MINISTRY OF EDUCATION AND TRAINING
No: 451 /QĐ-ĐHH
|SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – HappinessThua Thien Hue, April 22, 2021
On the promulgation of the Regulation on organizational structure and operation
of the Hue University Animal Ethics Committee
THE PRESIDENT OF HUE UNIVERSITY
Pursuant to the Decree No. 30/CP dated 04/04/1994 of the Government on establishing of Hue University;
Pursuant to the Circular No. 10/2020/TT-BGDĐT date 14/05/2020 of the Minister of Ministry of Education and Training on promulgate Regulations on organization and operation of regional universities and affiliated higher education institutions;
Pursuant to the Decision No. 20/QĐ-HĐĐH dated 31/07/2020 of the Council of Hue University on promulgate Regulations on organization and operation of Hue University, and Decision No. 07/QĐ- HĐĐH dated 19/01/2021 on amending and supplementing a number of articles of the Regulations on organization and operation of Hue University;
Pursuant to the Law of Veterinary dated 19/06/2015 and the Law of Livestock dated 19/11/2018;
At the request of Acting Director of the Department of Science, Technology and International Relations, and the Rector of University of Agriculture and Forestry – Hue University.
Article 1. This Decision is enclosed with “Regulation on organization and operation of the Hue University Animal Ethics Committee”
Article 2. This Decision comes into force as of the date of signing.
Article 3. The Deputy Chef of Hue University Office, Acting Director of Department of Science, Technology and International Relation, Heads of relevant units of Hue University shall implement this Decision./.
Nguyễn Quang Linh (signed)
The organizational structure and operation of the Hue University Animal Ethics Committee
(Promulgated together with the President of Hue University’s Decision No/ 451/QĐ-ĐHH of April 22. 2021)
CHAPTER 1. GENERAL PROVISIONS
Article 1. Scope of regulation and Subjects of application
- This Regulation provides for the establishment, organization and operation of the Hue University Animal Ethics Committee (hereinafter referred to as the Committee).
- This Regulation applies to agencies, organizations and individuals inside and outside Hue University that use animals in research activities and need approval on ethical aspects.
Article 2. Terminology
- Animal research means clinical trial studies on medicines or products, application of new equipment in animal husbandry; diagnostic, therapeutic, and epidemiological studies have been conducted on animals.
- Animal ethics refers to a field of implementing and ensuring the welfare of the animal and ethical enquiry arising in the relation of care and use involving animal participants.
- Researcher refers to a person responsible for the conduct of the research at a research site.
- Principal researcher/investigator: refers to a researcher who oversees or conducts the research process and reports the research process and results directly to the sponsor.
- Sponsor refers to an individual or organization that takes responsibility for the initiation, management, and/or financing of a research project
- Research monitoring and supervision refers to a process of monitoring and supervising research progress and adherence of a researcher to the approved protocol and relevant regulations of law on research.
- Conflict of interest refers to a situation where a researcher or Committee member has a conflict of interest if he/she stands to achieve personal gain by failing to discharge professional obligations, thereby potentially influencing the objectivity in research or research review.
- Benefit refers to a favorable consequence arising from a research study
- Risk refers to the probability of an adverse event (potential harm) or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
- Trial or experiment refers to a research study in which one or subjects are prospectively assigned to one or more interventions according to an approved plan to evaluate the effect of those interventions on animal health.
- Research proposal in short is a summary proposal to carry out a research topic, focusing on the use of animals in research.
- Experimental animals include terrestrial animals (buffalo, cow, goat, sheep, pig, chicken, duck…), ornamental animals, wild animals and aquatic animals (shrimp , farmed fish, ornamental fish ..) are used for research needs.
- The Three Rs (3Rs) principles are Replacement, Reduction, Refinement appear in science to guide principles for more ethical use of animals in testing with a focus on developing methods of replacement alternatives to animal use
Article 3. General principles of Animal ethics
- After the approval of the Scientist Committee and before the implementation, all research studies involving animal participants must be considered, assessed, directed and approved by the Animal Ethics Committee.
- All research studies involving animal participants must be under the supervision of a Committee during its conduct.
CHAPTER II. ESTABLISHMENT, FUNCTIONS, AND OPERATION OF COMMITTEE
Article 5. Establishment of Committee
- The President of Hue University shall establish The Hue University Animal Ethics Committee.
