Project: Deepening Research Ethics in Nigeria Project
| Acronym | DREIN (Reference Number: CSA2016ERC-1416) |
| Duration | 01/02/2018 - 31/01/2020 |
| Project Topic | In this project, we plan 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 aims of our 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 7 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-trials-registry/) 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 the following existing regulatory, training and infrastructural resources in the Federal Ministry of Health of Nigeria: 1. Regulatory agencies: a. NHREC - applicant organization - and registered NHRECs b. NAFDAC. Jointly regulates conduct of clinical trials and the Nigerian Clinical Trials Registry with the NHREC 2. Training and mentoring resources a. NIH funded Centre for Bioethics and Research, Nigeria provides bioethics training up to doctoral level in Nigeria. b. Registry of bioethicists in Nigeria maintained by the NHREC c. COHRED will provide web-based electronic ethics review software (RHInnO Ethics) and associated training 3. Resources a. Nigerian web-based electronic ethics review software developed in consultation with COHRED b. Nigerian clinical trials registry website c. Graduate training in bioethics at the University of Ibadan, Nigeria, implemented by the Centre for Bioethics and Research, Ibadan, Nigeria |
| Network | EDCTP2 |
| Call | Ethics and regulatory capacities 2016 |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 1 | Center for Bioethics and Research | Coordinator | Niger |
| 2 | Council on Health Research for Development | Partner | Switzerland |
| 3 | Federal Ministry of Health -Nigeria | Partner | Niger |
| 4 | National Agency for Food and Drug Administration and Control | Partner | Niger |