Consortium on Research Ethics collaborate on capacity building for research ethics committees in Nigeria

By Our Correspondent

As part of measures towards 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 cillaborated 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 with journalists, the Chairman of the National Health Research Ethics Committee of Nigeria, Professor Zubeiru Iliyasu, said Deepening Research Ethics in Nigeria (DREIN) project is funded by European & Developing Countries Clinical Trials Partnership (EDCTP). He said the project seek to spread information about research ethics in Nigeria. According to him, "this was awarded to a consortium made up of Center for Bioethics and Research (CBR), National Health Research Ethics Committee (NHREC), National Agency for Food and Drug Control and Administration (NAFDAC) and the Council on Health Research and Development (COHRED). 

"NHREC in partnership with the other consortium members is responsible for the 6 deliveries of the project. Specifically, NHREC is the lead organization responsible for the second delivery which is the conduct of Consultative meeting and oversight visits by NHREC and NAFDAC. NHREC also nominated her members and members of HRECs to be trained in the use of electronic ethics review platform - RHInnO Ethics which was developed by COHREC and is being implemented by ethics committees in Africa. 

"In addition, NHREC nominated participants from among its members and HRECs to acquire advanced skills through a blended advanced diploma in research ethics. Furthermore, the project has provided opportunity to build the capacity of research ethics and drug regulatory officials in Nigeria through sponsorship for Masters and Doctorate level training in Bioethics at the University of Ibadan, Nigeria". 

Commenting on the milestone so far achieved, Prof. Iliyasu said NHREC has sensitized all the state governments and health institutions in public and private sector on the necessity to adhere to internationally accepted highest standards of ethical conduct of research in humans and animals. He said the committee has produced guidelines and a national health research code. 

"We have also registered 49 HRECs nationwide. We have used the registration renewal system to monitor the functions of HRECs ensuring the protection of Nigerians and vulnerable groups in research. We have also developed policies on Biobanks, Animal research and have earned international recognition for NHREC approvals by adhering to high standards. NHREC is also listed in the international directory of Bioethics committees and has a functional website (www.nhrec.net). In addition, NHREC has produced and recently updated the Materials Transfer Agreement for transfer of samples and biological materials from humans, animals, herbs and plants out of Nigeria. It details  the nature of the samples, materials, anticipated use, location and duration of storage, limitations on use, transfer and termination of use of such materials. The purpose of MTA is to protect the interests of local researchers and prevent exploitation of Nigeria’s human and natural resources in all its biodiversity", he said 

Also 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. 

"The Center for Bioethics and Research also provides post graduate training in Bioethics at the University of Ibadan, upon successful completion of the training candidates receive a Master of science degree in Bioethics. The Center also provides 2 months online blended diploma training for interested persons, upon successful completion participants receive a diploma certificate", he added.

Mr. Adeyemo called on research ethics committee members, bioethicists and those interested in research ethics to attend the 2018 International Bioethics Forum taking place in Lagos from 12 to 13 December, 2018. According to him,  participants will have the opportunity of meeting and interacting with International Ethics Consultants that have over 20 years’ experience of working in the field of Bioethics. 

"The speakers at the forum will discuss issues ranging from participation in research, exploitation and vulnerability in research settings. It will also be a good opportunity to interact with Bioethicists from all around the World", he concluded.

Photo: Prof. Oluwole Isaac, Nigeria's Minister of Health