Informed consent : a strategy to mitigate vulnerability in hospital care

This text aims at identifying vulnerability as an inherent characteristic of human beings and introducing informed consent as a strategy to minimize it in the context of hospital care. Subjects who experience hospitalization are enclosed in an unknown environment upon which they have no control or knowledge. In addition, they are subordinate to the physician, who possesses the power to determine therapeutic conducts that may compromise their existence and life goals. As a result, their degree of vulnerability is increased. Vulnerability can be reduced through the informed consent that prioritizes information, understanding, possibility of deliberation and respects the patient’s self-determination in the choice of the proposed treatment. Thus, the application of the informed consent process can reduce the patient’s vulnerability pattern in a hospital environment.


Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163 Vulnerability is an inherent condition for every living being, since biological life is subject to a constant risk of destruction.However, human beings have more than their biological attributes jeopardized, because the social construction of human life, as well as its existential project, adds another dimension to vulnerability.In this sense, the anthropological character of vulnerability arises, to the extent that the individual recognizes her/himself as vulnerable and understands that she/he shares this condition with others.Human beings who make life projects and choose the way to conduct existence are also vulnerable to having their choices affected by social and political tensions characteristic of life in society.
It may be said that all living beings are vulnerable, that is, they are under risk and jeopardy.If this risk is materialized, if the survival, existence or life projects are affected, the living being moves from the situation of vulnerable to the condition of violated, having somehow suffered aggression.According to Schramm, it seems reasonable to consider it correct to distinguish the mere vulnerability from the actual "vulneration", seeing the former as mere potentiality and the latter as a 'de facto' situation, as this has relevant consequences at the moment of decision-making 1 .
Hospitalized patients who face a need to undergo surgical procedures may be considered vulnerable in this particular situation.This is due to multiple factors such as the disease itself, lack of information about their health and treatment options and lack of management over their own bodies and minds.Moreover, the possibility of being considered incapable of making decisions regarding to their own lives and receiving treatment that may go against their life projects exacerbates the situation of vulnerability.
The individual hospitalized for surgery is outside of his/her social and cultural environment, away from her/his social network that inspires confidence and security.In addition, the lack of knowledge may compromise their ability to express opinions about their treatment.In addition to these factors, the patient is under the care of professionals who do not know her/his history, experiences, wishes and life projects.These aspects cause fear, anxiety, and conflict in decision making.Disinformation increases the degree of uncertainty and may compromise the quality of care.
Understanding this, Rothrock 2 and Smeltzer et al 3 present proposals of nursing care focused on information to minimize these emotional situations which, according to them, are real and are related to the surgical assistance.These authors understand that the access to information prepares the patient to face his/her fears and decreases their fragilities in the context of the assistance.Thus, the process of informed consent may mitigate the situation of vulnerability related to hospitalization.This is because it is centered on the provision of understandable information which allow for the the choice by the patient about the treatment being offered.
It is noteworthy that such information must be provided in the context of the patient -health professional relationship.The purpose of the informed consent is to ensure respect for autonomy by providing information relevant to the procedure -such as benefits, risks, consequences and therapeutic alternatives.The ideal informed consent is pointed out by authors such as Muñoz and Fortes 4 , Lepine et al 5 , Fernandes and Pithan 6 , and Lorda and Judez 7 , among others, as a deliberation process involving the individual who needs to undergo the therapeutic procedures and/or diagnoses and the health professional responsible for implementing them.As a deliberative process, it implies the exchange of precise, objective and clear information, indispensable for decision making in awareness of the benefits, risks, therapeutic alternatives and consequences of the actions being proposed.
Goldim 8 refers to informed consent as a characteristic element of the medical practice, being the moral right of patients and not just legal doctrine.According to the author, it should be composed basically of three elements, which demand attributes of both professionals and patients involved: the patient's ability to act intentionally; the provision of adequate information, in addition to their understanding and consent.These elements relate to the conditions necessary for the intended consent to be considered valid.
The ability to consent is related to the provision of relevant information by the practitioner, covering the explanation about the risks, benefits, therapeutic alternatives and consequences, and depends on the patient's adequate understanding of this information.Their willingness to accept the proposal must be preserved and, at the end of the process, a reasoned decision, summarized in the act of consenting, is expected.Compliance with these steps contributes to giving informed consent the ethical, moral and legal validity required for health care 8 .

