To examine trends in the numbers of new applications for ethics clearance of health research and associated research ethics committee secretariat activity.
Data were obtained from research ethics committee secretariat databases with ethics approval.
General research applications increased from 440 in 2002 to 685 in 2011, all handled by one full-time staff member. This load is expected to increase by 250 per year for 2012, 2013 and 2014 before reaching a plateau. This new applications load per year is based on registered clinical postgraduates at the University of the Witwatersrand in a 4-year specialisation who must comply with the new Health Professions Council of South Africa requirement for completion of Master’s level research in order to register as a clinical specialist. Sponsored clinical trials have remained and should remain at approximately 100 per year but require three staff members to attend to this workload.
The increased workload is a serious challenge and has to be tackled first by increasing the administrative staff number.
Ethics screening of human research at the University of the Witwatersrand (Wits) began in October 1966 when John Hansen, head of the Department of Paediatrics, brought an important article in the June issue of the New England Journal of Medicine to the attention of the University authorities. In this article, Henry Beecher, Emeritus Professor of Anesthesiology at Harvard University, had described instances of unethical research and recommended the establishment of committees to oversee the rights of those participating in research.1 Wits agreed to form a human research ethics committee, which has functioned ever since and is currently registered for all types of research including clinical trials.
The committee, based centrally in the Wits Research Office (WRO), was reorganised in 1998 when a secretariat for sponsored clinical trials was formed in the Wits Health Consortium Ethics Division (WHCED), a Section 21 company in the Faculty of Health Sciences. Both secretariats serve the same Human Research Ethics Committee (Medical) (HREC (Medical)).
The committee has 37 members of various disciplines, includes members from outside Wits, and meets on the last Friday of January through November. Member attendance at meetings varies from 12 to 27. The first part of the meeting deals with clinical trials through the WHCED followed by general research applications from WRO. If an application is submitted as required by the 7th of a month through either secretariat, it is discussed at the same month’s meeting January through November.
During 2011, there was an increase in complaints from applicants about delays before hearing the outcome of general research applications – this prompted the 10-year review of application numbers and workload at both secretariats reported in this article.
Cleaton-Jones P (2012) Applications and secretariat workload at the University of the Witwatersrand Human Research Ethics Committee (Medical) 2002 – 2011: A case study. South African Journal of Bioethics and Law. 5(1) pp38-44 ISSN 1999-7639
Publisher (Open access): http://www.sajbl.org.za/index.php/sajbl/article/view/194/202