- The President of Hue University shall approve the Committee charter and decide on designation, dismissal, addition or replacement of its members
- A term of office of the National REC lasts 05 years and it is required to re-establish or re-organize the Committee upon the expiry of the term of office. The Committee for the next consecutive term of office must be joined by at least 1/3 of the previous official members.
- The Committee has seal and account of University of Agriculture and Forestry – Hue University to perform its functions and tasks and exercise its rights.
Article 6. Standards to be satisfied by Committee members
1. The Committee shall have from 9 to 13 official members that include a Chair, 01 Deputy Chair, 01 secretary and official members.
2. General standards of Committee members:
a) The member that has expertise in the animal husbandry, veterinary medicine, fisheries and biology sectors and the member that has expertise in animal welfare.
b) Every member must have experience, knowledge, necessary skills and competence to perform their tasks, ensure objectivity in research and protect rights of research subjects.
c) Every member must be voluntary and have sufficient time to participate in the performance of duties of the Committee.
d) Every member must be honest and objective; must undertake to maintain confidentiality of information relating to research and assigned tasks.
3. The Chair and Deputy Chair of a Committee must have at least 15 years’ relevant work experience, be reputable and sufficiently competent to manage the Committee in an independent, fair and unbiased manner without any pressure from the research presiding organization, researchers and other organizations and individuals, and have the appropriate certificate.
4. The Secretary of the Committee must have at least 5 years’ relevant work experience; must have knowledge of administrative operations; must have the capacity of organizing and processing documents, making necessary preparations for Committee meetings, preparing necessary documents, and carrying out other tasks of the Committee.
5. Committee members include: members in the field of animal husbandry, veterinary, and fisheries; members from unrelated research organizations; members that have expertise in the use of animals in research. The members must have at least 05 years’ relevant work experience.
6. In case of necessity, the Committee may invite consultants. An independent consultant is a person whose expertise is relevant to the research, who has experience in the use of animals in research. Consultants must not have any conflict of interest in the research which they are invited to review. Consultants are entitled to attend meetings to exchange and discuss research but do not have any voting authority.
Article 7. Functions, Tasks and Rights of the Committee
1. Committee exercise the function of reviewing research documentation in term of animal welfare in the use of animal in research with regard to regulations of Article 21 of the Law of Veterinary dated 2015 and Point 2, Chapter 5 of the Law of Livestock dated 2018.
2. The Committee has the following tasks
a) Consider and advise all requests of ethical and scientific aspects of a research involving animal participants before conducting research;
b) Consider, review and approve the research protocols based on the principle of the 3Rs to form a basis for the value of animals compare to the research benefits;
c) Approve the procedure of animal cares and the uses of animals in research of requested project proposals;
d) Supervise and monitor adherence to research protocols and regulations on the welfare and care of animals in research; handling of adverse events that occur during the course of the research, reporting and recommending to the competent authority if necessary;
đ) Archive and manage documents of the Committee in accordance with regulations of law on archives.
3. Rights of Committee
a) Approve and request modifications of research protocols or refuse to approve research documentation involving animal participants to form a basis for the competent authority to issue a decision to conduct research;
b) Make recommendations on necessary solutions to ensure that research complies with the animal welfare in the Law of Veterinary and the Law of Livestock and animal welfare regulations;
c) Supervise the receival, transportation, care, use or disposal of animal and the adherence in accordance with the approved protocol;
d) Approve changes of contents of a research study related to the use of Animal in research during its conduct;
đ) Request the competent authority to suspend the research if it is found that a researcher fails to use of animal to comply with Committee regulations or the safety of researchers and research animals is not ensured during the course of the research.
4. Responsibilities of Committee
a) Safeguard the rights, safety and well-being of all research subjects, and concerned communities;
b) Ensure the objectivity, the honesty, and the timeliness when evaluating all the aspects of the use of animal in research;
c) Ensure the legality and science of the research proposal, documents, and the confidentiality of the research.
Article 8. Operating principles of Committee
- Committee shall operate for non-profit purpose.
- Committee member who has direct benefits or conflict of interest of the considered research are entitled to attend meetings to exchange and discuss research but do not have any voting authority.
- The Committee shall make clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers.
- Committee shall operate in a collective, democratic and independent manner when undertaking review and making decisions.
