What is the Ethics Committee in Biomedical Research?
The Research Ethics Committee is understood as a group of leading experts in charge of consulting, reviewing, evaluating, and evaluating the ethical aspects of companies. human biomedical research.
This will help the research works to be carried out properly, in accordance with the regulations and guidelines on biomedical ethics of the domestic law.
Who is the biomedical research ethics committee?
The National Ethics Committee in Biomedical Research will be established by the decision of the Minister of Health. All activities as well as organizational regulations of the ethics committee will be approved by the Minister of Health. National Ethics Councils with at least five to nine full members ensure the membership structure and regulatory standards.
The term of the National Ethics Council is 5 years, the Ethics Council must be established or reorganized when the term expires. The composition of the Ethics Council for the next consecutive term must have the participation of at least 25% of the official members who are new members compared to the members of the Ethics Committee of the previous term.
What are the general ethics committee guidelines in biomedical research?
Like any other body, the ethics committee in biomedical research has certain general principles.
- Biomedical research projects and works can only be implemented when the research protocol is approved by the competent authority.
- The Ethics Council must fully apply the ethical principles as prescribed in relevant circulars and legal documents and follow the ethical guidelines in biomedical research of the organizations. international. Ethical guidelines adopted by the Ethics Committee must be clearly stated and made available to researchers in the study.
- The Ethics Council works according to the principles of collective, democratic and independent when evaluating and making decisions.
- For organizations that are not eligible to establish a grassroots biomedical research ethics committee, all review or evaluation of biomedical research involving humans will be carried out by An ethics committee established by the Department of Health or an ethics committee of another unit with appropriate expertise.
ISO Department of Vietstar Biomedical Research
Along with the reference to common domestic standards, Vietstar Biomedical Research has also decided to establish an ISO committee. With common functions such as applying the ISO 9001:2015 quality management system to training and communicating to management departments.
Along with that, there are amendments, updates as well as monitoring of the quality management system ISO 9001: 2015 of employees in the company, thereby making internal assessments to help the working process. Smoother, more stable. Since then also contributed to the project operation, the research work that Vietstar Biomedical Research cooperated with the parties was implemented perfectly.
VietStar Biomedical Research is a Contract Research Organization (CRO) approved by the Ministry of Health of Vietnam licensed for activities to support research sites and clinical trial sponsors in accordance with regulations of the Ministry of Health. and ICH GCP. We provide comprehensive clinical research services to the biopharmaceutical industry.
We provide a wide range of clinical trial research and legal services for the development of pharmaceutical and biotech products from phase I to phase IV in Vietnam.
To learn more, refer to our services, please contact at the address below: Room 201, Level 2, Building N01-T1, Diplomatic Corps Area, Xuan Tao Ward, Bac Tu District Liem, Hanoi City. Tel/ Fax: + (84 24) 32 000 867 - Hotline: + 84 (0) 903 40 43 34 , + 84 (0) 989 18 88 07. E-mail: contact@vietstar-research.com. Website: www.vietstar-research.com.