79C3C34C52B45572883A05D425EB0F82
MOH: Decision No. 460/QD-BYT – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of the Ministry of Health, Period 2012-
https://clinregs.niaid.nih.gov/sites/default/files/documents/vietnam/DecisionNo460-QD-BYT.pdf
http://leaux.net/URLS/ConvertAPI Text Files/609CDDEFCF9FAA6FFAEFE90C288945CC.en.txt
Examining the file media/Synopses/609CDDEFCF9FAA6FFAEFE90C288945CC.html:
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 1 |
| Social | employees | employees | 1 |
Health / Drug Usage
Searching for indicator drug:
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p.000001: shall be responsible to carry out this Decision./.
p.000001:
p.000001:
p.000001: Recipients:
p.000001: - As in Article 4;
p.000001: - Deputy Ministers;
p.000001: - Vietnam Medical Association, Vietnam Pharmaceutical Association;
p.000001: - Website of Ministry of Health;
p.000001: - Archived.
p.000001: MINISTER
p.000001: (Signed)
p.000001:
p.000001: Nguyen Thi Kim Tien
p.000001:
p.000001: MINISTRY OF HEALTH
p.000001: --------
p.000001: SOCIALIST REPUBLIC OF VIETNAM
p.000001: Independence - Freedom - Happiness
p.000001: ----------------
p.000001:
p.000001:
p.000001: No. 460 /QD - BYT
p.000001:
p.000001: Hanoi, February 16th 2012
p.000001:
p.000001:
p.000001: REGULATIONS
p.000001: On the organization and operation of Ethical Evaluation Committee in biomedical research of Ministry of Health, period
p.000001: 2012 - 2017
p.000001: (Promulgated with Decision No.: 460/QD-BYT dated February 16th 2012 of Minister of Health)
p.000001:
p.000001: Chapter I GENERAL PROVISIONS
p.000001:
p.000001: Article 1. This Regulation governs the organization and operation of Ethical Evaluation Committee in
p.000001: biomedical research of Ministry of Health, period 2012 – 2017 which was established with Minister of
p.000001: Health’s Decision No. 458/QD-BYT dated February 16th 2012.
p.000001: Subjects of governing of this Regulation include members of Ethical Evaluation Committee in biomedical research
p.000001: Ministry of Health period 2012 - 2017 and individuals and organizations in Ministry of Health who
p.000001: are related to the implementation, supervision, evaluation, and management of biomedical research on human.
p.000001: Article 2. Biomedical research in this Regulation comprise of: clinical drug trial, medical equipment;
p.000001: treatment methods, diagnostic methods; research using biological samples; epidemiological, socio-medical and
p.000001: psychological research on human subjects.
p.000001: Article 3. Before carrying out any research, all biomedical research on human subjects (hereinafter referred to as
p.000001: biomedical research) in Vietnam shall have to be examined and evaluated by Ethical Evaluation Committee in
p.000001: biomedical research (hereinafter referred to as Ethical Evaluation Committee) in terms of research ethical aspects
p.000001: and specialized scientific aspects in compliance with this Regulation and Guidelines of Good Clinical
p.000001: Practices promulgated with Decision No. 799/QD-BYT dated 7/3/2008 of Minister of Health and Guidance on
p.000001: clinical trial in Circular No. 03/2012/TT-BYT dated 02/02/2012 of Minister of Health.
p.000001: Article 4. The Standing Office locating at the Ministry of Health shall assist the Ethical Evaluation Committee.
p.000001: The Standing Office of the Ethical Evaluation Committee shall have legal status and use the stamp and
p.000001: account of the Ethical
p.000001: 1
p.000001:
p.000001: Evaluation Committee for transactions within their functions and duties. Budget for the operation of
p.000001: Ethical Evaluation Committee shall be from the State budget and other assistance fund in compliance with
p.000001: current regulations.
