As of February 20, 2025, Resolution 309 of 2025 came into force, establishing guidelines to guarantee the right to information, participation in health decision-making and the exercise of the progressive and contextual autonomy of children and adolescents, through assent and the informed consent process, but its application in clinical laboratories, in sampling and services that perform POCT tests poses challenges. Based on the same resolution, articles related to ethics in the decision making of minors, and knowledge of the service, we will review one by one the aspects that will provide the key to its application:

1. Mechanisms to formalize the decision of an assistance act in a child or adolescent:

Pediatric assent (PA), pediatric consent (PC) or surrogate consent (SC). The following table facilitates the understanding of these terms taking into account the provisions of Resolution 309:

Table 1. Prepared by the authors based on the provisions of resolution 309 of 2024, article three and technical annex number 13.

2. Evaluation of the level of risk of the assistance act:

In order to understand the risk of each assistance act, the definitions established in Resolution 309 of 2025 are adopted:

Low risk: Assistance with evident benefits for health, integral development and health maintenance. No risk or minimal risk to the integrity and integral development of the child or adolescent.

Medium risk: Care with benefits for health, integral development and health maintenance. With minimal to moderate risk to the integrity and integral development of the child or adolescent.

High risk: Care acts that may result in health benefits, integral development and health maintenance. With high risk for the survival, integrity and integral development of the child or adolescent.

3. Child’s capacity for decision making:

The capacity of the child or adolescent is evaluated based on two aspects adopted from Resolution 309 of 2025:

Progressive and contextual autonomy in health care: Principle of agency for self-determination, setting limits for oneself and others, based on personal characteristics, needs, capabilities, beliefs and values.

Health decision making skills: Decision making in the medical field is defined by the concurrence of the following skills: it is considered a truthful method if this indicator remains within a range of +2 or -2 standard deviations. Values that exceed these limits should be rigorously analyzed in order to determine the cause and define a plan of action.

 

It is the set of these skills and their development that allows people to voluntarily express a preference, express their concerns, think and choose independently, evaluate the benefits, dangers, risks and potential harms.

4. Intensity in accompanying children and adolescents in decision making:

will be determined by the following rules defined in resolution 309 of 2025:

*In emergency cases where the situation warrants immediate intervention, the physician may intervene without the patient’s consent or assent. The decision must always be weighed against the best interest of the minor.

Own elaboration, rules adopted from resolution 309 of 2025, article four.

5. Other relevant aspects of the resolution, grounded to the clinical diagnosis are:

Complementing the criteria established in Resolution 309, the algorithm (Figure 1) established by Montse Esquerda, Josep Pifarrea, and Sabel Gabaldónd is also analyzed and the application of each criterion in the clinical laboratory is indicated:

Esquerda M, Pifarrea J and Gabaldónd S. (2010). Algorithm in decision making in minors. In “Assessment of competence to make decisions about their own health in minor patients”.Source:

https://www.researchgate.net/publication/285867467_El_consentimiento_informado_en_el_menor_Evaluacion_de_la_competencia_para_decidir_sobre_su_salud

Maturity: “The age of 14 years is the moment that, in general, it has been established that minors may have the maturity to begin to assume obligations and responsibilities in society”. Taking this text from resolution 309 based on judgment C246 of 2017, the frame of reference for defining maturity is raised, having as an exception those over 14 years of age who have clinical conditions that prevent the exercise of autonomy.

Severity of the decision: Severity can be interpreted as the level of risk to which the minor is exposed with the procedure to be performed. Having the definitions of each level in Resolution 309, it can be determined that the sampling procedures are classified as low risk because they promise obvious benefits, no risk, or low risk.

Situational factors: Among the situational factors may be present in the sampling service: the presence of pain or discomfort taking medication that alters the level of consciousness, external group or family pressure, emotional state (stress, fear or panic, depression), chronic illness, and urgency of the examination.

As a key to guarantee the right of children and adolescents to make health decisions in the laboratory and to comply with Resolution 309 of 2025, the application of pediatric assent (PA), pediatric consent (PC) or substitute consent (SC) is proposed, as follows: PA: Assent, SC: Substitute Consent, PC: Pediatric Consent.

It is hoped that this analysis of the resolution, bibliography and other factors analyzed will provide greater clarity in the practical application of Resolution 309 of 2025 and thus guarantee the rights of children and adolescents in the taking of samples, clinical laboratories and other services that perform POCT (Point of Care Testing).

Written by

Yenny Marcela Gutiérrez Salazar, Consultant in regulations and processes.