- For issues not specified in this regulation, a Committee’s conclusion on the research shall be given by consensus of Committee members and specified in the minutes of Committee’s meeting or if it is beyond Committee’s competence, Committee may call upon Hue University authority for advice.
Article 9. Responsibilities of Committee members
- Committee members shall operate in the principle of an objective, independent manner and responsibility when reviewing, evaluating, and making decisions.
- Committee members are responsible for reporting to the Chair of Committee, and to the Board of Committee if they have any conflict of interest in the research which they are invited to review.
- Committee members are responsible for reviewing research documents, completing and sending evaluation sheets before the meetings as prescribed.
- Committee members are responsible for following the standard operating procedure of Committee.
- Committee members have the right to report to the President of Hue University any violations of working principles by the Chair of the Committee or by a member of the Committee.
Article 10. Funding for supporting Committee’s operations
- Funding for operation of the REC shall be covered by the state budget in accordance with current regulations applied to science and technology activities.
- For projects not funded by state budget (including of Hue University or relevant units of Hue University’s budget), researchers and sponsors shall prepare a plan to provide funding for covering costs of consideration, review, and evaluation by the Committee.
- For projects of organization or individuals outside of Hue University that request for evaluation of the Committee shall prepare a plan to provide funding for covering costs of consideration, review and evaluation by the Committee according to current regulation of the entity establishing the Committee
CHAPTER III. PROCEDURES AND CONTENTS THAT COMMITTEE NEEDS TO REVIEW
Article 11. Committee’s review procedure
1. The Committee receives and processes the application as the following steps:
a) Receiving, checking and assessing applications.
b) Providing comments and critical evaluation of the applications.
c) Organizing the Committee’s evaluation meeting
d) Giving notification of the results
2. The process for reviewing applications and responding to results is up to 04 weeks from the date of receiving the application.
Article 12. Documents required for review
1. Documents required for review include:
a) Application form (Form 01, Appendix)
b) Research proposal in short (Form 02, Appendix);
c) An adequate summary of the research product (applicable to research involving clinical trial);
d) Current curricula vitae and relevant certificates of the PI(s)
2. The project manage or PI completes the application form and sends 01 electronic copy to committee via online system: http://tapchi.tabaagritage.com/index.php/id20194 and 01 hard copy to the Secretary of the Committee.
Article 13. Organizing the Committee meeting
1. Preparation for meeting
a) The Secretary of Committee shall consult with the Chair and Vice-Chair of the Committee to appoint 02 critical reviewers and decide whether to invite experts.
b) The Secretary of the Committee arranges the meeting schedule with the members of the Committee.
c) All review documents shall be sent to critical reviewers at least 02 weeks, and to other members and experts (if any) at least 01 weeks before the meeting.
2. Conditions for organizing the Committee meeting
a) A meeting is led by the REC Chair or Deputy Chair as authorized by the REC Chair
b) A meeting shall only be conducted when at least 2/3 of the members of the Committee are present, in which it is mandatory to have a moderator, secretary of the Committee and at least 01 critical reviewers (If critical reviewers fail to attend a meeting, their written comments must be submitted to the Committee before the meeting, Form 3, Appendix)
3. Committee Meeting Procedure
a) The Committee shall determine and resolve any issues of conflicts of interest (if any) of the members related to reviewed documents;
b) The Secretary of the Committee shall introduce the summary of application and related procedural issues;
c) The project manager (PI) shall present the summary of research proposal in 15 minutes or less;
d) Committee members and experts shall give questions of any issues that need to be clarified in the documents to the project leader; After the question and answer session, the project leader shall not continue to attend the meeting of the Committee;
đ) The critical reviewers shall present their comments in details on the technical and ethical issues of research proposal in the use of experimental animals; Committee members and experts (if any) exchange, discuss and comment on ethical aspects of the research proposal;
e) Committee members shall evaluate the application form by secret ballot (Form 04, Appendix);
g) The Committee shall appoint a Committee of Vote Counting consisting of 2 members and the Secretary of the Committee (The Minutes of Vote counting is followed by Form 05, Appendix);
h) The Committee shall announce the results and sign the Minutes of the Committee meeting (Form 06, Appendix).
