Chapter IV
OPERATIONS OF RECS
Article 18. Operating principles of RECs
1. RECs shall operate for non-profit purpose.
2. RECs shall fully apply the ethical principles articulated in this Circular, relevant legislative documents and international ethics guidelines. The RECs shall make clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers.
3. RECs shall operate in a collective, democratic and independent manner when undertaking review and making decisions.
4. When considering research involving vulnerable persons, representatives of research subjects or experts with experience of working with these persons shall attend the REC meeting.
5. RECs shall establish the procedures for coordinating with and/or relying on the comments and reviews of other domestic RECs or RECs in other countries.
6. Where necessary, RECs may call upon independent consultants to provide special expertise to the RECs.
7. A REC’s conclusion on the research shall be given by consensus of REC members and specified in the minutes of REC meeting. If it is difficult to achieve consensus, the REC Chair is entitled to decide to immediately have a vote or request a PI to complete the research documentation in order for the REC to consider and vote at the next REC meeting.
The research shall be only approved when there are less than 02 disapproval votes out of valid votes.
Article 19. Contents that RECs need to review
When assessing research documentation, supervising the research process and assessing research results, the following shall be reviewed by the REC:
1. Research design and conduct of the research;
2. Risks and potential benefits;
3. Selection of research population, and recruitment and protection of research participants;
4. Financial benefits and financial costs;
5. Protection of research participants’ privacy and confidentiality;
6. Informed consent process;
7. Effects of research on communities from which participants will be drawn;
8. Capacity of researchers and research sites.
Article 20. Full and expedited review of research
1. Research documentation will be reviewed through a full procedure by the REC if:
a) it is ineligible to be reviewed through an expedited procedure prescribed in Clause 2 of this Article.
b) it has been reviewed through an expedited review but the reviewer requests a full review.
2. Research documentation will be reviewed through an expedited procedure by the REC if:
a) it contains minimal risks;
b) it has been reviewed by the REC before;
c) it has been reviewed and approved by another REC at the same level;
d) The periodic research report has been approved;
dd) The application for amendments to the approved research protocol has been approved;
e) The report on adverse events occurring in the context of the approved research has been approved;
g) The report on violations against the approved research protocol has been approved.
3. Within 30 days from the receipt of the satisfactory documentation, the REC shall review it and issue a REC’s decision to the applicant.
4. The documentation subject to a full review will be legally valid when a meeting it is summoned by the REC Chair or Deputy Chair (authorized by the REC Chair) and attended by at least 05 REC members, including at least one member with medical expertise, one lay member, one independent member and male and female members who are all present to make decisions about the research, and a minutes of meeting is required.
5. The documentation subject to an expedited review shall be legally valid only when at least 02 REC members assess it.
Article 21. Follow-up and irregular reviews of research
1. The REC shall carry out a follow-up review of ongoing research at intervals appropriate to the level of risks to research subjects, but the intervals should generally be at least once a year on or before the day the research protocol is approved by the REC. A decision resulting from a follow up review should indicate either that the original decision is still valid or that there has been a modification, suspension, or withdrawal of the REC’s original decision.
2. An irregular review shall include the following:
a) any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or the conduct of the study.
b) serious unexpected adverse events related to the conduct of the study or study product.
c) any event or new information that might affect the potential benefits or risks of harm involved in the study.
d) decisions made by a sponsor or regulatory authority to suspend a study in whole or in part.
Article 22. Guidelines for submission of documents to REC
RECs shall adopt written procedures that describe the requirements for submitting a research project for review. Submission requirements and required forms should be readily available to researchers. Application instructions generally include at least the following:
1. The name(s) and address(es) of the REC secretaries, officers or member(s) to whom the application material should be submitted or website where the online documents are submitted to (if any).
2. All written documentation to be submitted as part of the application;
3. The format for submission;
4. The language(s) in which documents are to be submitted;
5. The number of copies to be submitted;
6. The deadlines for submission of the application in relation to review dates;
7. The means by which notices about the incompleteness of an application package will be communicated;
8. The expected time for notification of the decision following review;
9. The time-frame to be followed in cases where the REC requests supplementary information or changes to documents from the applicant;
10. A fair and transparent fee structure if any, for reviewing a research project;
11. The procedure for seeking amendments to the protocol, or its related documents;
12. The required format for recruitment material, information to be given to prospective research participants, and the informed consent form.
Article 23. Documents required for review
1. In the case of review of the research protocol for the first time:
a) Signed and dated application form, including signatures of listed co-applicants and institutional officials where relevant.
b) The protocol for the research project (with date and version number), together with supporting documents and annexes (if any).
c) A project summary or synopsis in non-technical language.
d) A description (which may be included in the protocol) of the ethical considerations involved in the research; a description of measures that will be taken to ensure the protection of participants’ privacy and the confidentiality of data; a statement describing any remuneration or other goods or services to be provided to research participants; a description of arrangements for insurance coverage for research participants (if applicable).
dd) An adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the research product (applicable to research involving an experimental product).
e) All data collection forms to be used in the research project, with date and version number.
g) All forms, documents, advertisements to be used in recruitment of potential participants.
h) Informed consent form(s) (with date and version number) for the research subjects (if research subjects are aged 18 or older and have full legal capacity to provide informed consent).
i) Informed consent form(s) (with date and version number) for the research subjects and their parents or legal guardians (if research subjects are aged from 16 to under 18).
k) Informed consent form(s) (with date and version number) for the research subjects and their parents or legal guardians (if research subjects are aged under 16).
l) Assent form(s) (with date and version number) for the research subjects who are not competent to give legally valid informed consent, including children aged from 12 to under 16, person having insufficient legal capacity or cognitively impaired persons.
m) A detailed description of the recruitment and ICF collection process.
n) The procedure for monitoring, assessing and handling adverse events (applicable to research intervening in research subjects).
o) All previous decisions (including the reasons for previous negative decisions and modification(s) to the proposal made on that account) by other RECs or regulatory authorities for the proposed research.
p) Written permission for conduct of the research after obtaining the approval of the competent authority, which is granted by the organization managing research sites (if the research is conducted outside the entity establishing the REC).
q) A statement that the PI(s) agree to comply with ethical principles set out in relevant guidelines.
r) Current curricula vitae and relevant certificates of the PI(s).
s) Other relevant documents.
