Decision No. 5129/2002/QĐ-BYT On the issuance of the Code of Ethics for the Organization and Operation of the Bioethics Committee in Biomedical Research

Pursuant to …;

Regarding the issuance of the Code of Conduct on the organization and operation of the Bioethics Council in Biomedical Research

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 THE MINISTER OF HEALTH

Based on Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Based on the World Health Organization's Guidelines on the activities of Bioethics Committees in biomedical research;

Pursuant to the proposal of the Director of the Science and Training Department, and the Director of the Legal Affairs Department.

DECISION:

Article 1. Issued together with this Decision is the Code of Conduct on the organization and operation of the Bioethics Council in Biomedical Research.

Article 2. This Decision shall take effect fifteen days from the date of issuance. All previous regulations contrary to the Code of Conduct issued pursuant to this Decision are hereby abolished.

Article 3. The Director of the Science and Training Department is assigned responsibility for organizing the implementation and monitoring the enforcement of this Decision.

Article 4. The Heads of the Office, the Directors of the Science and Training Department, the Directors of relevant departments under the Ministry of Health, the Directors of the Vietnam Drug Administration, the Director of the Quality Control and Sanitation Safety Food Administration, the Heads of research and development agencies directly under the Ministry, the Directors of Provincial Health Services, and the Heads of health sectors are responsible for enforcing this Decision.

REGULATIONS

Organization and Operation of the Bioethics Council in Biomedical Research

(Issued pursuant to Decision No. 5129/2002/QD-BYT dated December 19, 2002 of the Minister of Health)

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 PART I

GENERAL PROVISIONS

Article 1. All biomedical research in Vietnam must be reviewed and evaluated for ethical considerations in research according to the provisions of this Code of Conduct.

Article 2. The biomedical research referred to in this Code includes: drug research (modern drugs, herbal medicines, traditional medicine), biological products (vaccines and other biological products), non-drug treatment methods, medical devices, radiation and imaging methods, surgical procedures, biological samples (blood, tissue specimens, breast milk), epidemiological, sociological, and psychological surveys conducted on humans.

Article 3. The Bioethics Council in Biomedical Research is a council established by entities with legal personality in the healthcare sector (Ministry, Research Institutes, Universities, hospitals, Provincial Health Departments) in accordance with their functions and powers as prescribed by law, consistent with community values and interests to ensure the dignity, rights, safety, and happiness of all individuals currently and potentially involved in the research process in biomedical studies.

Chapter II

ORGANIZATION OF THE BIOETHICS COUNCIL IN BIOMEDICAL RESEARCH

Article 4. Functions and responsibilities of the Bioethics Council in Biomedical Research.

1. Ensuring the dignity, rights, safety, and satisfaction of all subjects currently and potentially participating in the research.

2. Ensuring fairness for all subjects currently and potentially participating in the research (benefits and sharing of risks, distribution among groups and social strata, age, gender, economic status, cultural issues, and ethnic matters...).

3. Conducting independent, accurate, and timely evaluations of the ethical aspects of the research.

4. Working objectively, democratically, and honestly.

5. Conducting evaluations of proposed research before the research begins.

The Bioethics Councils in Biomedical Research have the responsibility to fully consider individuals who may participate in the research and the related communities, the rights and needs of researchers, managing organizations, and comply strictly with legal regulations.

Article 5. Establishment of the Bioethics Council in Biomedical Research.

1. Authorities with decision-making power establish the Bioethics Council in Biomedical Research. Specifically, as follows:

1.1. The Minister of Health issues decisions to establish the Bioethics Council in Biomedical Research at the Ministry of Health level to review ethical issues in biomedical research involving human subjects in projects and programs at the ministry and state levels, international cooperation projects, and projects and programs requiring review by the Ministry of Health's Bioethics Council.

1.2. The Heads of research units under the Ministry of Health, and the Directors of Provincial Health Departments (collectively referred to as provinces) issue decisions to establish the Bioethics Council in Biomedical Research to review ethical issues in biomedical research of scientific research projects managed by them.

