8. The ethical review process

8.1 Directive and policy

8.1.1 The Board of the MRC requires that an ethical review process be established and maintained both within the MRC and at every institution where MRC-supported animal studies are undertaken.

8.1.2 The performance of this institutional ethical review process is a precondition of MRC support, collaboration and co-operation.

8.2 Ethics Committee for Research on Animals (ECRA)

8.2.1 The ethical review process is to be performed by a designated ECRA.

8.2.2 The terms of reference of an ECRA are to: i. monitor, inspect and assess the acquisition, transport, production, housing, care, use and disposal of animals; ii. evaluate and approve, subject to possible modification, or reject written proposals for animal studies submitted for ethical review; iii. regularly review operating standards and the ECRA's managerial systems, procedures, policies and protocols which relate to the proper care and treatment of research animals; iv. report annually to the management of the institution; v. advise how staff involved with animal production, care and teaching may be appropriately trained and how competence can be assured; vi. withdraw approval for any approved project and/ or authorise the humane killing formally of any animal which is being subjected to unnecessary deprivation, fear, distress and pain; vii. maintain a register of approved projects and receive reports on their outcome; and viii. recommend to the institution any measures needed to ensure that the standards of the National Code11 are maintained.

8.3 Membership of an ECRA

8.3.1 An ECRA shall have a membership that will allow it to fulfil its terms of reference as defined in the SABS Code11 and shall comprise at least six persons, including a separate person appointed to each of the categories which follow.

8.3.1.1 Category A
A person with qualifications in veterinary science, with experience relevant to the activities of the institution or, in special circumstances, a person with qualifications and experience to provide comparable expertise.

8.3.1.2 Category B
A person with substantial recent experience in the use of animals in scientific or teaching activities.

8.3.1.3 Category C
A person with demonstrable commitment to and established experience in furthering the welfare of animals, who is not employed by, or otherwise associated with, the institution, and who is not involved in the care and use of animals for scientific purposes. The person should, where possible, be selected on the basis of active membership of and nomination by an animal welfare organisation.

8.3.1.4 Category D
An independent person who does not currently and has not previously conducted scientific or teaching activities using animals, and who is not an employee of the institution.

8.3.1.5 Category E
A person responsible for the daily care of animals within the institution who should also be a member of the ECRA.

8.3.1.6 Category F
A person who has had formal training in biomedical ethics.

The committee may include additional co-opted members to ensure that it can function effectively.

8.3.1.7 The chairperson should hold a senior position in the institution.

8.3.1.8 If the committee has more than six members, Categories C plus D should represent no fewer than one-quarter of the members.

The composition of the ECRA must also comply with all relevant legislation.

8.3.2 Confidentiality
Before appointment, all members of the ECRA shall acknowledge in writing their acceptance of the terms of reference of the committee and any requirements for confidentiality required by the institution. The committee should reach agreement on how advice may be sought without breaching confidentiality.

8.3.3 Conflicts of interest
No member of an ECRA may participate in a review or approval of a proposed animal study in which that member has a conflicting interest (e. g. such as being personally involved in such a study), other than to provide information. Members with conflicting interests should declare these and may not count towards a quorum or vote in such circumstances. Conflict of interest includes involvement in either potentially competitive research programmes, research, funding, or intellectual information which may provide an unfair competitive advantage. A member's bias as such may constitute a conflict of interest and interfere with impartial judgement.