p.000001:
p.000001: Chapter II
p.000001: FUNCTIONS, DUTIES, POWERS, RESPONSIBILITIES AND ORGANIZATIONAL STRUCTURE OF ETHICAL EVALUATION COMMITTEE
p.000001:
p.000001: Article 5. Functions, duties, powers, responsibilities of Ethical Evaluation Committee
p.000001: 1. Functions
p.000001: Ethical Evaluation Committee is the advisor to the Minister of Health in terms of ethical issues in biomedical
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Social / employees
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p.000003: inspection, supervision, and management of clinical trial research;
p.000003: b) To coordinate for the development of standard procedures on examination, evaluation, inspection,
p.000003: supervision, and management of clinical trial research;
p.000003: c) To coordinate for the implementation and to supervise the implementation of standard procedures on examination,
p.000003: evaluation, inspection, supervision, and management of clinical trial research;
p.000003: d) To act as a focal point in working with international and domestic organizations to develop
p.000003: the Ethical Evaluation Committee’s operations in compliance with international standards and Vietnamese regulations;
p.000003: đ) To prepare documents, to record and store the minutes of regular and ad-hoc meetings of the Ethical Evaluation
p.000003: Committee and relevant documents;
p.000003: e) To settle the payment of expenditures and prepare the final account of budget for the Ethical Evaluation
p.000003: Committee and Standing office of the Ethical Evaluation Committee in compliance with current financial
p.000003: regulations;
p.000003: f) To compile 3-month, 6-month and annual reports on the performance of the Ethical Evaluation Committee.
p.000003:
p.000003: 3. Powers
p.000003: a) To be entitled to select officers, civil servants, officials to work concurrently or as secondee at the
p.000003: Standing office of the Ethical Evaluation Committee in compliance with the current regulations to submit to the
p.000003: Ethical Evaluation Committee for consideration and further submit to the leaders of Ministry of Health for approval;
p.000003: b) To recruit and sign contract with domestic and international consultants, contract employees to work
p.000003: for the Standing office of the Ethical Evaluation Committee depending on the work demand in compliance
p.000003: with current regulations;
p.000003: c) To use public service budget for science and other sources of funding for the operations of Ethical Evaluation
p.000003: Committee and the Standing office of the Ethical Evaluation Committee in compliance with current regulations;
p.000003:
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p.000004: d) The Standing office of the Ethical Evaluation Committee is entitled to use the stamp and account of the
p.000004: Ethical Evaluation Committee for transactions within their functions and duties.
p.000004: đ) The Chief Secretariat of the Ethical Evaluation Committee Standing office is the Account Holder of the Ethical
p.000004: Evaluation Committee.
p.000004:
p.000004: Article 8. Structure of the Ethical Evaluation Committee Standing Office:
p.000004: 1. The Chief Secretariat of the Ethical Evaluation Committee Standing office is appointed and dismissed by the Chairman
p.000004: of the Ethical Evaluation Committee;
p.000004: 2. Staff of the Ethical Evaluation Committee Standing office comprises of 3 – 5 specialized officers who are
p.000004: experts from Department of Science and Training and other concurrent officers and secondees recruited by
p.000004: the Chief Secretariat of the Ethical Evaluation Committee Standing office to submit to the Ministry’s leaders for
p.000004: approval;
p.000004: 3. Besides, the Ethical Evaluation Committee Standing office has other experts, officers, and staff recruited
p.000004: by the Chief Secretariat of the Ethical Evaluation Committee Standing office for short-term working
p.000004: contracts in compliance with current regulations.
p.000004:
p.000004: Chapter III
p.000004: OPERATION OF THE ETHICAL EVALUATION COMMITTÊ
p.000004:
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Orphaned Trigger Words
p.000001: biomedical research (hereinafter referred to as Ethical Evaluation Committee) in terms of research ethical aspects
p.000001: and specialized scientific aspects in compliance with this Regulation and Guidelines of Good Clinical
p.000001: Practices promulgated with Decision No. 799/QD-BYT dated 7/3/2008 of Minister of Health and Guidance on
p.000001: clinical trial in Circular No. 03/2012/TT-BYT dated 02/02/2012 of Minister of Health.
p.000001: Article 4. The Standing Office locating at the Ministry of Health shall assist the Ethical Evaluation Committee.
p.000001: The Standing Office of the Ethical Evaluation Committee shall have legal status and use the stamp and
p.000001: account of the Ethical
p.000001: 1
p.000001:
p.000001: Evaluation Committee for transactions within their functions and duties. Budget for the operation of
p.000001: Ethical Evaluation Committee shall be from the State budget and other assistance fund in compliance with
p.000001: current regulations.
