CCAC guidelines on: transgenic animals (1997)

1. Education
   
   It is the responsibility of the ACC to ensure that all its members are informed about the ethical and technological aspects of transgenic animal use. A suggested reading list is attached. It is also recommended that researchers applying for ACC approval to create or use transgenic animals be conversant with ethical concerns surrounding the use of these animals, and be prepared to justify their work as being in the public interest.



2. Proposals to create new transgenic strains



1. Standard procedures for creating transgenic animals can be dealt with by ACCs according to their usual practices for surgical procedures.



2. In reviewing applications for creation of novel transgenic animals, ACCs should determine that:



• the investigator has competent technical assistance and experience in the necessary record-keeping for breeding colony maintenance;



• arrangements for surgical procedures, colony housing and maintenance, have been discussed with and approved by the local Animal Facility Management;



• the investigator and the technical staff involved in daily monitoring of the transgenic colony are familiar with signs of distress in the species of study;



• a frequent, reliable, thorough, and documented monitoring system is in place to detect behavioral, anatomical and physiological abnormalities indicative of animal distress; and



• endpoints for survival are clearly defined.
  
  
Standard operating procedures (SOPs) can be developed to deal with these concerns.


3. Proposals to create or use transgenic animals should include information about expected phenotype (as indicated in the Appendix), to include information about anticipated pain or distress levels in the transgenic animal, measures which will be taken to alleviate such distress, and the required monitoring system.



4. Proposals to create novel transgenics initially should be assigned CCAC category of invasiveness level "D" . If approval is merited, it should be provisional, limited to a 12-month period, and subject to the requirement that the investigator report back to the ACC as soon as feasible on the animals' phenotype, noting particularly any evidence of pain or distress.
   
   After receiving the report from the investigator, the ACC may confirm approval of the proposal and adjust the level of invasiveness. However, if the animals are noted to be suffering unanticipated pain or distress, the ACC will ask the investigator to provide a revised protocol which will minimize and alleviate distress, and will reconsider its approval of the proposal.


3. Proposals to utilize existing transgenic strains



1. A proposal on transgenic animals may have two parts: creation of the transgenic animals, and subsequent experimental manipulations of the animals. Except where subsequent manipulations are restricted to observation and euthanasia of the transgenic animal, creation and use proposals should be considered as separate proposals.



2. In reviewing use proposals, ACCs should consider whether procedures regarded as acceptable in non-transgenic animals, are still acceptable in transgenic animals where altered phenotype may impose additional stresses.



3. Proposals to use existing transgenic strains should also include the information requested in the Appendix.


4. Accounting



1. Estimates of all animals to be used or generated in a transgenic study should be stated in proposals to the ACC, listed by use category (e.g., oocyte donors, pseudopregnant females, male "studs", successful transgenics, etc.)



2. When completing the Animal Use Data Form for reporting annual animal usage to CCAC, investigators should identify transgenic animals separately from non-transgenic animals in the "Species" column.



3. To reduce overall animal use, CCAC encourages, when appropriate, assignment of non-transgenic animals, bred in a transgenic creation procedure, to other ACC-approved protocols. Asymptomatic heterozygotes must be clearly identified and should only be used for breeding purposes when the investigator is aware of their altered genotype. Accounting procedures within animal facilities must prevent double-counting of such transferred animals in annual use statistics.


5. Containment



1. All proposals for creation or use of transgenic animals must assure the ACC that risks to human health and the environment are minimized to an acceptable level. For transgenic animals created using micro-injection or replication-defective viruses, the containment risks are limited to those associated with the escape of the animal and interbreeding with wild stocks. Proposals should include information about:



• containment and security procedures in animal facilities and, if applicable, during transportation when importing the animal;



• plans for recapture should a breach of containment occur; and



• the consequences to human health or wild populations should containment fail.



2. For commonly-used transgenic species, each animal facility should have SOPs for containment, which can be referenced by proposals.



3. ACCs should discuss with the institutional Biohazard Committee any proposal which raises biohazard containment concerns.


6. Other regulations
   
   
   1. ACC approval of a proposal does not relieve the investigator of responsibility to satisfy the regulations of any other governmental agencies. For example, creation of any transgenic fish strain requires approval of the Department of Fisheries and Oceans. Biohazard approval may also be required for some proposals.

1. Education
   
   To update at least every two years a reading list on ethical and technical aspects of transgenic animal use which can be distributed to members of ACCs, this list to include articles appropriate for all members.



2. Accounting and reporting
   
   To include in its annual animal usage statistics separate totals for transgenic strains of each species used in experiments.

February 5, 1997

1. Species: Background Strain: Heterozygotes: and/or Homozygotes:	_________________________ ________________________________ _____ _____




2. To be housed in Room _____.




3. What is the health profile of the source colony? Provide the most recent serology report.




4. What known traits will affect breeding and lifespan?




5. What abnormalities are known to exist (or do you expect) in these animals?




6. If you expect these abnormalities will cause pain or distress, how will you minimize or alleviate it?




7. Describe your monitoring and recording procedures for detecting physical or behavioral abnormalities which are indicative of pain and distress.




8. What objective criteria will be used to determine if an animal will be removed from the study prematurely?




9. If biological containment is required, state reasons and the level required. Describe your containment and security procedures. How will you deal with breach of containment? Will there be any risks to human health, wild populations or the environment generally if containment fails?




10. If you are generating a novel transgenic strain, provide a timetable for this process and indicate when you expect to report back to the ACC on the phenotype obtained.

[ Back to top ]