1. Informed consent in persons with disabilities

The term informed consent has evolved to highlight its ethical and legal aspects, giving fullness in the daily medical practice to the quality with which medical information is given and received.

Informed consent is the classic institution of health law ⁽¹⁾ which is defined as the commitment of the physician and his/her patient to establish a communicative space in order to inform, orally or in writing, the nature, the purposes, the form of application of medicine, the benefits, the risks, the alternatives, and the means of the process. So that the person receiving care can decide and give clear, competent, and voluntary authorization ⁽²⁾, which implies considering the person as a rational moral subject ⁽³⁾, and this process as the tangible expression of autonomy in the areas of medical care and health research ⁽⁴⁾.

When we place ourselves in these health-illness contexts, care for people with disabilities is inherent. The World Health Organization ⁽⁵⁾ estimates that more than one billion people-about 15% of the world’s population-have a disability. In our country, the National Survey of Demographic Dynamics (ENADID) ⁽⁶⁾ in 2014 determined a prevalence of 6%, estimating that there are 7.2 million people with disabilities and 15.9 million people with mild or moderate difficulties in carrying out basic activities, who may present a disability condition in the future. Subject to general, family or specialized medical care, health personnel are in frequent contact with people with disabilities, whether or not this may be the reason for the consultation or the procedure leading to consent.

A change of paradigm has been generated in the field of disability. Indeed, the Convention on the Rights of Persons with Disabilities, an international treaty signed in 2006 by the United Nations General Assembly as a global legal recognition that consolidates previous regulations, defines it as the interaction between persons with impairments and barriers. This due to attitude and environment, which prevent their full and effective participation in society, on an equal basis with others. In Mexico, this treaty and its Optional Protocol were ratified in 2007 ⁽⁷⁾.

From that moment on, the norms relating to human rights are interpreted in conformity with the Constitution and international treaties on the subject, favoring the broadest protection of persons at any time and under any circumstance ⁽⁸⁾. Thus, every treaty that Mexico ratifies in the area of human rights has constitutional rank.

The right to health protection, as set forth in Article 4 of the Constitution and Article 25 of the Convention, emphasizes the active and responsible participation of individuals in health decision making, with prior information, which must be accessible in order to overcome barriers to seeing, hearing or understanding, which would call into question the validity of the informed consent process.

This article develops some bioethical reflections in order to empower persons with disabilities to make decisions about their health.

2. Bioethical aspects of the informed consent process in persons with disabilities

Bioethics, as a reflexive and normative discipline, deals with human acts that influence vital processes ⁽⁹⁾. In this case, the ethical weighting given to informed consent will reflect the quality of the doctor-patient relationship, which is also immersed in its own legal framework.

We will address the principle, personalist and human rights perspective, which coincide on a common point regarding consent: the recognition of the dignity and autonomy of persons.

3. Reflections to promote the competence of people with disabilities

Human decision making requires the integration of cognitive, emotional and motivational information; rationality alone is not enough ⁽¹⁸⁾. We should question whether in the process of informed consent we limit ourselves to providing cognitive information, or whether we take into account the emotional and motivational reasons that influence people’s choices, in order to favor freer decisions.

Autonomy, as the power to make decisions about one’s own life by assuming responsibility for them ⁽¹⁹⁾, implies being competent to make decisions as a central element. In the framework of the

Convention, it is analyzed from the perspective of the meaning of support, since there is a relationship of immediacy between one concept and the other ⁽²⁰⁾.

The role of health personnel, far from classifying the decision making of the person with a disability as right or wrong, is to provide assistance or support so that they can develop their own process of determining what they want and what they do not want regarding of their health. It should be remembered that the cognitive (scientific knowledge), emotional and motivational component of the health personnel is also present in the health relationship, and they should not coerce, manipulate or persuade patients or participants in research studies.

Beauchamp and Childress refer to competence as the ability to carry out a task, and its function is to differentiate those who can decide ⁽¹¹⁾ from those who have limitations to do so in a given situation. Arenas et al. ⁽¹⁸⁾ delve into competence as a threshold concept determined by four components: 1) the ability to understand and remember information; 2) the ability to manipulate information critically; 3) freedom of choice; and 4) the ability to express oneself.

The evaluation of competence is complex in people with or without deficiencies, because even in cases of cognitive impairment the competence to choose may or may not be affected. This would require an ad hoc assessment that should focus on the decision-making process (understanding the information, its implications, deciding and communicating the decision), and not only on the choice ⁽¹⁸⁾.

