Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law

Abstract

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

Resumen

La consolidación legislativa de los derechos del paciente introdujo modificaciones en la relación clínica y en la lex artis, pero su implantación progresa con dificultades en un entorno sanitario muy condicionado por la escasez de los recursos y la abundancia de las normas. Desde hace algunos años, la autonomía, el consentimiento y la responsabilidad forman uno de los ejes vertebradores de la profesión médica. Sin embargo, son objeto de controversia y causan malestar profesional. En la primera parte de este artículo examinamos las limitaciones conceptuales y normativas del principio de autonomía como fundamento del consentimiento informado, abordadas desde una perspectiva filosófica, histórico-jurídica, bioética, legal, deontológica y profesional. En la segunda parte analizamos la viabilidad del consentimiento informado en la medicina asistencial y su relación con la responsabilidad jurídica.

Introduction

In the first part of this article we examined the limitations of the principle of autonomy as the foundation of informed consent (IC). In second part we will approach the difficulties posed by getting IC in assistential medical care,¹ with specific references to radiodiagnosis. We will analyze the relation between IC with lex artis and juridical liability. We will describe the procedural significance of infringed autonomy by invalid consent. Finally, we will refer to the deficiencies that can undermine the legal validity of IC in lawsuits for professional or patrimonial liability.²

Informed consent in assistential medicine

Judicial-ethics and specialized training

Lack of judicial-ethics training provides confusion when it comes to the right to autonomy with the procedure ensuring it and with the document that certifies it.³ Even knowing the judicial-ethics stipulations, the physician usually focuses on the scientific-technical aspect, seeking new challenges and professional promotion. Perhaps that is why we tend to equate scientific excellence and professionalism. However, scientific excellence is not enough to characterize the good physician.⁴ On the other hand, the division of labor, inherent to specialized medicine, outlines the scope of professional duty and blurs the distribution of obligations.⁵ Perhaps this is why it is difficult to determine who should be informed and on what.⁶

A matter of logistics

The deliberative process of IC takes time, peace, space and furniture. The orthodox processing of IC is incompatible with an intensive exploitation of healthcare resources.⁷ However, IC can be expedited with structured interviews and audiovisual systems.⁸ This is why it is surprising to find out that there are very few provisions aimed at improving information and facilitating the decision. Although it is often thought that the physician does not know how or does not want to process the IC,⁹ perhaps the fact is that they do not have the means to do in a better way.

Communicative skills

Some physicians have difficulties disclosing the healthcare information in colloquial terms due to a lack of verbal skills, which is frequent in multicultural environments.¹⁰ On the other hand, translating the medical jargon into an accessible language requires empathy and motivation, without which it is not possible to evaluate the patient's understanding. In any case, there is indeed need for tools to estimate the patient's cognitive skills and specific training in communicative skills.¹¹

The sociology of risk

Society seeks security but it feels more and more insecure. The demand for protection increases the feeling of vulnerability and it in turn, greater demand. This concatenation suggests that the risk has a lot of social construct linked to the citizens’ own expectations.¹² In traditional medicine, the patient would accept all dangers. The IC however transforms the danger into risk, which is assumed by both physicians and patients.² The IC distributes risks and liabilities between both though it not always in a balanced way.

Amount of information

The amount of information the patient is given has great legal relevance. The basic regulatory law (BRL) that regulates the patients’ rights establishes that patients should be informed in a way that is adequate to their capacity for understanding, that they should be provided with all the information that they might need.¹³ Nevertheless, some physicians prefer to inform the patients about everything that may influence them, whether they need it or not.¹⁴ Having learned a lesson in lawmaking, the physician focuses on warning against the risks associated with the procedure offered. However, it is also important to fight unfounded beliefs and expectations.¹⁴ The physician tends to overestimate the amount of information revealed. The patient, in turn, usually needs data associated with their experience of the disease.¹⁵

Probabilistic information

Information about the serious and exceptional risks, which is both common and controversial, will be dealt with below from a radiological and lawmaking perspective. For now, let us just say that the explanation of low-probability risks is problematic. Although diagrams and comparisons with ordinary risks are useful, many physicians that are not used to handling probabilities do no manage to transmit intelligible notions, or else the patients do not manage to understand them.¹⁶

