DRAFT DISCUSSION DOCUMENT - CPUT



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CAPE PENINSULA UNIVERSITY OF TECHNOLOGY

INSTITUTIONAL ANIMAL ETHICS COMMITTEE

TERMS OF REFERENCE

NAME AND STATUS

Animal Ethics Committee: Cape Peninsula University of Technology (AEC: CPUT)

PURPOSE AND ROLE OF THE COMMITTEE

The Animal Research Ethics Committee (AEC) is a standing committee, which serves the entire institution of the Cape Peninsula University of Technology (CPUT), and reports to the Senate Ethics Committee (SEC) of the Cape Peninsula University of Technology. The AEC is located within the Institute for Biomedical and Microbial Biotechnology (IBMB). The Terms of Reference (TOR) of the AEC are aligned to the Standard Operating Procedure (SOP) of the AEC and to the TOR of SEC at the Cape Peninsula University of Technology. This AEC operates in line with the strategic goals of CPUT. The AEC must operate in a framework of being a self-monitoring committee accountable to the SEC.

This AEC will contribute to the protection of all laboratory-, wild-, agricultural- and any other non-human animals, including their eggs, embryos and fetuses, which are used for scientific purposes, including for research, education or testing. The AEC will also have input concerning the protection of investigators and CPUT-staff from harm or exploitation. The AEC will contribute to the protection of the environment, as it relates to the use of animals in research. The committee will promote a high standard of research and teaching, and maintain and enhance ethical standards of practice in animal use performed at CPUT.

All use of animals for scientific purposes at CPUT, or by CPUT staff and students at other institutions or locations, including use of animals in research, education or testing, including research not related to further qualifications, must serve at the AEC. This AEC takes responsibility for the ethics review of all scientific use of animal subjects of any nature performed at, or associated to CPUT, and will furthermore be open to advise on all matters pertaining to research ethics within CPUT. The AEC will not undertake functions that might conflict with the objectives and roles of the AEC.

COMPOSITION

1. The principles that determine membership of the AEC are:

1. Members should have a high regard for ethics and for the continued advancement of science in the interests of society with minimal impact on animal subjects under research.

2. The committee must have members that appropriately represent the ethical aspects of animal research conducted in all faculties, units and institutes within CPUT and that conforms to guidelines of the National Health Research Ethics Council (NHREC) of the Department of Health and the South African Veterinary Council (SAVC), as well as the latest version of the South African National Standard (SANS) for the care and use of animals for scientific purposes (SANS 10386).

3. The committee should have the competence to engage in critical review of research proposals, to reconcile the physical and psychological consequences of the research conducted and to consider the welfare of the animals involved in research.

4. The committee members should accommodate respected lay opinion in a manner that provides effective representation of the non-clinical and non-scientific community. Lay opinion means opinion from a lawyer, social worker, religious leader, teacher or other person of standing able to contend with pressures from individuals within health and science professions.

5. Members will serve on the AEC as autonomous individuals and not as delegates taking instruction from other bodies/departments etc. However, AEC members will not perform individual level service on the committee, i.e. their work will be incorporated into that of the committee.

6. AEC members will not be held personally liable for any act committed or omitted by the committee, or member of the committee, in good faith, in the course of the operations of the AEC.

2. The following members will constitute the Committee:

• DVC of Research and Innovation (ex officio)

• Head of the Office of Research Integrity (ex officio)

• A Chairperson and a Deputy Chairperson who will be elected by the AEC from the members of the AEC and approved by the office of the DVC of Research and Innovation

• The Chairperson or Deputy Chairperson of the IBMB

• Preferably, At least one member to represent classic laboratory animals and two members to represent other animal species (including marine life and wildlife)

• At least one person not practicing or trained in any animal related profession (Category E)

• At least one member who represents an animal welfare organization

• At least one member who is registered with the (South African Veterinary Council (SAVC) as a veterinarian or veterinary specialist

• At least one member who is not a staff member of CPUT

• Preferably members

o Experienced in statistical analysis

o Versed in law

NOTE: Any one member can meet more than one expertise but the committee will not be less than a total of 9 members.

NOTE: Balance between Categories A-ED should be maintained, as per SANS 10386.

3. The AEC shall have powers to co-opt any person whose knowledge and expertise is needed to expedite special assignments or functions.

