Strengthening research ethics oversight in Africa: The Kenyan example

• Jurisdiction: South Africa
• Date: 01 April 2023
• Pages: 19-22
• Published date: 01 April 2023
• DOI: 10.7196/SAJBL.2023.v16i1.199

April 2023, Vol. 16, No. 1 SAJBL 19

ARTICLE

Clinical trials are crucial in the research and development of new

health products, and key in the discovery of interventions for

otherwise devastating diseases endemic in Africa, such as malaria,

leishmaniasis, tuberculosis and trypanosomiasis. They bring with

them an accompanying improvement of public health and local

infrastructure, and the economic boost that results from massive

research funds invested locally.[1] The number of clinical trials taking

place in Africa is still relatively low compared with other parts of the

globe: although Africa represents ~15% of the world’s population,[2,3]

it is estimated that only 2% of clinical trials conducted worldwide

take place on the continent.[4] There are several possible reasons for

this disparity, chiefly the inadequate ethical and regulatory oversight

capacity for such trials.[5]

Despite this, Africa continues to see an upward trend in the

number of clinical trials as pharmaceutical companies move their

research sites to developing countries.[6] There are many reasons for

this shift: firstly, the higher cost of conducting trials in resource-rich

countries is becoming prohibitive to companies driven by the desire

to make a profit for their shareholders. Secondly, Africa provides

access to a population with diverse genetics, and large numbers of

treatment-naive patients. Thirdly, it is challenging to find enough

trial participants in large phase-three clinical trials in resource-rich

countries, making it necessary for sponsors to look for additional sites

in other parts of the world.

There are two major concerns in conducting clinical trials in Africa.

Firstly, many people on the continent are poor,[7] and for them clinical

trials are a way of accessing medical care. This puts them at great

risk of being exploited.[1] Secondly, the low level of education can be

a barrier in obtaining informed consent. Clinical trial information is

often too complex for participants to understand despite efforts by

researchers to simplify the language. People in Africa are therefore

easily enrolled into clinical trials on drugs and vaccines without giving

serious thought to their potential risks and possible side-effects.

One way of addressing these concerns is to have robust RECs to

ensure the safety of research participants by thorough review of

research protocols to be certain that international research ethics

This open-access article is distributed under

Creative Commons licence CC-BY-NC 4.0.

Strengthening research ethics oversight in Africa:

The Kenyan example

L Omutoko,1 PhD, MSc Global Bioethics; B Amugune,2 PhD, PgDip (Res. Ethics);T Nyawira,3 MSc Global Bioethics; I Inwani,4 MMed;

C Muchoki,3 MSc; M Masika,5,6 MB ChB, PhD; G Omosa-Manyonyi,5,6 MB ChC, MSc ID; C Kamau,3 MSc; L K’Apiyo,7 MBA;

W Jaoko,5,6 PhD, MSc Global Bioethics

1 Department of Educational Management, Policy and Curriculum Studies, University of Nairobi, Kenya

2 Department of Pharmacy, University of Nairobi, Kenya

3 National Commission for Science Technology and Innovation (NACOSTI), Kenya

4 Department of Paediatrics, Kenyatta National Hospital, Nairobi, Kenya

5 KAVI-Institute of Clinical Research, University of Nairobi, Kenya

6 Department of Medical Microbiology and Immunology, University of Nairobi, Kenya

Corresponding author: W Jaoko (wjaoko07@gmail.com)

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.

S Afr J Bioethics Law 2023;16(1):e199. https://doi.org/10.7196/SAJBL.2023.v16i1.199