Form of eligibility

The form is useful because it contains the exact terms of the information disclosed. A form that is well written and properly personalized bears witness to the offer the physician makes and the patient accepts. That is why it has great documentary value. However, the effectiveness of the form as an informative means is scarce and hard to optimize. It tends to be technical, or comprehensive and hard to read. On the other hand, the form focuses more on the offer than on its alternative, often replacing verbal exchange.¹⁷

Emotional stress

Every patient, because they are undergoing emotional stress to a greater or lesser extent may experience a diminished cognitive capacity. In these circumstances, the IC can reassure the patient though also increase their anxiety.¹⁸ Perhaps that is why many patients give their consent without paying attention to details. The patient's mood is such a priority to some physicians that they do not hesitate to omit real data or sugarcoat the information during IC processing.¹⁹

The imbalance of the clinical relation

Yet despite the IC, the clinical relation is and will always be an unequal relation. Although medical coercion is unacceptable, maybe persuasion is unavoidable.²⁰ The fact is well known that many patients feel intimidated during the IC processing. They wish they had more time or more information, but they do not dare ask.²¹ They are afraid of the consequences of refusing the procedure. Some do not know that they can refuse it. Their autonomous choice thus becomes a quiet acceptance of the risks associated with a single offer–one preferred by the physician who indicates and promotes it.

The effectiveness of information

The IC can improve therapeutic accomplishment, the patient's cooperation and overall satisfaction. It can also contribute to reduce errors and avoid lawsuits.²² But excess information can damage their cooperation. In fact, there is no evidence that IC improves clinical results. What information does is improve the patient's satisfaction by recognizing his/her own personal dignity.^9,14

Many patients do not assimilate or remember the information received. Some consider it inappropriate. Others do not get it with enough advance notice or do not understand its purpose.²³ Some patients suspect that the IC simply seeks to avoid lawsuits. No doubt understanding can and should be optimized. However, information may not be influencing the patient's decision as much as we think.^24,25

Informed consent in radio-diagnosis

The legitimacy of the radiologic act

The IC is one of the legal pillars of the radiological act, along with clinical indication and execution in conformity with lex artis.²⁶ The huge medical-legal relevance of these three legitimizing elements contrasts with the scarce attention they receive. However, the IC is a basic ingredient of radiological professionalism²⁷ and belongs to the training program of the specialty.²⁸

The legitimacy of the radiological act requires accepting a request that justifies a necessity.²⁶ This necessity admits degrees and it is usually clinical and scientific in nature. However, it has ethical, judicial, economic, administrative and psychological components that we should not ignore. The absence of this necessity leads to refusing some requests. This refusal can have a huge medical-legal impact.²⁹ Nevertheless, it is no good to prevent inappropriate lawsuits³⁰; it undermines the patient's demand³¹ and attributes ignorance to the applicant³² – sometimes unfairly. Also it grants a certain priority to the scientific criterion that it does not always exist. In any case the IC compels the radiologist to assume the need for the test he/she is performing, taking for granted another person's reasoning that justifies it is good.

Opportunity of interaction

In radiology, the relation with the patient is usually brief, which makes communication difficult.³³ On the other hand, radiology can be alienating because it puts a penalty on professionals with anonymity. Although there are other strategies to improve the visibility of the profession³⁴ the IC is an opportunity for interaction that can contribute to the social prestige of radiology. However, when the radiologist is not present and the interaction comes down to a brief protocol act, this benefit can be compromised.

Co-responsibility in the duty to inform

The BRL establishes that the physician responsible for the patient must ensure compliance with the patient's right to information.³⁵ However, the radiologist should also inform.⁶ There is co-responsibility in the duty of informing. This requires an adequate coordination, which is hard to get. On the other hand, it is common for the non-medical staff to do the informing.³⁶ In this sense, article 4.3 of the BRL states that the professionals who perform a procedure are also responsible for the information process.³⁵

Quality and security in radio-diagnosis

In radiology the parameters associated with the use of radiation and contrast are vital. They have a huge impact on the quality of the procedure and they are closely connected with the patient's own safety. They could have an even greater medical-legal repercussion than diagnostic error. In this sense, the IC should be understood as a reflection and guarantee of a quality offer linked with the means available and the protocols in force. Although the radiologist is deontologically bound to demand better means³⁷ every informed consent that he/she signs reconciles him/her with the existing ones, forcing him/her to seek optimal performance with them. On the other hand the IC is also a personalized offer that takes into consideration the generic risks of the procedure offered as well as the risk factors that are specific to each specific patient.

