UNIVERSITY OF CAPE TOWN
RESEARCH ANIMAL ETHICS COMMITTEE
GUIDELINES FOR RESEARCH PROTOCOL APPLICATIONS
PURPOSE
To provide guidelines on the correct procedures for completion and submission of
Research Protocol Applications by Researchers for intended research experiments to be
performed on animals.
To provide information on Animal Unit requirements.
SCOPE
Covers the required Documentation, the Research Animal Ethics Committee (RAEC)
and its functions, obligations of the Researcher and the functions of the UCT Animal
Unit (AU).
PROCEDURES
An official Protocol Application Form, and submission details, are obtainable from the
Secretary of the RAEC at:
Telephone 021 406 6338
Fax 021 406 6411
email : lemjedi@curie.uct.ac.za
Researchers are required to complete all sections of this Application Form with sufficient
detail to satisfy the RAEC.
The Application Form must be submitted to the Secretary of the RAEC by the stipulated
deadline date for submission. An official Reference Number will be assigned to each
protocol submitted. This reference number denotes the year and sequential reference
number, ie. 2004/001.
No late submissions will be accepted for a specific meeting date, and any late
submissions will be carried forward to the following RAEC meeting.
Protocols for review are distributed to the various RAEC members, for preview purposes,
prior to a full RAEC meeting.
Each protocol is reviewed by the RAEC panel and may be :
Passed Unconditionally, or
Passed provisionally – more details/explanation required
Rejected – reasons for rejection will be provided to researchers.
Protocols passed Unconditionally – the Chairperson of the RAEC will provide a Letter
of Authorization to the researcher and a copy to the AU (which is attached to the
accepted protocol) for audit purposes. This Letter of Authorization is the clearance for the
researcher to proceed with ordering the required animals through the AU, using the
correct Animal Request Form obtainable from the AU, at Tel 021 406 6737.
Protocols passed Provisionally – a Letter of Authorization will be issued to the
researcher once conditions and details requested by the RAEC are complied with
satisfactorily. The AU will not accept Animal Request Forms or order and supply animals
until this official Letter of Authorization is received, with the final amended and RAEC
accepted protocol.
Rejected protocols - reasons for rejections will be outlined. Resubmission to the RAEC
will be required. The protocol reference number will remain unchanged, and must be
quoted on all correspondence. Submission deadlines dates still apply in these cases.
The RAEC has the right to request progress reports and/or final reports on any research
experiment conducted. These reports shall include details of animal usage, animal
welfare observations during experimentation, adherence to protocol outlined procedures,
end point assessments, achieved results compared to animal usage, non utilized animals,
and any other relevant details deemed necessary by the RAEC.
Progress and Final Reports may be the determining factors in future review process and
animal allocations to researchers.
Animal usage, non usage, wastage numbers etc, are required by the Senate Animal Ethics
Committee for their Annual Reports. The RAEC and Animal Unit are required to
confirm these numbers, and report on all Animal Welfare issues.
Recommendation
That researchers apply to the RAEC annually for extension permission for projects which
have not yet been completed or initiated. This permission would be a formality but
provides a better control over project monitoring.
This extension application should contain a brief project progress summary and other
relevant data.
Extension applications and reports should be filed with the project case file, to be
administered by the RAEC secretary or the AU.
ANIMAL UNIT REQUIREMENTS AND CONDITIONS
Protocols passed officially by RAEC - the AU will receive a Letter of Authorization
signed by the Chairperson of the RAEC, which will be attached to the accepted protocol.
Researchers must now liaise with the AU and arrange to have the required animals bred
or sourced for the specific research experiment(s).
A Request for Animals Form is obtainable from the AU and needs to be completed well
in advance of experiment start date(s). Researchers are requested to manage their
planning to give AU sufficient time to comply with the requests.
A Request for Animals Form must be completed for each animal or group of animals
required for a specific phase of the experiment. AU requires this for animal control and
audit purposes. The original protocol reference number must be quoted on all request,
and subsequent request forms.
Animals issued for a specific protocol will be monitored and controlled against the
number requested and authorized, by RAEC.
No additional animals will be supplied without the written authority of the RAEC.
No change in species is allowed without the written authority of the RAEC.
Changes in protocols, procedures or any other amendments to protocols must be
authorizes by the RAEC and follow correct amendment procedures. This may require a
new full protocol submission.
Experiments are monitored by the AU. Any deviations from protocol outlined procedures
may result in recommendation that experiments are terminated. It is the responsibility of
researchers and their staff, to ensure strict adherence to their stated protocol procedures.
The AU reserves the right of admission to animal units under their management, and
requires that GLP and Code of Conduct principles are adhered to.