Chapter III
FUNCTIONS, TASKS, RIGHTS AND RESPONSIBILITIES OF RECs
Article 19. Functions of RECs
REC is meant to advise the head of the entity establishing the REC about considering and reviewing ethical and scientific aspects of research involving human participants to form a basis for approving, conducting and commissioning the research.
Article 20. Tasks of RECs
1. The national REC shall:
a) undertake ethical and scientific review of research involving human participants before conducting clinical trials that serve the purpose of product registration; clinical trials of products have not yet been licensed for sale in Vietnam; multicenter trials; research on application of new techniques and methods in humans in Vietnam; international research where biological samples of research subjects are sent abroad or research results that are representative of Vietnamese people and other biomedical research at the request of the Ministry of Health, organizations and individuals that preside over research.
b) review changes or additions to research protocols and relevant documents during the conduct of the research approved by the competent authority.
c) supervise and monitor adherence to research protocols and regulations on ethics in research; assess the recording, reporting and handling of adverse events that occur during the course of the research approved by the competent authority.
d) review research results according to approved research protocols of research approved by the REC and review results of other clinical trials that serve registration of pharmaceutical products, medical equipment, new techniques and new methods for medical examination and treatment.
dd) retain and manage documents of the REC.
e) advise regulatory authorities about developing policies and law relating to biomedical research involving human subjects and specialized operations of internal RECs.
2. Internal RECs shall:
a) undertake ethical and scientific review of protocols of research involving human participants other than the research specified in Clause 1 of this Article to request the competent authority to approve research.
b) undertake ethical and scientific review of protocols of research involving human participants in Point a Clause 1 of this Article that is presided over by the entity establishing the REC before submitting research documentation for approval by national REC.
c) performs the tasks specified in Points b, c, d and e Clause 1 of this Article with respect to research presided over by REC.
Article 21. Rights of RECs towards research
1. Approve and request amendments to the research protocol before granting approval, disapprove biomedical research documentation to form a basis for the competent authority to issue a decision to conduct research.
2. Decide to carry out expedited review of minimal risk research.
3. Approve or disapprove changes of research contents during conduct process.
4. Request PIs to conduct research and sponsor to report research data and results and documents relating to research.
5. Inspect and supervise the adherence to research protocols and GCP rules at research sites.
6. Request the competent authority to suspend the research if it is suspected or there is evidence that GCP requirements are not complied with or research protocol is violated or it is found that safety of research subjects is not ensured during the course of the research.
7. Suspend the recruitment of research participants, suspend the use of research products on research subjects where necessary in order to avoid causing harm to research participants and specify reasons for suspension.
8. Request amendments to research protocols, ICFs and other documents to be provided to research participants where necessary to ensure safety of research participants.
Article 22. Rights of RECs towards researchers
A REC that reviews research has the right to request researchers to take on the following responsibilities:
1. Submit all information required for a thorough and complete review of the ethics of proposed research.
2. Conduct the research in compliance with the protocol approved by the REC and competent authority.
3. Do not make any deviation or changes to the approved protocol or in following it without prior approval of the REC and competent authority, except where immediate action is necessary to avoid harm to research participants. In such a case, the REC is informed promptly of the changes/deviations made.
4. Obtain REC’s prior approval for amendments to selected documents, information provided to potential research participants or ICFs.
5. Notify the REC of any changes at the research site that reduce the protections or decrease the benefits provided or increase the risk to participants.
6. Promptly notify REC and/or other relevant authorities as required by REC policies and applicable laws of all serious, unexpected adverse events related to the conduct of the research/research product or unanticipated problems involving risks of harm to the participants or others.
7. Immediately implement any recommendations provided by the REC in response to safety reporting to safeguard the rights, safety and well-being of research participants.
8. Submit written summaries of the research status to the REC annually, or more frequently, if requested by the REC and provide information at the request of REC for follow-up reviews.
9. Notify the REC when the research is completed or prematurely suspended/terminated.
10. Notify the REC of the reasons for suspension/termination; provide a summary of results prior to prematurely suspending or terminating the research; describe the manner by which research participants will be notified of the suspension or termination and the plans for care and follow-up for the participants.
11. Notify organization conducting research studies, sponsors and other relevant organizations if the REC terminates or suspend the approval of research.
12. Keep the research participants and their family or communities of the progress of research by appropriate means when:
a) the research is terminated or suspended;
b) any changes occur in the context of the research that alter the potential benefits or risks;
c) the research is completed;
d) results of the research are available.
Article 23. Responsibilities of RECs
A REC shall provide counsel and be responsible to the head of the entity establishing the REC for its counsel on:
1. safeguarding the rights, safety and well-being of all research participants and relevant community. Special attention should be paid to trials that may include vulnerable subjects; safeguarding the rights of researchers.
2. ensuring fairness in sharing benefits and risks between groups by social class, age, gender, economic status, culture, ethnic group and religion of research participants.
3. reviewing research and relevant documents and giving its objective and unbiased opinions within a reasonable time. Promptly documents its opinions in writing.
4. ensuring legality and scientism of research protocols and dossier, and confidentiality of research.
5. considering the qualifications of the researcher as documented by a current curriculum vitae and/or by any other relevant documentation the REC requests.
6. conducting continuing review of each ongoing research at intervals appropriate to the degree of risk to research participants, but at least once a year in the case of clinical trials.
7. reviewing both the amount and method of payment to research participants to assure that neither presents problems of coercion or undue influence on the participants. Payments to a participant should be prorated and not wholly contingent on completion of the research by the participant.
