Brown University
IACUC Protocol Review Checklist
IACUC Office Use OnlyPI has signed certification form
Check for COEUS accuracy - all relevant tabs addressed and complete
All regulatory requirements addressed
Check for congruency between COEUS and animal use/study personnel forms
Check for congruency between COEUS and grant application OR department head approval
If hazardous agents used, PI has IBC approval
Veterinarian has been consulted and involved in the planning process for Category D and E Procedures
Regulation / ReferenceLay Statement:
There is an explanation of aim(s) and why the study is important to human or animal health, the advancement of knowledge, or the good of society, in language that a layperson can understand. / US Government Principles: II
Guide, p 25
Species:
The animals selected for a procedure are:
- of an appropriate species and quality and
- theminimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
PHS Policy IV.D.1.b
Housing and Husbandry:
The living conditions of animals are appropriate for their species and contribute to their health and comfort. See Mouse Housing Density and Overcrowding PolicySocial Housing Policy / AWR, Part 2, Subpart C, § 2.31 (d.1.vi)
US Government Principles: VII
PHS Policy IV.C.1.d
Guide, p 41
Procedures:
There is a complete description of the proposed use of the animals.
See Mouse Tail Biopsy Policy / PHS Policy IV.D.1.c
There is enhanced monitoring and reporting is in place for genetically modified animals. / Guide, p 28
Restraint:
- Period of restraint is the minimum to meet scientific objectives.
- Training of animals to adapt to restraint is provided.
- Animals that fail to adapt are removed from the study.
- Description of how often the animal will be observed during periods of restraint is provided.
- Restraint devices are scientifically justified [must].
Food & Fluid Regulation:
- Body weights for food/fluid restricted animals will berecorded at least weekly.
- Daily written records will bemaintained for food/fluid restricted animals.
- Animals will be monitored to ensure nutritional needs are met.
Pain and Distress:
Procedures avoid or minimize discomfort, distress, and pain (consider procedures causing pain or distress to humans may cause pain or distress in other animals). / AWR, Part 2, Subpart C, § 2.31 (d.1.x.i)
US Government Principles: IV
PHS Policy IV.C.1.a
Category D and E Procedures:
- Will be performed with appropriate sedatives, analgesics or anesthetics (unless justified for scientific reasons).
- Does not include the use of paralytics without anesthesia.
US Government Principles: V
PHS Policy IV.C.1.b
Guide, p 5
Surgery:
Pre-surgical plans are developed (e.g., location, supplies, anesthetic and analgesic use, peri-operative care, recordkeeping) and are in accordance with established veterinary medical and nursing practices. See Rodent Survival Surgery Policy / Guide, p 116
AWR, Part 2, Subpart C, § 2.31 (d.1.ix)
Surgical procedures are categorized as major or minor. / Guide, pp 117-118
Drugs:
- Procedures for monitoring surgical anesthesia and analgesia are in place.
- Pharmaceutical grade chemicals are used, when available (or described andjustified). See OLAW FAQ’s
Guide, p 31
Procedures are in place to assure antinoception(that the animal is fully anesthetized) before surgery begins [must] / Guide, p 122
Aseptic technique is described for all survival surgical procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques (includes operative procedures at field sites). / AWR, Part 2, Subpart C, § 2.31 (d.1.ix)
Guide, pp 118-119
For nonsurvival surgery, the site is clipped, gloves are worn and instruments and areaare clean. / Guide, p 118
Post-operative monitoring and care,including nonpharmacologic control of pain (i.e. heating pad),are provided by trained personnel and documented (e.g., thermoregulation, physiologic function, analgesia, infection, removal of skin closures). / Guide, pp 119-120
Guide, p 122
Location:
- Aseptic surgery conducted in dedicated facilities or spaces, unless exception justified.
- Major operative procedures on non-rodentsconducted only in facilities intended for that purpose.
Guide, p 116
Multiple Survival Surgeries:
- Scientific justification described and appropriate.
- If investigator plans to perform multiple survival surgeries on USDA regulated species in separate, unrelated protocols, APHIS approval received and included.
- Policy for Oocyte Harvesting in Xenopus Frogs
Guide, p 30
Euthanasia/Humane Endpoints:
There is a description of any euthanasia method to be used. See CO2 Euthanasia Policy / PHS Policy IV.D.1.e
Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved areeuthanized at the end of the procedure or, if appropriate, during the procedure. / AWR, Part 2, Subpart C, § 2.31 (d.1.v)
US Government Principles: VI
PHS Policy IV.C.1.c
Methods of euthanasia are consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia and in accordance with the definition of the term set forth in 9 CFR part 1, § 1.1(unless justified for scientific reasons). / PHS Policy IV.C.1.g
AWR, Part 2, Subpart C, § 2.31 (d.1.xi)
Guide, p 123
Humane endpoints established, particularly for studies that involve tumor models, infectious diseases, vaccine challenge, pain modeling, trauma, production of monoclonal antibodies, assessment of toxicologic effects, organ or system failure, or models of cardiovascular shock. See Rodent Tumor Policy / Guide, p 27
Alternatives:
Investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals including physical restraint, and has provided a written narrative description of the methods and sources. / AWR, Part 2, Subpart C, § 2.31 (d.1.ii)
Toe-clipping only used when no alternative available and performed aseptically and with pain relief (mice over 10 days of age). See Toe Clipping Policy / Guide, p 75
Exceptions and Departures:
Exceptions described and scientifically justified. Examples include food/water restriction,single housing of social species (see Social Housing Policy), withholding analgesics, no bedding, multiple survival surgeries and prolonged physical restraint. / US Government Principles: IX
Training and Qualifications:
Personnel conducting procedures on the species being maintained or studied have the relevant basic credentials/qualifications and, with requisite assigned training, are appropriate for the assigned work. See Training & Education Policy / AWR, Part 2, Subpart C, § 2.31 (d.1.viii)
US Government Principles: VIII
PHS Policy IV.C.1.f
References:
Brown University. (2015). IACUC Policies & Links.
National Research Council. (2011). Guide for the care and use of laboratory animals (8thed.).
Office of Laboratory Animal Welfare. (2015). Frequently asked questions.
Office of Laboratory Animal Welfare. (2015). Public health service policy on humane care and use of laboratory animals.
United States Department of Agriculture. (2013). Animal welfare act and animal welfare regulations.
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