The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review

Journal of Complementary Therapies in Health ISSN 2975-9323 |eISSN 2975-9552 Journal of Complementary Therapies in Health 2026:4(1). doi:10.5281/zenodo.17660881 institutoptc.com/journal-complementary-therapies Review The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. Ema Simões Calçada1*, and Liliana Sampaio dos Santos1,2 . 1 ABS – Atlântico Business School, Vila Nova de Gaia, Porto, Portugal; 2 IPB – Polytechnic Institute of Bragança, Bragança, Portugal. * Correspondence: [email protected] Abstract Background: Traditional Chinese Medicine (TCM), a complementary/non-conventional therapy, is increasingly being integrated into modern healthcare systems. However, its practice and research raise ethical challenges, particularly concerning Informed Consent (IC), an essential element for ensuring patient autonomy, transparency, and protection. Objective: This study aimed to conduct a Narrative Literature Review to identify the use of IC in clinical practice and research within TCM, highlighting its necessity and importance for protecting patient rights and promoting the adoption of ethical standards (including respect for autonomy, cultural sensitivity, trust, safety, and risk management). Informed Consent in TCM: IC is a fundamental ethical and legal requirement, defined as a voluntary process where an individual agrees to a procedure or treatment after fully understanding the risks, benefits, alternatives, and potential outcomes (disclosure, comprehension, and voluntariness). TCM, as a non-conventional therapy, is subject to legal frameworks requiring patient choice and informed consent for all professional acts. IC is especially critical in TCM to ensure clear, culturally adequate communication regarding holistic concepts like Qi and Yin/Yang. Conclusion and Recommendations: The review confirms that IC is a central ethical and legal prerequisite for TCM. Despite being widely recognised, the study suggests that its practical application often lacks quality and transparency, sometimes being treated informally. To address this, IC must evolve from a mere formality into an essential communicative process. Therefore, investing in specific ethical training for TCM professionals and the standardisation of patient information materials is strongly recommended to strengthen the clinical and social legitimacy of these practices. Keywords: Consent, Free and Informed; Traditional Chinese Medicine; Complementary Therapies. 1. Introduction Understanding how TCM emerged requires going back in time and history, as it is present in ancient medical practices. However, TCM has come a long way and, given its recognition as a medical practice, albeit non-conventional, it is beginning to be integrated into modern healthcare systems. And with its expansion on a global scale, its objective and meticulous readjustment to modern times is currently based on pragmatic concepts, aiming for better guidance in diagnosis and understanding of the subject 1. In this sense, there is a need, in our opinion, urgent, to analyse the ethical issues that guide its practice, particularly in relation to IC. It should be recalled that, despite the increasing recognition of TCM as a medical practice, it is noted that, unlike conventional Western medicine, where established IC protocols exist, TCM faces some challenges, which arise from differences in cultural norms, as well as diagnostic approaches and treatment methods 2-4. However, like Western medicine, whether in TCM clinical practice or its research, IC is a crucial Citation: Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. Journal of Complementary Therapies in Health. 2026;4(1) 10.5281/zenodo.17660881 Academic Editor: Jorge Rodrigues Received: 22 October 2025 Reviewed: 12 November 2025 Revised: 18 November 2025 Accepted: 19 November 2025 Published: 20 November 2025 Publisher’s Note: IPTC stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Copyright: ©2026 by the authors. Submitted for open access publication under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Journal of Complementary Therapies in Health 2026: 4(1). 2 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 element of ethical responsibility, ensuring respect for patient autonomy, as well as transparency between TCM professionals and their patients 5. In this line of thinking, it is important to highlight the importance of IC within the scope of TCM practice and research and, concomitantly, identify the ethical challenges associated with IC. This is because, by recognising and prioritising IC, professionals and researchers ensure that their practices uphold the rights, safety, and autonomy of patients and participants (in research), contributing to the assumption of ethical integrity in TCM, as well as its acceptance and integration into modern healthcare systems 2,4,5. Thus, the aim is to carry out a narrative literature review that identifies the use of IC in clinical practice and research in TCM and that highlights the necessity and importance of IC to guarantee the protection of patients' rights and, at the same time, promote the adoption of ethical standards in TCM, both at the level of clinical practice and research in this health area, namely, in relation to respect for autonomy, cultural sensitivity, building a therapeutic relationship of trust and based on transparency, safety, and risk management, ethical research practices, and compliance with ethical standards established by contemporary healthcare systems. 