Challenges Encountered when Applying for the Ethics and Permission to Conduct the Non-Clinical Trial Study in the Hospitals and Clinic

Download Article

Authors : Michael Sello Seahloli


A case study on the process of applying for ethical and provincial clearance to conduct a medical informatics research for a PhD programme in South African Hospitals. The programme was looking for current status of medical informatics and implementing electronic healthcare record, challenges, and future direction in South Africa. Nine provinces were contacted and all approved the study, however, the approval was obtained after averaged of 9 months which was longer than expected. The public hospital CEOs and medical managers were also contacted to acknowledge participation and give clearance for the study to be conducted at hospitals. After an average of 3 months to give clearance and out of 40 hospitals contacted only 70% acknowledged. Overall the process took longer than expected to approve a non-clinical trial study for academic purpose. This has delayed the start of the PhD research program and the challenges encountered in the provinces applications are due to autonomy and lack of standardisation of procedure between the provinces, lack of understanding the procedure of the study by the province personnel and hospitals, lack of expertise in handling electronic submissions and non-clinical trial submissions. IT is still a challenge to most of government employees and the infrastructure that can accommodate amount of information.


Ethics committee, South African Provincial clearance, Hospital clearance.


1.      Angell E and Dixon-Woods M. 2009. Do research ethics committees identify process errors in applications for ethical approval? J Med Ethics; Vol 35: pp 130-132.

2.      Baird D and van Niekerk D. 2004. The regulation of clinical trials in South Africa. Qual Assur J; Vol 8: pp 33-36.

3.      Bollyky TJ, Cockburn IM and Berndt E. 2010. Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases. Clin Trials; Vol 7, Issue 6: pp 719-734. []

4.      Burman W, Breese P, Weis S. et al. 2003. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials. Vol 24, Issue 3: pp 245–55.

5.      Clarke DL; 2014, Auditing the process of ethics approval for Master’s degrees at a South African university; S Afr J BL; vol 7, issue 1: pp 23-25. DOI:10.7196/SAJBL.301

6.      Cleaton-Jones P; 2010, Process error rates in general research applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand: A secondary data analysis.S Afr J BL; vol 3, issue 1: pp 20-24.

7.      Cleaton-Jones P and Vorster M. 2008. Workload of a South African university-based health research ethics committee in 2003 and 2007. S Afr J BL; vol 1, issue 2: pp 38-43.

8.      Deldenhuys H, Veldsman A, Tameris M, Luabeya A, Hanekom W, Mohomed H and Hatherill M. 2013. Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa. SAMJ, Vol 104 Issue 2: pp 85-89. DOI:10.7196/SAMJ.6390

9.      Dixon-Woods M, Angell E, Ashcroft RE and Bryman A. 2007. Written work: the social functions of research ethics committee letters. Soc Sci Med; Vol 65: pp 792-802.

10.  Dixon-Woods M, Angell E, Tarrant C and Thomas A. 2008. What do research ethics committees say about applications to do cancer trials? Lancet Oncology; Vol 9: pp 700-701. http://www.thelancet/oncology.

11.  Graham DG, Pace W, Kappus J, et al. Institutional Review Board Approval of Practice-based Research Network Patient Safety Studies; Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues); pp 453-465.

12.  Ndebele P, Blanchard-Horan C, Shahkolahi A and Sanne I. 2014. Regulatory Challenges Associated With Conducting Multicountry Clinical Trials in Resource-Limited Settings. J Acquir Immune Defic Syndr; Vol 65: pp 29–31.

13.  Wolf LE, Croughan M, Lo B. 2002. The challenges of IRB review and human subjects protections in practice-based research. Med Care; Vol 40, issue 6: pp 521–529.