Informed Consent as a Human Right in the Inter‐American Human Rights System (IAHRS)

ABSTRACT

Informed consent is presented as a fundamental right and principle in modern medical practice. It involves obtaining permission from a patient before any medical procedure, treatment, or research protocol. Although not explicitly recognized as a standalone right in international human rights instruments, informed consent in healthcare is considered a right derived from other rights, such as the rights to health and freedom. The jurisprudence of international human rights courts has permitted the reinterpretation of informed consent beyond just a bioethical principle. This article argues for the normative recognition of informed consent as a self‐standing human right, rather than simply a derivative right or an ethical guideline. It does this by analyzing related cases from the Inter‐American Court of Human Rights to demonstrate how its jurisprudence, though often linking informed consent to related rights like health, personal integrity, and self‐determination, supports an understanding of informed consent as a distinct and fundamental right. The source also mentions that its recognition as a right in fundamental laws, such as the Colombian Constitution, should be achieve through the application of these international standards or via the concept of emerging rights.

1. Introduction

The doctor–patient relationship has evolved away from the paternalistic model, which was characterized by a lack of patient participation in decision‐making regarding their health. This model was based on the patient's ignorance and the exclusive authority of the health professional in determining courses of action for medical care.

Free, prior, and informed consent does not have its explicit referent in the Hippocratic oath and was initially understood as an ethical principle to inform patients rather than to obtain the patient's willingness to undergo an intervention or treatment [1].

In fact, it was not until the middle of the 20th century that informed consent began to be given importance as an ethical duty of physicians. The 1947 Nuremberg Code was a milestone in establishing voluntary and informed consent as a fundamental requirement in human experimentation [2]. This was followed by the 1948 Geneva Declaration on the Ethical Duties of Physicians, which implicitly includes the principle of informed consent as part of the promise of respect [3]. Later, the 1979 Belmont Report further developed the ethical foundations for biomedical research by articulating the principles of respects for persons, beneficence, and justice [4]. Finally, the 1981 Lisbon Declaration recognizes informed consent as part of the right to self‐determination in connection with the right to freedom of choice [5].

However, these legal documents are not binding norms for States, as they are soft law norms that do not create legal obligations in international law for States. In addition, they are standards that were created within professional organizations or associations without the participation of governments. For that reason, informed consent has been considered as an ethical duty without legal or economic consequences.

Despite the crucial role of informed consent in clinical practice and its increasing recognition in ethical guidelines and some national regulations as a right related to patient autonomy or health, its status within the broader international human rights framework remains complex. Traditionally viewed through the lens of professional ethics or as a derivative of other established rights like health, freedom, or privacy, informed consent has often lacked explicit affirmation as a distinct, self‐standing human right in binding international instruments. This traditional framing contrasts with the evolving doctor–patient relationship, which now emphasizes patient autonomy and shared decision‐making, moving away from paternalistic models. The question thus arises whether this established understanding adequately captures the fundamental importance of informed consent for individual dignity and self‐determination in health matters.

In light of this background, the central question driving this article is whether informed consent should be recognized normatively as an autonomous and self‐standing human right, moving beyond its traditional characterization as solely an ethical principle or a derivative right. This study argues that evolving international human rights jurisprudence supports such a recognition. Focusing specifically on the Inter‐American Human Rights System (IAHRS), the article analyzes pertinent case law from the Inter‐American Court of Human Rights. By examining how the Court has addressed issues related to informed consent, the analysis aims to demonstrate the basis for understanding informed consent as a fundamental, distinct right within this system, thereby contributing to the argument for its broader normative recognition in legal frameworks.

The legal implications associated with the absence or defects in informed consent began to be analyzed from the perspective of medical liability. The first relevant legal cases came from the US court system, including “Mohr v Williams; Pratt v Davis; Rolater v Strain and Schloendorff v Society of New York Hospital.” These cases have “established and solidified the principle of patient autonomy that ultimately formed the basis of the requirement for informed consent in medicine and research” [6].