Administration of IV iodinated contrast

Obtaining the IC before the administration of IV iodinated contrast is very common practice. However, scientific societies³⁸ and experts³⁹ consider it unnecessary. In any case patients prefer to be informed of the risks associated with the contrast.⁴⁰ Although it is usually recommended to inform with enough prior notice – at least 24 h the BRL does not establish anything in particular about it. A comfortable prior notice does not seem to improve the understanding of risks.⁴⁰ Beyond the prior notice with which we inform the patient, it is important to make sure that they have the real possibility to refuse the procedure.

In conformity with BRL the injection of contrast may require a written IC if we think that it is an invasive procedure with risks of notorious and foreseeable negative repercussions.³⁵ If not a verbal IC would be enough.³⁵ The BRL stipulates the need to inform about the “risks” before the verbal IC and about the “probable risks” before the written IC.³⁵ Given that the serious risks associated with the injection of iodinated contrast are very unlikely, it could be understood that it is not necessary to inform about them in writing. Such is the understanding of the Sociedad Española de Gestión y Calidad en Radiodiagnóstico (Spanish Society for the Management and Quality of Radio-diagnosis). For this society the exceptional and unforeseeable risk is not sensitive to information in writing by the clinician no the radiologist.⁴¹

Use of ionizing radiations

The need to obtain the IC in procedures that use ionizing radiations is also an object of debate.^42,43 On one hand, it is imperative to determine whether ionizing radiation is to be considered or not an invasive element. Everything seems to indicate that it is. On the other hand, it is necessary to settle to what extent it is patients are eligible to being informed of cancer risks of 1/1000.^42,43 In any case, the Royal Decree 1976/1999, of December 23rd by which the quality criteria in radiodiagnosis are established, indicates that studies with high doses of radiation require written IC at the radiologist's own responsibility.⁴⁴ In turn, the Sociedad Española de Radiología Médica (SERAM–spanish Society of Medical Radiology) and the Sociedad Española de Protección Radiológica (Spanish Society of Radiologic Protection) recommend written ICs for studies with high radiation doses.⁴⁵ Some authors suggest obtaining IC for doses >1 mSv in adults,⁴³ and SERAM does the same with fetal exposure of >1 mGy.⁴⁵

Interventional radiology

The circumstances in which interventional radiology develops are more favorable for ICs that in other areas of radiodiagnosis. On one hand, there is a closer and more lasting interaction with the patient, and on the other, the decidedly invasive character of the procedure, the high radiation or the contrast doses that it may require, and the greater probability of complications, are identified with the assumptions that demand a written IC with great informative coverage.

Tele-radiology

SERAM's Decalogue of Good Practices in Tele-radiology states that also in this modality of radiodiagnosis the patient's rights on information, autonomy, privacy and confidentiality must be guaranteed.⁴⁶ The patient should be informed about the teleradiological procedure he/she is going to undergo and accept the risks. In these cases it is recommended to obtain a specific IC – one including (a) information about who is going to provide the service, (b) description of the service rendered, (c) a warning that says that the information may be compromised by electronic transmissions and (d) a description of the security measures implemented to preserve confidentiality.⁴⁶

Minimum requirements

Beyond the controversies on the indications and modalities of IC in radiodiagnosis, it would be advisable to remember what the minimal requirements that information and IC should be in clinical practice. There is general consensus in that it is not ethically correct or legally appropriate (a) to completely omit information, (b) to provide rushed and ceremonial information once the test has started and (c) to obtain a signature without any sort of prior verbal information.