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163 Obtaining informed consent is therefore a strategy that gives subsidies to the individual who needs health care so that he can exercise his autonomy, effectively participating in decisions about activities that interfere in the course of his existence.In this respect, understanding information, which is one of the main components of the informed consent process, is vital.According to Leite, the empowerment of the individual through information plays a fundamental role in the process of self-transformation of the person, insofar as it provides an environment of change in order to offer the individuals involved a certain autonomy 9 .
Thus, in this study we try to reflect on the existence of vulnerability of adult and capable patients, whose health is compromised, hospitalized in a public hospital and requiring surgical care, in the context of the physician-patient relationship.Likewise, the interference of the informed consent process is considered in the vulnerability pattern of these individuals.

On vulnerability
For Hossne 10 , the perception and awareness of the condition of vulnerability are capable of producing a sense of anguish in the human being in the face of threats to the projects of life she/he has made.The perception of vulnerability and the awareness of the need to defend themselves have led to the creation of protection strategies configured in social conventions, laws and standards of conduct.We are vulnerable even to the attacks of our own kind, which, therefore, motivated the elaboration of an ethical framework in order to protect the human social construction: ethics is imposed, among other reasons, because there is vulnerability 11 .
Kottow 12 argues that there are three levels of human vulnerability.Two are related to the maintenance of biological life (and would be the vital vulnerability and the subsistence vulnerability).The third, which he calls "existential vulnerability," is related to the mishaps and conditions that may compromise or jeopardize the continuity of life projects inherent to most human beings.The author refers to the establishment and respect for basic human rights as a way to mitigate what he calls "fundamental human vulnerability", so that in a fair society such rights are guaranteed equally for all members 12 .This claim leads us to the belief that the conception of human rights is directly related to the recognition of the fact that vulnerability is constitutive of the human being and that, in the face of it, mechanisms are necessary that safeguard the integrity of the dignified existence and life projects of individuals.It is important to note that there is a significant difference between being permanently vulnerable, being temporarily vulnerable and the condition of having been vulnerated.All who have biological life are vulnerable -or, with regard to human beings, a life project -and who are susceptible to weather or other eventualities.
The difference between being permanently vulnerable and being temporarily vulnerable concerns the context in question, especially when the focus is social vulnerability -inherent to the human being and other animals who live in social groups.Thus, certain environments or states may amplify or lower the pattern of vulnerability.For example, a man who leads a company if probably not in a state of vulnerability in relation to the physician who works in the same company.However, if this same man finds himself ill and seeks medical care, he will be in a situation of vulnerability, given the asymmetry in the relationship between physicians and patients 13,14 .On the other hand, the condition of having been vulnerated concerns the individual who has suffered damage and, due to this, in the context of human vulnerability, has had his/her life project compromised 1 .
Luna 15 clarifies that, although biological vulnerability is an inherent condition of the living, it is not the same when it comes to human vulnerability.This is because there are situations that can increase the vulnerability of certain individuals, while others are not affected.The author develops the concept of "layers of vulnerability" to explain that there are social contexts and characteristics of the person which, when overlapped, increase the vulnerability of certain individuals in a specific social context.Thus, vulnerability is not a watertight attribute that can be attributed to someone, but a circumstance that must be analyzed in the context in which it occurs.According to the author: This concept of vulnerability is closely related to the circumstances, to the the situation being analyzed and to the context.It is not a category, a label or a tag that we can apply.Another way to understand this proposal, which assumes the idea that someone is vulnerable, is to consider that a specific situation can make someone vulnerable. 16.