2. Traditional Chinese Medicine As Coimbra 6 explains, TCM is a system of diagnosis and healthcare that has developed over more than 3000 years, with the oldest records dating back to 1000 BC (before Christ), during the Shang dynasty, a time when complex medical issues were already being treated. It can be described as an ancient healthcare system that originated in China, based on a holistic approach to health and well-being with the aim of balancing the mind, body, and environment to promote healing and prevent disease. According to Williams et al. 7, TCM works on the premise that disease is created as a consequence of a disturbance that occurs in the person's emotional and mental body. Secondly, from a philosophical point of view, that healing is a process that must involve the whole body, that is, regardless of the physical point where the disease developed, it must be understood that the body is sick 7. This, which is one of several non-conventional therapies (NCTs), encompasses various practices and theories that differ from so-called conventional medicine, Western medicine, focusing on restoring the balance of the organism and not just treating specific symptoms, since TCM translates into a set of very sophisticated practices, aimed at curing disease and maintaining health and well-being 7. For a better understanding of what TCM is, it is important to introduce what are considered its fundamental concepts: Qi or Chi (energy); Jing (essence or ancestral energy); Xue (blood); Shen (spirit or consciousness); and organic Fluids 8. In terms of advantages, it is worth mentioning that TCM is effective in treating some chronic diseases; it adopts a holistic approach, addressing all aspects of the individual's health; it focuses on the fundamental cause of the disease and not merely on the visible symptoms 9. It can also be said that in practice, Chinese doctors differentiated the "root" of an illness, the pattern of energetic imbalance in the patient, from the "branches" that reached the apparent symptoms 9,10. This therapeutic system does not depend on drug therapy, in some cases associated with unwanted side effects; it promotes the person's general health, in addition to treating specific diseases; it tends to be more economically accessible than conventional allopathic treatment; it can be used in conjunction with Western medicine, including to alleviate the adverse effects of Western therapies 10,11. 2.1. Legal Framework As previously mentioned, TCM is an NCT and is therefore regulated by Law No. 71/2013, of September 2nd 12,13, which regulates access to and the exercise of professions within the scope of NCTs in the public or private sector, with or without profit, and which, in its Article 2, recognises TCM as an NCT. In this matter, it is also necessary to refer to Law No. 45/2003, of August 22nd 12,14, which establishes the framework for the activity and exercise of professionals who apply NCTs, as defined by the World Health Organization (WHO). According to this legal diploma, NCTs are therapies that are based on a different Journal of Complementary Therapies in Health 2026: 4(1). 3 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 philosophy from conventional medicine and apply specific diagnostic and therapeutic processes (no. 1, article 3) 14. Considering the theme of the work, it is important to mention that this diploma denotes a concern with ethics in the practice and research of TCM as an NCT and with IC. Let us consider its Article 4, where its guiding principles are set out: The individual right to choose the therapeutic method, based on an informed choice, about the safety, quality, efficacy, and possible risks; The defence of public health, in respect of the individual right to health protection; The defence of users, which requires that NCTs be practiced with a high degree of responsibility, diligence, and competence, based on the professional qualification of those who practice them and their respective certification; The defence of the user's well-being, which includes complementarity with other health professions; The promotion of scientific research in the different areas of NCTs, aiming to achieve high standards of quality, efficacy, and effectiveness 14. At the same time, Article 13 is highlighted, which refers to the right of option and to information and consent, meaning that "citizens have the right to freely choose the therapies they deem appropriate" (no. 1) and that "non-conventional therapy professionals can only perform acts with the informed consent of the user" (no. 2) 14. Therefore, the necessity and importance of IC being used in the practice and research of TCM is immediately evident. Finally, we want to highlight Ordinance No. 45/2018 of February 9th 15, which emphasises the need for a degree in TCM to include adequate training in all areas, including ethics. In its Article 9, directed at the TCM practice training component, it highlights the need for this training to include respect for safe practice, ethical, and deontological standards, and in complementarity, its Article 10 (training in other areas) emphasises the duty of the study plan leading to a degree in TCM to ensure, across the different components, adequate training in the area of ethics and deontology, among other areas 15. Thus, TCM, even though it is not a conventional medicine, is also guided by ethical and deontological principles, similar to conventional medicine, which allows us to underline the necessity of using IC in its practice and research, just as in the practice and research of Western medicine. In addition to the aforementioned legal documents, it is important to highlight others that establish the obligation to respect the person and their rights, as IC intends to do: at a national level, the Constitution of the Portuguese Republic, the Penal Code, the Civil Code, and the Basic Health Law are also highlighted; and on the international stage, the Universal Declaration on Bioethics and Human Rights, the Convention on Human Rights and Biomedicine, and the Charter of Patient Rights and Duties 16. 