However, these cases did not give consent sufficient legal force unless a causal link could be shown between its practice and the harm caused to patients, in the context of the tort law. It was in the case of Salgo v Leland Stanford Jr University Board of Trustees that particular importance was given to the need “to provide the patient with information about the potential benefits and risks of any medical procedure” [6].

The theory of informed consent, which is a product of these American common law precedents, has been the basis for medical liability under both battery and negligence. Battery applies in cases of physical contact with another person without that person's consent. Such contact results in a violation of the person's privacy or intimacy that is offensive in reasonable terms. In negligence, unintentional harm results from an unintentional act or omission that results in a breach of a duty of care. In this case, the physician fails to provide the patient with the information necessary to make an informed decision. In the healthcare field, malpractice includes professional negligence and battery [7].

Subsequently, this ethical‐legal duty to inform the patient was reinforced by ethical recommendations for the practice of informed consent in biomedical research. These include the Belmont Report, the Nuremberg Code, the Declaration of Helsinki and the CIOMS Guidelines [7]. These recommendations have inspired countries' internal regulations on biomedical research. Some of them are national laws, while others are national ethics recommendations.

In the countries of the American continent, which are part of the Inter‐American human rights system, the right to informed consent is recognized as an ethical guideline for biomedical research and as the right to autonomy of will and information of patients within the health system. This right is recognized in laws on the right to health or health systems, but does not have explicit constitutional recognition, for instance the Colombian political constitution explicitly protects dignity, self‐determination and freedom or the free development of personality, all closely related to informed consent.

However, since the Lisbon Declaration, the legal systems of these countries have adopted charters or catalogs of patients' rights. For example, there is Law 26,529/09 of Argentina (Public Health Law) [8], Law 18,335/08 of Uruguay [9], the Mexican General Health Law and its Charter of patients' rights and duties [10], and in Colombia, Resolution 13437 from 1991 [11] and Resolution 229 from 2020 [12], issued by the Ministry of Health and derived from the Lisbon Declaration [3] and the Health Statute Law (Law 1751 of 2015) [13].

In contrast, European countries such as Finland and Spain have specific national laws on patients' rights. Finland has the Act on the Status and Rights of Patients (785/1992) [14]. This law includes specific guidelines on the right to informed consent¹, that are related with the self‐determination right. On the other hand, Spain has the Law 41/02 [15], the basic law regulating patient autonomy and the rights and obligations regarding clinical information and documentation.

The absence of specific national laws on patients' rights that recognize the autonomous right to informed consent in the countries of the American continent does not imply that it is not a human right, as will be seen below.

2. Protecting Informed Consent in International Human Rights Law

Informed consent derives its protection from several international human rights instruments, including the Universal Declaration of Human Rights and the International Covenant on Civil and Political Rights, Article 7 (ICCPR). In addition, the universal system includes the Convention on the Rights of Persons with Disabilities. This treaty includes, in the provisions of Article 25 on the right to health, special duties related to obtaining informed consent:

d) Require health professionals to provide care of the same quality to persons with disabilities as to others, including on the basis of free and informed consent by, inter alia, raising awareness of the human rights, dignity, autonomy and needs of persons with disabilities through training and the promulgation of ethical standards for public and private health care. [16]

This means that consent is understood as derived from or included within the right to health. The convention is one of the first human rights treaties that recognizes autonomy, equality and nondiscrimination for persons with disabilities. This recognition applies to decision‐making in health interventions. Consequently, States must guarantee the adoption of relevant support measures for the exercise of their legal capacity with respect to informed consent.

For its part, the ICCPR explicitly refers to the right to informed consent in research. Article 7 states:

No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation. [17]

This right must be interpreted in connection with the right to respect for human dignity and the prohibition of cruel, inhuman, and degrading treatment, which are prohibited not only in the field of research but also in the field of medical health care.

The universal system has addressed cases related to informed consent in the provision of health services. The cases of S.C. and G.P. vs. Italy, submitted to the Committee on Economic, Social and Cultural Rights (CESCR), and N.A.E. vs. Spain, presented to the Committee on the Elimination of Discrimination against Women (CEDAW), are noteworthy. The first case refers to the relationship between the right to autonomy and informed consent, as individual rights, in connection with the right to enjoy the benefits of scientific progress under the ICESCR.

