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


A.2. Table B. Federally Mandated Functions of the IACUC



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A.2. Table B. Federally Mandated Functions of the IACUC



PHS


PHS Policy. IV.B.1-8


USDA


9 CFR. 2.31 (c) (1) – (8) and 2.31(d) (5) (6) & (7)



1. Review, at least once every six months, the research facility’s program for the humane care and use of animals, using the Guide as a basis for evaluation

1. Review, at least once every six months, the research facility’s program for humane care and use of animals, using title 9, chapter 1, subchapter A—Animal Welfare, as a basis for evaluation


2. Inspect, at least once every six months, all of the institution’s animal facilities (including satellite facilities) using the Guide as a basis for evaluation. Satellite holding facilities (a facility outside of a core facility or centrally designated area in which animals are housed for more than 24 hours) and areas in which surgical manipulations are performed must always be included.


2. Inspect, at least once every six months, all of the research facility’s animal facilities, including animal study areas, using title 9, chapter 1, subchapter A—Animal Welfare as a basis for evaluation. Areas where animals are housed for more than 12 hours are defined as “study areas”.

3.Prepare reports of the IACUC evaluations and submit the reports to the IO. The reports must contain a description of the nature and extent of adherence to the Guide and PHS Policy and identify specifically any departures from the provisions of the Guide and PHS Policy and state reasons for each departure. The IACUC may determine the best means of conducting an evaluation of its program and facilities. The IACUC may invite ad hoc consultants to assist in conducting the evaluation. However, the IACUC remains responsible for the evaluation and report.

Reports must distinguish significant deficiencies from minor deficiencies and must contain a reasonable and specific plan and schedule for correcting each deficiency. A significant deficiency is one that is or may be a threat to the health and safety of the animals. Reports must be made available to OLAW upon request.




3.Prepare reports of its evaluations (using the title 9, chapter 1, A – AWR) and submit to the IO. The IACUC may determine the best means of conducting evaluations of the research facility’s programs and facilities, provided that no member wishing to participate in any evaluation is excluded.

Reports must distinguish significant deficiencies from minor deficiencies and must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. A significant deficiency is one that is or may be a threat to the health and safety of the animals. A significant deficiency remaining uncorrected beyond the scheduled correction date shall be reported in writing within 15 business days by the IACUC, through the IO, to APHIS and any federal agency funding that activity. Reports must be made available to APHIS and to officials of federal funding agencies for inspection and copying upon request.



4. Review concerns involving the care and use of animals at the institution.

4. Review, and if warranted, investigate concerns involving the care and use of animals resulting from public complaints and from reports of noncompliance received from laboratory or research facility personnel or employees.


5. Make recommendations to the IO regarding any aspect of the animal program, facilities or personnel training.


5. Make recommendations to the IO regarding any aspects of the animal program, facilities or personnel training.

6. Review and approve, require modifications in, or withhold approval of those components of PHS-conducted or supported animal care and use activities. A complete review is required at least once every three years.

6. Review and approve, require modifications in, or withhold approval of those components of proposed activities related to the care and use of animals.

Continuing review of activities required not less than annually.


PHS


PHS Policy, IV, B, 1-8


USDA


9 C

FR. 2.31 (c) (1) – (8) and 2.31(d) (5) (6) & (7)



7. Review and approve, require modifications in, or withhold approval of proposed significant changes regarding the use of animals in ongoing activities.

7. Review and approve, require modifications in, or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities


8. Be authorized to suspend an activity involving animals in accordance with specifications in IV.C.6 of PHS Policy (i.e., an activity that is not being conducted in accordance with applicable provision of the AWA, the Guide, the institution’s Assurance, or PHS Policy.) This action may be taken only after review of the matter at a convened meeting of a quorum of the IACUC and a vote for suspension by the majority of the quorum present.

The IO in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.



8. Be authorized to suspend an activity involving animals if it determines that the activity is not being conducted in accordance with the description provided by the investigator and approved by the IACUC. This may be done only after review at a convened meeting of a quorum of the IACUC with the suspension vote of a majority of the quorum present. The IO, in consultation with the IACUC, shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any federal agency funding that activity.


References
The Public Health Service Responds to Commonly Asked Questions. Fall 1991. ILAR News Volume 33(4):68-70.
Robb, J. Wesley. 1993. Personal Reflections: The Role and Value of the Unaffiliated Member and the Non Scientist Members of the IACUC. ILAR News Volume 35:3-4.
OPRR Reports. 1997. 97-03, June 2, 1997.
NIH Guide for Grants and Contracts, Notice OD-01-017. February 12, 2001.
Frequently Asked Questions about The PHS Policy on Humane Care and Use of Laboratory Animals. Summer/Fall, 1993. ILAR News Volume 35(3-4):47-49.
Protocol Review. A Note from the NIH and USDA. 1996. Lab Anim. 25(5)22.
A.3. Operation and Administration
Institutional Responsibility for Animal Welfare

Assuring laboratory animal welfare necessitates a partnership among the Institutional Official (IO), the IACUC, the veterinarian and the investigators. Ultimately, accountability for assuring humane care and use of animals resides with the institution, but this may only be achieved when all of the players, i.e., the investigators and their research staff, the veterinary staff, animal caretakers and technicians, and the IACUC, contribute to a shared goal.


Each institution should provide a framework with appropriate resources for an animal care and use program that is managed in accordance with the PHS Policy, the Guide, and the Animal Welfare Regulations (AWRs). Organizations that function effectively have simple, clear and direct lines of responsibility and corresponding authority.


AWA - HREA





AWRs – PHS Policy




Institutional Official








Animal Care Program



Veterinarian

Chair

IACUC

IACUC

Office




Research Staff



Investigator

Components of an animal care and use program. Heavy lines represent the mandate from the Animal Welfare Act and Health Research Extension Act that the Secretaries of Agriculture and Health and Human Services develop guidelines for the use of animals in research, including IACUCs, and require established lines of authority from the IO to the IACUC, IACUC staff, and veterinarian, Dotted lines represent the need for cooperation and communication among components.
The PHS Policy and AWRs place a strong emphasis on senior manage-ment level responsibility and on use of the IACUC as an oversight committee to evaluate the program. The committee needs to work closely with the animal users, the animal care staff, and the responsible veteri-narians to ensure a high quality animal care and use program. The IO must support the IACUC by providing appropriate resources.




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