p.000001:
p.000001: Chapter II
p.000001: FUNCTIONS, DUTIES, POWERS, RESPONSIBILITIES AND ORGANIZATIONAL STRUCTURE OF ETHICAL EVALUATION COMMITTEE
p.000001:
p.000001: Article 5. Functions, duties, powers, responsibilities of Ethical Evaluation Committee
p.000001: 1. Functions
p.000001: Ethical Evaluation Committee is the advisor to the Minister of Health in terms of ethical issues in biomedical
p.000001: research.
p.000001: 2. Duties
p.000001: a) To evaluate the ethical issues in biomedical research documents (research proposals, relevant reports
p.000001: and documents) to ensure their legality, objectivity, and honest.
p.000001: b) To monitor, examine, and supervise the research in compliance with Good Clinical Practices and regulations on
p.000001: research ethics.
p.000001: c) To evaluate the research results of the approved research proposals based on the current guidelines and
p.000001: regulations.
p.000001: d) To train, guide, and improve the researchers for the health sector regarding research ethics and Good
p.000001: Clinical Practices (GCP).
p.000001: 3. Powers
p.000001: a) To accept or not accept biomedical research documents, serving as basis for management authorities to approve the
p.000001: conducting of research.
p.000001: b) To accept or not accept changes in research contents during implementation.
p.000001: c) To propose the termination of research upon signs of incompliance of GCP or discovery of risks to the research
p.000001: subjects’s safety which may possibly happen during the research process.
p.000001: d) To request the main researchers, organizations conducting clinical trials to report on the figures, data,
p.000001: research results and research-related documents.
p.000001: đ) To examine and supervise the compliance with Good Clinical Practices at research field and the figures,
p.000001: data, research results and research-related documents.
p.000001: 4. Responsibilities
p.000001: a) To protect the safety of research subjects and the community.
p.000001: b) To protect the rights of research subjects and researchers.
p.000001: c) To ensure justice for all research stakeholders.
p.000001: d) To ensure the scientific aspects and feasibility of the research.
p.000002: 2
p.000002:
p.000002: Article 6. Structure, membership, number of, positions and membership requirements of Ethical
p.000002: Evaluation Committee.
p.000002: 1. Organizational structure
p.000002: - Ethical Evaluation Committee comprises of Standing office, Standing subcommittee, 3 specialized
p.000002: subcommittees: Pharmaceuticals, Traditional medicines, Vaccines and secretary team.
p.000002: - Leaders of the Ethical Evaluation Committee include Chairman and Vice Chairmen.
p.000002: - The subcommittees include the Head of subcommittee and members.
p.000002: - The Standing office of the Ethical Evaluation Committee has its head office at Ministry of Health (138 A Giang Vo,
p.000002: Ba Dinh district, Hanoi) and its standing unit in Pasteur Institute Ho Chi Minh city (167 Pasteur, Precinct 8, District
p.000002: 3, Ho Chi Minh city).
p.000002: 2. Membership, number of members:
p.000002: a) Chairman, Vice Chairmen of the Ethical Evaluation Committee are scientists capable of embracing the fields related
p.000002: to the Committee’s duties.
p.000002: b) The Standing office of the Ethical Evaluation Committee comprises of the Chairman, Vice Chairmen of the
p.000002: Ethical Evaluation Committee and members of the Standing subcommittee. Members of the standing subcommittee
p.000002: has the following membership structure:
p.000002: - Including members of both sexes.
p.000002: - Including members representing the scientific management authorities, with good management skills and good
p.000002: legal knowledge.
p.000002: - Including members representing rights of research subjects, who are honest, impartial, with good sense of morality
p.000002: and good knowledge.
p.000002: - Including members who are lawyers or jurists to ensure the legality of research documents, to protect
p.000002: legitimate rights of research subjects as well as researchers, members of research teams.
p.000002: - Including members who are scientists with in-depth knowledge of clinical, epidemiology, pharmacy, medical
p.000002: statistics, research approach.
p.000002: c) Each specialized subcommittee comprises of 07 - 09 members who are scientists with in-depth knowledge
p.000002: of their specialized fields of pharmaceutical chemistry, traditional medicines, vaccines and medical biological
p.000002: products.