The analysis of competence in persons with disabilities can be specified in terms of functional ability with respect to the four points previously cited by Arenas et al., using the International Classification of Functioning, Disability and Health (ICF) proposed by the WHO in 2001 as a multidimensional, person-centered approach.

The ICF is applied to people with and without disabilities to visualize their biological circumstances in relation to their social and environmental environment ⁽²¹⁾, through an alphanumeric catalog that graduates the areas involved, and identifies the needs and adjustments that the person requires, enhancing facilitating elements and reducing barriers.

On the other hand, regarding the competence to decide, Bórquez et al. ⁽³⁾ point out a continuum between two extreme points: full capacity and total incapacity. The social and human rights model, affirms that disability can coexist with the full autonomy of the person. It is worth noting that «no one makes fully autonomous decisions, since other components of the environment weigh in, such as fear, insecurity, and the existential circumstance» ⁽²²⁾, the trust or uncertainty instilled by those who explain consent, beliefs, and the opinion of family and friends, among others. Thus, assistance, adjustments or support for decision-making in health aim to favor the greater autonomy of which the subject is capable.

Health professionals and researchers often rely on their clinical judgment and intuition ⁽¹⁸⁾ to determine the competence of individuals, in order to contend with medical information and make decisions; in the face of this subjectivity, prudence must be exercised.

In some cases, the treating physician consults when he or she has doubts about the competence of the patient or user for self determination. The problem is that in these cases, a mental health diagnosis is usually made, which is not exactly equivalent to a judgment regarding the ability to participate in the health-disease process ⁽³⁾.

Assessment of ability with cognitive tests may serve as a guide, but they are not adequate predictors of competence, and «no diagnosis or clinical judgment of disability should be made on the basis of the results of such tests» ⁽²³⁾.

Since 1994, White ⁽¹⁸⁾ has proposed instruments to assess cognitive and affective abilities, the ability to make choices, and the ability to understand.¹ Subsequently, some proposals have emerged to evaluate the capacity to consent, such as the MacArthur Competence Assessment Tool for Clinical Research, The California Scale of Appreciation, the Sitges Document^{2 (23)} and the Deaconess Informed Consent Comprehension Test ^{3 (18)}, which would have to be adapted and validated in Mexico.

Other aspects of optimizing the informed consent process in people with disabilities are: 1) unlink physical dependence from moral dependence; 2) proportionality, 3) voluntariness, and 4) non consent.

Regarding dependency, identified as the need for help from another person to carry out activities of daily living or instrumented activities, the idea that they also depend on the primary caregiver or other people to make daily decisions, decide on treatment, must be dissociated or participate in an investigation.

Proportionality refers to the degree of competence required according to the complexity of the decision. Abellán ⁽²²⁾ states that it is directly proportional to the level of risk associated with the decision, according to a sliding scale for capacity.

Muñoz et al. ⁽²³⁾ propose standards of competence according to the proposed task related to the context. For example, a person may be competent to decide on treatment or participate in research, but not in managing his or her finances. To do this, they summarize a profile of support needs, according to the assessment of five dimensions: intellectual skills, adaptive behavior, participation, health, and environmental and cultural context. It is similar to the scale of intensity of support (SIS) proposed by Verdugo et al. ⁽²⁴⁾, which measures frequency, time and type of support in people with intellectual and developmental disabilities.

The voluntary nature of the act in these support models is to ensure that the facilitator, assistant or human support does not coerce or influence people’s decisions to accept any medical procedure or participate in any research. The yes of the patient must manifest his or her free acceptance of the proposed procedure and «should even express his or her intention to collaborate and, why not say so, to take joint responsibility» ⁽²⁾.

Despite optimizing the previous parameters, it is necessary to remember that this process also implies that the person does not consent ⁽²⁵⁾. That is, once the proper support and adjustments have been received, persons with disabilities have the right to refuse procedures or to participate in protocols, and this should be recorded in the medical record with date, scope, and details of the informed risks. This revocation must be made in writing and does not prevent the verbal form, effective because of its immediacy in manifesting the patient’s will ⁽²⁰⁾.

4. Another challenge: the legal capacity of people with disabilities

An added challenge to clinical assessment of competence is to harmonize the term legal capacity, since it is capacity, not incapacity, which is universally presumed ⁽²⁴⁾.

Pablo Simón prefers to use the term competence for decision making in the health field. This to differentiate it expressly from the term «capacity to act in fact» and «capacity to act in law», according to Bórquez et al. ⁽³⁾. In the English-speaking literature, legal or de jure capacity refers to the term competence; in contrast, capacity as such is related to natural or de facto capacity.

