The importance of research is well understood around the country. It is mainly undertaken for the purpose of informing policy makers, so that policies address the needs and the situation of South Africa. As much important, is the quality of research that is undertaken. There are structures that have been established, for the purpose of ensuring that research undertaken in South Africa is of good quality and it is scientifically justified.
The structures, which exist in academic institutions i.e. universities and technikons, research bodies i.e. Medical Research Council, Anglo Gold etc, are called Research Ethics Committees [RECs]. All health related research and research involving animals for the ultimate benefit of human health, that is undertaken in South Africa should be approved by a Research Ethics Committee [REC].
In this update, we introduce the process whereby RECs are audited and accredited by a National Research Ethics Council, appointed by the Minister for Health and coordinated from the directorate: Health Systems Research, Research Coordination & Epidemiology in the National Department of Health.
The process of Auditing and Accreditation of RECs was introduced to research institutions/bodies in a workshop held on the 24th - 25th of February 2003 in Pretoria.
The National Health Research Ethics Committee has completed the document on Ethics in Health Research: Principles, Structures and Processes. The document will be published in 2004
The Directorate: HSSRCE is in the process of developing an electronic registration of all research that is conducted or commissioned out by the Department of Health. This will assist the Directorate in the establishment and maintenance of a proper research database. Currently a consultant had been contracted to develop a data base on HIV and AIDS research.
The HSSRCE Directorate conducts monthly Health Research Forums whereby researchers are invited to present important issues of their research findings to the senior managers of the Department of Health. For more information on research forums contact Claudia Shilumani at (012) 312 0782 or e-mail: Shiluc@health.gov.za
Almost all academic institutions of higher learning has a well established Research Ethics Committee (REC) that ensures protection of human and animal subjects in the design and conduct of research. Currently there are 23 institution based RECs that are known to the Interim National Health Research Ethics Committee (INHREC). The composition and functionality of these committees differs by institutions.
The National Interim Health Research Ethics Committee (INHREC) appointed by the Minister of Health (Dr Manto Tshabalala-Msimang) has among its mandates from Minister of Health, the auditing and accreditation of Research Ethics Committees (RECs) in South Africa.
Auditing and accreditation of RECs is high on the agenda of many countries and institutions, and there is a multitude of documents and procedures worldwide. The process described in the following section has not yet been published, but is suitable for the South African RECs. It will also provide a means of standardising the establishment of RECs i.e.Composition, functions etc.
In addition, the basic values on which audit and accreditation structures and procedures are based are undergoing major changes. In specific, values are shifting from prescription, control and enforcement towards guidance, training, and support.
Clinical trials and drug research in general are economically the most important applications of health research which, in addition, possibly pose the most risk for research participants, relatively standardized procedures (good practice guidelines and standard operating procedures) are in place to guide such research towards adequate ethical review, provided that RECs have the sophistication to deal with the intricacies of such research.
However, the bulk of research conducted in most countries, including South Africa, is not of a clinical trial or drug research nature but may, nevertheless, have substantial impact on health practice.
Although such research may pose risks for individuals and communities, such risks are less likely to be severe. For the ethical review of such research, there are fewer guidelines and established procedures, and review of such research may be less demanding. Consequently, the process of auditing and accreditation of RECs needs to differentiate between these two levels of competence required.
All RECs in South Africa that review research involving human subjects research or research involving animals for the ultimate benefit of human health need to be registered with the Interim National Health Research Ethics Committee, which will later be referred to as the National Health Research Ethics Council upon promulgation of the National health Bill.
Registration is required, in Year 1 (2004), on the basis of voluntary listing; RECs will complete all information requested in a questionnaire prepared by INHREC. Future registration will depend on timely submission of required information.
The criteria for accreditation will be gradually increased, following an annual review of registered RECs, their capacity, and ethical problems experienced nationally and internationally over the year since the last review. Once the first Accreditation Questionnaire has been completed, a much simplified questionnaire focussing on change of status will be required to be completed annually, while every three years a further comprehensive assessment needs to be done to validate the interim change of status reports.