3. Informed Consent IC can be described as a process through which an individual voluntarily agrees to participate in a medical procedure, research, or treatment, after fully understanding the risks, advantages, possible alternatives, and the results that can be obtained 17. That is, IC translates into the process that requires the individual to receive information, possess the mental capacity to understand and evaluate it, and be free from any form of persuasion or coercion. Therefore, there are two basic elements of IC: comprehension and free clarification. The first concerns the provision of correct and clear information about the diagnosis and therapeutic alternatives, in a way that is understandable to the individual; the second refers to the act through which the individual, of their own free will, consents and authorises an intervention or their participation in research 18. Therefore, it is understood that IC serves the purpose of disclosure, that is, providing all-important information to the patient such as the risks, advantages, alternatives, and the objective of the intervention/treatment/research. However, as ERS refers 18, the information to be provided must take into account three parameters: the common practice in the profession; the expectations of a specific patient; and the needs of a specific individual. In addition, depending on the mentioned parameters, the information provided in an IC must respect: Journal of Complementary Therapies in Health 2026: 4(1). 4 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 • the diagnosis and description of the clinical condition; • the description of the proposed treatment, its nature and objectives; • the risks and possible complications that may result from the treatment in question; • alternative treatments; • the risks of non-treatment; • the probability of treatment success 18. Comprehension is equally important and serves to ensure that the individual understands all the information provided, which can be done through questioning. Here, the importance of communication is highlighted, as the fact that the process is based on good communication makes IC a procedure that can be modified and evolve throughout the treatment 18. Voluntariness is another inherent characteristic of IC, allowing the individual to make a voluntary decision, of their own free will and free from manipulation or influence from third parties. This is because, free consent is an intentional and voluntary act, which authorises someone, in this case, the healthcare provider, either individually or institutionally, to act in a certain way during the therapeutic act 18. Finally, competence is another important aspect to consider, as it is necessary to confirm whether the person has the mental and legal capacity to make the decision. Therefore, in urgent situations, in situations where patients are temporarily or definitively unable to decide (coma, mental disability, children), the IC will have to be carried out by their legal representatives 16. According to ERS 18, one of the reasons that supports the existence of informed consent is related to the fact that it is admitted to be a benefit for the patient to actively participate in decisions about the medical care they undergo. This benefit of patient involvement in decisions about their health results, on the one hand, from being proactive, avoiding interventions that the patient may consider potentially dangerous to their health, and, on the other hand, from contributing to their well-being. In fact, only advantages result from IC, and there are several reasons that justify its importance, as it ensures respect for the person and their fundamental rights: 1) ensures respect for the patient's essential right to self-determination; 2) protects the patient against possible physical and psychological harm that may result from the disease or treatment; 3) promotes the benefit of the patient's active participation in decisions related to the medical care they receive 19. Therefore, IC is a crucial ethical and legal requirement, particularly in the area of health and research, as is the case with TCM practice and research, because it ensures respect for the autonomy and right of the individual to make their own decisions regarding their body and health. Furthermore, it fosters trust, essential for any therapeutic relationship 19, and therefore IC reflects an exchange of ideas that strengthens the doctor-patient relationship 20. The IC form is the document that materialises the IC itself, being an ethical and legal document that aims to inform the patient about the procedure the patient is going to undergo, with the purpose of the latter exercising their right to free autonomy, and at the same time, protecting the health professional 21, and therefore, it cannot be discredited or ignored, nor treated informally 22. For this very reason, we agree with the idea that assuming that informed consent should be based on comprehension and free consent, its correct application depends on the observance of these principles in the patient's decision-making process. As it is a process that involves not only the patient's autonomy and freedom, but also duty and responsibility, its application is not subject to precise evaluation, although strategies can be defined to implement its application and evaluate the rigor with which the process is approached 18. 