The principle of autonomy must be associated with the idea of individual hu- man freedom and the Kantian maxim that every person is a moral subject, capable of universalizing their actions. It presupposes the ability of any human being to control their actions without outside interference. This principle is part of Beauchamp and Childress’s principlism, and it may even be considered the most emblematic one, although, as we have already said, its existence can- not be explained by the ideas of these authors.
The first legal formulation of this principle can be found in the Nuremberg Code of 1947, drafted after the Second World War as a consequence of the Nazis’ experiments in biomedicine. The second time it was included in an in- ternational text was in 1964, in the World Medical Association’s Declaration of Helsinki (article 25).
The third occasion was in the Belmont Report, of 1979, the result of the commission that was created in the USA (1975-1978) to investigate the experi- ments carried out with Afro-Americans in Tuskegee, Alabama, for almost 40 years, although expressed as “respect for people”. The fourth time we find a precise formulation of this principle is in the European Convention on Bio- ethics, in 1997.
Since 2000, the year this convention came into force in Spain, this prin- ciple has become an essential part of our legal system. What is more, we could argue that the application of this principle made it possible to replace a paternalistic model — the heir to the clerical view of Francoism in which decisions were taken not only by healthcare personnel but also by the powers- that-be or the Catholic Church, instead of by those directly affected — with another model based on autonomy, in which the patient becomes a fully entitled subject and makes decisions according to their convictions and be- liefs.
Thus, different laws in the Spanish legal system, at both state and autono- mous community level, have included this principle, especially Law 41/2002, of 14 November, regulating patient autonomy and rights and responsibilities
in matters of information and clinical documentation, and Law 14/2007, of 3 July, of Biomedical Research.
The fifth occasion was in the Universal Declaration on Bioethics and Hu- man Rights, of 2005, under the auspices of UNESCO (article 5).
Due to the large number of laws that include this subject, we shall just mention the most usual consequences of the principle of autonomy.
3.1. Informed consent
It is a person’s right not to be subjected to any biomedical treatment, experi- mentation or research without their consent. We can compare how it is formu- lated by looking at different laws:
Art. 5 of the European Convention on Bioethics
An intervention in the field of healthcare may only be made after the person has given their free and informed consent.
Art. 3.a. of the Charter of Fundamental Rights of the European Union
In the context of medicine and biology the following will be respected, in par- ticular:
A) The free and informed consent of the person being treated, in accordance with the types established by law.
Art. 5 of UNESCO’s Universal Declaration on Bioethics
The person’s autonomy must be respected with regard to the power to take deci- sions, taking responsibility for them and respecting the autonomy of others.
Art. 2 of the Law of Patient Autonomy
2. Any and all action in the field of healthcare generally requires the prior con- sent of the patients or users. This consent, which must be obtained after the pa- tient is adequately informed, will be given in writing in the cases envisaged in the Law.
3. The patient or user is entitled to decide freely, after being suitably informed, between the available clinical options.
Art. 4 of the Law of Biomedical Research
1. The free autonomy of people who may participate in biomedical research or who may contribute their biological samples to it will be respected, for which they will necessarily have previously given their express consent in writing after being suitably informed.
The information will be given to people with disabilities in accessible condi- tions and formats appropriate to their needs.
If the subject of the research is unable to write, consent can be given by any means offered by the law to allow them to state their wishes.
The requirement for express consent generates a huge amount of case law when people’s autonomy is limited or non-existent. Nevertheless, the Euro- pean Union’s Charter of Fundamental Rights establishes no specific rules for these situations; and the clause established in article 5 of the Universal Decla- ration on Bioethics and Human Rights is too generic, as it simply says that “special measures will have to be taken to protect their rights and interests”.
In this respect, only article 6 of the European Convention on Bioethics has specified this case law, although based on the general rule that it will only be possible to intervene in people lacking the ability to express consent when it is for their direct personal benefit.
The Convention authorizes certain medical interventions, for example inter vivos transplants of regenerative tissue, if specific requirements are met (which we shall examine in the corresponding chapter) and the incapable person is not openly opposed to it, and even some experiments, if the beneficiary is:
[…] the person affected or other people in the same age range or who suffer from the same disease or the same disorder, or who present the same characteristics. (Art. 17.2.i).
