Informed consent is defined as "the free, voluntary and conscious agreement of a patient, expressed in the full use of his or her faculties after receiving adequate information, for an action affecting his or her health to take place".
In healthcare, Informed Consent (IC) should be understood as a process of communication and information between the healthcare professional and the person being treated; a process that culminates in the acceptance or refusal by the competent patient of a diagnostic or therapeutic procedure, after knowing the risks, benefits and alternatives, in order to be able to freely involve him/herself in the decision.
The process of information and decision-making in the healthcare setting is based on human rights and specifically on a person's right to freedom to decide about his or her own health.
The origin of this process is to be found in the vindication of civil rights, related to the development of biomedical research, the promulgation of the Nuremberg Code and the crisis of the paternalistic model in the healthcare relationship, which tends to strengthen the patient's right to autonomy. On the other hand, medical advances in complex situations such as transplants, in vitro fertilization, cloning, ICUs, etc. make decision-making more controversial.
IC is based on the fundamental recognition, reflected in the legal presumption of capacity, that individuals have the right to accept or refuse health interventions based on their scales of values and their desire to realize their own goals.
- To provide information in sufficient quantity and quality, so that the competent patient can make decisions regarding his or her process.
- To guarantee the right of individuals to their autonomy and freedom in decision making.
Stages of informed consent
Information and decision making in the clinical relationship are different and related moments of the same process that includes:
- The elaboration of the information by the professionals.
- Its transmission and discussion.
- The patient's understanding and assessment.
- The acceptance or not of the diagnostic procedure and/or the proposed treatment.
When these elements are collected in writing, it is called an IC document, which should not be confused for relational, ethical or legal purposes with the communicative process of information and decision-making.
What does the Law say?
- The patient will always be the recipient of the information, except in cases of incompetence or refusal to receive it, in which case said information will be addressed to the family or legal representative.
- The physician responsible for the patient must inform the patient, although different parts of the informative process may be assumed by different professionals, depending on the diagnostic tests, their complexity and the degree of agreement reached.
- The clinical process, diagnostic procedure or therapeutic action should be described in a clear and accessible manner, explaining the risks, benefits and alternatives, avoiding alarmist or simplistic aspects.
- The professional will offer availability and approachability, so that the patient can raise any doubts that may arise during the information process.
- The information should be provided in a delicate and progressive manner, allowing the patient to ask questions and resolving his or her doubts.
- Patients admitted to a teaching hospital have the right to be informed that medical and/or nursing students may be involved in the process of their health care. They should identify themselves as such when providing their services and seek the patient's permission.
- Medical interns and residents will participate in the information, in accordance with the level of training marked in the corresponding program, and with the degree of mentorship contained therein.
- A person can accept a procedure and not want information, in which case it will be reflected in the medical record. He/she can also refuse the procedure and in this case the patient or a witness will have to sign his/her refusal on the IC document.
- The written IC form represents the documentary support where it is verified that the patient has received and understood the information provided by the physician.
- Obtaining the IC document does not exempt the physician from possible liability for malpractice.
- The person who has signed the form may request a copy of it, which will be filed in the patient's history.
What does the Informed Consent form have to be like?
- Procedure-specific. General forms are neither ethically nor legally acceptable.
- Delivered with sufficient time for it to be read, discussed and clarified before requesting its completion.
- Obtained by persons directly related to the technique or treatment.
- Revised two years after its implementation, or when necessary due to the need of the process to which it refers.
The requirements to be met by the IC are as follows:
Only consent that is given by a person acting freely and voluntarily is acceptable from an ethical and legal point of view. There are several ways to limit freedom such as coercion, manipulation or persuasion beyond a reasonable limit.
Information in sufficient quantity and quality.
The objective of IC is the information itself and not just the completion and signing of the document.
A written informed consent form should respect at least the following information criteria:
- Nature of the intervention: what it consists of, what is going to be done.
- Objectives of the intervention: what is the purpose of the intervention.
- Benefits of the intervention: what improvement is expected.
- Possible risks, discomforts and side effects, including those resulting from not doing the intervention.
- Possible options to the proposed intervention.
- Brief explanation of the reason that leads the physician to choose one and not others.
- Possibility of freely withdrawing consent when desired.
The patient's ability to understand the situation he/she is facing, the possible options for action and the foreseeable consequences of each of them, in order to be able to make, express and defend a decision that is consistent with his/her own scale of values.
When a person is not competent to make a decision that affects him/her, family members or relatives should be contacted to act as guardians.
There are cases of incompetent persons who are also declared legally incompetent; in these situations the judge appoints legal guardians, who will decide for the patient.
If the patient is a minor over 12 years of age (in accordance with the provisions of article 162.1 of the civil code) and, in the physician's opinion, meets the conditions of sufficient maturity to receive the information and give consent, the IC form will be signed by him/her, in addition to his/her parents or legal representative.
Exceptions to the need to obtain IC are as follows:
(a) When the non-intervention poses a risk to public health.
b) When he/she is not capable of making decisions, in which case the right shall correspond to his/her relatives or persons close to him/her.
c) When the urgency does not allow delay because of the risk of irreversible injury or danger of death.
d) Legal imperative.
e) Information clearly harmful to the patient.
f) Waiver of the recipient of the information.
These circumstances must always be justified and documented in the clinical history.
To assess whether the informed consent has been correctly given or if, due to the defective consent, erroneous decisions have been taken that have led to an unexpected medical result that is detrimental to health and which the patient had no duty to bear, consult with expert lawyers in the field so that they can advise you and inform you about the viability of the liability claim. In COCA ADVOCATS, we will inform you, contact us.