Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols
Restricted accessResearch articleFirst published online April, 2019
Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols
In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.
AdamsP.PrakobthamS.LimphattharacharoenC.SuebtrakulS.VutikiesP.KhusmithS.. . . KaewkungwaJ. (2017). Ethical issues of informed consent in Malaria research proposals submitted to a research ethics committee in Thailand: A retrospective review. BMC Medical Ethics, 18(1), Article 50.
2.
AmdurE. A.BankertR. J. (2006). The institutional review board: Definition and federal oversight. In BankertE. A.AmdurR. J. (Eds.), Institutional review board: Management and function (2nd ed., pp. 24-25). Sudbury, MA: Jones & Bartlett Learning.
3.
AngellE. L.BrymanA.AshcroftR. E.Dixon-WoodsM. (2008). An analysis of decision letters by research ethics committees: The ethics/scientific quality boundary examined. Quality and Safety in Health Care, 17, 131-136.
4.
BarsdorfN.MillumJ. (2017). The social value of health research and the worst off. Bioethics, 31, 105-115.
BlackwoodR. A.MaioR. F.MrdjenovichA. J.VandenBoschT. M.GordonP. S.ShipmanE. L.HamiltonT. A. (2015). Analysis of the nature of IRB contingencies required for informed consent document approval. Accountability in Research, 22, 237-245.
7.
BoyceM. (2002). Observational study of 353 applications to London multicentre research ethics committee 1997-2000. British Medical Journal, 325, 1081-1082.
8.
BuenoM.BrevidelliM. M.CocarelliT.Silva dos SantosG. M.FerrazM. A.MionD. (2009). Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil. Clinics, 64, 831-836.
9.
ClarkeD. L. (2014). Auditing the process of ethics approval for Master’s degrees at a South African university. South African Journal of Bioethics and Law, 7(1), 23-25.
10.
Cleaton-JonesP. (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. South African Journal of Bioethics and Law, 3(1), 20-24.
11.
Cleaton-JonesP.WassenaarD. (2010). Protection of human participants in health research—A comparison of some US federal regulations and South African research ethics guidelines. South African Medical Journal, 100, 712-716.
Dal-RéR.MorejónE.OrtegaR. (2004). Nature and extent of changes in the patient’s information sheets of international multicentre clinical trials as requested by Spanish research ethics committees. Medicina Clínica, 123, 770-774.
14.
DawsonA. J.YentisS. M. (2007). Contesting the science/ethics distinction in the review of clinical research. Journal of Medical Ethics, 33, 165-167.
15.
DecullierE.LhéritierV.ChapuisF. (2005). The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: A retrospective cohort study. BMC Medical Ethics, 6, Article 9. doi:10.1186/1472-6939-6-9
16.
De JongJ. P.Van ZwietenM. C. B.WillemsD. L. (2012). Ethical review from the inside: Repertoires of evaluation in research ethics committee meetings. Sociology of Health & Illness, 34, 1039-1052.
Dixon-WoodsM.AngellE.AshcroftR. E.BrymanA. (2007). Written work: The social functions of research ethics committee letters. Social Science & Medicine, 65, 792-802.
19.
EdwardsS. J. L. (2010). The role, remit and function of the research ethics committee—2. Science and society: The scope of ethics review. Research Ethics, 6, 58-61.
20.
EmanuelE. J.CrouchA. R.ArrasD. A.MorenoD. J.GradyC. (2003). Ethical and regulatory aspects of clinical research: Readings and commentary. Baltimore, MA: Johns Hopkins University Press.
21.
EmanuelE. J.WendlerD.GradyC. (2008). An ethical framework for biomedical research. In EmanuelE. J.GradyC.CrouchR. A.LieR. K.MillerF. G.WendlerD. (Eds.), The Oxford textbook of clinical research ethics (pp. 123-133). New York, NY: Oxford University Press.
22.
EmanuelE. J.WendlerD.KillenJ.GradyC. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. The Journal of Infectious Diseases, 189, 930-937.
23.
Fernandez LynchH. (2018). Opening closed doors: Promoting IRB transparency. The Journal of Law, Medicine & Ethics, 46, 145-158.
24.
HappoS. M.HalkoahoA.LehtoS. M.KeranenT. (2016). The effect of study type on research ethics committees’ queries in medical studies. Research Ethics, 13, 115-127. doi:10.1177/1747016116656912
25.
HemminkiE.VirtanenJ. I.RegushevskayaE. (2015). Decisions by Finnish medical research ethics committees: A nationwide study of process and outcomes. Journal of Empirical Research on Human Research Ethics, 10, 404-413.
26.
HumphreysS.ThomasH.MartinR. (2014). Science review in research ethics committees: Double jeopardy?Research Ethics, 10, 227-237.
