Deepening Research Ethics in Nigeria: consortium to build capacity of research ethics committees

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By Isaac Eranga

As part of measures in strengthening the research ethics review and clinical trials oversight system at the Federal Ministry of Health, Nigeria, a consortium consisting of the National Agency for Food Drug Administration and Control (NAFDAC), Center for Bioethics and Research (CBR), Council of Health Research Ethics Development (COHRED) and National Health Research Ethics Committee of Nigeria (NHREC) have collaborated in deepening research ethics in Nigeria (DREIN) by  providing short, medium- and long-term training and mentoring of the administrative and technical staff of Research Ethics Committees (RECs) in Nigeria. 

Speaking, the Director of Center for Bioethics and Research (CBR), Ibadan, Professor Clement Adebamowo said the DREIN project aims at improving the capacity of Research Ethics Committee in Nigeria in order to implement standardized and efficient review of research and clinical trials protocols through increasing utilization of electronic ethics review platform - RHInnO Ethics which was developed by Council of Health Research Ethics Development (COHRED) and "is being implemented by ethics committees in Africa". He said the DREIN project was linked to the Federal Ministry of Health through the National Health Research Ethics Committee of Nigeria (NHREC) which is a subsidiary of the Federal Ministry of Health.

According to Professor Adebamowo, "the NHREC is the regulatory body for all Health Research Ethics Committees (HREC) in Nigeria and it is responsible for the establishment of HRECs and protection of human subjects involved in all clinical trials protocols.

"The DREIN project aims to enhance interactions between the Nigeria research ethics regulatory agency, NHREC, and the drugs regulatory agency, NAFDAC, through joint meetings, trainings, seminars and workshops with institutional research ethics committees".

Speaking on challenges facing research ethics in Nigeria, the Director of CBR said considering the interplay of Nigeria's economic and political challenges, evolving legal system and weak health system, the challenges to research ethics in Nigeria are numerous.

"Some of them are lack of government commitment to health research ethics leading to inadequate facilities and infrastructure, limited infrastructure, limited resources, little or no policies and significant brain drain in the medical field", said the Bioethicist.

Also speaking, the Manager of Center for Bioethics and Research, Mr. Olusegun Adeyemo said the rationale behind the DREIN project was ethical review of research and clinical trials and oversight requiring deep and sustained interactions between ethics and drug regulatory agencies on the one hand, and within ethics committees on the other, to reduce the risk of ethical misconduct and egregious harm to research participants. 

"Such interactions are built through mutual understanding of the roles and responsibilities of each of the agencies, joint meetings and consultations and open and frequent communications to resolve challenges", he said.

Appraising the practice of research ethics in Nigeria, Mr. Adeyemo said "Research ethics and clinical trials regulations in Nigeria and most African countries is in its nascent phase and there is very limited expertise beyond the basic principles. Oversight of clinical trials and complex epidemiological research requires more training than can be acquired in short courses yet most members of ethics committees are not available to undertake training that would have them away from their primary assignments for extended periods".

He said in order to meet the training need, the Center for Bioethics and Research conducts training on Modern Research Ethics for Ethics Committee members all over Nigeria, these trainings according to Mr. Adeyemo, are approved by the National Health Research Ethics Committee of Nigeria as part of accreditation for existing ethics committees and newly formed ethics committees. 

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