2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook


C.1. Table A. Regulatory Criteria Applicable to Protocol Review as Defined



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C.1. Table A. Regulatory Criteria Applicable to Protocol Review as Defined

in PHS Policy and USDA Regulations (continued)





US Government

Principles


PHS Policy on

Humane Care and Use

of Laboratory Animals

USDA AWR 9 CFR Part 2,

Subpart C

Principle IV: Proper use of animals, including the avoid-ance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.


(See C.2.a. Alternatives,

and C.2.d. Minimization of

Pain and Distress)

IV.C.1.a.: Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.



§2.31(d)(1)(i): Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals; (ii) the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available. (See also §2.31(e)(4)).



Principle V: Procedures with animals that may cause more than momentary or slight

pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or

other painful procedures

should not be performed on unanesthetized animals paralyzed by chemical agents.
(See C.2.c. Humane

Endpoints, and C.2.d. Minimization of Pain and Distress, and C.2.f. Veterinary Review and Consultation)



IV.C.1.b.: 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).


§2.31(d)(1)(iv): Procedures that may cause more than momentary or slight pain

or distress to the animals

will: (A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for

scientific reasons, in

writing, by the principal investigator and will con-

tinue for only the necessary period of time; (B) Involve,

in their planning, consulta-

tion with the attending veterinarian or his or her designee; (C) Not include

the use of paralytics

without anesthesia.


C.1. Table A. Regulatory Criteria Applicable to Protocol Review as

Defined in PHS Policy and USDA Regulations (continued)

US Government

Principles


PHS Policy on Humane Care and Use of Laboratory Animals

USDA AWR 9 CFR Part 2,

Subpart C

Principle VI: Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of

the procedure or, if appropriate, during the procedure.

(See C.2.b. Euthanasia)


IV.C.1.c.: Animals that would otherwise experience severe

or chronic pain or distress that cannot be relieved will be painlessly killed at the end of

the procedure or, if appropriate, during the procedure.

IV.C.1.g.: Methods of euthanasia will be consistent with the recommendations of

the AVMA Panel on Euthanasia, unless a deviation is justified

for scientific reasons in writing by the investigator [and approved by the IACUC].



§2.31(d)(1)(v): Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure.

§2.31(d)(1)(xi): Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR part 1, §1.1 of this subchapter, unless a deviation is justified for scientific reasons, in writing, by the investigator.



Principle VII: The living con-ditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedi-cal purposes must be directed by a veterinarian or other scientist trained and experi-enced in the proper care, handling, and use of the species being maintained or studied. In any case, veteri-nary care shall be provided as indicated.

(See B.2.b. Animal Environ-ment, B.2.c. Husbandry, and B.3. Role of the Veterinarian)



IV.C.1.d.: 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.

IV.C.1.e.: Medical care for animals will be available and provided as necessary by a qualified veterinarian.



§2.31(d)(1)(vi): The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.

§2.31(d)(1)(vii): Medical care for animals will be available and provided as necessary by a qualified veterinarian.



Principle VIII: Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.

(See C.2.e. Personnel Qualifications)



IV.C.f.: Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.

§2.31(d)(1)(viii): Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.


C.1. Table A. Regulatory Criteria Applicable to Protocol Review as

Defined in PHS Policy and USDA Regulations (continued)


US Government

Principles


PHS Policy on

Humane Care and

Use of Laboratory Animals

USDA AWR 9 CFR Part 2,

Subpart C

Principle IX: Where exceptions are required in relation to the provi-sions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

See C.1. above.

See §2.31(d) above.




D.1.: Applications and proposals…that involve the care and use of animals shall contain the following: …c) a complete description of the proposed use of the animals…

§2.31(e): A proposal…must contain the following: …(3) A complete description of the proposed use of the animals…




D.1.: Applications and proposals…that involve the care and use of animals shall contain the following: …d) a description of 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, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals.

§2.31(e): A proposal…must contain the following: …(4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals.



C.1. Table A. Regulatory Criteria Applicable to Protocol Review as

Defined in PHS Policy and USDA Regulations (continued)


US Government

Principles


PHS Policy on

Humane Care and

Use of Laboratory Animals

USDA AWR 9 CFR Part 2,

Subpart C







§2.31(d)(1) (ix): Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures;







§2.31(d) (1) (x): No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (A) justified for scientific reasons by the principal investigator, in writing; (B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian, or (C) In other special circumstances as determined by the Administrator on an individual basis.



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