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163medium, and arises from the imbalance in this relationship.This dynamic and relational characteristic pointed out by Luna 15 and Oviedo and Czeresnia 17 allows for the inference that if the conditions of the environment present risks to the survival demand of the living being, the consequence will be the expansion of its fragility.This broad construction serves both to make considerations about biological life and the peculiarities of social life.In this case, the living being, here understood as a human being, will need care and/or protection strategies that will reduce their fragility and, consequently, bring them closer to an existence free of damage: Fragility of the existential or social order refer both to the aspects that put in question the certainties about the course of everyday life (the critical trajectories of a patient, for example) and to the social interrelations that limit the potential of the individual.Institutional designs and forms of social organization that impede the present and future assurance of existence and social affiliation also limit the exercise of power and sustain situations of vulnerability 18 .
According to this, we can understand that institutional structures whose actions are capable of affecting the fundamental rights of individuals -such as autonomy, dignity and corporal integrity -can also confer or amplify individual vulnerability.This occurs if such actions are not conducted with the necessary care and respect for the existential projects of the assisted, subjecting them to a possible risk situation.It should be noted that vulnerability is not synonymous with risk; instead it represents the susceptibility to the risk presented 19 .Bertolozzi et al 20 state that vulnerability is determined by cognitive conditions 21 , and, thus, the access to information may interfere in its pattern.
For the authors, measures that contribute to the effective participation of the subject in the health-disease process -such as the provision of pertinent information, for example -can mitigate the patient's vulnerability pattern 20 .Thus, ensuring the patient access to relevant information about the treatment, clarifying the doubts inherent to the context in which she/he is, can reduce his/her vulnerability pattern.This provides subsidies that allow patients to consciously participate in the decision-making process on the therapy that will be instituted, which will have implications for the course of their existence.

Consequences of the recognition of vulnerability
It is important to emphasize that if, on the one hand, receiving the designation of vulnerable can guarantee the achievement of rights, on the other hand it can also contribute to the emergence or strengthening of social discrimination, placing the individual in a situation of greater fragility and helplessness 17 .Recognizing the subjects' vulnerability means highlighting their fragilities and setting goals to overcome them, ensuring that these subjects can continue their life projects under similar conditions of opportunity to those of others within a given society.It should be emphasized that the recognition of fundamental human rights and the construction of an ethical framework for them contributed to the identification and treatment of fragilities and thus the vulnerability of groups and/ or individuals could be mitigated 17 .
However, in order to reach this level, it is necessary that human rights be recognized in their universal indissociable principles, thus allowing members of a fair society to enjoy the same possibilities of existence and fulfillment of their life projects.It is clear that civil and political rights can only be fully exercised in the exercise of social, economic and cultural rights and vice versa.In all walks of life, rights intertwine being interdependent and indispensable for the viability and attainment of each other and, therefore, change the pattern of vulnerabilities.In this sense, recognizing vulnerabilities is to mitigate differences in opportunities so that everyone has real possibility of success 10,22 .
It is important to say that the recognition of vulnerabilities of certain groups can erroneously serve to stigmatize them and to separate them from the proper conviviality in the social setting to which they belong.This occurs when evidence of fragility, rather than guaranteeing protection, generates discrimination and social exclusion, as observed in studies on Aids 19 .It should be noted that the concept of vulnerability gained strength and visibility in the area of Brazilian public health with the advent of AIDS, by the association of the way of disseminating the disease to the concept of risk.
Classifying certain individuals as members of risk groups allowed for the occurrence of disturbing situations that bring segregation and prejudice in relation to HIV positive people.In addition, the establishment of vulnerable populations in this context led individuals not classified as "at risk"

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163 to the consequent exposure to the danger of contamination 19,23 .In the view of Luna's 15 , the concept of vulnerability should not only serve to classify individuals by giving them a permanent label.Rather, it should serve to indicate that in any given situation there is a need for a sensitive look to provide some protection and greater consideration to those involved.
Exposing vulnerabilities that make the enjoyment of fundamental rights difficult or impossible leads to the construction of strategies of action that can contribute to social equity.Identifying socially vulnerable subjects should aim a offering them conditions to overcome their vulnerabilities and, from this, to promote their effective participation in society, in a dignified and independent way, in the full exercise of citizenship.

The role of education
To successfully achieve the proposition previously presented, education is pointed out as essential.Formal and informal education that prioritizes respect for human rights, through the construction of values such as respect for others, nature and the norms that govern society in general.An attitude of citizenship is necessary for the emancipation of human rights 24 .Another model of education pointed out as capable of empowering subjects, allowing them to emancipate, is the one that happens as a cultural action for liberation.This model gives subsidies for the subjects to understand the social and political determinants of their vulnerabilities, and enables them to elaborate the necessary responses for human emancipation 25 .Baquero clarifies: 26 .

