MEDICAL RESEARCH COUNCIL OF ZIMBABWE

Establishment

The Medical Research Council of Zimbabwe, which is the National Ethics Committee (NEC) was established in 1974 in terms of the Research Act of 1959 and Government Notice Number 225 of 1974 in order to provide health researchers and institutions which/in which health research is conducted, with independent ethical advice on research conducted by those researchers or by/within those institutions. The MRCZ is established and supported by the Government of Zimbabwe through the Ministry of Health and Child Welfare. The MRCZ is composed of scientists, medical experts, ethicists, patient representatives, and community representatives. It is independent in its reflection, advice, and decision. The MRCZ depends on annual grant from the Ministry of Health and Child Welfare as well as donations from well-wishers. The MRCZ also raises income through other means such as charging for services rendered. Donations in any form are most welcome.

Objectives

The MRCZ is established in order to among other functions, provide independent guidance, advice, and decision on biomedical research conducted/carried out within Zimbabwe by all researchers and institutions, as well as ethical advice on issues presented to it by the Institutional Ethical Committees that exist within the various health institutions in Zimbabwe. The MRCZ's functions are similar to those of an institutional review board (in USA). The Medical Research Council of Zimbabwe undertakes the following specific tasks:

• To keep under review medical research in Zimbabwe with particular attention to that research important to the health needs of the country.
• To provide guidance, advice, and decision (in the form of 'approval /disapproval') of specific research protocols intended to be conducted in Zimbabwe by all researchers and health institutions.
• To provide ethical guidance and advice on research programmes undertaken by researchers within Zimbabwe.
• To provide an ethical review and monitoring body to ensure the protection of the rights of the individuals involved in research as subjects.
• To monitor and facilitate the functioning of Institutional Review Boards in the protection of human subjects of research.
• To provide ethical guidance and advice on specific ethical issues presented to it by the IERCs and any other interested parties.
• To develop and /or review, as requested, ethical guidelines for Zimbabwe.
• To promote all aspects of Medical Research hence ensuring maximum co-operation and co-ordination between individuals and groups undertaking research.
• To especially support with guidance and funding research devoted to the critical areas of Health in Zimbabwe.

The MRCZ is particularly concerned with research that addresses issues that are of relevance to Zimbabwe. The MRCZ presents the conclusions of its reflections to the applicants (Principal Investigators) in the form of an independent decision (approval/disapproval or positive/negative advice).

Principles and Procedures

The MRCZ recognizes that the protocols it approves may also be reviewed by other ethics committee prior to their implementation in specific localities. In evaluating protocols and ethical issues, the MRCZ is mindful of the laws and practices governing research and medical practice in Zimbabwe as well as international guidelines. It keeps itself informed of the requirements and conditions of research in Zimbabwe regarding the research it considers. The MRCZ also seeks to be informed as appropriate, of the outcome of the research it has approved.

The MRCZ is guided in its reflection, advice, and decision by the ethical principles expressed in the Declaration of Helsinki as well as the CIOMS guidelines. It makes further reference to other international and national research guidance documents.

The MRCZ establishes its own standard operating procedures based on the Operational Guidelines for Ethics Committee That Review Biomedical Research (WHO TDR) and the WHO & ICH Guidelines for Good Clinical Practice.

The MRCZ has obtained recognition from the US Office for Human Research Protections (OHRP) and is established and functions in accordance with Zimbabwean Laws.

In providing assurances of the good functioning of its operations, the MRCZ refers to the Complementary Guidelines for Surveying and Evaluating Ethical Review Practices (WHO TDR).

