Regulations governing clinical research serve the purpose of providing ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human participants (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice [ICH-GCP]). Failure of the research enterprise might be a reflection of the relative failure of national regulations to have a downstream effect on the practices of research staff (Rab et al., 2008). In South Africa, Chapter 9 of the National health act, Act 61 of 2003, makes the conduct of ethical health research a legal requirement.
Health research is defined in the National Health Act as any research that contributes to knowledge of:
1. The biological, clinical, psychological or social processes in human beings;
2. Improved methods for the provision of health services;
3. Human pathology;
4. The causes of disease;
5. The effects of the environment on the human body;
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6. The development or new applications of pharmaceuticals, medicines and related substances;
7. The development of new applications of health technology.
The rapid proliferation of clinical trials, where clinical trials are defined as a systemic study involving human subjects that aims to answer specific questions about the safety or efficacy of a medicine or method of treatment (section 72(7) of the National Health Act), and the increasingly complex regulations governing research (Chaddah, 2008) have had a negative impact on the continued growth of research. While some concerns have been raised that the protection of research participants is often assumed to be inadequate in the formulation of policy or legislation, other concerns exist that protection programmes result in overregulation, increasing the time and expense devoted to activities of marginal utility in protecting human research participants (Fost and Levine, 2007: 2196).
South Africa has a well-established regulatory process based on guidelines for clinical studies (Scholtz and Pretorius, 2005). Section 12 of the Bill of Rights of the constitution of South africa, Act 108 of 1996, affirms that no one will be involved in medical experimentation without providing informed consent. The National Health Act stipulates the basic ethical requirements in the conduct of research. The principles emphasised in the Act include confidentiality (section 16) when using medical records for research purposes, respect for persons, and autonomy by allowing self-determination in the requirement for written informed consent form (section 71). These principles are also found elsewhere in the regulations governing research in South Africa, including the South african good clinical practice guidelines, 2nd Edition 2006, and the Department of Health’s Research Ethics guidelines, 2004. Enshrined in Chapter 9 of the National Health Act is section 69 which provides for the establishment of a National health Research committee. This committee is mandated in terms of the Act to identify research priorities of the nation (section 70). Realisation of distributive justice is enhanced through this provision as this section serves to eliminate research that is biased towards an elite group while disregarding
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the needs of the poorer communities. Inadequate protection of research participants could have deleterious effects on research, as participants might be less willing to engage in research (Campbell, 2004). Section 72 of the National Health Act provides for the establishment of a National Health Research Ethics Council (NHREC). This Council, which was established in October 2006, has been directed by the Act to establish Research Ethics committees (REcs) accredited with it and to register and accredit existing RECs. Flawed implementation of regulations by local RECs or in the governing regulations themselves where investigators perceive problems could stifle research activities (Whitney et al., 2008: 71). The former is likely to be minimised through the accreditation process when it is implemented, however, as the NHREC will monitor and investigate the policy standards and standard operating procedures, training and capacity building, appeals and subcommittees of local RECs (Article 3.2, Ethics Guidelines, 2004).
The statutory functions of the NhREc include:
a) determining guidelines for the functioning of health research ethics committees;
b) Registering and auditing health research ethics committees;
c) Setting norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials;
d) adjudicating complaints about the functioning of health research ethics committees;
e) hearing any complaint by a researcher who believes he or she has been discriminated against by a health research ethics committee;
f) Referring to the relevant statutory health professional council matters involving the violation or potential violation of an ethical or professional rule by a health care provider;
g) instituting such disciplinary action as may be prescribed against any person found to be in contravention of any norms, standards or guidelines set for the conducting of research in terms of the National health act;
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h) advising the national and provincial departments on any ethical issues concerning research.
The NHREC therefore has obligations to both researchers and research participants to ensure the creation of an enabling environment for the conduct of ethical clinical research. It is imperative that the NHREC is supported by the national Department of Health in implementing its mandate. It is also imperative that implementation is carried out efficiently and without delay and that members of this very important Council have the necessary competence to allow for the optimal functioning of this body. In addition, both researchers and health research ethics committees need to be aware of the NHREC, its mandate and any pertinent ethics guideline documents emanating from it to allow for informed decisions on the ethical aspect of studies. Functional knowledge and understanding of ethics in research on the part of health research ethics committee members would also serve to facilitate the research process rather than stifle it as is currently the common perception. Stifling of research due to a lack of awareness of national and international guidelines by REC members, as reported by Ikungura et al. (2007) for Tanzania (>50%), could be minimised through the accreditation process.
In terms of section 73 of the National Health Act, every institution, health agency and health establishment at which health research is conducted, must establish or have access to a health research ethics committee, which is registered with the National Health Research Ethics Council. The provision further outlines the functions of the RECs, including review of research proposals. Within the South African regulatory framework, limitations are placed on RECs with regard to the type of proposals that they are allowed to review based on their accreditation level. Article 3.3.2 of the Ethics Guidelines (2004) articulates that RECs would be accredited as either level 1 or level 2, depending on the capacity of the committee. Level 1 committees would assess straightforward research designs that involve minimal risk to human participants or low budget research (less that R250 000). Level 2 committees would review all types of health research proposals. This division of committee functioning could help to expedite review of minimal-risk research. It has been
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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).