Empowerment, as a category, pervades the notions of democracy, human rights and participation, but is not limited to these. It is more than working at a conceptual level, it involves acting, implying processes of reflection on this action, aiming at an awareness of factors of different orders -economic, political and cultural -that conform reality, focusing on the subject. In this sense, an effective empowerment process needs to involve both individual and collective dimensions
The quest for psychosocial emancipation is also pointed out by Paiva 27 as a fundamental path for the formation of subjects aware of their citizenship and to guarantee them access to social rights as good assistance services.For the author, the perspective of the individual citizen is that of someone capable of recognizing their rights and responsibilities, capable of acting to achieve their rights and to demand the creation of new ones.Finally, a subject politically and socially engaged in the constant tension that is to achieve rights and keep them in the dynamics of unequal societies in opportunities and distribution of resources 27 .The ways to arrive at this subject are conditioned to the creation of strategies like facilitation of the means of access, investment in the empowerment of the individual to exercise citizenship, promotion of liberating education and reduction of social inequalities.
It should be stressed that access to education is crucial in this process, but the educational project must value, integrate and respect the values of the subjects in the construction of knowledge, so that they can get out of the situation of being excluded and vulnerable 27 .Enabling the access to, and the understanding of, the context of hospital care in which the patient is inserted is a way of providing the person with subsidies to exercise one's autonomy and to take control of one's health and existence.In this sense, the process of informed consent constitutes an important element to provide the individual with conditions to participate in decisions about the maintenance of his health.

Informed consent and vulnerability
It is important to consider that the vulnerability referred here is the one made evident by adverse social conditions which directly limit and affect the potential of action of individuals (…), making it impossible to ensure the present and future of existence (…), limit the exercise of power (…) [and, thus,] support situations of vulnerability.It is the existential and social vulnerability that leads to the impossibility of affirmation and exercise of freedom and relative autonomy 18 : Vulnerability in the social dimension refers to the existence of relationships that limit people's ability to act and withdraw the institutional support of social security, that is, situations that deny the effective exercise of rights and, therefore, present insecurity and evanescence of future projects 28 .
The biomedical model prevalent in health institutions is an example of the situation described, because it favors technology and focuses on the biological character of diseases.This contributes to the devaluation of the patient's experience and subjectivity, minimizing the importance of the role

