Biosafety Guidelines For Research On Genetically Modified ...

APPENDIX 12: PROCEDURES FOR EXPERIMENTS INVOLVING TRANSGENIC
ANIMALS
Introduction
Genetic manipulation work which involves the use of animals includes:
• introduction of DNA into the fertilized oocyte or zygote or early embryo, or which
may be carried out in or involve whole animals;
• introduction of a fragment of the whole genome or a virus into an embryo to produce
a transgenic animal secreting infectious viral particles;
• use of genetically modified micro-organisms to infect animals.
All investigators and IBCs responsible for genetic manipulation work which involves
transgenic animals should be familiar with the requirements of the NACLAR Guidelines
on the Care and Use of Animals for Scientific Purposes and laboratory biosafety.
Procedures
(A) For Principal Investigators
Investigators planning work which will fall under Category B (i.e., production of
transgenic animals) and which will not fall under Category A nor involve planned
releases of genetically manipulated organisms should:
1. Complete a GMAC ‘Proposal Form for Assessment of Genetic Manipulation Work’.
2. In addition, attach a description addressing each of the points listed in Appendix 13
(1- 8).
3. Submit the proposal to their IBC.
4. Do not initiate work involving these animals until IBC approval has been received.
(B) For Institutional Biosafety Committees
Upon receipt of a proposal for work with transgenic animals, the IBC should:
1. Assess the information provided in the proposal form and the description of the
animal facilities. Points to consider in the design of facilities are laid out in Appendix
13.
2. Inspect the proposed facilities.
3. Either
(i) approve the proposed protocol and facilities, or
(ii) recommend additional precautions and give approval when these have been
implemented.
4. Attach a copy of the terms of the approval if IBC approval is qualified in any way, or
if additional conditions are required, and provide this advice to the investigator.
Appendix - Page 24