Description of the project:
Established in 1984, the Botswana National Ethics Committee (NEC) and its Secretariat aim to develop capacity for research and regulate all health and health-related research that is conducted in Botswana, and provide training in Health Systems Research. Initially the NEC mainly focused its work on the review of non-complex or low-risk studies that did not require a strong legal and ethical oversight framework to protect participants.
There is a need to strengthen the Botswana NEC to accommodate the increase in volume and complexity of research proposals being submitted for review. This can be achieved through training of members in scientific and ethical review of proposals as well as sensitising the local communities and the public at large about the value of clinical research and protection of the rights, safety and well-being of potential participants.
The problem addressed in the study
This project addresses the strengthening of the Botswana ethics capacity to promote practical application of ethical principles of respect for persons, beneficence and non-maleficence as well as justice to achieve scientific goals in the contexts of national and public health interests..
- To strengthen the Botswana National Research Ethics Committee (NREC) and establish Institutional Review Boards (IRBs)
- To sensitise and increase awareness of communities on the values of clinical trials and ethical conduct of relevant research in their communities as well as the obligation of investigators to protect the rights, safety and welfare of research participants and communities
- To establish IRBs in all Health Training Institutions and Districts in Botswana
- To train ethics committee members in ethical and scientific review of research proposals, auditing and monitoring of approved studies especially clinical trials
- To develop review guidelines, Standard Operational Procedures (SOPs) and Clinical Trial Guidelines
- To Improve office infrastructure through purchase of equipment and stationery.
The project will strengthen the capacity of the Botswana research oversight by putting into practice concrete mechanisms to enforce ethical requirements in conducting research. This will improve the quality of biomedical research conducted in Botswana. Quality research will help Botswana Ministry of Health, policy makers and other stakeholders to make evidence-based decisions when setting national research priorities and addressing public health problems. Developed regulatory guidelines such as SOPs and Clinical Trials guidelines will provide with clearly articulated standards of good clinical practice that are relevant to the local context in Botswana. It will also ensure that clinical trials conducted on human participants are designed and follow sound scientific and ethical standards. Training clinical trial auditors and monitors will ensure that the rights, safety and well-being of participants in clinical research are protected. Collaborative efforts will assist in harmonising operational procedures thereby narrowing the gap between international ethical standards and local practices.
At national level, the project will be implemented through a partnership between the National Research Ethics Committee (NREC), the University of Botswana, Institutes of Health Sciences and communities in Botswana. At an international level, two collaborating partners will be involved in this project, namely South Africa, Uganda and Zimbabwe. Through this collaboration with the NREC links will be created, including to the African Bioethics Initiatives like SARETI, ACRO and IRENSA, partners from the Fogarty Bioethics Programmes at Michigan State University and Johns Hopkins School of Hygiene and Public Health, and the National Institute of Health (NIH). Collaborative partnerships will be established with the IRBs of the institutions that conduct research in Botswana, such as the Baylor School of Medicine, Harvard School of Public Health, University of Pennsylvania Centre for Bioethics and Center for Disease Control. Partnership with Uganda and South Africa will also provide links to NREC that have been established with their institutions. More collaboration will be formed through meetings like workshops, seminars and conferences.
Relevance to the EDCTP objectives and mission
Strong research oversight systems will enhance the capacity of researchers, ethics committees and community advisory members to collectively contribute to carefully construct clinical trials that can achieve the scientific goals while protecting the rights, safety and welfare of participants.
Through training of participants in research ethics, it is expected that trainees will go a long way in training their colleagues and students in the future, and thus further strengthening ethics capacity in the country. The professional relations and partnerships established among the trainees and facilitators will help their institutions/organisations in forming new ethics networks and contribute to an ethics system at national and international level in the future. Trainings were done in collaboration with universities (e.g. University of Botswana and University of Pennsylvania) which will be strengthened in future to ensure that efforts to develop research ethics in Botswana are sustained. The equipment purchased through this project will continue to be used in the future to help the Health Research Division in their daily activities, and hence improving their efficiency in handling health research ethics issues. Established community advisory boards will be sustained through members acting as trainers and as a link between the researchers and the communities.