4. Decision of Committee as the results of voting
a) The research protocol will be approved as “Approved without revision and improvement” if 2/3 attending committee members select “Approve” and there is no suggestion on “Need to be revised and improved”;
b) The research protocol has been approved as “Approved after revision and improvement” when 2/3 attending committee members select “Approve” and there are at least 01 comments to suggest “Need to be revised and improved”;
c) The research protocol has been not approved as “Not Approved” when above 1/2 attending committee members select “Not Approved”;
d) The research protocol has been identified as “Need to be reconsidered” in the remaining case (from 1/2 to less than 2/3 of the attending members select “Approved”).
Article 14. Contents that Committee need to review and make conclusions
1. Committee members evaluate the applications based on criteria agreed by the Committee, including:
a) Review the technical and legal issues related to the use of experimental animals such as: making animals painful and stressful or creating behavioral changes caused by physical or chemical effects, etc.;
b) Review all issues related to emergency treatment, euthanasia, the most humane animal euthanasia, …;
c) Define the level of risk (mild, moderate, or severe) and benefits, potential risks for experimental animals used in the research, and consider the benefit-risk of research;
d) Review the appropriateness of research design and implementation in the basis of animal welfare principles.
e) Review the number of animal, the number of each animal that used in the research.
f) Review the capacity of researchers for the study.
2. The Committee’s conclusion must identify and recommend the following:
3. Potential risks and benefits of experimental animals used in the research;
4. The risks are minimal and reasonable compared to the expected benefits;
5. Protect and care for experimental animals used in research;
6. Fairness in choosing the type and number of experimental animals in the research;
7. The truthfulness and integrity of the collected data;
8. Protect the confidentiality of research participants.
Article 15. Notification, process and archive of results of research review
1. Notification of results of research reviews
a) Within 03 working days after Committee’s meeting, the Committee shall send a written notification of review result (Form 07, Appendix) to the project manager or PI.
b) Beside the case “Approved without revision or improvement”, written notification of review result must be enclosed with an excerpt of the Minutes of the Committee, clearly identify all requirements, comments, and related reasons.
2. Process of results
a) If the research protocol has been approved with “Approved without revision or improvement“, the Committee shall give an approval certificate as prescribed within 2 weeks after the date of meeting.
b) If the research protocol has been approved with “Approved after revision or improvement“, the project leader or PI must revise and improve the application according to the requirements of the Committee and return the completed application (together with 01 report on modifications) to the Secretary of the Committee within 01 weeks from the date of receiving the notification of results. The Secretary of the Committee is responsible for checking the amendments and revisions and reporting to the Chair for final decision. The certificate will be issued within 02 weeks after the Chair of the Committee accepts the explanation and correction.
c) If the research protocol has been assessed as ” Need to be reconsidered “, the project leader or PI must to revise the application, provide all the relevant documents according to the requirements of the Committee, and re-submit the completed application (together with 01 report on modifications) to the Secretary of the Committee. The Committee shall organize the second meeting to review and vote, the procedure of Committee meeting is the same as that of the first meeting without the procedure of critical reviewer’s evaluation.
d) If the research protocol has been considered as ” Not approved “, the written notification of the Committee to the project manager must clearly indicate the reasons for not accepting and the Committee will not accept the re-submitting of that proposal.
2. Archiving documentation
The documents should be archived in both hard and electronic copies at The office of Committee for a minimum period of 05 years from the date on which the research is completed.
CHAPTER IV. IMPLEMENTATION CLAUSE AND TERMS
Article 16. Implementation Clause
- The Department of Science, Technology and International Relations is responsible to carry out inspections of compliance with regulations of this Decision and report to the President of Hue University
- Rector of University of Agriculture and Forestry is responsible to provide legal and policy instruments, facilities, and human resources to support Committee’s operations.
- Heads of relevant units of Hue University are responsible for the implementation of this Decision, supporting scientists of their units to join the Committee; encourage and support Principle investigator of projects to submit the application to the Committee for consideration and approval.
Article 17. Implementation Terms
- For issues not specified in this regulation, or complaints about evaluation results beyond the competence of Committee, the Chair of the Committee shall report to the President of Hue University for consideration and decision.
- Difficulties that arise during the implementation of this Decision should be promptly reported to the President of Hue University (through the Department of Science, Technology and International Relations) for consideration, amendment and supplement.
Nguyễn Quang Linh (signed)