Informed Consent: what is it and how do I do it?

Recently, with some colleagues we launched an initiative aimed at disseminating and making accessible information about the rights of patients in psychotherapy ().

The initiative especially emphasizes the right of people to receive information about their diagnosis and treatment, that is, the central points of informed consent as indicated by both the National Mental Health Law and the Patient’s Rights Law. It may seem unnecessary, but in clinical practice it is common to find that people are unaware that they have the right to access that information when requesting it.

Now, when disseminating the initiative we found that there are several confusions among professionals themselves regarding the issue of informed consent. This is not surprising – in fact, in my own undergraduate training (far away and a long time ago, but not that long ago), informed consent was not part of the curricular content, which is why I came to find out about it after finishing the race.

I would then like to briefly review its central points, and give some suggestions for its practical implementation. Keep in mind that this is a topic, each of whose aspects has arduous and delicate ethical considerations, which, true to our tradition, we will brutally simplify. If you are interested in a more detailed and careful approach, you can review the texts that are among the references, in particular Faden and Beuchamp (1986).

What is informed consent about?

Let’s start with the first thing, which is a good way to start.

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Informed consent, simply put, is the authorization given by the patient to begin treatment – ​​hence “consent”. This is, in essence, the same requirement that applies to sexual relations: to move forward with one, it is essential that all participants give their consent, whether they are two, three, or one hundred and fifty.

But that authorization implies that the patient has received and understands all the important information about the decision to be made – that is the “informed” part. Continuing with our previous analogy, if you are going to appear in the bedroom wearing a costume of , it is preferable that you first inform tell your partner what is going to happen to avoid misunderstandings (“this was not what I imagined when you told me what you wanted to do.” dirty“). For this, it is the health professional’s task to provide the information that is relevant so that the person can make a decision.

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In other words, informed consent involves that the patient understands the relevant information about his or her health status and the treatment that is being proposed, and that he or she has accepted that course of action. If, having all the pertinent information, the treatment is rejected, that act is called a informed rejection (like when someone says “I understand that Alf was a character that marked your childhood, but I’m not going to wear that costume, Roberto”).

We can say it in slightly more academic terms, citing Faden and Beuchamp (1986): “Informed consent is the autonomous action of a subject or patient that authorizes a professional either to involve the subject in research or to initiate a plan. doctor for the patient (…) if a patient or subject with (1) substantial understanding and (2) with a substantial absence of control by others, (3) intentionally (4) authorizes a professional.” (p.278)

It is a practice that is not exclusive to psychotherapy, but rather emerged in medicine and research and from there spread to the rest of the health professions.

Because?

Although there is some historical precedent from the 18th century, the concept and widespread practice of informed consent are relatively modern, only being widely adopted in the mid-20th century. One of the first modern formalizations of informed consent is in the Nuremberg Code, published in 1947 after medical experiments on human beings during Nazism came to light. The first article of the Code reads:

The voluntary consent of the human subject is absolutely essential. This means that the person involved must have the legal capacity to give consent; his situation must be such that he can be able to exercise a free choice, without intervention of any element of force, fraud, deception, duress or other form of constraint or coercion; He must have sufficient knowledge and understanding of the elements involved to enable him to make a reasonable and enlightened decision.

This last element requires that before the experimental subject accepts an affirmative decision, he must know the nature, duration and purposes of the experiment, the method and the means with which it will be carried out; all the inconveniences and risks that may reasonably be expected and the effects on his health and person that may possibly arise from his participation in the experiment.

The duty and responsibility to ensure the quality of consent lies with each individual who initiates, directs or is involved in the experiment. It is a personal duty and responsibility that cannot be delegated with impunity.

Informed consent is, above all, a way to respect the autonomy and freedom of people in everything related to their health. On the one hand, this allows people to not be involuntarily subjected to procedures that could be harmful to themselves or others (for example, a treatment for a pregnant woman that could be harmful to the fetus).

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But, on the other hand, consent is also opposed to medical paternalism, which does not consist of being the father of Hippocrates, but is what the practices in which a professional interferes with a person’s freedom of action are generally called, ignoring their wishes and choices, arguing that they do so motivated by that person’s own well-being (Dworkin, 1971). That is, treating patients as if they were children to be protected, rather than autonomous people who make their own choices.

Of course, none of these considerations are absolute, but there are many and varied shades of gray. Certain contexts may require that the principle of autonomy be overlooked, such as when mandatory vaccination is dictated for some diseases that affect general health. These contexts have been the subject of arduous and extensive ethical discussions that can be reviewed in the references. But, if we omit these exceptional situations, in most cases it is possible and desirable to respect people’s right to make informed decisions about their body and health.

Facilitating informed consent “encourages a shift from indoctrination to shared information, and from paternalism to respect for patient autonomy. In this way, we help access, validate, empower, and challenge our patients’ natural strengths so they can use them to help themselves more effectively” (Beahrs & Gutheil, 2001, p. 6).

What should informed consent include?

For what follows I will be guided by Argentine legislation. In any case, although each country has different ways of implementing it, the informed consent guidelines are practically universal.

In Argentina, the right to informed consent is provided for in the and in the . In particular, Chapter III of Law 26,529 details the points that must be conveyed to the patient to obtain informed consent, which are: a) the patient’s state of health; b) The proposed procedure, with specification of the objectives pursued; c) The expected benefits of the procedure; d) The foreseeable risks, inconveniences and adverse effects; e) The specification of the alternative procedures and their risks, benefits and harms in relation to the proposed procedure; f) The foreseeable consequences of not carrying out the proposed procedure or the specified alternatives. Let’s see what one of these points implies.

a) Your state of health

The first point of informed consent stipulates that it is necessary for the patient to understand what is related to their state of health. This is, in general terms, her diagnosis.

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This does not necessarily imply using standardized diagnostic labels such as those of the DSM or ICD, but what it is about is communicating the evaluation of the situation that the professional carries out using his or her knowledge, so it may be an evaluation based on functional analysis. , in psychodynamic, cognitive processes, etc. However, if any DSM label applies, I think it is good practice to communicate it to the patient, since it has become a standard. de facto for professional communication, and knowing it can help the patient to seek more information on their own or to consult other professionals about it.

Now, it is not a matter of merely communicating the diagnostic label or evaluation to the patient, since it is difficult for a layman to understand what something like “acute stress disorder” means, but rather it is a matter of providing a description of the situation that is understandable to the patient. the patient, so it is necessary to adjust the language and details to what he or she can understand.

b) The proposed procedure, with specification of the objectives pursued

This point indicates that the patient must be informed of what the treatment or procedure that we propose consists of according to the evaluation carried out, and what the objectives are to be achieved through that procedure.

For example, a cognitive behavioral therapist can explain to a patient with a diagnosis of phobia that he proposes to carry out an exposure-based treatment, which consists of activities in which we will carry out a gradual approach to the feared stimulus, with the aim of reducing the anxiety that experience in front of it. Now, an ACT-oriented therapist may propose the same procedure for that situation, but with different goals: instead of reducing anxiety, the goal may be to ensure that the feared stimulus is not an obstacle to taking some worthwhile action.

The point here is that informed consent is not uniform, but varies depending on the theoretical model and the characteristics and possibilities of understanding of the patient.

c) The expected benefits of the procedure

This point is closely linked to the previous one. The idea here is: if the treatment worked, how would it improve the patient’s life?

The point here is not to stay with intratheoretical objectives: “contact with emotions”, “make the unconscious conscious”, “reduce experiential avoidance”, but to connect the treatment with the concrete impact it can have on your…