Informed consent and responsibility

Responsibility binds the physician to be accountable for his/her own acts, especially those that have damaged the patient. The physician can be declared liable in different competences. In the private healthcare system his/her civil liability is declared when a negligent action causes damage and there is a provable causal link between the medical act and the damage inflicted. In public healthcare system it is more common to declare patrimonial liability for the Administration's normal or abnormal work. Also the physician can fall into legal, deontological or disciplinary liability. Healthcare centers can also be sued for negligence due to their scope of control.^47–49

Diligence required, lex artis and informed consent

Lawsuits can affect one or several physicians, the institutions or healthcare authorities. In assistential medicine, most lawsuits by civil or patrimonial liability try to clarify whether physical damage inflicted as the result of a medical act is eligible to collect damage.^47,48 Damage can originate from omission of assistance, such as study that should have been properly indicated but never carried out. When the physical damage derives from a medical act there can be a real error, an apparent error linked to an unforeseeable damage or a situation of known risk that the patient may or may not have been warned against and that ends up materializing.⁴⁷

As a general rule, the burden of proof falls on the patients. It is the patient who needs to prove physical damage, lack of medical diligence and the causal link between the medical act and the damage caused. However, when the burden of proof is inverted, it is the physician or the Administration who need to prove that the medical act was diligent and there was no causal link between the intervention and the damage. This inversion is applied (a) in cases of satisfaction or non-curative surgery, (b) in cases of disproportionate damage, foreign to the known complications of a procedure, whose mere existence suggests negligence, and (c) in cases of evidentiary ease when it is considered that it is easier for the physician or the Administration to access evidentiary means.^47,48

In the case of the Administration's patrimonial liability, the patient needs to prove that there is individual, effective, economically and assessable physical damage, derived from the Administration's normal or abnormal work, imputable to a subject that operates on its behalf. Although in principle, it is a system of objective liability, without guilt, jurisprudence has been demanding for years that damage should be anti-judicial (damage the patient is not bound to withstand) and that there should be negligence in the acting from the physician or the center.^47–52

Regardless of the way in which the liability is demanded, the determination of the required medical diligence is the key to many claims.⁵⁰ Since medicine cannot guarantee results, required diligence equals the will to apply the techniques in keeping with the state of science. This obligation of means is the lex artis ad hoc, defined as the assessment criterion for the correction of the medical act that takes into account the characteristics of its author, those of the profession itself, the characteristics of the patient and other factors to qualify the act in conformity with the technique required.⁵⁰

But lex artis ad hoc combines multiples scientific-technical and judicial-ethics precepts applicable to the every case. As a part of lex artis and an element that is easy to verify from a factual perspective, the IC has become an essential assessment criterion of every medical act and the case or evidentiary element of countless liability lawsuits.⁵¹ This is why in medical-legal terms, informing the patient appropriately is as important as giving the patient proper medical assistance.

Responsibility for the unfulfillment of the obligations to inform and obtain consent

Unfulfilling the IC prevents the patient's autonomy; violates lex artis and can be a recoverable cause of civil or patrimonial liability. In this sense, jurisprudence has evolved from its original refusal of liability (due to the absence of causality) to attribute responsibility based on the theory of displacing risk or loss of opportunity. In any case, jurisprudence understands that violating the patient's autonomy is in itself a serious moral damage, regardless of the materialization of risk. However, such violation is not recoverable when physical damage does not follow.^50–52

When it is claimed that the patient's right to autonomy has been violated, it is the private physician's or the Administration's duty to prove that the IC was processed correctly. On the contrary, it is the plaintiff who has to prove that the damage claimed was the result of lack of information, of the defective processing of IC or its complete omission. In other words, it is the patient who has to prove the causal link between violation of autonomy and physical damage. Nevertheless, when the damage is disproportionate, it is agreed to let the Administration prove that there was no such link.

In patrimonial liability, violation of lex artis due to breach the IC confers an anti-judicial character to physical damage, which usually contributes to the fact that damage should be collected. However, the damage derived from unforeseeable events or essential medical acts, which would have occurred just the same in case their risks had been informed, cannot be collected. In any case, the correct processing of the IC does not free from the liability that can be derived from violating other aspects of lex artis.⁵³

Cases where informed consent can breach lex artis ad hoc

Violating the patient's right to autonomy can derive from omission of IC, its inadequate processing or the impossibility of proving that it was processed correctly.⁵¹ The first assumption tends to be quite unusual, given the growing degree of awareness among medical professionals. When it comes to the to unsatisfactory processing of the IC–that is much more common, the plaintiff's allegations can focus on formal defects or on inadequacy of information.^50–53

The plaintiff can claim (a) little or excessive notice in advance, (b) that the form lacks dates or has the wrong date, (c) that the form has not been signed or that it was signed on the wrong place, that the signature is unintelligible or belongs to another physician, (d) that the form is generic, not personalized, does not contemplate the right risk factors or refers to an act different from the one in question, or (e) that the form was delivered without further explanations or that the explanations were rushed.^53–61 Although many of these allegations are rejected, it can be interesting to know that they usually happen.

