RESEARCH ETHICS COMMITTEES: FEATURES OF INSTITUTIONAL DEVELOPMENT
DOI:
https://doi.org/10.62405/osiconf.2026.33Keywords:
research ethics committees; ethical review; research ethics and integrity; research governance.Abstract
The aim of the article is to identify the features of the institutional development of research ethics committees as a component of the research governance system, to generalize European institutional practices and to develop recommendations for their development in Ukraine. A historical-institutional approach was used to study the genesis of the formation of ethics committees; a documentary analysis was used to analyze the regulatory and organizational basis of their functioning; and a comparative analysis was used to compare institutional practices. The results of the study showed that modern committees combine ethical risk assessment and protection of research participants with advisory support for researchers, ethical training and mentoring, prevention of potential violations, development and implementation of institutional policies and procedures, and integration of ethical principles into the governance system. Recommendations are proposed for Ukrainian higher education institutions/scientific institutions: regulatory consolidation of the institutional status of research ethics committees, in particular in the field of non-medical research; ensuring the independence and competence of their members; development of advisory and educational functions; integration of ethical expertise into the research governance system and research integrity policies; introduction of appropriate procedures for institutional support, documentation and monitoring of committee activities.
References
All European Academies. (2023). The European code of conduct for research integrity (Revised ed.). https://doi.org/10.26356/ECOC
Council for International Organizations of Medical Sciences. (1993). International ethical guidelines for biomedical research involving human subjects. CIOMS. https://cioms.ch/publications/product/international-ethical-guidelines-for-biomedical-research-involving-human-subjects/?utm_source=chatgpt.com
ETH Zurich. (n.d.). Ethics Commission. https://ethz.ch/en/the-eth-zurich/organisation/boards-university-groups-commissions/ethics-commission.html
European Commission. (2021). Horizon Europe programme guide. Publications Office of the European Union. https://research-and-innovation.ec.europa.eu/index_en
Health Research Authority. (2026a). UK Research Ethics Committee policy document. https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/
Health Research Authority. (2026b). Research Ethics Committee standard operating procedures. https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-committee-standard-operating-procedures/
Hemminki, E. (2016). Research ethics committees in the regulation of clinical research: Comparison of Finland to England, Canada, and the United States. Health Research Policy and Systems, 14, 5. https://pmc.ncbi.nlm.nih.gov/articles/PMC4750216/
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1996). ICH harmonised tripartite guideline: Guideline for good clinical practice E6 (GCP). European Medicines Agency. https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline
Klitzman, R. L. (2013a). How IRBs view and make decisions about coercion and undue influence. Journal of Medical Ethics, 39(4), 224–229. https://doi.org/10.1136/medethics-2011-100439
Klitzman, R. L. (2013b). How IRBs view and make decisions about social risks. Journal of Empirical Research on Human Research Ethics, 8(3), 58–65. https://doi.org/10.1525/jer.2013.8.3.58
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf?utm_source=chatgpt.com
National Research Act, Pub. L. No. 93-348, 88 Stat. 342. (1974). https://www.congress.gov/93/statute/STATUTE-88/STATUTE-88-Pg342.pdf?utm_source=chatgpt.com
Nuremberg Code. (1947). In Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Avalon Project, Yale Law School. https://avalon.law.yale.edu/subject_menus/imt.asp
QS. (2025). QS World University Rankings: Europe 2026. https://www.qs.com/insights/world-university-rankings-europe
Royal College of Physicians. (1967). Report of the Committee on the supervision of the ethics of clinical investigations in institutions. Royal College of Physicians. https://www.infectedbloodinquiry.org.uk/sites/default/files/Other%20grade%201%20docs%20rows%202075-2188%20copy/Other%20grade%201%20docs%20rows%202075-2188%20copy/RCPH0000009%20-%20Committee%20on%20the%20Supervision%20of%20the%20Ethics%20of%20Clinical%20Investigations%20in%20Institutions%20-%2001%20Jul%201967.pdf?utm_source=chatgpt.com
Tapscott, R., & Machón, D. R. (2025). Procedural ethics for social science research: Introducing the Research Ethics Governance dataset. Journal of Peace Research, 62(3), 789-798. https://doi.org/10.1177/00223433241249352
U.S. Department of Health and Human Services. (2018). Federal policy for the protection of human subjects («Common Rule»), 45 C.F.R. pt. 46, subpt. A. Office for Human Research Protections. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
U.S. Department of Health and Human Services. (2026). Protection of human subjects, 45 C.F.R. pt. 46. Office for Human Research Protections. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
U.S. Department of Health and Human Services. (n.d.). Evaluating institutions. Office for Human Research Protections. https://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.html
U.S. Food and Drug Administration. (2026a). Institutional review boards, 21 C.F.R. pt. 56. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/protection-human-subjects-standards-institutional-review-boards-clinical-investigations
U.S. Food and Drug Administration. (2026b). Protection of human subjects, 21 C.F.R. pt. 50. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/protection-human-subjects-informed-consent
U.S. Public Health Service. (1966). Investigations involving human subjects, including clinical research: Requirements for review to insure the rights and welfare of individuals (Policy and Procedure Order No. 129, revised). U.S. Public Health Service. https://digirepo.nlm.nih.gov/ext/mm/2934097RX289/PDF/2934097RX289.pdf
UK Research and Innovation. (n.d.). Criteria for research ethics committee review. https://www.ukri.org/councils/esrc/guidance-for-applicants/research-ethics-guidance/research-organisations-and-research-ethics-committees-our-principles-research-ethics-committees/criteria-for-research-ethics-committee-review/
University College London. (n.d.). Committees and governance: Research ethics. https://www.ucl.ac.uk/research-innovation/funding-and-support/research-ethics/committees-and-governance
University of Amsterdam. (n.d.). Research ethics and integrity. https://www.uva.nl/en/about-the-uva/organisation/faculties/faculty-of-economics-and-business/research/ethics-committee/economics-and-business-ethics-committee.html
University of Cambridge. (n.d.). University Research Ethics Committee (UREC). https://www.research-services.admin.cam.ac.uk/manage-risk/research-ethics/university-research-ethics-committee-urec
University of Oxford. (n.d.). Research ethics policy. https://www.ox.ac.uk/research/support/governance-and-committees/research-policies/research-ethics-policy
Université PSL. (n.d.). Scientific integrity. https://psl.eu/en/research/research-psl/scientific-integrity
Weijer, C. (2000). The ethical analysis of risk. The Journal of Law, Medicine & Ethics, 28(4), 344–361. https://doi.org/10.1111/j.1748-720X.2000.tb00686.x
Weijer, C., & Miller, P. B. (2004). When are research risks reasonable in relation to anticipated benefits? Nature Medicine, 10(6), 570–573. DOI: 10.1038/nm0604-570
World Medical Association. (1964). Declaration of Helsinki: Ethical principles for medical research involving human subjects. https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/
