary with the schedules of committee members. To allow for adequate time for distribution of protocols to committee members and protocol review, the electronic protocol must be submitted to firstname.lastname@example.org by the close of business on the second Tuesday of the month. A form submitted without a detailed project description will not be reviewed by the committee. Investigators are always welcome at IACUC meetings to discuss their protocols or other animal care and use concerns.
Regulations require review based on both ethical value and scientific merit. The IACUC relies on external funding agencies to provide adequate scientific review. Internally funded, non-peer-reviewed projects may be sent to outside consultants for scientific review if the IACUC determines it does not have the expertise to adequately review the project. Outside reviewers cannot vote on protocol form approval by the IACUC. The investigator will normally be contacted for a list of suggested reviewers. This can result in delays in approval. Investigators should plan ahead when submitting protocols for review.
The PI will be notified in writing within one week of the IACUC's meeting of its decision. All committee actions are the result of a majority vote of the members present. Four categories of action may be taken by the committee on any protocol submission.
- Approval Withheld. The committee deems the project inadequate to warrant the use of animals. This may be due to flawed science, poor experimental design, or lack of ethical justification for approval. Investigators may not proceed with the project.
- Tabled. The committee deems the protocol to have insufficient or unclear information for adequate review. The investigator will be notified of the committee's deliberations and requirements for further review. Investigators may not proceed with the project.
- Modifications Required to Secure Approval (MRSA). The committee deems the protocol to have sufficient ethical and scientific merit to warrant approval, but minor point(s) require clarification before full approval will be granted. Investigators may not proceed with the project until all minor points have been clarified and approved by IACUC staff, and they assign a status of Approved to the protocol.
- Approved. The committee deems the protocol acceptable as submitted or amended. Investigators may proceed with the project as facilities and animal availability allow.
For all protocols that are determined to fall under category MRSA above The Campus Veterinarian or other reviewer designated by the committee may grant full approval based on satisfactory clarification of all questions raised in the Modifications Required to Secure Approval decision.
Protocols only receive approval when a majority of a quorum votes for approval.
- Guidelines for Review of PHS Applications and Proposals
In order to approve protocols or proposed significant changes in ongoing activities, the IACUC will conduct a review of those sections related to the care and use of animals and determine that the proposed activities are in accord with regulations and University policy unless acceptable justification for a departure is presented. Further, the IACUC will determine that the activity conforms with the institution's NIH assurance statement and meets the following requirements:
- Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
- Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator and approved by the IACUC.
- Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.
- The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling and use of the species being maintained or studied.
- Medical care for animals will be available and provided as necessary by a qualified veterinarian.
- Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures. Approval will not be granted unless the principal investigator and all personnel listed on the protocol have completed the University's animal care and use training seminar.
- of euthanasia used must be consistent with the recommendations of the current AVMA Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
- Changes in Procedures, Animal Numbers, or Species
Under regulations and University policy, the investigator is required to submit proposed changes in protocols for IACUC review prior to the changes being implemented. A memo detailing the proposed changes and the reasoning for the change must be submitted to the IACUC for review. In extenuating circumstances, such as when a delay until the next committee meeting is not possible, the Campus Veterinarian should be contacted directly.