In this way, the use of people who are incapable of expressing their consent is avoided in experiments that benefit society as a whole, but not them or those who are in a situation similar to them.
Developing this possibility, the Law of Biomedical Research allows, in ar- ticle 19, for experimentation with pregnant women, embryos or foetuses, pro- vided that, besides meeting certain requirements, the research benefits them personally or pregnant women, embryos, foetuses or newborn babies as a whole; and in article 21, experimentation with people whose “emergency clin- ical situation” does not allow them to express consent. In these cases, the ben- eficiary of the research must be the person affected or others in the same situ- ation. Moreover, among other requirements, the law demands that the Public Prosecutor be informed and that the consent of the person affected or their relatives be obtained whenever possible.
In the case of minors, the European Convention on Bioethics, in article 6.2, requires that the minor’s degree of maturity, age and comprehension be
properly assessed depending on the type of treatment, as well as collecting the express consent of their parents or representatives.
Respecting the content of the Convention, article 4 of the Spanish Law of Biomedical Research establishes that:
2. Consent shall be given by a representative when the person is legally incapaci- tated or is a minor, provided there are no other alternatives for the research. Consent through representation shall be given to the investigation to be carried out and shall be made respecting the person’s dignity and for the benefit of their health.
Incapacitated people and minors will participate as far as possible and ac- cording to their age and capacities in the decision-making throughout the re- search process.
On this point, we should point out that Spain prohibits inter vivos organ donation to minors, even though the parents may agree to it (we shall examine this in the corresponding chapter), and abortion used to be permitted for mi- nors aged 16 or 17, even if the parents were opposed to it or did not know about it (the situation has changed, but we shall also analyse that later on).
In the event of a dispute between the parents and the minor the interven- tion of a third party may be necessary, which in the case of Spain means a court, without prejudice to the intervention of the Public Prosecutor to pro- tect the interests of the minor. In certain situations, even though minors and parents agree, it may be necessary to notify the Public Prosecutor so that they are at least aware of this and may oppose it if they feel that the minor is being unjustifiably harmed.
A singular case in this subject is presumed consent in the context of trans- plants, a subject that we shall examine in the corresponding chapter.
Lastly, there are not usually any rules to specifically protect particularly vulnerable groups, such as people with very little money, the long-term unem- ployed, ethnic minorities, sick people (for example, a patient must not be led to believe that his or her medical treatment is going to be better or there will be more possibilities of survival or a cure if they voluntarily submit to a medi- cal experiment), and so on.
3.2. The right to be informed of the consequences of medical treatment
Article 5 of the European Convention on Bioethics establishes that the person who is going to receive treatment in the field of healthcare:
[…] must be suitably informed beforehand of the purpose and the nature of the intervention, and of its risks and consequences.
The citizen is entitled to have the information adapted to his or her educa- tional level or ethnic or linguistic group, with the ultimate aim of the affected person being able to fully understand the information. In this respect, articles 2 and 4 of the Law of Patient Autonomy establish the patient’s right to be “suitably informed”, which as a general rule must be done verbally, even though a note will made in the clinical record. This information must be of- fered “comprehensibly and suited to their needs”, with the object of them understanding “at least, the purpose and the nature of each intervention, its dangers and consequences”, which will allow them to make “decisions accord- ing to their own free will”.
For its part, article 4 of the Law of Biomedical Research establishes that: The information will be provided in writing and will include the nature, impor- tance, implications and risks involved in the research, in the terms laid down by this law.
Sometimes, the law demands that the information be especially detailed, as is the case with assisted reproduction:
The information and guidance about these techniques, which must be given to those who wish to have recourse to them and to those who, where appropriate, are going to act as donors, will include their biological, legal and ethical aspects, and it must likewise specify the information relative to the financial conditions of the treatment. The medical teams performing these techniques in the hospi- tals and services authorized for their practice will be legally obliged to provide the said information in the proper conditions in order to facilitate its compre- hension. (Art 3.3 of the Law of Human Assisted Reproduction Techniques, Law 14/2006, of 26 May).
3.3. The right to refuse treatment or withdraw consent at any time
The right to receive information, conversely, entails the possibility of refusing treatment after receiving it, or even withdrawing consent once it has been given, even though the patient may die as a result. Thus, article 6 of the Euro- pean Convention on Bioethics states that: “The person affected may freely withdraw their consent at any time.”
