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Enhancing capacity of research ethics review committees in developing countries: The Kenyan example

Gloria Omosa Manyonyi, Walter Jaoko, Kirana Bhatt, Simon Langat, Gaudensia Mutua, Bashir Farah, Jacquelyne Nyange, Joyce Olenja, Julius Oyugi, Sabina Wakasiaka, Maureen Khaniri, Keith Fowke, Rupert Kaul, Omu Anzala

Abstract


Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.

Methods. The Kenya AIDS Vaccine Initiative (KAVI) Institute of Clinical Research (ICR) (KAVI-ICR) and the Kenyan National Council for Science and Technology (NCST) embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps. Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country.

Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi.

Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region.


Authors' affiliations

Gloria Omosa Manyonyi, KAVI-Institute of Clinical Research, University of Nairobi, Kenya

Walter Jaoko, KAVI-Institute of Clinical Research, University of Nairobi, Kenya

Kirana Bhatt, Department of Medical Microbiology, University of Nairobi and Department of Internal Medicine and Clinical Therapeutics, University of Nairobi, Kenya

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

Gaudensia Mutua, KAVI-Institute of Clinical Research, University of Nairobi, Kenya

Bashir Farah, KAVI-Institute of Clinical Research, University of Nairobi, Kenya

Jacquelyne Nyange, KAVI-Institute of Clinical Research, University of Nairobi, Kenya

Joyce Olenja, School of Public Health, University of Nairobi, Kenya

Julius Oyugi, KAVI-Institute of Clinical Research, University of Nairobi and Department of Medical Microbiology, University of Nairobi, Kenya

Sabina Wakasiaka, KAVI-Institute of Clinical Research, University of Nairobi and School of Nursing Sciences, University of Nairobi, Kenya

Maureen Khaniri, KAVI-Insitute of Clinical Research, University of Nairobi, Kenya

Keith Fowke, Department of Medical Microbiology, University of Nairobi, Kenya and Department of Medical Microbiology, University of Manitoba, Canada

Rupert Kaul, Department of Medical Microbiology, University of Nairobi, Kenya and Department of Medicine, University of Toronto, Canada

Omu Anzala, KAVI-Institute of Clinical Research, University of Nairobi and Department of Medical Microbiology, University of Nairobi, Kenya

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Keywords

Research ethics; Clinical trial; Capacity building

Cite this article

South African Journal of Bioethics and Law 2014;7(2):59-63. DOI:10.7196/SAJBL.308

Article History

Date submitted: 2014-01-19
Date published: 2014-11-04

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