The Research Ethics Review Committee for Research Involving Human Subjects: The Second Allied Academic Group in Social Sciences, Humanities and Fine and Allied Arts

To comply with international standards in protecting those who are involved in research, Chulalongkorn University has appointed “The Research Ethics Review Committee for Research Involving Human Subjects: The Second Allied Academic Group” in accordance with the University’s Regulations, Stipulating the Promotion of Ethics in Research Involving Human Subjects.   This is for the protection of the rights and welfare of the research sampling population or participants so as to enable the research procedure to continue correctly according to ethics in research involving human subjects, which are accepted at the national and international levels.  The Committee is assigned with the responsibility of reviewing research projects in social sciences, humanities, fine and applied arts as well as other related fields in order to help to prevent faculty members, researchers and graduate students who conduct research for their theses from facing problems when they apply for research funding from outside sources or when they have their academic work published in national or international journals or when they apply for an academic appointment.

The Research Ethics Review Committee for Research Involving Human Subjects: The Second Allied Academic Group is assigned with the following responsibilities:

1. Considering full research proposals/full thesis proposals and reviewing the research procedure, with emphasis on the steps and methods used in collecting information from humans and the ethics in research involving human subjects as well as the researcher’s readiness to conduct research projects submitted to the Committee.
2. Reviewing, at the appropriate time and at least once a year, the progress of the research and risks to the research sampling population/participants. The Committee also has the right to observe the consent process involving the research sampling population/ participants as well as other processes related to their rights and welfare.

3. Imposing suspension, withdrawal or termination on the research project in cases where it might cause more risk to the research sampling population/participants than had been expected or in cases where the research fails to comply with the ethical principles of research involving human subjects or fails to observe those principles in a consistent manner. Such a decision has to be made by the consent of a full board meeting of the Research Ethics Review Committee and evidence of this consent must be recorded in writing.

4. Limiting the scope of the research project or suspending the execution of certain parts of it in cases where the researcher fails to comply with the ethical principles of research involving human subjects according to those specified by the Committee, which are a condition required for the approval of the research project which may only be conducted after the researcher has complied with the said specifications and the principles.

There are three categories of review for full research proposals/full thesis proposals, namely, Exemption Review, Expedited Review and Full Board Review, details of which follow.

• • • The First Category: Exemption Review
    • The Second Category: Expedited Review
    • The Third Category: Full Board Review

The Research Ethics Review Committee for Research Involving Human Subjects: The Second Allied Academic Group at Chulalongkorn University adheres to the framework and international principles concerning ethics in research involving human subjects, the details of which are summarized in the document below.  However, certain concepts and perspectives have been adjusted to make them match the situation and the research method in Social Sciences, Humanities and Fine and Applied Arts.  This is to bring it into line and make it appropriate to the nature of research involved with society, culture, art and languages, which have been created, maintained and developed by different human groups.

1. The National Ethical Guidelines for Research Involving Human Subjects, issued by the Ethics Committee Forum of Thailand (2002).
2. The ethical principles of the Declaration of Helsinki (2024) (Cilck)
3. The Belmont Report (Click)
4. The World Health Organization (WHO) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (GCP).

1. Alignment with Research Objectives
2. Expert Validation and Standardization, such as the Index of Item-Objective Congruence (IOC), Content Validity Index (CVI), and comprehensive content and linguistic reviews.
3. Permission for Proprietary Instruments

1. The informed consent process shall be conducted in accordance with applicable ethical guidelines (e.g., ICH-GCP and local IRB/IEC requirements). Participation is entirely voluntary, free from coercion or undue influence. Participants have the right to refuse participation or withdraw from the study at any time without providing any reason and without any penalty or loss of benefits to which they are otherwise entitled.
2. Only data essential to the research objectives shall be collected. No unnecessary personal or identifiable information shall be obtained beyond what is justified by the study protocol.
3. The potential benefits of the research shall be clearly described, including direct benefits to participants (if any), as well as indirect benefits to the community, society, and advancement of scientific knowledge.
4. All foreseeable risks and discomforts shall be carefully considered and disclosed, including physical, psychological, social, and economic risks, as well as any potential inconvenience to participants.
5. The anticipated risks shall be reasonable in relation to the expected benefits and the importance of the knowledge that may reasonably be expected to result.
6. Adequate provisions shall be in place for risk prevention, monitoring, and management of adverse events. Appropriate medical care, support, and compensation shall be provided in the event of research-related injury or harm, in accordance with applicable regulations and institutional policies.
7. Compensation and reimbursement, including payment for time, travel expenses, or other related costs, shall be appropriate, non-coercive, and compliant with IRB/IEC guidelines.
8. Participant privacy and data confidentiality shall be strictly protected. Data shall be anonymized or coded where appropriate. Identifiable data (e.g., photographs or audio recordings) shall be securely stored and destroyed after study completion unless additional explicit consent is obtained for further use.
9. The inclusion of vulnerable populations shall be scientifically and ethically justified. Additional safeguards shall be implemented to protect their rights, safety, and well-being, in compliance with applicable ethical guidelines.

