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ROLE OF NATIONAL ETHICS COMMITTEE |
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The role of the National Ethics Committee is to safeguard the dignity, rights, health and wellbeing of those participating in biomedical research, to ensure that informed consent is granted, and to approve protocols and research projects which meet ethics standards.
The Committee’s mission is to examine all the human research projects to be conducted anywhere within Rwanda and any modifications to be made to them, regardless of the nationality of the promoters. It also is the approval authority for such projects. Any decision must be
properly justified.
To promote the principle of equity, whereby the weight and benefits of the research must be equitably distributed among all groups and classes of society.
The purpose of the ethics committee is to bring to research projects competent independent analysis in the area of ethics. It also oversees quality assurance of biomedical research. |
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About the Rwanda National Ethical Comitee |
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The Rwanda National Ethics Committee was created in May 2003 by Dr Ezechias Rwabuhihi, Minister of Health.
Dr Jean-Damascene Ntawukuliyayo: Chairman, Professor Justin Wane: Secretary, Five others members: Sister Josephine Mukamunana, Pasteur Elizee Musemakweli, Mrs. Rose Mukantabana,Dr Naasson Munyandamutsa, Dr kayitesi Kayitenkore
On 15th February 2005, Dr Jean-Damascene Ntawukuliyayo, the former Honorable Minister of Health appointed an Acting Chairman and added a new member: Professor Emmanuel Bajyana. The Minister of Health, being the regulatory authority is no more a member of the National Ethics Committee.
For a thorough and complete review, all research proposals shall be submitted with the following information to NEC at least 15 (fifteen) working days before the scheduled meeting date.
- 11copies of the request letter
- 11 copies of the protocol and summary
- 11 copies of the patient informed consent and the patient information sheet in English or French and Kinyarwanda
- 11 copies of the financial agreements with the researchers
- 11 copies of the previous decisions from other ethics committees or regulatory Authorities
- 11 copies of placebo usage justification (if necessary)
- 5 copies of the researcher’s brochure (Phase I, II & III)
- One copy of each researcher’s CV (1 copy of each document)
- One copy of the insurance certificate if any
- To provide study budget
- A check for submission fees made out to the Ethics Committee must be enclosed with the file submitted. The submission fees can also be paid to the following account number: Rwanda National Ethics Committee 130- 10 53 298 in COGEBANQUE.
- The principal Investigator(PI)/ Co- investigator should come to present the Protocol at the meeting.
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