What should an informed consent include?

Informed consent is a document that requires to be signed in many situations, so you should be fully aware of its conditions of use, as well as of its content. Below there is a summary of what is considered most important when used.

Few issues are as sensitive as those related to people’s health and privacy. To protect citizens in these matters, both national and community authorities have developed regulatory frameworks tailored to different case scenarios. 

One of the key aspects of health and protecting health information is informed consent. In Spain, Law 41/2002 is in force to regulate this topic, to which we add the GDPR.

Below we outline the most relevant concepts of these legal texts in terms of informed consent, in order to be clear when it should be used, who should sign it and mandatory information

Informed consent according to the GDPR 

Article 4.11 from the GDPR defines consent:

‘’Consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her’’

This regulation clarifies that consent must meet 4 fundamental requirements. Let’s unpack these concepts:

  • Freely given
  • Specific
  • Granular
  • Accreditable

Freely given

Means the data subject is not obliged to give consent. This means both the option of refusing and accepting the consent shall be considered. Finally, this freely given consent implies that there are no negative consequences for the data subject in the event of not agreeing to give consent.


This means that the information made available must be used solely and exclusively for the purposes for which it has been accessed by request for consent.

Naturally, these purposes should not be changed or extended once the person has signed the consent


Granularity means there must me an option to give or withhold consent for each purpose of the content on the consent. In addition, the following headings must appear in the document:

  • Need
  • Timing
  • Purpose
  • Rights
  • Information from the people involved


This last condition refers to the fact that the content on the consent must be verifiable and comparable whenever it is required. Legal guarantees are included when consulting the details of the consent. These details will remain unchanged once the document is signed.

informed consent

GDPR and informed consent in the health industry

Within the General Data Protection Regulation, we must pay special attention to the health sector. The special categories of the new GDPR include data relating to health which is processed subject to the following conditions:

  • To protect vital interests of the data subject or who is not qualified to consent.
  • For the purposes of preventive medicine, assessment of the worker’s ability, social or health therapy and assistance, managing health and social care systems and services, or under an agreement/contract with a healthcare professional.
  • For reasons of public interest in the field of public health, protecting against serious cross-border threats to health, ensuring high levels of quality and safety of the healthcare system, medicines and medical products.
  • For scientific, historical research or statistical purposes, complying with principles of proportionality to achieve the objective pursued, respecting data protection and laying down appropriate and specific measures to protect the fundamental rights and interests of the data subject.

Spanish regulations on informed consent

In the context of the health industry, informed consent is included in the Spanish legal framework in Law 41/2002 Of 14 November, Regulating Patient Autonomy And Rights And Obligations Regarding Clinical Information And Documentation 

‘’Informed consent: A subject’s free and voluntary expression of his or her willingness to give consent, after receiving adequate information, to allow an activity to take place that may affect his or her health.’’

By giving informed consent, the patient declares that he/she fully understands everything the health professional has told him or her about the proposed treatment.

In some cases, the patient will not need to sign the consent, but a legal representative. These situations are covered by the law as follows:

  • To be declared incompetent by a judge.
  • Be under 16 years of age if the minor is not intellectually or emotionally disabled
  • If the minor is under 12 years of age, consent will be given by the minor’s legal representative after hearing the minor’s opinion.
  • If the minor is over 16 years old or is emancipated and the situation involves a serious risk, the opinion of the parents or legal representatives will be taken into consideration.
  • Incapacity to make decisions due to because of the patient’s physical or mental condition

It is very common for this consent to be expressed orally, however, in some particular cases Law 41/2002 requires that this consent shall be in writing in situations such as:

  • Surgical intervention.
  • Diagnostic techniques and invasive procedures.
  • When there is a notable and predictable risk for the patient or when the results of the procedure are doubtful.

We will also encounter situations where informed consent does not need to be signed. These are:

  • When the patient expresses a desire in writing not to receive the information
  • When there is a risk to public health due to health 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 authorization, consulting with his/her family or relatives.

Content of an informed consent

This Law 41/2002 sets out the minimum requirements for informed consent, which are:

  • The relevant or important consequences that the intervention will certainly bring about.
  • The risks related to the patient’s personal or professional circumstances.
  • The probable risks under normal conditions, according to experience, the state of science or those directly related to the type of intervention.
  • Contraindications.

It is clear that everything relating to informed consent is duly regulated, both at Spanish and European level, and both are perfectly compatible.

In this way, both consents are capable to protect the rights of the patient as well as enabling the healthcare professional to act freely complying with the current regulation.

At Viafirma we have solutions to speed up the digital signature of the informed consent, either face-to face encounters by means of the biometric signature or remotely thanks to other ways of signing digitally available in our tool. Would you like to know more? Get in touch and we will gladly provide you with further information.