In any case, the strongest allegation refers to the materialization of a serious, exceptional risk about of which the patient has not been informed during the IC process. Based on the prevailing jurisprudence, there is no obligation to inform about uncommon complications in curative or satisfactory medicine. However, in the lawsuits for the Administration's patrimonial liability, the theory of disproportionate damage justifies informing about all known risks, regardless of the odds that such risks might happen.⁵²

The custody of the IC form is responsibility of the institutions. In case it is lost, mentioning its existence in the medical history is enough for evidentiary purposes.⁴⁷ The form is the key reason why many lawsuits, often with little foundation, do not prosper. If the document is complete enough, justice will not easily pay attention to allegations aimed at undermining it.⁶ This unquestionable documentary value of what was exactly signed contributes to consolidating the use of lengthy forms that surpass the recommendations of scientific societies.

Medico-legal litigation and prospective relation with informed consent

Medico-legal litigation has been showing a well-defined trend in the last few years. The number of lawsuits increases, the collection of damage grows, defensive medicine moves forward, healthcare processes slow down and professional unease spreads, in a social context that is prone to litigaton.⁴⁹ Absence of a specific legislation makes the judges’ work difficult. On the other hand, there have been claims that are too dissimilar in jurisprudence about the appealing claim for objective liability. Fortunately, it tends to be ever more restrictive and reluctant to convict physicians or institutions.

It is hard to assess the influence of IC in medico-legal litigation.⁵³ In general, it is believed that an IC that has been processed in an orthodox manner prevents litigation because it generates satisfaction, reduces inadequate expectations and provides documentary evidence of good medical praxis. However, extensive use of IC as the argumentative axis of allegations for patrimonial liability suggests that the IC casuistry can have a revitalizing effect for them.^2,53

In the USA, the IC is an uncommon cause of lawsuits in radiodiagnosis, far behind diagnostic errors–above all in mammary and skeletal radiology and the complications of interventional radiology.⁶² In Europe the relative weight of IC in lawsuits is probably greater.^63,64 On the other hand, more than half the radiologists feel unsatisfied with the way they process the IC⁶⁵ which without a doubt reflects how difficult the procedure really is.

In any case, the deficiencies of the IC claimed in the jurisprudence and the existing sentences to collect damages make us to reconsider the legal and economic importance of healthcare information and the IC. Also there are several measures to prevent litigation, among those most frequently cited we find compliance with legislation, fulfilling the medical history, clinical activity based on protocols, humane and professional treatment, avoiding guaranteeing any results, avoiding criticizing other colleagues’ actions, training the assistance staff and risk management.⁶⁶

Conclusions

In the first part of this paper we examined the conceptual and normative limitations of the principle of autonomy as the foundation of IC. In this second part we have reviewed the practical difficulties posed by processing IC in assistential medical care, and more specifically in radiodiagnosis. We have analyzed the procedural significance of infringed autonomy by invalid IC as the cause for civil or patrimonial liability. We have talked about the circumstances that can undermine the legal validity of the IC, in the light of recent jurisprudence. And lastly, we have tried to summarize the master lines of the existing vast literature that tirelessly debates the intricate processes that turn IC into preventive strategy, procedural argument and documentary evidence of countless lawsuits for civil or patrimonial liability. In short, we have reviewed, with the help of experts, the hybrid, controversial character of IC–a legal process designed to ensure the patient's rights before and after the medical act.

Ethical disclosures

Protection of human and animal subjects

The authors declare that no experiments with human beings or animals have been performed while conducting this investigation.

Confidentiality of data

The authors confirm that in this article there are no data from patients.

Right to privacy and informed consent

The authors confirm that in this article there are no data from patients.

Conflict of interest

The authors declare no conflict of interest associated with this article whatsoever.

Acknowledgements

I wish to thank Leyre Elizari Urtasun, Proffesora of Civil Law at the Navarra State University who generously helped me with her dedication during the process of editing and proofreading this manuscript. I also wish to thank Sandra Marcos Mondón resident of radiodiagnosis at the Hospital Universitario Miguel Servet who helped me gather bibliographic references.