AEC Terms of Reference and Standard Operating Procedures

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FACULTY OF HEALTH SCIENCES (FHS)
RESEARCH ANIMAL FACILITY (RAF)
TERMS OF REFERENCE
[Last updated 4th June, 2013]
Note: This Document Must Be Read In Conjunction with the UCT RESEARCH ETHICS CODE
FOR USE OF ANIMALS IN RESEARCH AND TEACHING
1.
PURPOSE
To ensure that scientific research and teaching activities involving animals in the Faculty of
Health Sciences (FHS) comply with SANS 10386, incorporating the core ethical principles of
i. Replacement of the use of animals with alternative models where feasible
ii. Reduction of the number of individual animals used
iii. Refinement of experimental design, procedures, care and husbandry, to minimise or
eliminate the impact on individual animals in terms of actual or potential pain,
suffering, stress, and lasting harm.
To ensure that research proposals involving the use of animals undergo rigorous scientific
and ethical review processes.
2.
COMPOSITION
Animal Ethics Committee (AEC) members are appointed by the Dean in consultation with
the Senior Management Team of the Faculty. Various categories of members are dictated by
international and national standards including the SABS SANS Code 10386 (revised in 2008).
Four categories of member are required:
A: Veterinarians
B: Scientists with substantial and recent experience in the use of experimental
animals
C: Animal welfare organisation representatives
D: Academic staff representatives from FHS not involved in animal experimentation,
from other Faculties and/or non-UCT organisations.
The composition of the FHS AEC is as follows:



The Vice-Chancellor (ex officio)
The Deputy Vice-Chancellors (ex officio)
Animal Ethics Committee (AEC) members are appointed by the Dean in consultation
with the Senior Management Team of the Faculty. Membership is made up as
follows:
o The Chair, who should be a senior member of the University, located in the FHS, and
who is not an “animal user”
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o The Director of the Animal Unit, Faculty of Health Sciences (by definition, a
registered veterinarian)
o Four other members of academic and research staff from FHS, with substantial and
recent experience in the use of experimental animals
o Five other senior members of academic and research staff (from FHS and other
Faculties, including UCT retirees, or non-UCT organizations) who are not involved in
animal experimentation and who preferably have had training in research ethics
o Two persons from officially recognised animal welfare organisations
o One postgraduate student from FHS with recent experience in the use of
experimental animals, appointed by the Postgraduate Students’ Committee (PSC)
Two deputy chairs must be appointed from amongst the members, one being a
member of academic or research staff who is not involved in animal experimentation
and who is not from the FHS.
For capacity building, alternatives from the required categories can be appointed to
attend a specific meeting when a member from the same category is unable to
attend.
Where appropriate, specialists and other advisers may be invited to attend meeting
and/or give input. Such members are not eligible to vote.
Observer members and applicants may be invited to the meetings. Such members
are not eligible to vote.
3.
Executive Committee
EXCO comprises the Chair, two Deputy Chairs and the Director of the Animal Unit (the FHS
veterinarian) and deals with urgent matters that arise between meetings of the FHS AEC. All
decisions of the EXCO must be tabled at the following meeting of the AEC.
4.
QUORUM RULES
Six members, which must include a member from each category A, B, C, and D as described
in SANS 10386 5.2.3, constitute a quorum. As there is only one member from category C
(representing a welfare organisation), a second member from this category will be identified
by the welfare organisation to act as an alternate.
5.
TERM OF OFFICE
Animal Ethics Committee members are generally appointed for a period of up to three
years, with possible renewal.
The rotation of members will be done annually and may include up to one third of the
members being replaced by new members.
Students are appointed for one calendar year, with possible renewal.
6.
TERMS OF REFERENCE
6.1
To advise its appointing authority (Dean and Deputy Dean: Research, FHS) as
well as the Senate Animal Ethics Committee (SAEC) on all matters pertaining
to the ethics of research and teaching involving animals.
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6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
7.
To ensure that committee members attend an Induction Course at the start
of their term of office, run by an appropriate member of the FHS AEC
together with staff from the Animal Unit.
To examine and authorise, subject to modification, or reject all proposals for
research and teaching involving animals to be carried out within the ambit of
UCT FHS, in accordance with current standards and guidelines.
To monitor studies in accordance with FHS AEC Standard Operating
Procedures (SOPs).
To report at least annually to the FHS Deputy Dean: Research and to Senate
via the SAEC.
To deal with protocol deviations and violations, plus animal welfare issues
and alleged unethical treatment of research animals through the mechanisms
as detailed in the appropriate SOP.