Muñoz et al. ⁽²³⁾ define it more clearly, stating that the de facto or natural capacity determines the legal capacity, in line with previous bioethical reflections.

In some countries, civil law distinguishes between capacity for enjoyment, such as the legal ability of individuals to acquire rights and obligations. Capacity for exercise, such as the ability of individuals to act on their own behalf ⁽³⁾. In the area of disability, the Convention constantly advocates for such capacity for enjoyment, and it is up to the health team, to provide the facilitators and avoid physical and attitudinal barriers, to enhance exercise capacity through adjustments or supports.

In Mexico, various legal forms do not necessarily equal incompetence to make health decisions for a person with a disability (especially intellectual or psychosocial). For example, a ruling of invalidity or permanent disability according to the Federal Labor Law or the Social Security Law; a certificate of disability or a declaration of mental incapacity, which also do not equal a court sentence of interdiction.

Muñoz et al. ⁽²³⁾ take up the consideration of the insane, the prepubescents and the deaf-mute who cannot make themselves understood in writing as absolutely incapable. However, in light of the Convention and the support models, it is essential to expand the communication alternatives that enhance the capacity to receive, understand and weigh health information, with the corresponding use of the current nomenclature regarding organic or functional deficiencies, according to the ICF.

The greatest challenge in assisting and supporting a person with a disability is to develop his or her own decision-making process, collaborating even with the reasoning process ⁽²⁰⁾, thus replacing the representative figure with the personal assistant.

According to the magnitude of the decision and to safeguard the autonomy-beneficence binomial in people who, despite adjustments and/or support, have difficulty understanding medical information and deciding for themselves, the need for consent by substitution or representation arises. This must be explained both to the person with a disability -if he or she has a certain degree of receptive and communicative capacity- and to his or her responsible family member, guardian or legal representative, who will sign the document if he or she accepts the medical or research procedure.

The objective in these cases is to avoid that people with difficulty in making certain decisions run risks that they are not assuming from their personal freedom. On the other hand, to avoid the temptation of overprotection, paternalism, the board of directors ⁽²²⁾ and the rush to comply with consent as a requirement, and not as the process that has been emphasized.

This substitution of the will of the legally incapable person for that of a representative must reflect the best interest of the represented person, always considering a criterion of gradualness of legal capacity and its permanent judicial review ⁽¹⁸⁾.

So, would consent by substitution have a defined validity in a succession of medical procedures in the medium and long term? According to Article 12, paragraph 4 of the Convention, each case must be evaluated according to the functional prognosis and be recorded in the clinical or research file. Providing for an approximate period of time for legal substitution, since disability is an evolving concept and representation may not be necessary for subsequent acts.

On the other hand, if the spouse, partner, relative or close relative accompanying the patient manifests an unjustified refusal, conflicting decisions or multiple criteria, as a measure of last resort, judicial intervention is required. Galán Cortés, emphasizes that it is necessary to limit the powers of third parties to intervene, to avoid that a third party, against the will of the owner, decides for him what risks he has to assume or which assets he has to renounce. Thus, it could be said that expropriating such a very personal decision would amount to the ‘reification’ of man, according to Sorgi et al. ⁽²⁰⁾.

Finally, in emergencies with a certain and imminent risk of a serious evil to the life or health of persons with disabilities, advance medical directives are of importance. It is necessary to inquire whether they expressed or designated the person or persons who are to express consent, and who do not decide in the patient’s place, but rather communicate their will or best interest. In the absence of family members or representatives, the physician may dispense with consent ⁽²⁰⁾.

5. Conclusions

Both the concept of disability and that of validly informed consent have undergone paradigm changes, and seek to respond to the ethical and legal needs of a growing population, under the binding force of constitutional rank offered by the Convention.

The doctor-patient relationship is the space par excellence, where this process favors decision-making in health, enhancing the autonomy of people as the tip of an iceberg that reveals complex processes for determining the competence to exercise their legal capacity. Also discovering other topics that can violate their living conditions, such as the management of their own or inherited material resources, access to financing and the possibility of leading an independent life, among others.

Facilitate the capacity of exercise through the implementation of assistance, adjustments or support that replace the figure of legal representation, promotes an effective capacity of enjoyment through a functional assessment of the hand of the CIF, as an element of synergy between managers and health providers who serve people with disabilities, making tangible other bioethical and human rights principles such as non-discrimination, charity and justice, as well as sociality and subsidiarity.