Strengthening research ethics oversight in Africa: The Kenyan example
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Abstract
Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level.
Objectives. To describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country.
Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals.
Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing.
Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity.
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References
Weigmann E. The ethics of global clinical trials. EMBO Reports 2015;16:566-570.
https://doi.org/10.15252/embr.201540398
Fekadu A, Teferra S, Hailu A, et al. International Clinical Trial Day and clinical trials in Ethiopia and Africa. Trials 2014;15:493. https://doi.org/10.1186/1745-6215-15-493
Livi-BacciM.AConciseHistoryofWorldPopulation.NewJersey:JohnWiley&Sons, 2017.
Bairu M, Chin R, eds. Global Clinical Trials Playbook: Capacity and Capability Building. Amsterdam: Elsevier, 2012.
Nabyonga-Orem J, Asamani JA, Makanga M. The state of health research governance in Africa: What do we know and how can we improve? Health Res Pol Sys 2021;19(1):1.
Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: A perspective. Curr Opin Cardiol 2009;24(4):295-300. https://doi. org/10.1097/HCO.0b013e32823af21b6.
Castaneda Aguilar RA, Lakner C, Prydz E, et al. Estimating Global Poverty in Stata: The PovcalNet Command. Washington, DC: World Bank, 2019.
KrugerM,NdebeleP,HornL,eds.ResearchEthicsinAfrica:AResourceforResearch Ethics Committees. Stellenbosch: Sun Media, 2014:4-10.
Washington HA. Medical Apartheid. New York: Anchor Books, 2006:392‐393.
Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V. Ethics Dumping: Case Studies from North-South Research Collaborations. Cham, Switzerland: Springer Nature, 2020.
Chatfield K, Schroeder D, Guantai A, et al. Preventing ethics dumping: The challenges for Kenyan research ethics committees. Res Ethics 2021;17(1):23-44. 12. Benatar SR. Reflections and recommendations on research ethics in developing countries. Soc Sci Med 2002;54:1131‐1141.
Silaigwane B, Wassenaar D. Biomedical research ethics committees in sub-Saharan Africa: A collective review of their structure, functioning and outcomes. J Empir Res Human Res Ethics 2015;10(2):169-184.
Mokgatla B, Ijsselmuiden C, Wassenaar D, Kasule M. Mapping research ethics committees in Africa: Evidence of the growth of ethics review of health research in Africa. Dev World Bioethics 2018;18:341-348.
Wassenaar D. South African Research Ethics Training Initiative (SARETI). S Afr J Bioethics Law 2011;4(2):107-108.
Keymanthri M, Rennie S. Advancing Research Ethics Training in Southern Africa (ARESA). S Afr J Bioethics Law 2011;4(2):104-105.
Training and Resources in Research Ethics Evaluation (TRREE). https://elearning. trree.org/ (accessed 5 May 2023).
Global Health Network. Global Health Training Programme. https://
globalhealthtrainingcentre.tghn.org/elearning/research-ethics/ (accessed 5 May 2023). 19. Collaborative Institutional Training Initiative (CITI). https://www.citiprogram.org/
(accessed 5 May 2023).
National Institute of Health (NIH). NIH research ethics training. https://
researchethics.od.nih.gov/ (accessed 5 May 2023).
Family Health International. https://www.fhi360.org/countries/kenya (accessed
May 2023).
National Bioethics Committee, National Commission for Science, Technology and
Innovation. Training Guide for Institutional Ethics Review Committees in Kenya.
Nairobi: NBC/NACOSTI, 2020.
Kabeyi MJB. Organisational strategic planning, implementation and evaluation
with analysis of challenges and benefits. Int J Applied Res 2019;5(6):27-32.
Akyar I. Standard operating procedures (What are they good for?) In: Akyar I, ed.
Latest Research in Quality Control. Turkey: IntechOpen Books, 2012:368-390.
DaviesH,WellsF,DrumlC.Howcanweprovideeffectivetrainingforresearchethics committee members? A European assessment. J Med Ethics 2008;34:301-302.