4. The Chairpersons of all Faculty Research Committees (FRC) will be invited as observers to meetings of the AEC, but will not be allowed to vote or interfere with committee decisions.

5. A Chairperson and Deputy Chairperson of the AEC will be elected by the AEC at the first meeting of the year where the positions have become vacant.

6. The term of office of elected members shall be three (3) years and ex officio members shall serve as long as they occupy their positions.

7. Membership shall be terminated under the following conditions:

• 3 consecutive meetings missed without apology;

• 4 consecutive meetings missed with an apology (unless on sabbatical or study leave);

• After 3 consecutive meetings missed with an apology, the Chairperson shall write to the member and the relevant line manager about his or her attendance record.

FUNCTIONS OF THE COMMITTEE

The AEC should at all times perceive animal research as having a potential benefit to animals and/or society. The committee should therefore take care not to impede good research and should assist investigators wherever possible to facilitate ethical research standards. In order to fulfil these aspirations the functions of the AEC are to:

1. Advice all bodies, including Faculties, Units, Institutes, Senate and Council within CPUT on matters related to the ethics of research, education and testing involving or affecting animals.

2. Liaise with external organisations and institutions to strengthen animal research ethics at CPUT and become part of the national and international research ethics community.

3. Review ethics applications for masters and doctoral level research after the research proposal is approved by the appropriate FRC and before submission to the Institutional Higher Degrees Committee.

4. Conduct an ethics review of all animal research by staff in CPUT after the research proposal is approved by the appropriate FRC.

5. To approve studies reviewed only if they adhere to the standards set out in the newest version of the SANS guidelines, and only if the use of animals cannot be avoided in the study, together with proven considerations of animal welfare.

6. Monitor progress and problems related to animal ethics that may be experienced in the conduct of research, including acquisition, transport, production, housing, care, use and disposal of animals.

7. Ensure that appropriate post-approval monitoring of AEC protocols are conducted.

8. Investigate allegations of scientific misconduct or neglect of animal welfare and take action to stop such research if it is still in progress and report the findings to an appropriate body (employer, research sponsor, NHREC, SAVC, NSPCA) in order that they are informed and can take appropriate action. Remedial action taken by the AEC may include the withdrawal of ethics approval, or if necessary appropriate treatment or termination of animals may be authorised by the AEC.

9. Maintain a register of studies issued with ethical approval certificates by the AEC.

10. Collaborate with the appropriate FRCs in order to inform, initiate and contribute to capacity development within faculties, units and institutes within CPUT with regard to research ethics through discussion, workshops, seminars, conferences, mentoring etc.

11. Ensure that all persons who use and care for animals are appropriately educated, trained and competent in their tasks, including persons who take care of animals, monitor the welfare of animals, euthanase animals, perform procedures on animals, capture or restrain animals, and persons who design procedures or projects.

12. Inform on external opportunities for research ethics capacity building and involvement.

13. Make recommendations to the SEC and ORI to ensure that the use of animals for scientific purposes complies with relevant regulatory and legal requirements.

QUORUM

8. Fifty (50) percent plus one (1) of the membership of the Committee shall constitute a quorum.

9. Individuals in attendance by invitation at the Committee meetings may participate in the discussions but do not vote or contribute to the quorum of the Committee meetings.

MEETING PROCEDURES

10. Standard meeting procedures will apply.

11. The AEC shall meet once a semester if there are new applications.

12. The DVC research will service the committee through the duly appointed Administrative Assistant.

13. Dates will be confirmed as soon after the institutional calendar is available as possible, but not later than December of the previous year in order to inform the researchers and facilitate submissions.

14. The final submission date for applications will be 14 days prior to each meeting and will be strictly applied to enable review.

15. Meeting agenda and documents will be circulated to members at least one week (7 days) in advance of a scheduled meeting.

16. The AEC may appoint individuals or task teams to attend to specified matters.

17. In the event of an extraordinary matter, the Chairperson may call for an additional meeting.

18. Postgraduate students and their supervisors will not be allowed to attend AEC meetings except upon the invitation of the committee. Committee members who submit proposals for review may act only as observers when their proposals are discussedhave to recuse themselves from the meeting whilst their application are discussed by the committee.

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