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INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

 
 
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PROTOCOL SECTION

The following is a table categorizing the protocol form by section corresponding to six specific regulatory agencies.

Protocol Form by Section

USDA

Guide

PHS

FDA

AAALAC

CDC

 

 

 

 

 

 

 

Cover Sheet-Instructions

 

 

 

 

 

 

Face Sheet-Contact Information

 

 

 

 

 

 

IIII-Investigator Assurance

 

 

 

X

 

 

IV-Departmental Assurance-Scientific Merit

X

 

 

 

 

 

V-Justification

 

 

 

 

 

 

1. objective

X

X

X

 

 

 

2. plain language description (society)

 

 

 

 

 

 

3. species

X

X

X

 

 

 

4. experimental design

X

X

X

 

 

 

5. justify the number of animals

X

X

X

 

 

 

6. alternatives

X

X

X

 

 

 

7. searches (databases)

X

 

 

 

 

 

i) Replacement

X

X

X

 

 

 

ii) Reduction

X

X

X

 

 

 

iii) Refinement

X

X

X

 

 

 

VI-Animal Use Checklist (see attachments)

 

 

 

 

 

 

VII-Pain Class

X

 

 

 

 

 

Species, strain, procedure by pain class

X

X

X

 

 

 

VIII-Housing

X

 

 

 

 

X

Special requirements for housing

 

 

 

 

 

X

IX-Euthanasia

X

X

X

 

 

 

X-Animal ID

 

X

 

 

X

 

XI-Environmental Enrichment

 

X

 

 

X

 

Dogs

X

 

 

 

 

 

Primate

X

 

 

 

 

 

Other species

 

X

 

 

X

 

XII-Personnel, training,  position, procedures

 

X

X

 

X

 

XIII-Occupational  Health

X

X

X

 

X

 

Special vaccines or additional health screening

 

X

 

 

 

 

XIV-Transport

X

X

X

 

 

 

XV-Conditioning and Quarantine

X

X

X

 

 

 

XVI-Suspended Caging

 

X

 

 

X

 

Attachments

 

 

 

 

 

 

A-Fluid collection

 

 

 

 

 

 

B-Immunization

 

 

 

 

 

 

C-Anesthesia, Analgesia or Paralysis

X

X

X

 

 

 

D-Survival Surgery

X

X

 

 

 

 

E-Non Survival Surgery

X

 

 

 

 

 

F-Justification for Pain Class E

X

 

 

 

 

 

G-Animal Restraint

X

X

 

 

 

 

H-Infectious agents, Biohazards, Recombinant DNA

X

X

X

 

X

 

I-Tumors In Animals

 

 

X

 

 

 

J-Administration of Exogeneous Substances or Tissues

 

 

 

 

 

 

K-Irradiation

 

 

 

 

 

 

L-Alternative Housing

X (12 hrs)

X

X (24 hrs)

 

X

 

M-Manipulation diet or environment

 

X

 

 

 

 

N-Behavioral Test

 

 

 

 

 

 

O-Other Procedures

 

 

 

 

 

 

P-Field Studies

 

 

 

 

 

 

Q-Rabies Waiver

 

X

 

 

 

 

Regulatory Agency

USDA - United States Department of Agricultural
Guide – Guide for the Care and Use of Laboratory Animals
PHS – Public Health Service on Humane Care and Use of Laboratory Animals
FDA – Food and Drug Administration
AAALAC – Association for Assessment and Accreditation of Laboratory Animal Care International
CDC – Center for Disease Control