What should informed consent contain is a question that has arisen for many of us due to its obligatory nature in many medical procedures or dental interventions, for example. It is important to know in depth its conditions of use, as well as its content. In this article, we summarise the key elements of the document, as well as a summary of what the informed consent should essentially contain.
Few issues are as sensitive as those related to the health and privacy of individuals. To protect citizens in these areas, national and EU authorities have developed regulatory frameworks adapted to the different circumstances that may arise.
One of the key aspects that refers to health and the care of health-related information is informed consent. In order to regulate this matter, Law 41/2002 is in force in Spain, to which the General Data Protection Regulation, the GDPR, must be added.
The most relevant concepts of these legal texts regarding informed consent are described below, in order to clarify in which cases it is required, who must sign it and what it must contain as a minimum.
What the informed consent must contain according to the GDPR
Article 4.11 of the General Data Protection Regulation (GDPR) defines consent as follows:
“Consent is any freely given, specific, informed and unambiguous indication of the data subject’s agreement, either by a statement or by a clear affirmative action, to the processing of personal data relating to him or her.”
According to this regulation, the informed consent document must meet 4 fundamental requirements to be considered as such. These are:
- Free
- Specific
- Granular
- Acreditable
Free
The person giving consent must do so freely. This means that the option of refusal must be clearly provided for, in addition to the option of acceptance. Finally, this freedom also implies that there are no negative consequences for the person in the event of non-acceptance of consent.
Specific
By this condition we mean that the information that is disclosed must be used solely and exclusively for the purposes for which it has been accessed by consent.
Of course, these purposes should not be changed or extended once the person signing the consent has signed this document.
Granular
Granularity means that there must be an option to give or withhold consent for each purpose of the data being transferred. In addition, there are some headings that the informed consent must contain:
- Need
- Temporality
- Finality
- Rights
- information from the responsible parties
Acreditable
The latter condition refers to the fact that the entire content of the consent must be verifiable and verifiable at any time it is required. This provides all the legal guarantees thanks to the possibility of consulting the details of the consent, details that will remain unalterable once the signature has been executed.
GDPR and informed consent in the health sector
Within the General Data Protection Regulation, we must pay special attention to the references made in this text with respect to the health sector. The new GDPR includes data relating to health among the special categories, the processing of which is subject to the following basic conditions:
- To protect the vital interests of the data subject or of another person not capable of consenting.
- For the purposes of preventive medicine, worker capacity assessment, health or social care or treatment, management of health and social care systems and services, or under a contract with a health professional.
- For reasons of public interest in the field of public health, protection against serious cross-border threats to health, to ensure high standards of quality and safety of healthcare and of medicinal products and medical devices.
- For the purposes of scientific or historical research or statistical purposes, complying with requirements of proportionality with the aim pursued, essentially respecting data protection and providing for adequate and specific measures to protect fundamental rights and interests of the data subject.
Spanish regulations on informed consent
Continuing with the field of health, informed consent is described in the Spanish legal framework by Law 41/2002, of 14 November, the basic law regulating patient autonomy and the rights and obligations regarding clinical information and documentation.
“Informed consent: the free, voluntary and informed 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.
By means of informed consent, the patient declares that he/she has received and understood everything that the healthcare professional has conveyed to him/her regarding the proposed treatment.
In some cases, it is not the patient who must sign the consent, but a legal representative. These situations covered by the law are as follows:
- Be declared incompetent by a judge.
- Be under 16 years of age if you are not intellectually or emotionally incapacitated.
- If the minor is 12 years of age or older, consent shall be given by the minor’s legal representative after hearing the minor’s opinion.
- If the minor is over 16 years of age or emancipated and the situation involves a serious risk, the opinion of the parents or legal representatives shall be taken into consideration.
- Inability to make decisions, either because of their physical or mental condition.
It is very common for this consent to be expressed by voice, however, in some particular cases Law 41/2002 obliges it to be in writing in situations such as:
- Surgical intervention.
- Diagnostic techniques and invasive treatments.
- When there is a significant and foreseeable risk to the patient or when the results of the procedure are doubtful.
We will also encounter situations where an informed consent document is waived. These are:
- When the patient expresses his or her wish in writing not to receive the information.
- When there is a risk to public health due to sanitary reasons established by law.
- When there is an immediate serious risk to the physical or psychological integrity of the patient and it is not possible to obtain his or her authorisation, consulting, when circumstances permit, his or her relatives or persons with whom he or she is de facto related.
What the informed consent must contain according to Law 41/2002
Law 41/2002 sets out the minimum elements that informed consent must contain, which are as follows:
- The relevant or significant consequences that the intervention is certain to bring about.
- Risks related to the patient’s personal or professional circumstances.
- Risks likely to occur under normal conditions, according to experience and the state of the art or directly related to the type of intervention.
- Contraindications.
As we have seen, everything related to what informed consent should contain is duly regulated, both at Spanish and European level, both being perfectly compatible.
In this way, both parties involved have sufficient support to guarantee the patient’s rights and to enable healthcare staff to act in accordance with the patient’s wishes and the regulations in force.
Viafirma offers solutions that speed up the digital signature of the informed consent, either in situ through biometric signature or remotely through other types of electronic signature included in our tools. Do you want to know more? Contact us and we will inform you in detail.