In the case of S.C. and G.P. v. Italy, the committee recognized that the right to health incorporates the right to make free and informed decisions about any medical treatment a person may undergo. In this case, the couple sought to prevent the uterine transfer of embryos affected by a genetic disorder. However, the embryo transfer was carried out without the woman's informed consent. The committee's recommendation focused the need for the Italian state to “adopt legislative and/or administrative measures” to guarantee both the exercise of free and informed decision‐making on any medical intervention and the right to withdraw informed consent at any stage [18].

In consequence, according to the CESCR “the transfer of an embryo into S.C.'s uterus without her valid consent constituted a violation for her right to the highest attainable standard of health and her right to gender equality in her enjoyment of her right to health, amounting to a violation of article 12, read alone and in conjunction with article 3, of the Covenant”. Thus, informed consent is closely related to the right to health, and in the exercise of the right to sexual and reproductive health, its restriction seriously affects women [18].

The case of N.A.E. vs. Spain involves a Spanish woman who underwent premature induction of labor and a cesarean section without her consent, and was therefore considered a victim of obstetric violence. According to the opinion of the CEDAW Committee, violations of informed consent in women's health care directly affect the right to moral integrity and freedom. Consequently, these violations deprive the holder of her personal autonomy, generating physical and psychological affectations [19].

The European human rights system includes the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. This convention has two complete chapters on rights, rules, and principles related to informed consent and the right to information. Consequently, this instrument is the first human rights treaty to recognize informed consent as a human right [20].

However, the case‐law of the European Court on Human Rights (ECtHR), in regard to the lack of informed consent, relies on Article 8, taking it as an interference with private life. In fact, the Court in the Reyes Jimenez v. Spain case, reiterated that “the imposition of medical treatment without the patient's consent (…) would entail a violation of the physical integrity of the person concerned that could call into question the rights protected by Article 8(1), but also that persons exposed to a risk to their health should have access to information that would allow them to assess that risk” [21, 22].

In addition, the European Court has accepted that the absence of informed consent in health care services constitutes a violation of Article 3 of the Convention, when it fails to demonstrate the necessity of the intervention to protect the life and integrity of the person. Thus, in the case of V.C. v. Slovakia, involving sterilization without informed consent, the Court applied a “severity test.” The violation of Article 3 is determined by the purpose of the medical intervention. So, the treatment must attain a minimum level of severity, which depends on all the circumstances of the case [23].

3. The Inter‐American System and the Recognition of Informed Consent as a Human Right

In the Inter‐American Human Rights System, informed consent has indirect protection in the American Convention on Human Rights and in the American Declaration of the Rights and Duties of Man.

The Court has studied contentious cases related to the right to health. For example:

• a. Case of Gonzales LLuy et al. v. Ecuador, related to the HIV infection of a minor as a result of a blood transfusion. In addition to medical liability for the absence of timely examinations of the donor, the omission of the risks as part of informed consent was a topic to be considered by the Court. The Court recalls that the accessibility of the right to health includes the right to access to information as highlighted by the Committee on ESC rights in its General Comment No. 14. This right is also a fundamental element of the right to education, especially the right to timely and unbiased information on HIV/AIDS [24].
• b. Case of Angulo Losada v. Bolivia, involving a case of sexual abuse of a minor. Although it was not the central point, the case raised ethical issues related to the forensic medical care of the victim who refused to be attended by male students and felt that the procedure was conducted in a coercive manner. The Court highlights the importance of informed consent in children and adolescents according to their degree of maturity to guarantee the right to be heard, privacy, and intimacy [25].
• c. Case of I.V. vs. Bolivia, is a case law related to the involuntary sterilization. The woman was a victim of forced sterilization at the Women's Hospital of La Paz. After giving birth, I.V. tubal ligation was performed without her prior free and informed consent. While the case proceeded between 2000 and 2006, it did not end with a sentence, but with a judicial decision that extinguished the criminal action. Consequently, the medical team that practiced tubal ligation went unpunished [26, 27]. The Court recognizes that this case involves the rights to family privacy and the right to find a family.