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163 of the personal relationship between the subjects involved.It also leads to the strengthening of the asymmetry in the relationship between physicians and patients, in which the professional assumes a dominant role, since it has both the power of information and knowledge and the determination of what is going to be performed.This sublimates the action capacity of the individual under their care, leaving to the patients only the passive role of submitting themselves 14 .
Quoted by Ayres et al 23 , Gorovitz describes the indissociable qualities of vulnerability: multidimension, gradient and instability.The author concludes that people are not intrinsically vulnerable, they are always vulnerable to something, to some degree and form, and in a certain point in time and space 29 .Adding this to the reference that those authors 23 and Luna 15 make to the relational character of vulnerability, it is possible to attribute it to the individual who demands medical care in a hospital.Since in the Western conception of human rights the principle of human dignity is the central focus, it is possible to attribute vulnerability to subjects who are in a lower position in a relationship of domination.
In this type of relationship, the dominator is one who has the power to supplant the right of the other, either through effective actions or denial of rights, as the participation in matters that concern the existence worthy of the dominated in the context under consideration.For Figueiredo and Noronha 30 , when analyzing the process of determining human rights, two groups are always identified to be in conflict: the strongest and the weakest.When the dominators win, one speaks of hegemony, and when the weakest ones win, by virtue of their resistance, one speaks of human rights.In this sense, it is considered as vulnerable the one who has somehow supplanted or evaded one's own rights 30 : Thus, vulnerability in this model is given by the position that the person or group occupies in a given society: by the relation between the existence of special needs and the recognition of these situations by the state (considering that, in these societies, it is also the role of the state to ensure rights).Thus, this model allows us to analyze different groups through interpretative keys that make them symmetrical but not equal 31 .
It is a fact that the hospital context is not the domain of the patient.There, the patient is biologically and socially fragile, away from social and family life because of a health situation that imposes physical, labor and social constraints on him/her, factors associated with her/his lack of knowledge about her/his own health situation and treatment create a feeling of disability.The very biomedical language, impregnated with specific jargon and scientific terminology, makes it difficult to fully grasp the aspects related to one's state of health.In addition, and often because of this, the asymmetry in the physician-patient relationship is notorious.
The two social actors who participate in this "conversation" speak distinct languages, an aspect often not valued by the one to whom it is possible to bring these languages closer together -the professional.One might say that this asymmetry is even expected.But what can not be admitted in the context of this relationship is that the physician uses this asymmetry to supplant the individual's freedom of decision over her/his own body, disregarding her/ his life plans with a mode of action that eliminates the patient's autonomy and ignores his/her ability to act.For Goldim 32 , not to respect a person's autonomy is to violate the person's fundamental right to self-determination, is to go against the principle of respect for the person who forms the basis of the principle of bioethics, which seeks to guide ethical conduct in the relations between professionals and patients.
For Beauchamp and Childress 33 , it is fundamental for autonomy that the person be free of controlling influences, as well as limiting factors that hinder their deliberation.It is worth remembering that respect for autonomy in the context of health care is represented by the need to obtain informed consent of the patient in relation to therapeutic, surgical and examination procedures, situations in which manipulation and the invasion of the physical body occur 33 .However, simply obtaining a document of consent does not guarantee that the subject has been respected and/or has had his/her fragilities considered in the context of the agenda.
In order to effectively represent consideration of the patient's vulnerability, as well as evidence of respect for autonomy, it is mandatory that informed consent be obtained following a procedure that prioritizes information, understanding and the lack of coercion on the one who consents.If informed consent was given under the observance of these aspects, it can be said that autonomy has been respected, that the individual's vulnerability pattern in that context was mitigated.Reducing the patient's vulnerability pattern occurs because all relevant information has been given to him/her, ensuring his understanding of the benefits, risks, therapeutic alternatives and consequences of the

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163proposed intervention.Based on this content, it will be possible for him/her to understand and decide on the best course of action to follow in the context of his assistance.
Regarding the issue of information, Leite emphasizes that -when appropriate, that is, when it prioritizes understanding -it gives the patient the possibility to move from the role of mere receiver to the category of central actor of the process of appropriation 9 , allowing the patient to be and active participant.This allows us to infer that when the patient receives pertinent and adequate information about his/her condition and the existing treatment options, her/his vulnerability pattern in the context of hospitalization is reduced.According to Schramm 34 , the quality of information raises important concerns in the field of bioethics, as information is the part of the message that is possibly subject to manipulation and, as such, may be involved in conflicts of interest and/or structures of power and domination of some humans over others.
Care should therefore be taken to ensure that the information on the issue of consent is not coercive or manipulative.The author also emphasizes that access to free and comprehensive information is vital in the context of care, since it should aim at giving subsidies to the individual so that one can protect oneself from abuses or actions that jeopardize one's free action 34 .However, it should be pointed out that, just as attention to the quality of information and its adequate understanding are necessary, patient voluntariness must also be respected.The informed consent only reduces the individual's vulnerability pattern when it is obtained free of coercive influences, without the use of persuasion or manipulation by the professional.
According to Lorda and Concheiro 35 , the consent obtained without the patient acting voluntarily is neither ethical nor legally acceptable.The authors emphasize that in the physician-patient relationship, the professional has greater power, and this allows him/her to act persuasively when he/she does not present alternatives for the therapeutic proposal she/he offers.It also enables she/he to act coercively when, in providing the information, she/he makes implicit or explicit threats to patient deliberations that do not comply with the proposal offered.The deliberate manipulation of information, given in order to make the patient believe that the best alternative is the one being offered, also compromises the quality of the consent obtained.For the authors, in all these cases the patient's voluntariness is annulled, and the consent ceases to represent the expression of autonomous choice 35 .
According to Beauchamp and Childress 33 , as well as Ferrer and Álvarez 36 , most theories that postulate autonomy agree that there are two essential conditions for an action to be autonomous: external freedom -no coercive or controlling forces -and agency -or internal freedom, which is the ability to act intentionally.However, it should be emphasized that being autonomous does not mean that the individual is respected as an autonomous agent, since this attribution is conditioned to the recognition of the right of the person to have their opinions, to make their own choices and to act based on values and personal beliefs 37 .
For people inserted in the hospital context, with such different peculiarities from the social reality that they experience, the explanation of intersubjective autonomy defended by Schumacher et al 38 seems interesting.In this modality, the subject, despite his/her fragilities, has her/his peculiarities recognized and perceives him/herself respected and integrated to the deliberation of the actions that relate to her/his own life and particular interests.It should be emphasized that care actions that restrict or impede the participation of the subject -through the denial of pertinent information and/or considering that she/he is incapable of apprehending elements that would enable him/her to deliberate on the best options for the recovery of its health -eliminate the possibility of exercising any type of autonomy.This is because their self-respect, elfconfidence and self-esteem are directly violated, causing them to perceive themselves as incapable of deciding and taking for themselves the course of their existence.Thus, these decisions are taken entirely by the one who supposedly holds power over their existence in the hospital environment, who is the master of the knowledge inaccessible to the patient, the physician 38 .In this context, obtaining informed consent according to the procedural mode advocated by mainstream bioethics can minimize the subject's vulnerability.This is because the provision of pertinent and accessible information to their understanding empowers them and enables them to participate effectively in their care, respecting their agency, preparation and deliberation capacities.
The act of consent thus refers to the attitude of the patient.This attitude is grounded on reflection about the possibilities presented, the elaboration on the risks and consequences that the therapeutic proposal imposes, and the decision on what in their

