Protocols

Protocols

What is a Protocol?

According to the Institute for Laboratory Animal Research Journal, a protocol can best be defined as "a detailed description of the proposed use of animals prepared by the researcher for IACUC review and approval. Activities involving animals in research, testing, and teaching can begin only after they have been reviewed and approved by the IACUC." (Volume 60, Issue 1, 2019)

Emory Institutional Animal Care & Use Committee (IACUC)

The Emory University Institutional Care and Use Committee (IACUC) provides oversight over the humane and ethical animal care and use of animals in research. The IACUC ensures compliance with federal regulations, reviews and approves all animal projects, inspects animal facilities and laboratories, investigates animal concerns, and performs reviews of the University’s animal programs.

IACUC Chair
Dr. Jeffrey Boatright

Vice-Chairs
Dr. Denyse Levesque
Dr. Thomas Wichmann

The IACUC Office supports the Committee in fulfilling its functions according to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and the US Department of Agriculture (USDA) Animal Welfare Act.

Visit the IACUC Page to Learn More

Animal Numbers in Protocols

The rationale for animal numbers should be provided logically along the lines of the number (or range) of subjects required per experimental group, the usual number of experimental groups per study, the number of repetitions of the same experiment that may be needed or are expected, the approximate number of studies of the general design projected over the next three years to satisfy the needs of the funding source(s), and the number of additional subjects required to compensate for expected mortality or complications, unforeseen losses, to train new personnel, maintain and replenish production colony breeding stock, and any post-weanling culls that may be produced in excess or because of gender, genotype or other factors to be not useful experimentally.

Animal Numbers & Tracking FAQs

You can access your protocols via IACUC's eIACUC system using the portal at the IACUC web site. The number of animals approved, used and remaining in each pain-distress category will be displayed.

The rationale for animal numbers should be provided logically along the lines of the number (or range) of subjects required per experimental group, the usual number of experimental groups per study, the number of repetitions of the same experiment that may be needed or are expected, the approximate number of studies of the general design projected over the next three years to satisfy the needs of the funding source(s), and the number of additional subjects required to compensate for expected mortality or complications, unforeseen losses, to train new personnel, maintain and replenish production colony breeding stock, and any post-weanling culls that may be produced in excess or because of gender, genotype or other factors to be not useful experimentally.

In the case of renewal of an existing, expiring protocol it is also important to include any animals on the census of the expiring protocol in the total number for the new protocol as they will be debited from the number approved when they are transferred from the expiring protocol to the new one.

The IACUC appreciates that activities involving the production of genetically-manipulated animals at the point of founder animals are of low yield, but require the production of unpredictably large numbers of animals, the vast majority of which are unsuitable for research. The expectation, however, is that the number of breeders and the expected number of offspring both useful experimentally and culled will be accounted. For mice on an inbred background, a safe rule of thumb is to assume the birth of 0.3-0.5 live pups of either gender per breeding female per week. Some proportion of these pups will be useful for experiments or continued breeding (e.g., backcrossing) and it is recommended that this be described.

Where animals are used as sources of tissue (or cells), providing a detailed breakdown of how many experiments must be done, the amount of material needed for each, the amount available from the typical animals, and a calculation of animal numbers takes the guessing (and more questions) out of reviewer hands.

Additional detail may be useful or necessary in the case where the model is expected to experience higher than normal losses (>10-20% for rodents or any losses for federally regulated species, i.e. those species other than rats, mice, fish and birds).

In some instances, such as in the case of technical or experimental failures, it may be sufficient to list the number of failures, explain why they failed, and compensate with an equal number of replacements.

Although neither the PHS Policy nor the Animal Welfare Act Regulations (AWAR) explicitly require an institutional mechanism to track animal usage by investigators under IACUC-approved activities, both require that proposals to the IACUC specify and include a rationale for the approximate number of animals proposed to be used (AWAR §2.31(e)(1-2); PHS Policy IV.D.b, p. 9; Guide for the Care and Use of Laboratory Animals, p. 25). These provisions implicitly require that institutions establish mechanisms to monitor and document the number of animals acquired/produced and used in approved activities (Potkay S, Garnett N, Miller JG, Pond CL and DJ Doyle. Frequently asked questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Cont Topics Lab Animal Sci 36 (2):47-50, 1997). The PHS, through the Office of Laboratory Animal Welfare, has more recently clarified:"…it is incumbent upon an institution to establish mechanisms to monitor and document the number of animals acquired and used in approved activities…Many institutions have automated tracking systems that will alert an appropriate individual when an investigator has reached a preset percentage (e.g., 80-90%) of the animals approved for a specific project, and can prevent ordering animals in excess of the number approved." Source: Institutional Animal Care and Use Committee Handbook, 2nd edition, Office of Laboratory Animal Welfare, NIH, 2002, p. 153. DAR has also found that our notifications have been helpful to alert investigators unaware of animal breeding or purchases in excess of their plans and budgets.

The DAR uses a cage population benchmark of 3 mice per cage. Any time a new cage is added to the census, 3 mice are debited from the number original number approved by the IACUC. In lieu of this methodology, it is possible for investigators to report the actual number of weaned mice to DAR. To enable smooth and hassle-free debiting, this must be done consistently on a monthly basis and before the 10th of the month.

Unfortunately, no. Once animals are weaned and put into a new cage, a new cage card is generated. Each new cage card is linked to an account number and an approved IACUC protocol. Our software assumes there are 3 mice in the new cage and the protocol is debited accordingly. Per diems also begin to accrue at the time the new cage is established.

One approach would be to biopsy neonates for genotyping before weaning and cull them prior to weaning. The IACUC, for example, permits tail biopsy and accompanying toe snipping without anesthesia on mice up to 12 days of age. This also saves costs preventing the generation of cages of unneeded animals. For more information see Biopsy Policy.

If this approach is not possible, the IACUC does appreciate that some protocols may generate many more animals than are used particularly if supported by a breeding colony where there may be extensive back-crossing or other genetic manipulations ongoing. The recommendation is that cull animals weaned but not to be used experimentally should be listed in Class B on the IACUC application. If procedures are done requiring anesthesia, such as tail biopsy of weaned animals, these mice should be categorized in Class D (painful or distressful with relief).

This can be prevented by using cards or labels with the "EU Separation" designation instead of "EU Weaned" counterparts. Please see the facility supervisor to obtain these.

This can be accommodated by using cards or labels with the "EU Transfer" designation for the newly transferred animals and scanning-out their former cage card. Facility staff can provide these cards or labels.

This is most likely the case. When the old cage card was scanned-out and the new one was scanned-in, the animals were treated as newly acquired on the new protocol. This should be taken into consideration when renewing an existing protocol at a 3-year time point.

The IACUC will notify you that you may not purchase any additional animals or breed additional animals until the matter has been addressed. The DAR is likewise notified and posts signage on the rooms where these mice exist on census and on each cage providing notification of prohibition to use or breed the mice.