27.
KlitzmanR. (2015). The ethics police? The struggle to make human research safe. New York, NY: Oxford University Press.
28.
LangatS. K. (2005). Reuse of samples: Ethical issues encountered by two institutional ethics review committees in Kenya. Bioethics, 19, 537-549.
29.
LidzC. W.AppelbaumP. S.ArnoldR.CandilisP.GardnerW.MyersS.SimonL. (2012). How closely do institutional review boards follow the common rule?Academic Medicine, 87, 969-974.
30.
LutgeE.SlackC.WassenaarD. (2017). Defining and negotiating the social value of research in public health facilities: Perceptions of stakeholders in a research-active province of South Africa. Bioethics, 31, 128-135.
31.
Martín-ArribasM.Rodríguez-LozanoI.Arias-DíazJ. (2012). Ethical review of research protocols: Experience of a research ethics committee. Revista Española de Cardiología (English Edition), 65, 525-529.
32.
National Health Act. (2003). South African National Health Act (Act No. 61 of 2003). Pretoria, South Africa: Government Gazette. Retrieved from https://www.gov.za/documents/national-health-act
33.
NdebeleP.WassenaarD.BenatarS.FleischerT.KrugerN.AdebamowoC.. . . HyderA. (2014). Research ethics capacity building in Sub-Saharan Africa: A review of NIH Fogarty funded programs 2000-2012. Journal of Empirical Research on Human Research Ethics, 9(2), 24-40.
34.
Nuremberg Code. (1947). Trials of war criminals before the Nuremberg military tribunals under control council law (Vol. 10). Washington, DC: U.S. Government Printing Office.
35.
O’ReillyM.Dixon-WoodsM.AngellE.AshcroftR.BrymanA. (2009). Doing accountability: A discourse analysis of research ethics committee letters. Sociology of Health & Illness, 31, 246-261.
36.
RussH.BustaS.RiedelA.ZollnerG.JostB. (2009). Evaluation of clinical trials by ethics committees in Germany: Experience of applicants with the review of requests for opinion of the ethics committees—Results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA). German Medical Science, 7, 1-18. doi:10.3205/000066
37.
SatharA.DhaiA.van der LindeS. (2013). Collaborative international research: Ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee. Developing World Bioethics, 14, 150-157.
38.
ShahS.WhittleA.WilfondB.GenslerG.WendlerD. (2004). How do institutional review boards apply the federal risk and benefit standards for pediatric research?Journal of the American Medical Association, 291, 476-482.
39.
SilaigwanaB.WassenaarD. (2015). Biomedical research ethics committees in Sub-Saharan Africa: A collective review of their structure, functioning and outcomes. Journal of Empirical Research on Human Research Ethics, 10, 169-184.
40.
SlackC. (2014). Ancillary care in South African HIV vaccine trials: Addressing needs, drafting protocols and engaging community. Journal of Empirical Research on Human Research Ethics, 9, 83-95.
41.
SofaerN.StrechD. (2011). Reasons why post-trial access to trial drugs should, or need not be ensured to research participants: A systematic review. Public Health Ethics, 4, 160-184.
42.
StarkL. (2012). Behind closed doors: IRBs and the making of ethical research. Chicago, IL: The Chicago University Press.
43.
TersmetteD. G.EngbertsD. P. (2017). Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee. AJOB Empirical Bioethics, 8, 52-57.
44.
TindanaP.MolyneuxC. S.BullS.ParkerM. (2014). Ethical issues in the export, storage and reuse of human biological samples in biomedical research: Perspectives of key stakeholders in Ghana and Kenya. BMC Medical Ethics, 15, Article 76. doi:10.1186/1472-6939-15-76
45.
TolichM. (2014). How idiocultures and warrants operate independently in New Zealand health ethics review boards. Research Ethics, 11, 67-81.
46.
Tsoka-GwegweniJ.WassenaarD. R. (2014). Using the Emanuel framework to examine ethical issues raised by a biomedical research ethics committee in South Africa. Journal of Empirical Research on Human Research Ethics, 9, 36-45.
47.
van LentM.RongenG. A.OutH. J. (2014). Shortcomings of protocols of drug trials in relation to sponsorship as identified by research ethics committees: Analysis of comments raised during ethical review. BMC Medical Ethics, 15, Article 83. doi:10.1186/1472-6939-15-83
48.
WassenaarD. R.SlackC. M. (2016). How to learn to love your research ethics committee: Recommendations for psychologists. South African Journal of Psychology, 46, 306-315.
49.
World Health Organization. (2011). Standards and operational guidance for ethics review of health-related research with human participants. Geneva, Switzerland: Author.
