Governing Agencies and Ethics Review Structure
Both the Health Research and Development Committee (HRDC) and the Health Research Unit (HRU) of the Ministry of Health are responsible for ethical and scientific oversight of human subjects research protocols being conducted in Botswana. HRU functions as the secretariat for HRDC, and performs initial reviews of submitted protocols.
- Human Subjects Research Application
- Clinical Trials and Biomedical Research Application
- Assent Form Guide
Points to Consider – Investigators
- New Applications: All new submissions should be made at least five weeks prior to the next monthly meeting with all documents indicated on the application form.
- Continuing review applications: All continuing review applications should be submitted made at least three months before the expiration date. Two copies of the continuing review application form must be submitted, along with the protocol, consent forms, and annual report of the study.
- Amendments and close-outs: Amendments and close-outs may be submitted at anytime throughout the duration of the study. Two copies of the amendment application must be submitted, along with a copy of the tracked changes and clean version of the protocol and consent forms.
Points to Consider – US IRBs
Local Research Institutions
- University of Botswana
- Princess Marina Hospital
- Botswana-Harvard Partnership (BHP)
- Nyangabgwe Hospital