APPLICATIONS FOR ETHICS AUTHORISATION FOR RESEARCH INVOLVING EXPERIMENTAL ANIMALS
STANDARD OPERATING PROCEDURE
[Last updated June 2012]
1.INTRODUCTION
1.1 Scientific studies and teaching activities that use experimental animals may be performed only when they are believed to be essential to maintaining or improving the health of humans and other animals. A cost / benefit evaluation of each study forms the basis on which a research proposal is evaluated.
1.2 Scientific studies and teaching activities that use animals may only be performed when appropriate non-animal alternative methods are not available, in accordance with the principles of Replacement, Reduction and Refinement.
1.3 All animals must be treated with respect and humanely and their welfare is essential in the planning and conduct of studies.
1.4 Researchers and teachers are directly and personally responsible for all matters relating to the welfare of the animals they use, especially when conduct is negligent or unprofessional. Note however that the university carries insurance against accidents.
1.5 No research may begin before written authorisation has been granted by the FHS AEC to the Principal Investigator. Failure to obtain prior ethics clearance and authorisation constitutes research misconduct which could lead to disciplinary procedures. PLEASE NOTE ethics authorisation from non-UCT animal ethics committees does not substitute for this requirement.
2.APPLICATION AND REVIEW PROCESS
2.1 Researchers and teachers must submit to the FHS AEC written proposals for all animal studies on the prescribed application form.
2.2 Proposals must be submitted to the FHS AEC Secretariat in accordance with the monthly deadlines in hardcopy format.
2.3Each application is pre-reviewed by two reviewers nominated by Exco; their comments enable the researcher to revise if necessary, where after 19 copies must be supplied.
2.4 The AEC meets monthly (at present at 13h00 on the 3rd Thursday of the month, in the Dean’s Committee Room, FHS).
2.5Proposals must explain in detail the expected value of the knowledge to be gained, the full justification for the study, and must discuss all ethics and animal welfare aspects.
2.6The application must include evidence that non-animal alternatives have been carefully considered for all studies. In the case of research proposing to use non-human primates, such evidence should be particularly detailed.
2.7Proposals that require the use of non-human primates are subjected to a “Decisional Analysis” as required by the “UCT Policy on the Experimental Use of Non-human Primates” in addition to the usual review process.
2.8The revised protocol, together with all reviewer comments, is discussed at the next meeting of the FHS AEC. The committee decides whether:
• to authorise without further amendment
• to require further minor amendment(s) to secure authorisation
• to require major revision and resubmission
• to reject.
2.9Protocols that require minor changes may, upon resubmission, be authorised by Exco, provided the committee has authorised this process and the decision is minuted. The decision of Exco must be reported and minuted at the next meeting of the AEC.
2.10Minor changes to previously authorised protocols require submission of a Minor Amendment application, which may be expedited, i.e. the application is reviewed by Exco, which decides whether to authorise the request or take it to the full committee. Any minor amendment applications authorised by Exco must be reported and minuted at the next meeting of the AEC.
2.11Major changes require a full revised application and must undergo the usual full application and review process.
2.12A C1 Form (obtainable from RCIPS) is required for any externally funded Contract Research.
2.13 Where Biosafety or Genetic issues are pertinent, appropriate approval from those committees must be supplied as indicated on the application form.
2.14Principal Investigator grievances concerning the Application and Review process may be lodged in accordance with the SAEC Appeal Process SOP.
3. General
3.1Committee members are required to attend an Induction Course as close as possible to the start of their term of office, run by an appropriate member of the AEC along with staff from the Animal Unit.
3.2The Animal Unit presents regular (at least annual) Induction Courses on the Ethics, Care and Use of Laboratory Animals in Research, for animal users involved in the use of animals.
3.3Animal users are expected to complete the UCT course successfully. Training completed elsewhere may be accepted at the discretion of the Exco.
3.4Animal users are expected to renew their ethics certification every three years.