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” 1 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. 2 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 3 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. 4 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. 5