2. In the case of re-review of the research protocol:
a) A description of opinions of the REC.
b) Modified research protocol and documents.
3. In the case of follow-up review of ongoing research report
a) Summary of the research protocol.
b) A complete research protocol, including the modifications previously approved.
c) Research progress reports.
d) Report on number of subjects that are selected, complete or withdraw from participation in the research or whose track is lost.
dd) Reports on adverse events and issues involving risks of harm to the participants, and cases of withdrawal from participation.
e) Summary of relevant information, especially information about safety.
g) Current ICF.
h) Independent audit reports of the researcher and the sponsor.
i) Notification from the PI or sponsor with regard to suspension/premature termination or completion of the research.
4. In the case of review of documents about modifications to the research protocol
a) A report on modifications.
b) Modified documents.
c) Other relevant documents.
5. In the case of review of report on adverse events occurring in the context of the research
a) A report on adverse events occurring in the context of the research
b) Other relevant documents (if any).
6. In the case of review of report on violations against the research protocol
a) A report on violations against the research protocol.
b) Other relevant documents (if any).
7. In the case of review of the research result report
a) Signed and dated application form, including signatures of listed co-applicants and institutional officials where relevant.
b) A research result report (with date and version number), together with supporting documents and annexes (if any).
c) Study products (if any).
d) Other relevant documents.
Article 24. Notification of results of research reviews by RECs
1. Within 05 working days from the date on which the result of research documentation review is available, the REC shall send a written notification of review result to the entity presiding over the research and PI and publish the result on the bulletin board or website of the REC or the entity establishing the REC.
2. If the research protocol has been approved by the REC, the REC shall give a written approval as prescribed in the Appendix 02 hereof.
3. If the research protocol has been approved by the REC, the REC shall give a written approval as prescribed in the Appendix 03 hereof.
4. If the research result has been approved by the REC, the REC shall send a written notification as prescribed in the Appendix 04 hereof.
5. If the REC grants conditional approval for the research protocol or modification to the research protocol or research result, it shall send a written notification as prescribed in the Appendix 05 hereof.
6. If the REC does not grant approval for the research protocol or modification to the research protocol or research result, it shall send a written notification as prescribed in the Appendix 06 hereof.
Article 25. Archiving documentation of RECs
1. All documentation and communication of an EC should be dated, filed, and archived according to its written procedures and regulations of law on archives.
2. REC records may be kept in hard copy, electronically, or both.
3. REC documents to be archived by the REC include:
a) Any documents formally establishing the REC;
b) The REC’s SOPs;
c) Documents published by the REC;
d) Annual reports summarizing REC activities;
dd) Academic records of all REC members;
e) Financial records of the REC;
g) Agendas of the REC meetings;
h) Minutes of the REC meetings;
i) Document certifying approval of the REC;
k) Regulatory texts used by the REC;
l) Ethical guidelines used by the REC;
m) All documents and materials related to the review of specific projects, including one copy of all materials submitted to the REC; any correspondence by the REC with PIs or concerned parties regarding applications, decisions, and follow-up; the notification of the completion, premature suspension, or premature termination of a study (if any); the final summary or final report of the study.
n) Other relevant documents.
4. The REC’s SOPs should specify length of time documents must be archived in accordance with regulations of law on archives. The documents should be archived for a minimum period of 05 years from the date on which the research is completed or the written consent to termination of the research is obtained.
Article 26. RECs’ Regulation on organizational structure and operation and SOPs
1. A REC must have a Regulation on organizational structure and operation that is approved by the head of the entity establishing the REC at the request of the REC Chair and the head of the entity licensed to manage scientific research activities conducted by the entity establishing the REC. The Regulation on organizational structure and operation shall be conformable with regulations of this Circular and conditions of the REC.
2. The REC shall develop, approve, make publicly available, comply with and annually review SOPs to perform its functions and tasks.
3. REC’s SOPs shall address the following issues:
a) System management: guidelines for writing and presenting SOPs; control of documentation; internal assessment; cooperation with other RECs.
b) Establishment of REC and training of members: composition, tasks, responsibilities and organizational structure of the REC; designation, dismissal, resignation and replacement of REC Chair, members and secretaries; protection of confidentiality of information, management of conflicts of interests; training of REC members; selection of independent consultants.
c) Methods for research review: expedited review; full review; emergency meeting.
d) Administrative procedures: requirements for submitting an application for review, including the forms to be completed, the documents to be submitted and any related process issues; receipt of applications; meeting preparation; meeting management; preparation and approval of minutes of meeting; preparation and notification of review results; measures for handling the applicant’s response to REC comments; management of documents during the research; archiving and making of copies of research documentation; storage and arrangement of administrative records, logbooks and forms of the REC; maintenance of confidentiality of research documentation and REC records.
dd) Technical procedures: review of research documentation for the first time; re-review of research documentation; mid-term review of research; review of changes and additions; review of research completion reports; processing of serious adverse event reports; actions against violations of research protocols; handling of complaints and requests of research subjects; review of prematurely terminated research; inspection of research sites; use of protocol assessment forms.
4. RECs should make reference to guidelines on the website of the Administration of Science Technology and Training to design and publish forms used in operating procedures of the RECs.
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