Research Ethics of Natural Medicinal Plants in The Perspective of CIOMS-WHO 2016
Main Article Content
Research into natural medicinal products (NAPs) from medicinal plants is growing rapidly in line with the increasing use of traditional and complementary medicine in various countries, including Indonesia. However, NAP research poses complex ethical challenges, involving safety, scientific validity, protection of traditional knowledge, involvement of indigenous communities, and equitable benefit sharing. This article aims to analyze the relevance and implementation of the 2016 CIOMS-WHO Ethical Guidelines in medicinal plant OBA research in Indonesia through a literature review approach. The discussion focuses on the main principles of the 2016 CIOMS, including social value and scientific validity, informed consent, risk-benefit assessment, protection of vulnerable populations, community engagement, and access and benefit sharing in the utilization of genetic resources and traditional knowledge. This article was compiled using a narrative literature review approach of various international publications and regulations related to the ethics of medicinal plant OBA research. It also examines implementation challenges in Indonesia, including standardization of medicinal plant materials, quality control, protection against biopiracy, harmonization of national regulations with the Convention on Biological Diversity (CBD) and the Nagoya Protocol, and strengthening the capacity of Health Research Ethics Committees. The study results indicate that the 2016 CIOMS-WHO provides a relevant and adaptive ethical framework for medicinal plant ABM research, but its implementation requires strengthening national regulations, standardizing medicinal plant research methodologies, and protecting the rights of indigenous peoples and biodiversity.
Keywords:
natural medicinal products, medicinal plants, research ethics
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Akpa-Inyang, F. (2025). The San Code of Ethics versus international ethical guidelines: A cross-cultural analysis. African Journal of Inter-Multidisciplinary Studies, 7(1). https://doi.org/10.51415/ajims.v7i1.1367
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Amusan, L. (2016). Politics of biopiracy: An adventure into Hoodia/Xhoba patenting in southern Africa. African Journal of Traditional, Complementary and Alternative Medicines, 14(1), 103–109. https://doi.org/10.21010/ajtcam.v14i1.11
Antons, C. (2010). The role of traditional knowledge and access to genetic resources in biodiversity conservation in Southeast Asia. Biodiversity and Conservation, 19. https://doi.org/10.1007/s10531-010-9816-y
Arjjumend, H. (2018). Recognition of Indigenous Peoples in access and benefit sharing (ABS) legislation and policies of the parties to the Nagoya Protocol. BRICS Law Journal, 5(3), 86–113. https://doi.org/10.21684/2412-2343-2018-5-3-86-113
Awoke, A., & Cosendey, B. N. (2025). Investigate the ethnomedical practices of different indigenous communities: A literature review. International Journal of Ethnoscience and Technology in Education, 2(1). https://doi.org/10.33394/ijete.v2i1.13903
Gavanji, S. (2023). Cardiotoxicity effects of herbal medicine: A review article. Biology, Medicine, & Natural Product Chemistry, 12(1), 89–96. https://doi.org/10.14421/biomedich.2023.121.89-96
Gordon, B. G. (2020). Vulnerability in research: Basic ethical concepts and general approach to review. Ochsner Journal, 20. https://doi.org/10.31486/toj.19.0079
Haunschild, R., Kays, J., Rägo, L., & Kays, M. (2024). Bibliometric analysis of publications that cited the CIOMS 2016 “International ethical guidelines for health-related research involving humans.” Heliyon, 10(17), e36833. https://doi.org/10.1016/j.heliyon.2024.e36833
Jefferson, D. J., & Robinson, D. F. (2025). Biopiracy and beauty brands? Patent trends of cosmetics and skin care companies. Journal of World Intellectual Property. https://doi.org/10.1111/jwip.12348
Kashuri, M., Ikrar, T., Sutriyo, S., Mun’im, A., & Yanuar, A. (2026). Evidence-based production framework for herbal medicine regulation in Indonesia. Frontiers in Pharmacology, 16, 1730273. https://doi.org/10.3389/fphar.2025.1730273
Kpobi, L., Read, U. M., Selormey, R. K., & Colucci, E. (2023). “We are all working toward one goal. We want people to become well”: A visual exploration of what promotes successful collaboration between community mental health workers and healers in Ghana. Transcultural Psychiatry. https://doi.org/10.1177/13634615231197998