  In this case, the Inter‐American Court noted that in matters of consent, the corpus juris is supported by international declarations, guidelines, opinions of expert medical committees, guidelines, criteria and other authorized pronouncements of bodies specialized in the subject such as the World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the World Medical Association (WMA), the United Nations Educational, Scientific and Cultural Organization (UNESCO), the United Nations treaty bodies, the Council of Europe, and the European Court of Human Rights, among others. These bodies have erected common legal standards that build general protection around the prior, free, full, and informed nature of consent.

• d. Case of Poblete Vilches vs. Chile, is a case law related medical and administrative negligence, but takes into account some issues about surrogate autonomy. Mr. Vinicio Antonio Poblete, due to severe respiratory failure, entered the public hospital “Sótero del Río” and remained in the intensive care unit. While he was unconscious, he underwent surgery without doctors obtaining the consent of his relatives. Upon being discharged, and in the absence of available ambulances, the Poblete Vilches family had to hire a private ambulance to transfer him to their home. Soon, he had to enter the hospital again due to respiratory failure and probable septic shock. Despite the seriousness of his condition, he was housed in the intermediate care unit due to the lack of beds in the intensive care unit. Mr. Poblete Vilches died on February 7, 2001. His relatives went to court and requested that the negligence of the intervening doctors be investigated, without the responsibility for the death of Mr. Poblete Vilches being determined to date [28, 29].

  Regarding surrogate autonomy, the distinction between a possible omission and negligence is likely. It is not an omission, because it can be verified that it was not a deliberate act, or that the possible damage was not taken into account. Knowingly and with full freedom the medical staff of the hospital did not attend Vinicio Antonio Poblete for the second time, even though they themselves aggravated his condition. The above can be interpreted in a neoliberal context of rationalization of resources.

• e. Case of Guachalá Chimbo and others vs. Ecuador, is one of the first cases involving the psychiatric hospitalization of a person with disability and their health right protection. The case is related to the disappearance of Mr. Guachalá Chimbo, a mentally disabled person, while he was in the Psychiatric Hospital in the city of Quito (January 2004). In addition, the absence of informed consent and the medical treatment received were central issues in the case. The Inter‐American Court of Human Rights determined that the Ecuadorian State was responsible for the violation of the rights to recognition as a person before the law, life, personal integrity, personal liberty, dignity and privacy, access to information, equality before the law and health, in accordance with Articles 3, 4, 5, 7, 11, 13, 24 and 26 of the American Convention on Human Rights, in relation to the obligations to respect and guarantee rights without discrimination and the duty to adopt provisions of domestic law, established in Articles 1.1 and 2 of the same instrument [30, 31].

According to the jurisprudential precedents of the Inter‐American Court of Human Rights, the recognition of informed consent as a right has moved from being an element of the right to health to being interpreted as an autonomous right based on self‐determination.

Patient self‐determination is a fundamental principle in modern healthcare, emphasizing the autonomy and rights of individuals to make informed decisions about their own medical care. This concept underscores the importance of respecting patients' preferences, values, and choices regarding treatment options, including the right to accept or refuse medical interventions. Healthcare providers play a crucial role in supporting patient self‐determination by providing clear and comprehensive information, fostering open communication, and respecting patients' decisions even when they may differ from medical recommendations. Ultimately, promoting patient self‐determination not only enhances patient satisfaction and trust in healthcare but also contributes to more patient‐centered and ethically sound medical practice.

These cases highlight the implications of inadequate informed consent procedures in healthcare and the importance of obtaining informed consent from patients. They also reflect how international jurisprudence closely links informed consent to the right to health, life and integrity of the person.

These cases collectively underscore the critical importance of informed consent as a cornerstone of patient autonomy in healthcare, addressing issues ranging from medical negligence to violations of human rights and ethical standards. They highlight the necessity for healthcare providers and states to uphold patients' rights to make informed decisions about their medical care, ensuring respect for dignity, privacy, and personal autonomy.