3.1. The Four Ethical Principles It has been argued, regarding IC, that TCM practice and research, even though not falling under conventional medicine, should be guided by IC protocols. In this line of thinking, it is recognised that the four ethical principles that currently prevail in Western medical ethics can and should be applied in the context of NCTs, such as TCM. They are: non-maleficence; beneficence; respect for autonomy; and justice 23. Thus, respect for the Journal of Complementary Therapies in Health 2026: 4(1). 5 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 principle of non-maleficence is based on the idea of doing no harm 24-26. That is, it inherently carries the idea that the patient should not be harmed, ensuring that the health professional must avoid causing harm to the patient. For this very reason, there must be prevention of direct harm, as well as a cautious assessment of the risks arising from the intervention, in order to avoid complications and minimise any negative consequences. Conversely, the principle of beneficence is based on the idea of doing good 24-26, ensuring that the health professional acts in the best interest of the patient, in order to promote their well-being and maximise the benefits for their health and quality of life. In turn, the principle of respect for autonomy guarantees the patient's right to make their own decisions regarding their body and health, based on their beliefs, values, and preferences, that is, the person chooses 24,26. Therefore, it allows the patient the freedom of decision, with knowledge of the facts and without coercion, through correct information 25. To ensure this right, it is the responsibility of the health professional to correctly inform the patient about their disease, their state of health, existing treatments, and the risks and advantages associated with each of them, so that the patient can make an informed and voluntary decision. The principle of justice, in the context of medical ethics, advocates the fair and egalitarian treatment of all patients, regardless of their socioeconomic status, religion, political option, sexual orientation, among others. This principle is based on the idea of "prioritising equitably, using available resources judiciously 24,26. In this regard, Rosa et al. 25, based on the contribution of other theorists, say that this principle refers to the equitable distribution of resources necessary for assistance, as well as guaranteeing access to healthcare for all citizens. This principle is extremely important, as it prioritises a fair distribution and access to health resources, that is, it guarantees access to healthcare and treatment without discrimination or any kind of favouritism. Although these principles apply to Western medical ethics, they can be transposed to TCM, assisting its professionals, just as happens in conventional medicine, in their decisions. Because the formulation of an ethical decision is based on the understanding of these fundamental principles of bioethics that apply to common problems of clinical practice and is facilitated when institutional and individual responsibility are well defined 25. These principles guide health professionals, in the sense of seeking to find a balance between the rights and interests of patients and their responsibility and duties, and the limitations of the current health system which, although already beginning to recognise and integrate NCTs, are still not the object of the recognition they deserve. 3.2. The Importance of Informed Consent in TCM Practice and Research IC is an essential process in the practice and research of TCM, due to ethical factors, which are the focus of this work, as well as clinical and cultural factors. Regarding the challenges of ethical review in TCM clinical research, Zhang et al. 27 state that in China this is highly convergent with that of Western medicine, however, it lacks the characteristics and culture of TCM, which is particularly important when we think about the Portuguese reality, where it is necessary, in order to achieve this convergence between Western medicine and Eastern medicine, to have greater knowledge and regulation of TCM. Firstly, respect for patient autonomy has been widely referred to, and just as in conventional medicine, in the context of TCM too, patients have the right to make their own informed decisions about their health and body. At the same time, similar to what happens in Western medicine, where patients do not have medical knowledge about treatments, in TCM they also do not have knowledge of its practices and treatments. Therefore, IC ensures that they understand what they are agreeing to, and by being informed, they gain knowledge to make their informed choices based on their preferences, values, and beliefs. In this regard, it is worth mentioning the article by White et al. 28, which underlines the right of patients to be informed about the risks and benefits of any examination or treatment and the obligation of doctors to obtain prior IC. The same authors also mention the importance of information about the risks and advantages of this technique being available to health professionals and patients, having designed an information leaflet that not only identifies Journal of Complementary Therapies in Health 2026: 4(1). 