A System-Based Framework for Enhancing Human Research Ethics Governance in Higher Education: Evidence from Phetchaburi Rajabhat University, Thailand
Article Sidebar
Main Article Content
Abstract
This study examined the current conditions, management constraints, and development strategies for strengthening human research ethics governance at Phetchaburi Rajabhat University, Thailand. The study employed qualitative documentary research, supported by descriptive analysis of operational statistics from 84 research protocols submitted to the university Research Ethics Committee (REC) during 2022-2024. Primary documents included institutional regulations, standard operating procedures, application forms, REC meeting records, annual reports, and user satisfaction reports. Secondary documents included national and international standards, particularly the National Ethics Committee Accreditation System of Thailand (NECAST), the CIOMS guidelines, ICH-GCP, and World Health Organization guidance. Data were analyzed using content, comparative, and gap analyses, as well as data triangulation. The findings indicated that the university had established a formal research ethics governance system, including institutional regulations, a multidisciplinary REC, standard operating procedures, and an online submission platform. However, six major limitations were identified: increasing secretariat workload relative to staffing capacity, insufficient lay representation, absence of systematic individual development plans, review timelines that exceed expected benchmarks, and a 100% protocol revision rate before approval, incomplete post-approval monitoring, and a partially digitized information system. Based on the findings, the study proposes a System-Based REC Development Framework comprising inputs, NECAST-based processes, outputs, outcomes, and continuous improvement. The framework emphasizes strengthening human resources, policy integration, pre-review support for researchers, electronic post-approval monitoring, and an integrated e-REC system. The proposed framework can be applied by medium-sized higher education institutions seeking to improve REC efficiency, transparency, accountability, and participant protection in line with national and international research ethics standards.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Claudia Vadeboncoeur, C., Townsend, E., Foster, C., Sheehan, M., & Parker, M. (2016). Variation in university research ethics review: Reflections following an inter-university study in England. Research Ethics, 12(4), 217-233.
Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving humans (4th ed.). CIOMS. https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans
Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189(5), 930-937. https://doi.org/10.1086/381709
Glasziou, P., Chalmers, I., Rawlins, M., & McCulloch, P. (2021). Improving research ethics review and governance can improve human health. Journal of the Royal Society of Medicine, 114(12), 556-562.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2016). Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2). https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
National Research Council of Thailand. (2022, June 2). NECAST accreditation/survey of research ethics committees (RECs) in Thailand. https://en.nrct.go.th/hilghlight/detail/159
National Research Council of Thailand. (2024). Handbook of the national policy and ethical guidelines for research involving human subjects (National Ethics Committee Accreditation System of Thailand: NECAST). National Research Council of Thailand.
Phetchaburi Rajabhat University. (2022a). Appointment order of the Human Research Ethics Committee No. 996/2022. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2022b). Regulation on human research B.E. 2565. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2022c). Standard operating procedures for human research ethics, Version 1, B.E. 2565. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2022d). Annual report of the Human Research Ethics Committee, fiscal year 2022. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2023). Annual report of the Human Research Ethics Committee, fiscal year 2023. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2024a). Annual report of the Human Research Ethics Committee, fiscal year 2024. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University. (2024b). Standard operating procedures for human research ethics, Version 2, B.E. 2567. Phetchaburi Rajabhat University.
Phetchaburi Rajabhat University Human Research Ethics Committee. (2026). EC-PBRU Submission Online. Retrieved May 18, 2026, from https://ec.pbru.ac.th
Panichkul, S., et al. (n.d.). Current status of research ethics committees in Thailand. https://www.fercit.org/file/Current_Status_of_the_Research_Ethics_Committees_in_ Thailand.pdf
Solutions IRB. (2025, February 12). Timing your IRB application for success. Solutions IRB.
World Health Organization. (2021). Standards and operational guidance for ethics review of health-related research with human participants. World Health Organization.