4. Conclusion: From Principle to Human Right

According to previous case law, informed consent deserves recognition as an independent human right and must be kept analytically separate from the positivist exercise of cataloging protections already found in treaties, statutes, and case law. While positivist analysis reveals scattered safeguards, it also exposes doctrinal gaps, inconsistent enforcement, and the tendency to subsume consent under broader health or privacy rights. The current legal framework is fragmented and conditional, failing to guarantee the full measure of individual autonomy and dignity demanded by modern biomedical and data‐driven contexts. Reclassifying informed consent as an autonomous human right would do more than add another layer of regulation. It would recalibrate the hierarchy of obligations, place the burden of justification on those who would limit consent, and provide courts and policymakers with a clearer normative compass. Therefore, such a reconceptualization is indispensable to transitioning from a patchwork of protections to a coherent, rights‐based framework capable of safeguarding individuals in an era of rapidly evolving technological and clinical interventions.

Informed consent is a human right recognized in the jurisprudence of the Inter‐American human rights system, which protects the autonomy and dignity of individuals in relation to their health and body. The protection of this right is essential to guarantee the quality of medical care and respect for human rights in all circumstances.

The recognition of informed consent as a right has been strengthened by the changing physician–patient relationship of recent decades. Overcoming the paternalistic model towards informative, interpretive and deliberative models has strengthened this vision of a rights‐based approach in relation to the right to health and access to health services. The informative model focuses on the quality and quantity of information provided by the healthcare professional for the patient to make decisions. The interpretive model focuses on determining the patient's values and what he or she really wants. Finally, the deliberative model seeks a dialogue between physician and patient to define the values to be adopted in a given clinical situation [32].

These new models allow patients to make informed decisions about their health and are strengthened by patients' rights recognized in national regulations. The recognition of patients' autonomy as active subjects in the doctor‐patient relationship allows them to identify themselves with conceptual categories such as health system user, medical consumer, health services consumer, health consumer or pharmaceutical consumer.

The Inter‐American system, unlike the European human rights system, does not have a legal instrument that recognizes the right to informed consent. As a consequence, the judgments of the Court have extended the interpretation of the right to information, the right to integrity, the recognition of juridical personality and the right to liberties to configure this right to informed consent.

To understand the elements of this right, it is necessary to resort to soft law standards on the subject. Some of these standards are specific to the field of biomedical research. The Inter‐American Human Rights System should move towards the recognition of the right to informed consent, as proposed by the European Human Rights System, both in the clinical setting and in biomedical research. In this sense, an instrument similar to the European Convention on Biomedicine and Human Rights would represent a step forward in this area for the Inter‐American system.

Therefore, the normative recognition of informed consent as a self‐standing human right, rather than solely as an ethical principle or a right derived implicitly from others. The analysis of the Inter‐American Human Rights System (IAHRS) jurisprudence strongly supports this claim. While the IAHRS currently lacks a single legal instrument explicitly recognizing informed consent as a distinct right, unlike the European system, the case law of the Inter‐American Court demonstrates a clear evolution. Cases such as I.V. v. Bolivia and Guachalá Chimbo and others v. Ecuador, among others, illustrate how the Court has increasingly interpreted informed consent, initially often linked to rights like health or integrity, through the lens of autonomy and self‐determination. This jurisprudential trend, alongside the Court's reliance on international standards and expert pronouncements, indicates a movement towards understanding informed consent as fundamental per se to protecting individual dignity and control over one's body and health decisions. The broader implication of this recognition is significant: elevating informed consent to a self‐standing human right provides a more robust legal basis for challenging violations beyond the confines of medical liability, reinforcing patient autonomy as a core human right principle, and underscoring the necessity for explicit legal frameworks, ideally through a dedicated instrument within the IAHRS, to ensure its comprehensive protection in both clinical and research contexts.

Conflicts of Interest

The authors declare no conflicts of interest.