1. The investigator is appropriately qualified by education, training, and experience, and has sufficient time to properly conduct and complete the research.
2. Adequate facilities, materials, and equipment are available to support the proper conduct of the research.
3. Sufficient and appropriate funding is available to ensure proper management and completion of the research.
4. The investigator has no record of misconduct or ethical violations that would affect the integrity of the research.
5. The investigator is capable of ensuring personal safety and implementing appropriate measures to protect themselves from potential risks or hazards associated with the conduct of the research.

1. The investigator is appropriately qualified by education, training, and experience, and has sufficient time to properly conduct and complete the research.
2. Adequate facilities, materials, and equipment are available to support the proper conduct of the research.
3. Sufficient and appropriate funding is available to ensure proper management and completion of the research.
4. The investigator has no record of misconduct or ethical violations that would affect the integrity of the research.
5. The investigator is capable of ensuring personal safety and implementing appropriate measures to protect themselves from potential risks or hazards associated with the conduct of the research.

1. The investigator acknowledges that it is unethical to initiate any research-related activities, including data collection, prior to obtaining approval from the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
2. If the research approval expires, all research activities must be suspended. Renewal approval must be obtained at least one (1) month prior to the expiration date, together with submission of a progress report.
3. The research must be conducted strictly in accordance with the approved study protocol.
4. Only IRB/IEC-approved and stamped documents shall be used, including the Participant Information Sheet, Informed Consent Form, and recruitment materials (if applicable).
5. Any serious adverse event (SAE) occurring at the approved study site must be reported to the IRB/IEC within five (5) working days.
6. Any proposed amendments or modifications to the study must be submitted for IRB/IEC review and approval prior to implementation.
7. For research projects with a duration not exceeding one (1) year:
   1. A final report and research abstract must be submitted within thirty (30) days after study completion.
   2.  For thesis-related research, the research abstract must be submitted within thirty (30) days after study completion.

IRB/IEC Certification and Approved Documents

The Office of the IRB/IEC shall affix an official approval stamp on the protocol approval certificate (including protocol number, approval date, and expiration date), Participant Information Sheet, Informed Consent Form, research instruments, and recruitment/advertisement materials. The investigator must use only the IRB/IEC-stamped versions consistent with the approved documents.

• Chula MOOC https://mooc.chula.ac.th/course-detail/62
• Basic Human Subject Protection Course NU, Thai MOOC https://lms.thaimooc.org
• Ethics of research in humans, Thammasat University https://www.med-tu.org/GCP/
• CITI Program (Collaborative Institutional Training Initiative at the University of Miami) Human Subjects Research (HSR) https://about.citiprogram.org
• Protecting Human Research Participants; PHRP course,  National Institutes of Health (NIH) http://phrp.nihtraining.com/

• Associate Professor  Nuannoi Treerat, Ph.D. : Chairperson
• Associate Professor  Sumalee Chinokul, Ph.D. : Vice Chairperson
• Associate Professor Wannee Kaemkate, Ph.D. : Committee Member
• Assistant Professor Nunghatai Rangponsumrit, Ph.D. : Committee Member
• Assistant Professor Yupin Patarapongsant, Ph.D. : Committee Member
• Assistant Professor Atthaphon Ponglawhapun, Ph.D. : Committee Member
• Mrs. Patamakorn Catithammanit : Committee Member
• Mr. Weerapong Kriengsinyos : Committee Member
• Sayamon Charoenrat, Ph.D. : Committee Member and Secretary