The preparation of the measurable criteria that will be used for accreditation of RECs in the future will be done throughout 2004, by summarizing, interpreting, and contextualising the data from NHREC questionnaires, and the information from the most relevant documentation available globally on the topic of accreditation of RECs.
In principle, the nature of accreditation and audit in South Africa will be one of empowerment, not enforcement, but the latter is not excluded. The proposed council, to be established under the National Health ACT, makes provision for enforcement for which the current INHREC does not have competence. The following structure will be implemented to give effect to this decision:
Two levels of accreditation are created as mentioned in the background, related to competence and expertise required from a REC:
Level 1: RECs that may review health research proposals that do not involve drug research, biomedical research involving human tissues, high-budget research (more than R250.000 per annum), high-technology research (invasive, radiological, radio-active, and other research requiring substantial equipment).
Collaborative international health research, multi-centre studies, and long-term studies exceeding 1 year duration, are also not considered to be within the competence of Level 1 RECs. In brief, Level 1 RECs are meant to review minimal risk research only, and are meant as a stepping stone towards a Level 2 accreditation. Level 1 RECs should err on the side of caution in judging what research they will review.
It is proposed that a REC may be a Level 1 REC for a duration of at least five years, after which it is either promoted to full Level 2 REC status or dis-accredited.
INHREC/NHREC may withdraw accreditation at any time should Level 1 RECs review research that is considered to be outside their level of competence.
Level 2: RECs that may review all types of health research proposal.
For purposes of building capacity in ethics review of health research in South Africa, the accreditation criteria will be divided into minimal (the achievement of which will entitle a REC to be listed as a Level 1 REC) and optimal (the achievement of which will entitle a REC to be listed as a Level 2 REC). At both levels, both audit and enforcement will be introduced, using the same mechanisms and criteria.
For purposes of enabling non-accredited RECs to become accredited RECs, and for Level 1 RECs to advane to Level 2 RECs, the INHREC / NHREC will identify resources, including Standard Operating Procedures, training materials and courses, web-based information, query and appeal procedures, and will include criteria related to training and maintenance of expertise as part of the accreditation criteria to be developed during 2004.
Where needed, INHREC/NHREC will draft, summarize and clarify the legal framework within which RECs will function, in addition to the provisions of the National Health ACT.
Given the increasingly international nature of health research, it is of importance to include international ethics expertise in review of INHREC activities, and of audit and accreditation criteria and procedures. INHREC/NHREC will make proposals for external inputs in its activities.
INHREC/NHREC will periodically appoint from within its members a sub-committee tasked with overseeing the implementation of audit and accreditation:
The first subcommittee on accreditation will consist of the members who were tasked to develop the process.
The actual data collection process will be undertaken by the directorate: Health Systems research, Research Coordination & Epidemiology within the National Department of Health under the guidance of the subcommittee on accreditation;
The legislation required to establish the National
Health Research Ethics Council has not yet been
passed; as a consequence, the INHREC can only
prepare the ground for a system of audit and
accreditation of RECs, it can not make final decisions
on the format, process, and implementation.
The Auditing and Accreditation process is the biggest step by the National Department of Health to ensure that human subjects are protected from exploitation during research.
RECs should see Auditing and Accreditation as a capacity building process rather than a policing one.
Compiled by Claudia Shilumani
Reviewed by Matsie Ratsaka-Mothokoa
For more information, contributions or ideas on this issue of Research Update contact:
The National Department of Health
Directorate: Health Systems Research, Research Co-ordination and Epidemiology
Private Bag X 828
Pretoria
0001
Tel: (012) 312 0782
Fax: (012) 312 0784
Email: HSRRCE@health.gov.za
Research Updates are quarterly publications of the Department of Health, focusing on the important/current research findings.