8. ensuring that information regarding payment to subjects, including the methods, amounts, and schedule of payment to participants, is set forth in the ICF and other documents to be provided to participants.
9. enabling researchers to discuss concerns with REC members, both on general matters and in response to REC decisions on particular research studies.
10. making REC decisions, excluding confidential information publicly available, through mechanisms such as clinical trial registries, websites, newsletters, bulletin boards and other appropriate manner of REC.
11. specifying operation code of REC in certificates of approval of REC.
12. adopting all protection measures to maintain confidentiality of documents. SOP shall specify persons granted privileges to documents of the REC.
13. ensuring confidentiality of information and protecting REC members from retaliation based on positions taken with respect to REC-related matters or review of research proposals.
14. retaining and managing documents of the REC in accordance with regulations of law on archives. Retain research review documents for a period of at least 05 years after commissioning.
Article 24. Responsibilities of REC members
1. The REC Chair has the responsibility to:
a) decide to carry out expedited or full review of research documentation.
b) assign REC main assessors and invite independent consultants to provide counsel on research documentation.
c) summon and conduct recurrent or unscheduled meetings of REC and take responsibility for his/her conclusion.
d) represent REC on behalf of regulatory authorities and the public.
dd) direct formulation and approve plans for organization of REC meetings and other activities of REC.
e) promptly process REC's documents, especially REC's comments on ethical approval for research proposals.
g) direct and supervise administrative secretaries of the REC preparing operating budget of REC.
h) supervise and propose training provided to the REC members and consultants.
i) decide on emergency cases to ensure safety of research participants on behalf of the REC.
k) inspect and sign the REC’s SOPs before submitting them to the head of the entity establishing the REC for promulgation or promulgate them as authorized by the head of the entity establishing the REC.
l) promulgate forms and documents of the REC.
m) promptly notify the head of the entity establishing the REC of the REC decisions on research studies.
n) take on responsibilities of REC members as prescribed in Clause 4 of this Article.
2. A REC Deputy Chair has the responsibility to:
a) take on responsibilities of the REC Chair if the REC Chair authorizes them to do so or the REC Chair has a conflict of interest in the reviewed research.
b) take on responsibilities of a REC member as prescribed in Clause 4 of this Article.
3. A REC main assessor has the responsibility to:
a) perform professional tasks, review ICFs and other documents relating to the research. Send assessment forms to the REC secretary for consolidation.
b) express his/her views on research-related matters at REC review meetings.
c) take on responsibilities of a REC member as prescribed in Clause 4 of this Article.
4. A REC member has the following responsibilities:
a) Attend at least 70% of REC meetings and do not miss no more than 03 consecutive REC meetings without reasonable reasons.
b) Send research documentation assessment forms on schedule, attend REC meetings and vote.
c) Review, discuss and assess research protocols, ICFs and other documents included in the research documentation. For lay members not having expert in the health sector, it is required to review and comment on ICFs to safeguard the rights of research subjects.
d) Consider and report progress, monitor and supervise ongoing research studies.
dd) Supervise serious adverse events and propose appropriate solutions.
e) Assess final report and research results.
g) Maintain confidentiality of documents and discussions at REC meetings.
h) Provide their academic records to administrative secretaries of the REC.
i) Notify the REC Chair of their conflicts of interests in the reviewed research (if any).
k) Perform the tasks as assigned by the REC.
l) Join recurrent training courses on bioethics and biomedical research.
m) Comply with the REC’s SOPs.
5. Replacements shall take on responsibilities of the replaced official members and have the voting authority when replacing the official members.
Article 25. Responsibilities of REC secretaries
1. A specialized secretary has the responsibility to:
a) identify and recommend research studies subject to expedited or full review to the REC Chair.
b) recommend main assessors for each research study to the REC Chair.
c) truthfully write minutes of the REC meetings and prepare annual reports of REC activities.
d) follow up with tasks that the REC requests the PIs to perform such as progress reports, final reports, corrective actions and amendment of approved protocols or ICFs.
dd) cooperate with administrative secretaries in performing the tasks specified in Clause 2 of this Article.
2. An administrative secretary has the responsibility to:
a) inform and advise the PIs, sponsors and new REC members of applicable regulations, guidelines, processes and procedures. In some cases, the secretary shall maintain a website ensuring public access to this information.
b) identify and request missing documentation in applications and prepare the completed file for committee review.
c) prepare the meetings of the REC, including the distribution of relevant documentation to the members and independent consultants, scheduling the meetings, and ensuring the quorum.
d) keep and maintain records, research protocols and all correspondence in relation to their review, as well as records of any continuing oversight that may be required after approval. The secretary ensures that the confidentiality of REC records is maintained.
dd) keep contact with REC members and applicants for review.
e) facilitate access to literature and educational programmes useful to the members of REC.
g) update information about REC membership, including declarations of potential conflicts of interests.
h) Closely cooperate with the REC Chair and submit operating budget of REC to the competent authority.
i) prepare, review and promulgate the REC’s SOPs.
k) update the REC on new issues concerning REC activities.
l) provide administrative assistance and perform other tasks as assigned by the REC Chair relevant to professional qualifications and tasks of the secretary.
m) comply with the REC’s SOPs.
Tìm kiếm
Thông tư 45/2017/TT-BYT (Bản Pdf)
Thông tư 45/2017/TT-BYT (Bản Word)