versão On-line ISSN 2078-5135
SAMJ, S. Afr. med. j. vol.100 no.11 Cape Town Nov. 2010
Accreditation of training courses in good clinical practice
To the Editor: The Medicines Control Council of South Africa requires health care professionals and others involved in conducting clinical studies to attend a training course in good clinical practice (GCP) every 3 years. The need for standardised training and accreditation in South Africa is recognised.1 However, the way in which the accreditation of training courses is to be implemented from 2011 will result in conflicts of interest that would be best avoided.
The National Health Research Ethics Council (NHREC) has decided that the South African Clinical Research Association (SACRA) should serve as the oversight body for the accreditation of GCP courses that relate to GCP training in South Africa. SACRA will organise a committee of stakeholders to give input into the process. SACRA is a non-profit and capable organisation, but is strongly linked to the pharmaceutical industry (pharma) and commercial research organisations (http://www.sacraza.com).
There are many stakeholder sin research, each with specificinterests- governments, institutions, commercial sponsors, participants and others. These interests may conflict with each other.2,3 It is arguably unethical to single out any one player to have the predominant role, whether it be industry, government or any single university.
Pharma can take pride in its many achievements to improve health care. Pharma validly promotes clinical research for scientific and commercial reasons. The latter may, however, result in a conflict of interests, if pharma were to have a predominant influence in accrediting the training courses for such research. Notwithstanding the intention to meet high ethical standards, there are many examples in clinical research and elsewhere of misjudgements and mishaps that have arisen through neglect of avoidable conflicts of interest.
Potential unwanted and unintended consequences include bias in the accreditation of lecturers linked to industry or of lecturers who do not have the appropriate depth of knowledge - for example data handlers, although very skilful in their own areas of expertise, may be accredited to lecture on subjects such as the scientific method or on ethics, which require a sound academic grounding. In addition, the marketing divisions of pharma may have interests in supporting those who spend more heavily on their products so that there is a risk of selective funding to attend SACRA-organised meetings - a possible platform for the selection and functioning of the working committee.
It is possible to resolve real and potential conflicts of interest in a more inclusive and transparent manner that satisfies ethical norms and also meets the requirements of pharma. Oversight of accreditation might take place through independent professional organisations such as the Colleges of Medicine of South Africa or a continuing medical education (CME) group linked to the South African Medical Association. Under this umbrella, there could be collaborative involvement of universities, industry, researchers and ethicists.
It is recognised that the problem of oversight may be related in part to inadequate funding for bodies fulfilling regulatory roles. This could be addressed by government and industry at a cost that would be a small fraction of the overall budget for research. The separation of funding and course content by means of an unrestricted grant, coupled with disclosures of financial interests by lecturers, is common practice in CME.
All stakeholders wish to take clinical research forward for the benefit of patients and to have high-quality training courses in GCP. Vigilance is required to avoid the conflicts of interest that will inevitably arise from a single stakeholder having a predominant role.
Raymond P Abratt
Alistair J Hunter
Groote Schuur Hospital and
University of Cape Town
1. Burgess LJ, Sulzer NU. GCP accreditation - a worthwhile investment? S Afr Med J 2006;96:161-116. [ Links ]
2. Shuchman M. Commercializing clinical trials - risks and benefits of the CRO boom. N Engl J Med 2007;357:1365-1366. [ Links ]
3. Piccart M, Goldhirsch A. Keeping faith with trial volunteers. Nature 2007;446:137-138. [ Links ]