Any institution that does not have a registered ethics committee cannot approve a clinical trial, says NHREC Boss

The National Health Research Ethics Committee of Nigeria (NHREC), was  established in order to ensure that Nigerians are protected from exploitation and harm while at the same time encouraging their participation in ethically conducted research for discovery of vaccines, drugs and methods for prevention, treatment and rehabilitation of the citizenry. The Chairman of NHREC, Prof. Zubeiru Iliyasu spoke with the SOCIAL REPORTERS NEWS SERVICE about NHREC's milestone, achievement and challenges. Excerpts:

Q - What is NHREC doing to attract government to health research ethics?

A - NHREC (National Health Research Ethics Committee) of Nigeria was established by government through the National Health Act of 2014. This act provided for the establishment of the National Health Research Ethics Committee (NHREC) by the Honourable Minister of Health. It specified the composition, roles and responsibilities of the committee. The NHREC derives its powers from this piece of government legislation. Therefore, being a body set up by government, with her secretariat in the Department of planning, research and statistics of the Federal Ministry of Health, one wouldn't talk about attracting government to health research ethics. It is a clear demonstration that the government recognised the need to regulate the ethical conduct of research on humans and animals in all parts of the country. It established the committee to ensure that Nigerians are protected from exploitation and harm while at the same time encouraging their participation in ethically conducted research for discovery of vaccines, drugs and methods for prevention, treatment and rehabilitation of the citizenry. 

Q - Policy formulation in regulating RECs in Nigeria, how far has NHREC gone?

A - NHREC regulates activities of Research Ethics Committees (RECs) in the Ministries of Health and Health Institutions in the states and the Federal Capital Territory. The National Code of Health Research Ethics is the overarching guidance document for conducting ethical research in Nigeria. It applies to all health research involving human participants, conducted, supported or subject to regulation by any institution in Nigeria. Other guidelines developed by NHREC include the “Ethics Code for Animal Research” and the “Policy Statement on Establishment of Biobanks and Biorepositories.”

NHREC ensures ethical conduct in Nigeria by:

-Setting norms and standards for conducting research on humans and animals, including clinical trials;
-Determining the extent of health research to be carried out by public and private health authorities;
-Registering and auditing the activities of Health Research Ethics Committees (HRECs) in the country
-Adjudicating in complaints about the functioning of HRECs and hear any complaint by a researcher
-Referring to the relevant statutory health regulatory body, matters involving the violation or potential violation of an ethical or professional rule by a health care provider;
-Recommend to the appropriate regulatory body such disciplinary action as may be prescribed or permissible by law against any person found to be in violation of any norm, standard or guideline under this Act;
-Advising the Federal Ministry of Health and State Ministries of Health on any ethical issue concerning research on health

Q - How does NHREC monitor the activities of RECs across the country?

A - This is one of the key mandates of NHREC. It is a basis for ensuring the right membership and capacity for the ethics committees. So far, 49 ethics committees have been registered by NHREC. Any institution that does not have a registered ethics committee cannot approve and cannot host a clinical trial. However, this number is a far cry from what is expected. It is expected that all teaching hospitals, federal medical centres, research institutes, universities  and State Ministries of Health will have registered HRECs. The lifespan of any HREC registration is two years, after which the institution shall apply for renewal. The application for renewal of registration must be submitted within the last 6 months of the expiry of the current registration. Otherwise the HREC will be de-registered and will need to apply afresh. NHREC assesses the capacity of HRECs and registers them in appropriate categories to review research proposal that their level of expertise allows. The committee also monitors the activities of HRECs through planned monitoring visits and adhoc visits to oversee and participate in HREC meetings to see how they conduct their business. During such visits we also evaluate the capacity in terms of members training and experiences, resources for the conduct of their work, record keeping and evaluate their status for upgrade or withdrawal of registration if they under perform. We also visit and arbitrate between researchers and committees if there is a complaint. Similarly, if there is infraction in ethical conduct of research or if we receive reports of unethical conduct of research in any part of the country, we investigate and recommend disciplinary action which is carried out by the relevant professional body to which the researcher belongs.

Q - How will you appraise the practice of research ethics in Nigeria?
 
A - I think Nigeria is at the forefront of ensuring that research conducted within her shores are done in accordance with highest ethical standards and good clinical and laboratory practices. We have received requests from other countries to assist them in strengthening their ethics committees and policies. We also have several online visitors to benefit from online training programmes and our code of practice documents.

Q - What is the role of NHREC in DREIN?

A - Deepening Research Ethics in Nigeria (DREIN) project is funded by European & Developing Countries Clinical Trials Partnership (EDCTP). The project seek to spread information about research ethics in Nigeria. 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.

Q - What milestone has been achieved so far by NHREC?

A - 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. 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.

Q - What is the major challenge facing NHREC?

A - Major challenge is that many states and institutions do not have HRECs. The 49 HRECs registered with NHREC is a far cry from what is expected. It is expected that all teaching hospitals, federal medical centres, research institutes, universities  and State Ministries of Health have HRECs with current registration with NHREC. While many institutions have HRECs, but they are not regular in renewing their registration. Delayed budgetary releases also pose challenge to the smooth conduct of the activities of the committee including logistics and human resources required for monitoring and oversight functions of the committee. The need to ensure that HRECs deploy information technology in managing their reviews e.g. RHINO software. The cost of subscription and renewal is in hard currency and can be prohibitive. Some researchers have complained that HRECs request them to submit their reviewed protocols for further review. This is unnecessary and causes delay in commencement of studies. It is clearly indicated in the national code that researchers that have obtained NHREC approval, only require administrative permission to conduct the study at the site not another ethics review.