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stated, however, that the danger with this division is that it could encourage the diversion of resources from areas of greater need to minimal or no-risk research (Gunsalus, 2006; Boronstein, 2007) because of the perception that there would be less stringent review. Other concerns include the fact that the accreditation systems could reduce the number of operating RECs and discriminate against historically disadvantaged institutions (Moodley and Myer, 2007).
ETHICS GOVERNANCE: REC COMPOSITION, FUNCTIONS,
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establish and maintain a REC in accordance with national and international norms and standards. A further obligation placed on institutions is that they accept legal responsibility for the decisions and advice received from the REC, and that they also indemnify the REC members.
A REC should thus consist of members who collectively have the qualifications and experience to review and evaluate the science, health aspects and ethics of proposed human-subject research, and should be independent, multidisciplinary, competent and pluralistic. The REC must be representative of the communities it serves and, increasingly, reflect the demographic profile of the population of South Africa, and must include:
1. Members of both genders, although not more than 70% should be either male or female;
2. At least nine members, with 60% constituting a quorum;
3. At least two lay persons who have no affiliation to the institution, are not currently involved in medical, scientific or legal work and are preferably from the community in which the research is taking place;
4. At least one member with knowledge of, and current experience in, areas of research that are likely to be regularly considered by the ethics committee;
5. At least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people. Such a member might be, for example, a medical practitioner, psychologist, social worker or nurse;
6. At least one member who has professional training in both qualitative and quantitative research methodologies;
7. At least one member who is legally trained.
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Most of the RECs in the country that are affiliated to health sciences institutions have organised, or are currently in the process of organising, their membership and standard operating procedures to be in line with these guidelines and the National Health Act. At most institutions, however, support for, and commitment to, these processes lag far behind. Furthermore, REC workloads are also increased as a result of the breadth of the definition of health research, resulting in an ever-larger number of studies being submitted for ethics review and approval. Local REC members undertake their work in nearly all cases as volunteers, over and above their daily professional activities (Cleaton-Jones, 2007). REC members are usually faculty staff who struggle to combine their busy service commitments with REC activities.
The size of REcs in Africa ranges from nine to 31 members, with the majority of members being clinicians and physicians (Kass et al., 2007). RECs in South Africa typically comprise seven to 29 individuals, with a median of 16 members (Moodley and Myer, 2007) of which 46–82% are men and 18–54% are women.
None of the RECs in Africa require gender balance, although all consciously include women (Kass et al., 2007), save for South Africa which has regulations stating that not more than 70% should be of the same sex (Article 4.1, Ethics Guidelines, 2004). The majority of REC members in South Africa are health scientists/clinicians who make up 61% of membership, compared with 49%
in the US (Moodley and Myer, 2007), with ethicists being under-represented (Milford et al., 2006). There is usually a provision for at least 25% lay member representation to prevent intimidation of lay members during REC deliberations.
While regulations require that lay members should be part of the community being researched, Moodley and Myer (2007) showed that this is not always the case. Most RECs have at least one full-time administrative staff member.
The skewed composition of RECs results in a lack of expertise on RECs in many African countries, which impedes research (Ikungura et al., 2007). In South Africa, lack of diversity of expertise within RECs is attributable to the nature of the faculty community where most of these committees are housed (Moodley and Myer, 2007). It is questionable whether RECs have adequate capacity for effective assessment of ‘non-biomedical’ protocols (Boronstein, 2007). Lack
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of diversity on the RECs, which are typically made up of researchers and physicians, leads to bias towards quantitative research (Green et al., 2006:215;
Milford et al., 2006), and a tendency to engage mainly with technical issues that fall outside the expertise of non-scientists (Schuppli and Fraser, 2007).
Lack of expertise, accountability and open dialogue is also prominent in self-appointed private commercial and non-commercial RECs (Milford et al., 2006). Some private RECs have full-time members and review protocols more frequently (Moodley and Myer, 2007).
How members are appointed onto the RECs determines the expertise that exists in these committees. The Portuguese government nominates all 34 members of a central ethics committee in Portugal – the Ethics Committee for Clinical Investigation (CEIC) (Hedgecoe, 2006). The appointment of members of both the central ethics committee and local ethics committees in Sweden is by the Swedish Government (Hedgecoe, 2006). In Canada, university administrators, such as the vice-president of research, are formally responsible for appointing members, but the committees themselves tend to forward names (Schuppli and Fraser, 2007). The UK’s central ethics committee, the UK Ethics Committee Authority (UKECA), comprises the Secretary of State for Health and representatives from the National Assembly of Wales, the Scottish Ministers and the Department of Health (Hedgecoe, 2006) who are politicians. In South Africa, members of the NHREC are ministerial appointees (section 72, National Health Act). Membership of local RECs is determined by the respective institutions according to their individual policies.
The political appointment of members to an REc poses some challenges which could effect its integrity, independence and efficiency. It could also negate the multidisciplinary and multi-sector framework that is vital for good REC functioning (Van Bogaert and Tangwa, 2007). Politically sensitive research could in effect be censored because of the REC review process (Hamburger, 2004: Boronstein, 2007) as the committees would be vulnerable to political manipulation. Abuse of power in selectively choosing which research should be approved, coupled with a shortage of avenues for appeals against an REC decision, could stifle research (Boronstein, 2007).
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In the case of some RECs, recruiting of members is by word of mouth (Schuppli and Fraser, 2007). This means that membership is open to people with various motives other than promoting the mandate of the REC (Schuppli and Fraser, 2007). Most REC members do not have a stipulated tenure. Low turnover of membership may stifle the introduction of new ideas, limit the possibility of new volunteer membership, and increase the risk of indoctrination (Schuppli and Fraser, 2007). Some senior faculty within institutions avoid serving on RECs as they feel constrained in exercising their autonomy because of the bureaucratic requirements of regulations governing RECs, which they perceive as focusing on unimportant minutiae (Fost and Levine, 2006).