6 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 the risks but can also be adapted for the construction of an IC form 28. TCM, as already mentioned, approaches health and disease holistically, prioritising the relationship between body, mind, and environment, and therefore its philosophy includes concepts such as Qi and the balance of Yin and Yang, concepts that can be difficult for patients unfamiliar with them to understand. In this sense, IC in TCM necessarily requires clear and culturally adequate communication, in order to ensure that patients understand the nature, objectives, and mechanisms of the treatment to follow. However, it is noted that IC for treatment such as acupuncture, for example, is treated as an informal matter, meaning that most of its practitioners probably only provide information about risks when asked, and IC is assumed by the fact that the patient appeared at the clinic and undressed to prepare for treatment 29. On the other hand, it is important that patients seeking TCM are aware of the risks and benefits inherent in each treatment, and therefore IC allows them to be informed about the risks, advantages, and effectiveness results of the treatment in question. As White et al. 30 emphasise, "theoretically, any health professional who does not respect the principle of informed consent may be the subject of a lawsuit by the patient and an action by their professional body. Touching a patient without valid consent, for example, can constitute a civil or criminal offense of assault. Furthermore, if health professionals fail to obtain informed consent and the patient subsequently suffers harm as a result of the treatment, this fact may be a factor in a negligence complaint against the professional." At the same time, ethical and legal responsibility is also present in TCM, and therefore IC establishes an ethical and legal basis that holds the health professionals who practice it accountable, ensuring that this intervention is practiced responsibly, contributing to greater patient safety and trust. For this very reason, the key principles of informed consent are that consent must be given by a patient a) voluntarily, b) who has the capacity to understand and c) who has been given appropriate information 30. Finally, in terms of research, IC is important for protecting participants. That is, through IC, participants in a TCM study are informed about whether the treatment is experimental, what the objective of the study is, and what the inherent risks are. Furthermore, in this context, the patient's identity is normally protected, and IC serves precisely to guarantee their anonymity and the confidentiality of the information provided by them. Therefore, the importance of IC in practice and research within TCM is a step for it to assert itself at the level of conventional medicine and to regularise itself, being in tune with the ethical standards that are required in all forms of medical practice. IC is thus a crucial procedure to ensure that patients (clinical practice) and those investigated (research) understand the treatment they will undergo or the study they will participate in and with which they have agreed, finding that the general ethical principles are the basis of the ethical review of TCM, where IC appears as one of the aspects to be considered due to the characteristics of TCM21. 3.3. Importance and Necessity of Informed Consent in Non-Conventional Therapies IC is a crucial aspect in NCTs not only because of the unique challenges they raise, but also because of the ethical considerations involved in treatments that, for the most part, are not part of conventional medicine guidelines. Going somewhat along the lines of what was previously mentioned regarding IC in TCM, in NCTs, which include TCM, respect for the patient's right to autonomy is also fundamental. In fact, NCTs cover a large set of practices (e.g., herbal medicine, homeopathy, acupuncture, TCM, etc.), and may include therapeutic approaches that are unfamiliar and unknown to many patients. In this way, IC gains particular relevance, as professionals, after clearly informing their patients about the various treatment alternatives (indicating only those that are appropriate for their disease/condition), allow them to make an informed choice based on their values and beliefs, respecting and ensuring the right to their autonomy and self-determination. ERS 18 refers that one of the fundamental reasons for the existence of informed consent is respect for the person. It is now an accepted fact in our societies that each of us is the holder of a set of principles and characteristics that makes us a unique being, whose dig- Journal of Complementary Therapies in Health 2026: 4(1). 7 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 nity involves being able to assume their own individuality. The individuality of the human being is associated with the concept of autonomy, which in this context cannot be dissociated from the capacity for choice and self-determination. Once the right to autonomy is recognised, understood as the capacity to ethically determine one's way of life, it would be an unacceptable ethical violation to condition their freedom of choice, inducing choices or refusing their active participation in making decisions that may affect their future. On the other hand, we want to underline the importance of IC in defining realistic expectations, in protection against exploitation, and in encouraging transparency and trust. Regarding expectations, it is noted that individuals may resort to NCTs as a result of the ineffectiveness of conventional medicine treatments. Therefore, IC serves for professionals to inform about the scientific evidence of these therapies, their effectiveness in the face of the illness in question, contributing to patients creating realistic expectations regarding treatment through NCTs. In relation to protection against exploitation, IC protects patients from unethical practices, ensuring that they understand the options available to them, as well as the associated financial costs. Regarding the encouragement of transparency and trust, IC allows health professionals to explain how a therapy works, demonstrating the honesty of their actions, as well as the openness to establishing a therapeutic relationship