p.000002: d) The Secretary team comprises of 07 - 09 members who possess good management skills and knowledge of
p.000002: biomedical research.
p.000002: đ) Members of the subcommittees and secretary team must be provided with Ministry of Health’s training
p.000002: program on "Good Clinical Practices".
p.000002:
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p.000003: 3
p.000003:
p.000003: Article 7. Functions, duties, powers of the Standing office of the Ethical Evaluation Committee
p.000003: 1. Functions
p.000003: The Standing office of the Ethical Evaluation Committee assists the Ethical Evaluation Committee in
p.000003: developing planning, plans, arranging the examination, evaluation, inspection, supervision, and management of
p.000003: clinical trial research.
p.000003: 2. Duties
p.000003: a) To develop long- and short-term plans on the development of Ethical Evaluation Committee’s operations
p.000003: in compliance with international standards and Vietnamese regulations, including: examination, evaluation,
p.000003: inspection, supervision, and management of clinical trial research;
p.000003: b) To coordinate for the development of standard procedures on examination, evaluation, inspection,
p.000003: supervision, and management of clinical trial research;
p.000003: c) To coordinate for the implementation and to supervise the implementation of standard procedures on examination,
p.000003: evaluation, inspection, supervision, and management of clinical trial research;
p.000003: d) To act as a focal point in working with international and domestic organizations to develop
p.000003: the Ethical Evaluation Committee’s operations in compliance with international standards and Vietnamese regulations;
p.000003: đ) To prepare documents, to record and store the minutes of regular and ad-hoc meetings of the Ethical Evaluation
p.000003: Committee and relevant documents;
p.000003: e) To settle the payment of expenditures and prepare the final account of budget for the Ethical Evaluation
p.000003: Committee and Standing office of the Ethical Evaluation Committee in compliance with current financial
p.000003: regulations;
p.000003: f) To compile 3-month, 6-month and annual reports on the performance of the Ethical Evaluation Committee.
p.000003:
p.000003: 3. Powers
p.000003: a) To be entitled to select officers, civil servants, officials to work concurrently or as secondee at the
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p.000005:
p.000005: Article 11. Physical and technical conditions for Ethical Evaluation Committee:
p.000005: The Ethical Evaluation Committee and its Standing office shall be provided with sufficient physical
p.000005: facilities to perform their duties: including offices, equipment, supervision and monitoring tools, and operating
p.000005: budget to satisfy the management requirements and plan implementation as provided for in this Regulation.
p.000005: The Ministry’s Office shall be responsible to arrange offices for the Ethical Evaluation Committee Standing
p.000005: office at the Ministry of Health’s head office. In case it is impossible to arrange an office at the Ministry of
p.000005: Health’s head office, the Ethical Evaluation Committee Standing office is allowed to rent an office.
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p.000006: The Ethical Evaluation Committee shall be provided office equipment and supplies and stationery to serve
p.000006: the meetings and other equipment and supplies to perform their functions and duties.
p.000006:
p.000006: Chapter IV IMPLEMENTATION PROVISIONS
p.000006:
p.000006: Article 12. This Regulation shall be applicable since the date of effectiveness. Based on this Regulation, the
p.000006: Ethical Evaluation Committee shall consider the development of the standard operational practices (SOPs) for the
p.000006: Committee’s specific activities.
p.000006: The agencies and entities under the Ministry of Health shall carry out their research activities in
p.000006: compliance with this Regulation in order to organize and develop the Operating Rules of their own Ethical Evaluation
p.000006: Committees to ensure compliance with the fundamental principles of research ethics.
p.000006: If there are any difficulties during the implementation, individual and organizations shall report
p.000006: to the Ministry of Health (Department of Science and Training) for consideration to amend and supplement this
p.000006: Regulation. All complaints on ethical evaluation in biomedical research shall be sent to the Ethical
p.000006: Evaluation Committee Standing Office for examination and resolution in compliance with current law./.
p.000006: MINISTER
p.000006:
p.000006: (signed) Nguyen Thi Kim Tien
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Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| employees | employees |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
developing
ethics
justice
protect
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 1 |
| Social | employees | employees | 1 |