With the aim of providing healthcare personnel with legal certainty, article 4.2 of the Law of Patient Autonomy requires this refusal to be made in writing. And article 4, sections 3 and 4, of the Law of Biomedical Research, develops this right even further, in the context of experimentation in biomedicine:
3. The persons taking part in biomedical research may revoke their consent at any time, without prejudice to the limitations established by this law. The persons or bodies that have received this consent will take the necessary steps for the effec- tive exercise of this right.
4. The lack of consent or the revocation of consent previously given will not af- fect the subject’s healthcare attention in any way.
Among other implications, this right entails not only the possibility of ceas- ing to participate in an ongoing experiment, but also not transferring the em- bryos generated in a fertility treatment procedure already underway;21 or not
making an inter vivos organ donation even though consent was initially given.22
It is important to point out that the withdrawal of consent must not sup- pose a financial, equity or personal cost for the subject, although the law does not always expressly acknowledge that the said refusal will not affect the indi- vidual negatively.
Going into this issue in greater detail, in a document the University of Bar- celona’s Bioethics and Law Observatory dealt with the problem arising from reconciling the principle of autonomy, the right to life and religious freedom in
21 Article 3.5 of the Law of Human Assisted Reproduction Techniques, Law 14/2006, of 26 May, estab-
lishes that “the woman in receipt of these techniques may ask for their application to be suspended at any time during the process prior to embryonic transfer, and this request must be respected”.
22 Article 13 of the Additional Protocol to the Convention on Human Rights and Biomedicine con-
cerning Transplantation of Organs and Tissues of Human Origin, drafted in Strasbourg on 24 Janu- ary 2002. Instrument of ratification by Spain. BOE no. 25 (Thursday, 29 January 2015).
reference to Jehovah’s Witnesses, since this group refuses blood transfusions, which can have serious consequences for their health. The Observatory’s rec- ommendations were to respect this group’s freedom to refuse transfusions, even though it could cost them their life (except when they are minors, in which case their right to life prevails and the courts may even be required to inter- vene), but that they should be consistent with this decision and should not demand alternative treatments that could be costly for the Treasury in a con- text of budgetary constraints.23
3.4. The right not to be informed (or the right not to know)
This right, which may seem paradoxical, can be explained because in certain cases a patient might not want to know what disease they have or how it is progressing, handing over the decision-making to the healthcare staff. In other cases, it may be that they do not wish to know their genetic information in case they are found to have a predisposition to an incurable disease.
The problem is that there may sometimes be third parties involved. Thus, if a person suffers from a contagious infectious disease, their health is a matter of public order, whereby their right not to know must be overruled by the right of the society in which they live to be protected. Moreover, a person’s health condition may be shared unwittingly by the members of their family. And so, if it is discovered that an individual has a particular mutation that predisposes them to an illness, it is reasonable for their close relatives to receive that same information, so that they can take preventive steps if possible.
The right not to be informed is succinctly included in article 4 of the Law of Patient Autonomy, and, in greater detail, in article 4.5 of the Law of Bio- medical Research, in the context of genetic information:
Every person has the right to be informed of their genetic data and others of a personal nature that are obtained in the course of biomedical research, according to the terms in which they expressed their wish. The same right is acknowledged for a person who has contributed biological samples for the purpose indicated, or when other biological materials have been obtained from them.
The person’s right to decide not to be notified of the data referred to in the previous section, including any unexpected discoveries that may be made, will be
23 Martorell, M. V.; Sánchez-Urrutia, A. (coords.) (2005). Declaration on the Refusal of Jehovah’s
respected. Notwithstanding this, when this information, in the opinion of the doctor in charge, is necessary to avoid serious harm to their health or that of their biological relatives, a close relative or a representative will be informed, after consultation with the medical committee if there is one. In any case, notification
will be limited exclusively to the data necessary for these purposes.24
3.5. Consent through advance directives
Article 9 of the European Convention on Bioethics establishes that:
Wishes expressed previously with respect to a medical intervention by a patient who is not in a position to express them at the time of the intervention will be taken into consideration.
Although the living will, or advance directives, will be examined in detail in the chapter referring to dignified death, we can say here that the function of this kind of document is to make up for the lack of ability to give consent in situations that are unlikely (for example, the request for a person not to be kept alive artificially), but no less deserving of attention.