Method of Working

• The Committee will need substantial administrative and secretarial assistance from the Research Office.
• Authors of research proposals may be invited to attend meetings of the EC when their study is being reviewed.
• Some business may be conducted by mail, but reasonably frequent meetings are essential to allow committee ethos to develop.
• A quorum should include a lay person, a research oriented member who is broadly familiar with the proposed field of study, and a member of each gender.
• Decisions will be made normally by consensus.
• The Chairman's approval may be given for studies that pose no ethical problems.
• Such approvals shall be reported to the next meeting of ERC for ratification.
• Investigators are entitled to have an adverse decision reviewed, and to make written and/ or oral representations to the Committee.
• The Committee may withdraw approval if dissatisfied with the conduct of the investigation.
• The ERC should approve amendments to protocols that affect human subjects.
• Confidentiality of the Committee's proceedings should be preserved.
• Members of the Committee should declare their own interests, for example when testing of the product of a company of which the member is an advisor.
• Serious adverse events should be reported promptly to the Chair.
• Members should not be paid; however, if honorarium is necessary, then it should be modest.

Composition

The MRCZ is composed of fourteen (14) members nominated by the various constituencies represented on the Council, and appointed by the Minister of Health and Child Welfare. Members are nominated and selected for appointment in their personal capacities, based on their interest, ethical and / or scientific knowledge and expertise, as well as on their commitment and willingness to volunteer the necessary time and effort for the MRCZ's work.

Members must disclose any interest or involvement (financial, professional or otherwise) in a project or proposal under consideration. The MRCZ will decide the extent to which members that might have a conflict of interest may participate in bringing out a decision.

Members will be required to sign a confidentiality agreement at the start of their term. The confidentiality agreement protects the privacy and confidentiality of all parties whose information may be disclosed to the MRCZ in the course of its work.

The MRCZ is wholly made up of volunteer individuals from the government, the private sector and the universities. The Council is constituted as follows:

1. one member is the Secretary for Health and Child Welfare (Ex officio)
2. three are nominated by the University of Zimbabwe
3. two are nominated by the Zimbabwe Medical Association.
4. one is nominated by the National Association of Medical Aid Societies
5. one is nominated by the Life Offices Association of Zimbabwe and
6. four are appointed by the Minister of Health and Child Welfare.

Council members work on part-time basis as they are engaged on full time basis elsewhere. The MRCZ has a small secretariat consisting of a Liaison Officer and a Secretary who execute the decisions of the Council and co-ordinate its work. The present Council was constituted in 2000 for a four year term of office. Members do not participate in the voting on their own protocols. Such protocols are discussed at the end of the meeting during which time such members are required to recuse themselves from the meeting.

Members of the Council

The professions represented by the members at all times include the following:

• community representatives
• members with clinical or research experience
• ethicists
• physicians

Members are appointed for a period of 4 years. Their appointments may be renewed by the Minister of Health and Child Welfare. The Minister ensures some rotation after each three-year period, but also strives to ensure continuity within the Council.

The MRCZ may be further supported in its reflections on specific protocols or requests for advice on specific ethical issues by Independent Consultants. Independent Consultants are nominated by the Council and appointed by the Chairman of the MRCZ. Their professional qualifications may be in the areas of community and /or community representative, medicine, statistics, social science, law, ethics, religion. Independent Consultants are appointed for the duration of the period sought or to specifically assist in the review of a particular protocol.

MRCZ Contact Information

As a semi-autonomous body with its own secretariat, the MRCZ is headed by the Liaison Officer who is responsible to the Chairman. The Secretariat operates on full time basis and executes all the decisions of the Council. The Secretariat is headed by Paul Ndebele who has been trained in research ethics.

Downloadable Forms and Guidelines (PDF format)

Form: Application to Conduct Research
Form: Continuing Annual Review
Form: Amendment/Change
Form: Reviewers' Evaluation
Guidelines for Researchers and Ethics Committees

Contact Information

Medical Research Council of Zimbabwe
c/o Blair Research Institute
Corner J. Tongogara Ave/Mazowe Street
P O Box CY573
Causeway
Harare

Tel 263 4 791792
Fax 263 4 736 919

E-mail :
mrczimbabwe@yahoo.com
pndexas@yahoo.com