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assurance in research (Lavery et al., 2004). A study on monitoring clinical research at St Mary’s Hospital Centre, Montreal, revealed flaws in the consent process: 3.8% of the consent forms used were different from the one approved, and there was a discrepancy between the age of participants and the age criteria specified in the protocol in 1.3% (McCuster, 2001). Deviation from the original research protocol without the approval of the RECs was reported in research by Weijer et al. (1995). It is obviously imperative that the ethics of research be monitored to safeguard both the participants and the clinical research enterprise itself. The enormous workload associated with monitoring as many as 1 500 projects per year, as is the case with the HREC of the University of the Witwatersrand (Cleaton-Jones and Vorster, 2008), remains a considerable challenge.
Recent amendments to the Helsinki Declaration leave little room to manoeuvre on the use of placebos in clinical trials. It states that “a new intervention must be tested against the best current proven intervention.” A placebo is acceptable “where no current proven intervention exists” or where its use is necessary to determine an intervention’s efficacy (Normile, 2008).
The stringent stipulations of the Helsinki Declaration have resulted in the FDA allowing applicants for new drug approvals to bypass the Helsinki Declaration, and instead to comply with the ICH-CGP when conducting trials outside the US (Normile, 2008). This lack of universal uniformity in review standards creates inconsistencies in review processes that could harm the research enterprise.
While the FDA’s approach is less rigorous and more flexible and hence could facilitate research, there is a concern that this may be happening at the cost of compromising ethics.
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serious problem. Much attention is accordingly being given to signed ‘conflict of interest‘ statements required of all authors before publication.
While this has not yet been an issue in South Africa, careful attention needs to be given to the ethics of publishing, both within institutions and by regulatory bodies.
CONCLUDING REmARKS
Because clinical research is a social contract, ethical oversight is imperative as it is a public affirmation by RECs of their commitment to the ethical conduct of experimentation involving humans. Identifying and overcoming barriers to the successful conduct of research plays an important role in promoting and safeguarding the clinical research enterprise. Addressing the challenges at different levels in research in South Africa would assist in allowing clinical research to flourish.
Establishing new or strengthening existing programmes on research methods and ethics would be invaluable in promoting clinical research both at undergraduate and postgraduate levels. Incorporating ethics into research methodology would also be a major objective of any such programme.
Institutions and the Department of Health must support REC functioning both from an administrative and review perspective. RECs cannot continue to be viewed as committees with simple administrative functions. Where necessary, RECs should be able to carry out consultations with experts. Post-approval responsibilities, including passive and active monitoring of approved research by RECs, must also be adequately supported. Perhaps the time has also arrived for RECs to employ full-time, salaried reviewers, possibly drawn from the growing pool of retired experts.
Understanding and correctly implementing national and international regulations and guidelines by REC members serves to facilitate rather than hinder clinical research. Focused, ongoing educational programs for REC members on ethics protocol review, current and past ethics research discourse
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and debate and ethics regulation are necessary to ensure competent, high-quality review, which should itself be subject to quality assurance at predetermined intervals.
Empirical research on REC functioning and the ‘life-cycle’ of clinical studies, from application for ethics review and clearance up to publication, is much needed, as is research and evaluation of ethics training curricula with regard to impact and implementation, at both researcher and REC levels.
Creation of a central REC to overcome multiple obstacles encountered by researchers in multi-centre projects is recommended. A centralised REC, through a versatile combination of centralisation, specialisation and management, could expedite multi-centre research, lessen the workloads of submitters and enable better coordination of study start-ups at multiple sites across regions (Chaddah, 2008). The role of the local RECs would then merely be to ensure that the research takes into consideration local nuances specific to the local context.
Adopting a system of expedited review for minimal-risk research could result in a significant reduction in the turn-around time for relatively innocuous studies.
FINDINGS
1. Research should be viewed as a social enterprise, i.e. a contract with society whereby ethically conducted research will serve to assure society that individuals will not be harmed.
2. The primary function of Research Ethics Committees (RECs) is thus the protection of research participants, including adequate scientific review for excellence and relevance.
3. The laws governing the conduct of research in South Africa are generally adequate, as are the institutional provisions for ethics governance and regulation. The National Health Act has set the standards for ethics
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in research, but implementation of these standards is far from being realised.
4. While legislative changes have resulted in increasing numbers of research projects requiring ethics review and approval, there has not been a parallel increase of support for REC functioning, resulting in often unnecessary delays (this is particularly problematic regarding multi-centre studies).
5. Very few RECs are in a position to honour their obligations to monitor and provide oversight for the research they approve, despite the fact that the majority of REC members in South Africa are health scientists and clinicians and that RECs operate largely within university environments.
6. The shift of clinical trial commissioning from academic institutions to the private sector weakens the access of academic institutions to funding and their ability to develop research capacity.
7. Only a handful of core researchers are doing trials, and those that do conduct too many trials concurrently.
RECOmmENDATIONS
1. Institutions and the Department of Health must support RECs both from an administrative and review perspective.
2. This includes post-approval responsibilities, including passive and active monitoring of approved research; the monitoring and evaluation of REC functioning; and making information about clinical research more widely available.
3. The operational independence of the National Health Research Ethics Council should be maximised, while emphasising its overall accountability to government and society.
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4. The National Health Research Ethics Council should register and accredit RECs and expedite their ability to process applications.
5. A system of expedited review for minimal risk research could result in a significant reduction in the overall turn-around time of study proposals.
6. Institutions and RECs should collaborate to reduce duplication in ethics review in South Africa and thus facilitate multi-centre studies.
7. Focused, ongoing educational programmes for existing and potential REC members on ethics protocol review, current and past ethics research discourse and debate, and ethics regulation are required to ensure competent, high-quality review, which should itself be subject to quality assurance at predetermined intervals.
8. Editors of journals publishing clinical research should maintain strict surveillance of conflicts of interest and inappropriate interference with publishing by sponsors.