To ensure
6.7.1 that the 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
6.7.2 that the Animal Unit regularly updates and reports to the Committee
on its SOPs, using current standards and guidelines as the minimum
standard for evaluation.
To review and revise, as appropriate, the FHS AEC ethics guidelines and SOPs,
lodging revisions with SAEC in accordance with the SAEC Terms of Reference.
To prepare written procedures, to be adopted by FHS and Senate, to deal
with non-compliance with current standards and guidelines, allegations of
research misconduct, appeals and any other grievance related to the FHS AEC
process. Such procedures must clearly define the reporting mechanisms and
responsibilities of all parties to ensure fair and effective processes.
PROCEDURES
7.1
The Committee meets monthly to examine proposals for research and other
matters pertaining to FHS AEC.
7.2
The Committee must communicate to, and require implementation by, the
University via the FHS Deputy Dean of Research and SAEC any measures
needed to ensure that the current standards and guidelines are implemented
and maintained, including institutional plans and policies that might affect
animal welfare.
7.3
The Committee must authorise only those studies for which animals are
essential and which conform to the current standards and guidelines, taking
into consideration ethical and welfare aspects as well as the scientific and
educational value of the proposed research.
7.5
In the case of proposals for research using Non-Human Primates, the review
process includes monitoring of the proposal by SAEC in accordance with the
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UCT Non-Human Primate policy. Only after the SAEC has ratified the preauthorisation by FHS AEC, may the research be initiated.
7.6
The Committee must maintain a register of authorised projects.
7.7
The Committee receives reports from the Independent SAEC Veterinarian
and the Animal Unit concerning regular monitoring, inspections and
assessment of the acquisition, transport, production, husbandry, care, use
and disposal of animals used in research or teaching. All of these aspects
must be in accordance with current standards and legislation relating to the
ethics, welfare and use of animals. The Committee is expected to act on the
reports as necessary.
7.8
The Committee must receive annual progress reports and a final report for
every protocol authorised, kept on record at the FHS Research Ethics Office.
7.9
The Committee must establish procedures and processes:
7.9.1 to address conflicts of interest for committee members and
researchers
7.9.2 to maintain records in accordance with the adopted guidelines
7.9.3 to address allegations of non-compliance and allegations of research
misconduct, and to hear appeals.
8.
CONFIDENTIALITY
Committee business is confidential so as to protect intellectual property, researchers’
interests, and to permit committee members to speak freely and frankly, as well as to
protect the public image of the University. This policy is affirmed by signing a statement on
the attendance register at every meeting. However, this does not mean that the committee
is secret.
Concerns about breaches of confidentiality should be raised with the Chair of the FHS AEC in
the first instance and, if not addressed to the satisfaction of the complainant, thereafter
with the FHS Deputy Dean of Research.
9.
DELEGATED AUTHORITY
The Committee has the power to act on behalf of Senate
9.1
To review and authorise, require modifications in (to secure authorisation),
or withhold authorisation of those components of proposed research or
teaching activities related to the care, husbandry and use of animals.
9.2
To review and authorise, require modifications in (to secure authorisation),
or withhold authorisation of proposed changes regarding the care, husbandry
and use of animals in ongoing authorised activities.
9.3
To withdraw authorisation for and suspend an activity involving animals for
any project that fails to comply with current standards and guidelines.
9.4
To review and investigate concerns involving the care, husbandry and use of
animals in accordance with the SOP for Reporting of protocol deviations,
unanticipated problems and welfare violations in animal research.
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9.5
10.
To authorise treatment or humane killing of any animal used in research or
teaching.
SERVICING OFFICERS
This committee is serviced by the Research Ethics Office of the FHS.
APPENDIX
Current membership of the FHS AEC – May, 2013
There are currently 17 members, categorised as follows:
A: (2) Prof GJ Louw [Chair: FHS AEC], Dr B Mohr [Director: Animal Unit and FHS
Veterinarian];
B: (9) Dr N Davies, Dr M Kruger, Dr W Horsnell, Dr A Soares, Dr E van der Merwe, Dr
T Kolbe-Alexander, & Ms J Womersley [student representing the Postgraduate
Students’ Association at FHS];
C: (1) Sr E Vercuiel & Sr Vanessa Anderson [representing the NSPCA];
D: (5) A/Prof L Van Sittert, Mr R Sayed or alternative appointee [biostatistician], Mr
M Bennun and Mrs I Wasserfall, or Ms K Lehmann as an alternative member if one of
the previous two have sent apologies [latter 3 from Faculty of Law, UCT], Dr S Field.
Administrative staff: Ms L Emjedi and Mrs N Tsama.
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