Ethical Review Board
· The Ethical Review Board for Biomedical Research of Hanoi School of Public Health was established under the Decision Number 645/QĐ-YTCC - 07/1//2003 (Formation of Ethic Council) and Decision number 284/QĐ-YTCC - 16/6/2004 (addition of member for Ethic Council) of Dean of Hanoi School of Public Health
· Term of duty: 4 year.
· Ethic Council composition: 1 Chairman, 6 official members (1 official member from community – represent for rights and interest of research participants), 2 alternative members and 2 secretaries.
· Institutional Review Board of Hanoi School of Public Health: Registration code with USA Ministry of Health: - IORG number 0003239 , FWA number FWA00009326, since 8/2003
· Some pictures of Ethic Council Activities.
THE BY-LAWS OF
THE ETHICS IN BIO-MEDICAL RESEARCH COUNCIL
(Issued by Decision 491/QD-YTCC of September 24, 2004 of the Dean of HSPH)
(EXCERPTS)
Article 1: Every bio-medical research that is sponsored, managed, conducted or participated by the Hanoi School of Public Health must be filed with the Ethics in Bio-Medical Research Council of the School (EBRC from now on) for ethical consideration, monitoring and evaluation. Filed research shall be allowed to start only after being granted in writing by EBRC[1].
Article 2: Bio-Medical research regulated by this bylaws includes studies in pharmaceutics (modern pharmaceuticals, pharmaceutical materials, traditional pharmaceutical formulas), biological products (vaccines and others), drugless treatments, medical equipment, radiation treatment and imaging, procedures, surgery, bio-samples (blood, pathological samples, mother's milk), epidemiological, social and psychological surveys conducted on human being. From now on, these kinds of research will be called bio-medical research (BR).
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Artical 8: Consideration of the filed research
BRs are considered by EBRC by conventional or fast tracks. BRs that are not categorized in Articles 1, 2 and 5 of this Bylaws should submit a waving application or a request for being considered by a higher authority.
This Bylaws of EBRC is available in the Information and Library Center and at any Department/Office of HSPH.
Forms and Appendices are updated regularly and saved at the EBRC Secretariat and on the HSPH website.
For further information, please contact EBRC Secretaries:
1. Nguyen Hoang Oanh, Pharmacist - (04) 266-2329; nho@hsph.edu.vn
2. Le Thi Thanh Ha, MS in Epidemiology - (04) 266-2327; lth@hsph.edu.vn
FORMS NEEDED FOR EBRC'S ETHICAL CLEARANCE OF RESEARCH
I. Forms that researchers need to complete:
EBRC (HĐĐĐ) - Appendix 6 (Request for Clearance by Research Director)
EBRC (HĐĐĐ) - Appendix 10 (Check list for Fast-Track Consideration)
EBRC (HĐĐĐ) - Appendix 11 (Check-list for Conventional Consideration)
EBRC (HĐĐĐ) - Appendix 12 (CVs of Research Director and Researcher-in-Chief)
Form 2-Research: Research Outline
Other related documents (see Part 3 of Appendix 5)
II. Appendices that researchers need to know:
EBRC (HĐĐĐ) - Appendix 5 (List of items needed to be completed by researchers)
EBRC (HĐĐĐ) - Appendices 1 to 4 (items that researchers need to consider)
EBRC (HĐĐĐ) - Instructions for completing appendix 10
EBRC (HĐĐĐ) - Instructions for completing appendix 11
EBRC (HĐĐĐ) - Coverpage of the Bio-Medical Research File
Instructions for writing a Research Outline