Update
Informed consent: a strategy to mitigate vulnerability in hospital care http://dx.doi.org/10.1590/1983-80422017251163opinion is the best for their existence, considering the social and cultural context in which they are inserted.The information intended is one that is not limited to listing protocols.On the contrary, it expands when presenting and discussing with the subject the possibilities of conduct, respecting their cultural peculiarities and existential projects, in order to ensure that the act of consent is not the result of imposition or coercion.
The process of obtaining informed consent is indicative of respect for the patient's autonomy.The impediment of autonomy in the hospital context compromises the performance of the subject in determining which paths will be followed to recover their health.Thus, regardless of whether or not he or she has the right to have his/her autonomy respected, the patient will have her/his situation of vulnerability magnified in this context if he/she is prevented from participating in decisions that relate to the course of his/her life as a subject of therapeutic procedures.

Final considerations
The situation of disease and the need for hospitalization confers vulnerability to the individual to the extent that these generate feelings of fear and insecurity related to the continuity of one's own existence.This factor, associated to the component of disinformation about the consequences of the therapy and the procedures that will be instituted, can compromise the agency capacity of this subject, increasing their fragilities.On the other hand, the knowledge about the implications involved in the hospitalization context subsidizes and provides the individual with instruments, to make possible the deliberation process regarding the conduct of their treatment.Consequently, patients can act in some way to control their own existence, keeping their life projects viable.
The information component is an essential element in the informed consent process, which is not restricted to the provision of data, but covers the guarantee of adequate understanding by the individual so that the individual can decide on the best path for her/himself and her/his treatment.With this, we can say that the adequate process of obtaining informed consent contributes to overcome the range of fragilities that the patient experiences in hospital care.As a result, their vulnerability in this environment is reduced.This way, the informed consent process is an important element to change the pattern of vulnerability of individuals in a situation of hospitalization to undergo surgeries.It is necessary to emphasize, however, the need for this consent to be obtained following the established procedures, by providing information that provides relevant subsidies for the reflection and deliberation of the patient.Thus, the patient's autonomy will be respected in this context, and from this the patient will be able to consent (or not) to the procedures, thus configuring their effective participation in those events that obviously will interfere in their project of life and in their social construction.
Study developed within the "Programa de Pós-Graduação em Bioética, Ética Aplicada e Saúde Coletiva" (graduate program in bioethics, applied ethics and collective health) of the Universidade Federal do Rio de Janeiro (the Federal University of Rio de Janeiro).