1.3. Projects and programs at the ministry and state levels, and institutional and foreign organizations, private, semi-public, and public institutions with foreign investment when conducting research involving human subjects must be reviewed for ethical issues in biomedical research through the Ministry of Health's Bioethics Council.

2. Number, composition, positions, and qualifications of members of the Bioethics Council in Biomedical Research:

2.1. Regarding the number of the Bioethics Council in Biomedical Research:

2.1.1. The Bioethics Council at the ministry level has nine members and three secretaries assisting the Council. The secretariat assists the Council and is located at the Science and Training Department of the Ministry of Health.

2.1.2. The Bioethics Council in Biomedical Research of research units under the Ministry and Provincial Health Departments has seven members and two secretaries assisting the Council. The secretariat assists the Council and is located at the research management department or a suitable functional department (for units without a science and technology management department) and is decided by the unit head.

2.2. The Bioethics Council in Biomedical Research consists of the following components:

- Chairperson of the Council.

- Vice-Chairperson of the Council (if necessary).

- Members of the Council.

- Secretary of the Council.

a) The Chairperson and Vice-Chairperson of the Council are reputable scientists in the field, honest, impartial, and always protect the rights of researchers and research subjects. To ensure objectivity, the Director or Head of the unit or agency does not participate as the Chairperson of the Council.

b) Members of the Council include the following components:

- There shall be one member representing the managing agency of the research topic, appropriate to the level of management of the research topic, with qualifications in management and a deep understanding of the law.

- There shall be from one to two members representing the interests of the research subjects. These individuals must be honest, impartial, and qualified (in terms of ethics and knowledge) to represent the interests of the research subjects.

- The remaining members shall be scientists with a deep understanding of the specialized field.

c) Secretary of the Council:

- The Secretary of the Council is responsible for receiving, processing files, preparing all conditions for the Council's work, completing all documents and Decisions of the Council, and implementing tasks as required by the Council.

- The Secretary of the Council must be honest, impartial, knowledgeable about scientific and technological management, scientific research, ethics in biomedical research, administrative procedures, documentation, and management duties.

Chapter III

ACTIVITIES OF THE BIOMEDICAL RESEARCH ETHICS COUNCIL

Article 6. Regulations on the operation of the Biomedical Research Ethics Council.

1. The term of office of the Biomedical Research Ethics Council is stipulated in the Decision establishing the Council, with a five-year term for the Ministry of Health's Biomedical Research Ethics Council, a four-year term for the Biomedical Research Ethics Councils of units under the Ministry of Health, and the Provincial Health Departments' Biomedical Research Ethics Councils.

2. The Minister of Health, Heads of Units under the Ministry of Health, and Directors of Provincial Health Departments issue decisions to establish the Council, dismiss or replace members of the Biomedical Research Ethics Council.

3. The Biomedical Research Ethics Council is responsible to the Head of the Agency that established the Council for the Council's decisions made when considering ethical issues in biomedical research.

4. The Biomedical Research Ethics Council operates by secret ballot when considering and making decisions. A meeting of the Council has legal validity only if at least three-quarters of the Council members are present, and a decision made by secret ballot has legal validity only if at least three-quarters of the attending members agree.

5. The Chairman (or Vice-Chairman authorized by the Chairman) presides over Council meetings and has the authority to approve or veto the majority opinion if the majority of Council members' opinions go against the interests or violate the dignity of the research subjects. In such cases, the Council does not vote, and the Chairman is responsible for reporting to the Head of the Directly Managing Agency of the Council for resolution.

6. Council members have the right to report to the Head of the Directly Managing Agency of the Council to resolve violations of the Chairman's working principles or those of any other member of the Council.

7. After reviewing and concluding on ethical issues in biomedical research of a project or proposal, the Council sends the evaluation record and related documents to the scientific and technological management agency of the unit or individual who requested the evaluation. Within ten days from the date of receipt of complete files, records, and Council decisions, the scientific and technological management agency must notify the organization or individual with the biomedical research project or proposal requesting the ethical evaluation of the results.

8. The Council may invite consultants when necessary, and their advisory opinions are valuable for the Council to consider. Consultants do not participate in secret ballots.