based on trust. A study carried out by Ieong 29 discusses the state of TCM in Portugal comparing it with the system in force in the country where it originated (China) and where it is recognised in legislative, administrative, educational, and practice terms. The study's conclusions show that, in national territory, the TCM regime is part of the inclusive system according to the WHO's definition and description for the integrative, inclusive, and tolerant system. This same study highlights the importance of IC in TCM practice in Portugal, emphasising its indispensable and special role, largely justified by the particularity of the diagnosis, prescription, and treatment method. Ieong 29 thus concludes that the NCT system in Portugal is still in a very remote phase, lacking development, with the purpose of improving and developing the realisation of the IC doctrine in this recently legalised domain. 4. Final remarks It can be said that the four principles of IC are usually present in studies and in the literature that researches TCM, where IC operationalises respect for autonomy and contributes to beneficence and non-maleficence by informing the patient about risks/benefits and alternatives 24-26. However, as expressed by Zhao et al. 5, although many studies refer to IC, this does not guarantee that consent is, effectively, informed and that it complied with all ethical requirements, namely, communication of risks, voluntariness, possibility of withdrawal, among others. That is, although many trials mention the application of IC, there is no certainty about the quality of this process and whether it was documented in accordance with rigorous ethical standards 5. In fact, several authors who comment on the IC process emphasise that consent is a communicative process and not a simple form, and must ensure the comprehension, voluntariness, and decision-making capacity of each participant 31,32. In this sense, Zhang et al. 2 defend the idea that in order to obtain high-quality IC in TCM clinical trials, it is necessary to improve transparency, language, relational care, and ensure that participants understand all relevant and inherent aspects of the study/intervention they are participating in. Empirical research 5 found that only a small fraction of the reported trials mentioned clinical trial registration and that ethical approval was referred to in less than a quarter of the papers, which highlights a gap in practice and reporting. Thus, it is important here to emphasise the study by Zhao et al. 5, which contemplated IC in its research and treated it as an object of investigation, insofar as they did not assume that IC was provided to participants, concerning themselves with this aspect by questioning them about how the process was. In the same sense, it is understood that Li et al. 33 developed a protocol that considers the necessary ethical requirements for research on human beings, including specifically informing participants about the objectives, procedures, possible risks, and benefits before signing the IC. TCM trial participants Journal of Complementary Therapies in Health 2026: 4(1). 8 of 10 Calçada E.S., dos Santos L.S. The Ethics of Informed Consent in Traditional Chinese Medicine Practice and Research: A Narrative Literature Review. doi:10.5281/zenodo.17660881 ask for clear explanations about the proposed mechanisms, interactions with Western treatments, duration, visits, adverse effects, and alternatives to non-treatment 2,5. This indicates that standard forms/leaflets used in the clinic should include these items in a simple and illustrative way, and tools such as the model leaflet by White et al. 30 (for acupuncture) or the WHO models for the ICF can be adapted to include specific sections on "what TCM is applied here", "what are the differences in relation to Western treatment", "what are the expected effects and potential adverse effects" 30,32. Regarding the study by Barros et al. 34, it allows for highlighting gaps in conceptualisation among professionals/managers. Thus, to guarantee quality IC, it is necessary to invest in the ethical training of TCM professionals, not least because IC protects against practices that promise extraordinary cures without any scientific evidence. For this reason, IC should include an honest balance between the evidence (what is known and what is not known) and realistic expectations, preventing psychological and financial harm from false expectations. 5. Conclusion This review confirms that IC is a fundamental ethical and legal prerequisite for the practice and research of TCM. While IC is recognised and commonly mentioned in protocols, significant deficiencies in its quality, transparency, and practical implementation may occur. The core finding is that IC must evolve from a mere formality to an essential communicative process to guarantee patient autonomy and trust. To strengthen TCM's ethical foundation, the standardisation of information materials and dedicated ethical training for professionals are strongly recommended, ensuring these practices align with contemporary healthcare standards. Credit author statement: Conceptualization: E.S.C. and L.S.S.; Investigation: E.S.C. and L.S.S.; Writing, reviewing and editing: E.S.C. and L.S.S. All authors have read and agreed to the published version of the manuscript. Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Conflict of Interest: The authors declare that there are no conflicts of interest. Institutional Review Board Statement: Not applicable. Informed Consent Statement: Not applicable. Data Availability Statement: The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author. References 1. Greten HJ. 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