Duties and powers of the Ethics Council in biomedical research in Vietnam

Duties and powers of the Ethics Council in biomedical research in Vietnam​ (Image from the internet)

1. Duties of the Ethics Council in biomedical research in Vietnam

* The grasshoot-level Ethics Council has the following duties:

- Evaluate the following documents for clinical trial research on drugs, clinical trials on medical devices, and clinical trials on new techniques and new methods in medical examination and treatment before submitting them to the national-level Ethics Council:

+ Research dossier, research proposal, competence of the investigator and the research site.

+ Dossier requesting changes to the research proposal, regular research evaluation, ad-hoc research evaluation.

+ Research result report.

- Evaluate the following documents for bioequivalence studies of drugs so that the person responsible for professional duties at the facility accepting bioequivalence studies can approve: research dossier, research proposal, competence of the investigator and the research site; dossier requesting changes to the research proposal, regular research evaluation, ad-hoc research evaluation; research result report.

- Monitor and supervise the research for adherence to the proposal and ethical research regulations; evaluate the documentation, reporting, and management of adverse events occurring in the research.

- Store, manage, and secure the operational records of the Ethics Council in accordance with the law.

* The national-level Ethics Council has the following duties:

- Evaluate research dossiers, research proposals, competence of the investigators, and research sites before the research is conducted.

- Evaluate research during its implementation at the facilities accepting the trial, including: evaluating changes to the research proposal, regular research evaluation, ad-hoc research evaluation.

- Evaluate research result reports of the facilities accepting the trial.

- Monitor and supervise the research for adherence to the proposal and ethical research regulations at the trial facilities; evaluate the documentation, reporting, and management of adverse events occurring in the research at the trial facilities.

- Store, manage, and secure the operational records of the Ethics Council in accordance with the law.

2. Powers of the Ethics Council in biomedical research in Vietnam

- Approve or disapprove:

+ Research dossier, research proposal, amended proposals, supplementary research proposal, research result report;

+ Waiver of obtaining research information provision and volunteer participation forms in cases where absolute confidentiality is required for research participants or consent from the participant or legal representative cannot be obtained, based on comprehensive consideration of the benefits, risks of the research to the participants, and protective measures for the rights and safety of the participants;

+ Use of documents in electronic format according to related legal regulations.

- Invite independent consultancy experts to provide professional opinions for the Ethics Council.

- Require the principal investigator, the leading organization, and the study sponsor to: report data, research outcomes, documents related to the research, and amend research proposals to ensure participants' safety.

- Propose competent authorities to terminate the research upon discovering non-compliance with the principles of good clinical practice or violations of the research proposal.

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