9. When evaluating and making decisions, the Biomedical Research Ethics Council needs to pay attention to the following aspects:

a) Scientific design and organization of research.

b) Selection of research subjects.

c) Care and protection of the safety of research subjects.

d) Protection of confidentiality for those involved in the research.

(Attached to this Regulation is an appendix providing detailed guidance).

Article 7. Evaluation process of the Council.

1. The Secretariat receives applications and files of projects requesting ethical evaluation (according to the prescribed form).

2. The Secretariat reviews and completes the files, prepares documents and conditions for the Council's work, and forwards the files to the Council members.

3. Each Council member reads the file of the project requesting evaluation transferred by the Secretariat (files must be sent to the members at least seven days before the Council meeting).

4. The Biomedical Research Ethics Council convenes a meeting after the Scientific and Technological Council reviews the research outline according to the regulations on scientific and technological management already issued, and the Biomedical Research Ethics Council only considers the ethical aspect of biomedical research based on the Scientific and Technological Council's review of the research outline regarding academic, technical expertise, and scientific aspects.

In cases where the directly managing agency assigns the Council the task of reviewing the research outline for academic, technical expertise, and design according to the regulations on scientific and technological management, the Council will undertake both the review of the research outline and consideration of the ethical aspect of biomedical research. For such cases, the establishment decision must clearly specify the Council's tasks.

5. Within sixty days from the date of receipt of valid files, the Council must convene a meeting to evaluate and make a decision.

6. After reaching a conclusion and obtaining approval from the Council (according to the model in Appendix 7-8), the Head of the Directly Managing Scientific and Technological Management Agency issues a notification of the result to the requesting unit and individual and issues a Decision approving the project for the principal investigator and the main agency to implement.

Article 8. Provisions on application files for ethical evaluation in biomedical research:

1. Application files and documents: The applicant must submit complete files and documents in accordance with the regulations (Appendix 5).

2. The application for ethical assessment in biomedical research of a project or topic must be signed and the responsibility assumed by the principal investigator of the project or topic. The principal investigator must be a reputable scientist with professional expertise in the relevant field, confirmed by the competent authority (the leading agency of the project or topic). The application for assessment must be made according to the form prescribed by the Ministry of Health (Annex 6).

3. The application and all documents in the ethical assessment application file must be in the Vietnamese language; if they are translations from foreign languages, they must be notarized.

4. A valid original file must be submitted to the Secretariat of the Council.

5. The file must be submitted to the Secretariat of the Council at least two months prior to the date of the Council meeting.

6. The assessment costs and financial support for the activities of the Biomedical Research Ethics Committee shall be implemented according to the financial regulations applicable to scientific research activities (Scientific and Technical Council reviewing the research outline) and shall be drawn from the regular budget of the operating expenses for public institutions. For international collaborative projects, private healthcare facilities, semi-public, non-profit organizations, and those with foreign investment, the actual costs for organizing the assessment according to the requirements of the science and technology management agency and financial management authorities based on current regulations must be borne by themselves.

7. In cases where individuals or units wish to amend or supplement the files, documents, or information about the research, such actions must be approved and directed in writing by the direct science and technology management agency before being presented to the Council. Any amended or supplemented files that are legally submitted after the Council has convened will not alter the conclusions of the Council. If necessary, upon approval by the Council, the Council may reconvene to conduct the assessment.

Chapter IV

IMPLEMENTING PROVISIONS

Article 9. These regulations apply to all science and technology management agencies under the Ministry of Health, research and development units directly under the Ministry of Health, provincial health departments under central municipalities, sectoral health departments, domestic and foreign organizations and individuals when conducting research related to humans in Vietnam.

Article 10. The heads of science and technology management agencies under the Ministry of Health, the heads of units directly under the Ministry, the directors of provincial health departments under central municipalities, and the heads of sectoral health departments are responsible for directing, guiding, and organizing the implementation of these regulations.

Article 11. During the implementation process, if there are difficulties or obstacles, the heads of units must report to the Ministry of Health (Department of Science - Training) for consideration, amendment, and supplementation. All complaints regarding ethical assessments in biomedical research from organizations and individuals must be sent to the science and technology management agency at the appropriate level of authority for review and resolution in accordance with current laws.