Deepening Research Ethics in Nigeria (DREIN)

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By Isaac Eranga

The DREIN (Deepening Research Ethics in Nigeria) Project consortium consists of 4 organizations, they are: National Agency for
Food and Drug Administration and Control. (NAFDAC), Center for Bioethics and Research Nigeria. (CBR), Council on Health Research for Development South Africa, (COHRED). National Health Research Ethics Committee of Nigeria (NHREC).

The workplan in this project is joint action by the drug regulatory agency and ethics regulatory agency in Nigeria to enhance their joint roles and build their capacity for mutual ethical oversight of research in Nigeria. In fulfilment of this action, the regulatory agencies jointly implement and further the goals of the Nigerian Clinical Trials Registry through joint trainings, seminars, workshops and meetings. They partner with Council on Health Research for Development (COHRED) for provision and training on their proprietary electronic health research ethics review platform, RHInnO Ethics to institutional research ethics review committees in Nigeria. They work with the Center for Bioethics and Research (CBR), Ibadan, Nigeria for provision blended medium term diploma and postgraduate degrees in Research Ethics to members of institutional health research ethics committees and staff of the regulatory agencies. Each work package on the project engages relevant expertise from the collaborating institutions to ensure that its objectives are delivered within its timeline. These activities are interrelated because they provide training and engagement at multiple levels for NHREC, NAFDAC, institutional research ethics committees and biomedical researchers in Nigeria.

This project aims to strengthen the research ethics review and clinical trials oversight system at the
Federal Ministry of Health of Nigeria by providing short, medium- and long-term training and mentoring of the administrative and technical staff of Research Ethics Committees (RECs) in Nigeria. The other aims of the project are:
1. Enhance capacity of institutional RECs in Nigeria by providing blended 2 months long research ethics diploma training in collaboration with the Centre for Bioethics, Nigeria for members of institutional RECs.
2. Improve the capacity of REC in Nigeria to implement standardized and efficient review of research and clinical trials protocols by:
a. Enhancing the capacity and quality of ethics review for 6 high volume health RECs by training members to use an electronic ethics review software - RHInnO Ethics and upgrade their currently installed software from version 1.2 to version 2.0 to allow them to review complex clinical trials and report serious adverse events online.
b. Training on the integration of the Nigerian Clinical Trials Registry (http://nhrec.net/nigeria-clinical-trialsregistry/) to enhance transparency in clinical trials data
3. Enhancing collaboration between RECs and regulatory agencies through annual joint training and
consultative workshops of the Nigerian National Food and Drugs Administration and Control (NAFDAC) and the Nigerian National Health RECs (NHREC) and Centre for Bioethics and Research, Ibadan, Nigeria.
4. Provide advanced training in research ethics for key officers of NAFDAC and NHREC.
5. Provide technical consultations to update the Nigerian National Code for Health Research Ethics and develop additional sub-codes for research in vulnerable populations.
These aims will be achieved by building upon and linking existing regulatory, training and
infrastructural resources in the Federal Ministry of Health of Nigeria.

The Center for Bioethics and Research, Nigeria has partnered with the Bioethics Society of Nigeria (BESON) to enhance awareness of research ethics among biomedical research and Nigerian public through implementation of the annual International Bioethics seminar and utilization of mass and social media on the 12th & 13th of December, 2018.

Please visit the project website at https://edctp-drein-project.com/about-the-project for more information.

The project is supported by the European Development Clinical Trials Partnership (EDCTP) and the European Union.

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