10. Template of MRC's application form for ethical review by the ECRA (Annexure 2)

Access application forms on page 5 of the annexures (pdf format, 150 kb)

11. ECRA operating procedures

11.1 Appointment of Committee
After taking appropriate advice, the Board of the MRC shall formally appoint the ECRA.

11.2 Duration of membership
The period of membership of individuals may be prescribed, such as from 3 to 5 years, and may be renewed. It should be appreciated that members need time to absorb the ethos and develop the skills of ethical review.

11.3 Election of Chairperson and quorum
The Committee should elect its own Chairperson and Deputy Chairperson from among its members and should have a quorum of not less than five members.

11.4 Administrative support
The ECRA shall be supported by a Secretariat based within the MRC to perform its administrative duties, provide secretarial assistance, and maintain records of all ECRA documents and correspondence.

11.5 Meetings
The ECRA should meet four times a year at the MRC's Head Office at Medicina in Parowvallei, Cape Town, to review applications for ethical review and to conduct other business which falls within its terms of reference. The dates of meetings shall be set at the first ECRA meeting of each year. Notice of meetings and the agenda and working papers shall be sent to ECRA members to arrive at least 7 working days before the next meeting.

11.6 Chairperson's approval
The Chairperson may deal with minor matters with or without consulting the other members. Progress reports and the outcomes of all completed animal studies shall, however, be reported to all members at the next meeting of the Committee. Where possible, consensus should always be sought on urgent issues arising between meetings by electronic communication between the Chairman and ECRA members.

11.7 Co-options
The ECRA is empowered to co-opt additional non-scientist members and professional advisors onto the committee. Such co-options are to be approved by the Board of the MRC.

11.8 Recording of proceedings
Minutes shall be kept which record decisions and all other aspects of the ECRA's deliberations and business.

11.9 Equity in ethical review
The ethical review of proposed animal studies shall be conducted fairly and in a comparable manner. Where possible, decisions on whether or not to approve applications shall be made on the basis of consensus rather than by majority. The decision-making process should systematically evaluate the morally relevant factors which should be assessed. These should be formally documented at ethical analysis meetings. This documentation should be in the form of a checklist to assist in explicitly justifying the choices being made by the reviewing committee. The decisional system to be used is not prescribed. It may, however, be modelled on the decisional system proposed by Stafleu et al. 14 which is appended to these guidelines as Annexure 3.

11.10 Grant application approvals
Special consideration will be given to provisionally approving applications that are required to meet deadlines for grant applications. Such applications, which often propose a series of animal studies, may be provisionally approved subject to their having to undergo a further ECRA review after they have been successfully funded by granting agencies. These applications can be considered by e-mail consultation and communication between the Chairperson and Committee members in order to expedite their provisional approval. However, such provisional approval does not imply that after funding, permission has been granted by ECRA for the studies to proceed.

11.11 Communication with applicants
Researchers and teachers shall be informed of ECRA decisions in writing. No animal-based research, testing or teaching activities may commence before written ECRA approval has been received.

11.12 Adverse decisions and appeal
Although it is rare for a proposal to be judged to be totally unacceptable, it is common for projects to be modified on the advice of the ECRA. If an adverse decision is made, the reasons for this should be conveyed to applicants. They should also be made aware that they are entitled to have such a decision reviewed, and be invited to make written submissions and oral representations to the ECRA. If this is still not successful, the applicants may request that the MRC either seeks external opinion or sets up an ad hoc committee to review the project and the decision.

11.13 ECRA register
A register of all approved projects, with their starting dates, 6-monthly reporting dates and end-of-project reporting dates shall be maintained.

11.14 Monitoring
It is not practical or even feasible for the ECRA to closely monitor the conduct of approved ongoing animal studies. This is a primary responsibility of the animal care staff and the Animal Unit Manager. However, the ECRA should not lose contact with applicants whose studies have been approved. Follow-up, in the form of monitoring replies to questionnaires sent to applicants, shall be done every six months. This will establish whether the project has been completed or abandoned ( in which case a reason should be given), or is still in progress. In these questionnaires researchers and educators will be asked to certify that the animal studies are still being carried out according to the protocol. Any intended modification of the original protocol must be conveyed to the ECRA in writing, and approval thereof be obtained before it is implemented.

11.15 Reports
The ECRA shall report annually to the MRC Board on its membership and numbers of meetings held, and provide a list of titles of projects reviewed. The names of investigators will not be included in these reports. This report should be available for inspection by the public. The only exception to public inspection may be to protect commercial interests. A full record of such research and 6-monthly reporting on such projects must be kept by the ECRA secretariat.