Lang, M. H. K. (2017). Critical analysis of the Council for International Organizations of Medical Sciences 2016 international guidelines for health-related research involving humans. Medwave, 17(4), e6956. https://doi.org/10.5867/medwave.2017.04.6956
Lee, E. L., Richards, N., Harrison, J., & Barnes, J. (2022). Prevalence of use of traditional, complementary and alternative medicine by the general population: A systematic review of national studies published from 2010 to 2019. Drug Safety, 45(7), 713–735. https://doi.org/10.1007/s40264-022-01189-w
Liauw, W. (2021). Western medicine and traditional Chinese medicine: Encouraging the twain to meet. Internal Medicine Journal. https://doi.org/10.1111/imj.15362
Meza, M. B., Luengo-Charath, X., Arancibia, M., & Madrid, E. (2018). Council for International Organizations of Medical Sciences (CIOMS) ethical guidelines: Advancements and unsolved topics in 2016 upgrade. Medwave, 18(2), e7208. https://doi.org/10.5867/medwave.2018.02.7208
Monera-Penduka, T. G., Maponga, C. C., Morse, G. D., & Nhachi, C. F. B. (2017). Capacity for ethical and regulatory review of herbal trials in developing countries: A case study of Moringa oleifera research in HIV-infected patients. Journal of Pharmaceutical Policy and Practice, 10. https://doi.org/10.1186/s40545-017-0099-5
Morrison, C., Humphries, F., & Lawson, C. (2021). A regional review of genetic resource access and benefit sharing: Key issues and research gaps. Environmental Policy and Law. https://doi.org/10.3233/EPL-201028
Mukti, B. H. (2024). Ethnobotanical studies of medicinal plants in Borneo. Health Sciences International Journal, 2(2). https://doi.org/10.71357/hsij.v2i2.41
Pan, S.-Y., Zhou, S.-F., Gao, S.-H., Yu, Z.-L., Zhang, S.-F., Tang, M.-K., Sun, J.-N., Ma, D.-L., Han, Y.-F., Fong, W.-F., & Ko, K.-M. (2013). New perspectives on how to discover drugs from herbal medicines: CAM’s outstanding contribution to modern therapeutics. Evidence-Based Complementary and Alternative Medicine, 2013, 627375. https://doi.org/10.1155/2013/627375
Schenberg, E., & Gerber, K. (2022). Overcoming epistemic injustices in the biomedical study of ayahuasca: Towards ethical and sustainable regulation. Transcultural Psychiatry. https://doi.org/10.1177/13634615211062962
Seneviratne, R. D. A. (2023). Ethics of research. Journal of the National Science Foundation of Sri Lanka, 51(2), 183–184. https://doi.org/10.4038/jnsfsr.v51i2.11747
Sharma, M., Grover, M., Sharma, N., Shukla, V., & Suryavanshi, S. J. (2025). Comparative review of clinical trial regulations in different countries: Current scenario and future prospect. Reviews on Recent Clinical Trials. https://doi.org/10.2174/0115748871365320250529125930
Sihombing, L., & Nugraha, S. E. (2025). The impact of halal certification in herbal medicine on Indonesia’s agribusiness and pharma sectors: A review. Journal of Global Innovations in Agricultural Sciences. https://doi.org/10.22194/JGIAS/25.1579
Singh, A. K. (2019). Nagoya Protocol of CBD, mechanism to facilitate international collaborative development of plant-based products: India a case study. International Journal of Phytocosmetics and Natural Ingredients, 6. https://doi.org/10.15171/ijpni.2019.01
Sreeja, S. S. S., & John, A. (2026). The Indian legislative framework and biopiracy: A critical analysis. Indian Journal of Legal Review, 6(7). https://doi.org/10.65393/ijlrv6i765
Suparmi, S., Yuliyanti, S., Karyadini, H. W., Syamsudin, A. M. R., & Gau, E. K. (2023). Toxicity of sibutramine hydrochloride-adulterated weight loss supplements in rats based on biochemical and organ weight parameters. Journal of Pharmacy & Pharmacognosy Research, 12(2), 363. https://doi.org/10.56499/jppres23.1852_12.2.363
Un, C., Cheang, L., Lei, J., Leung, S., & Yeung, H. W. (2008). Chinese medicine (CM) matters. Chinese Medicine, 3, 16. https://doi.org/10.1186/1749-8546-3-16
Utomo, A. W., Annisaa’, E., Antari, A. L., & Armalina, D. (2022). The use of herbal medicines in patients with type-2 diabetes mellitus in Indonesia. Sains Medika: Jurnal Kedokteran Dan Kesehatan, 13(1). https://doi.org/10.30659/sainsmed.v13i1.13487
Yip, C., Han, N.-L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian Journal of Anaesthesia, 60(9). https://doi.org/10.4103/0019-5049.190627
