Overview
Definition:
Informed consent is a voluntary agreement given by a legally competent individual after receiving adequate information about a medical procedure or treatment, including its risks, benefits, and alternatives
Assent is a child's affirmative agreement to a medical intervention, which is sought when the child is able to understand the nature, risks, and benefits of the proposed intervention but is not legally capable of providing consent
It is a process rather than a single event.
Epidemiology:
The principles of consent and assent apply to all pediatric patient encounters involving medical decision-making, from routine check-ups to complex interventions
Age-appropriate communication strategies are crucial for effectively obtaining assent from children across various developmental stages.
Clinical Significance:
Upholding principles of consent and assent is a fundamental ethical and legal obligation in pediatrics
It respects the autonomy of both parents/guardians and, to the extent possible, the child
Proper adherence prevents ethical breaches, legal challenges, and fosters trust between healthcare providers and families, ultimately leading to better patient outcomes and adherence to treatment.
Age Considerations
Infancy Early Childhood:
For infants and very young children (typically under 6-7 years), assent is not typically formally sought as their cognitive capacity to understand is limited
Decisions are made based on parental/guardian consent, guided by the child's best interests.
Middle Childhood:
Children aged approximately 7-12 years can often provide assent
They can understand basic explanations about treatments, their purpose, and potential discomfort
It is important to explain procedures in simple terms and allow them to ask questions
Their agreement should be sought, even if parental consent is the legal basis for treatment.
Adolescence:
Adolescents (typically 13 years and older) have a greater capacity for understanding and making decisions
While parental consent is usually still required, the adolescent's assent becomes increasingly important, especially for sensitive issues or long-term treatments
In some jurisdictions, mature minors may have the legal right to consent or refuse treatment independently.
Special Populations:
Children with developmental disabilities, chronic illnesses, or those who have experienced trauma may require tailored approaches to communication and assent-seeking, considering their specific cognitive and emotional capacities.
Clinical Presentation
Decision Making Context:
The need for consent/assent arises in any situation requiring medical intervention, including diagnostic procedures, therapeutic treatments, surgeries, participation in research, and provision of vaccinations.
Elements Of Informed Consent:
Key elements include: Disclosure of information (diagnosis, prognosis, nature/purpose of treatment, risks/benefits, alternatives, prognosis without treatment)
Understanding (patient/guardian comprehends the information)
Voluntariness (decision is free from coercion or undue influence)
Competence (patient/guardian has the legal capacity to make decisions).
Elements Of Assent:
Assent involves: Communicating information in an age-appropriate manner
Allowing the child to ask questions
Listening to the child's wishes and concerns
Respecting the child's agreement or disagreement with the proposed intervention, while balancing this with parental consent and the child's best interests.
Diagnostic Approach
History Taking:
Assess the child's developmental stage and cognitive ability
Understand the family's cultural and religious beliefs regarding medical decision-making
Identify any prior experiences or knowledge the child or family may have regarding the condition or treatment
Document the consent/assent process meticulously.
Legal Framework Understanding:
Familiarize yourself with local and national laws regarding consent and assent for minors, including the concept of mature minors and exceptions to consent requirements (e.g., emergencies, court orders)
Consult legal counsel if unsure.
Communication Strategies:
Use simple language, visual aids, and storytelling for younger children
For adolescents, engage in open dialogue, address their concerns about privacy, body image, and future implications
Involve child life specialists or social workers when appropriate.
Documentation:
Detailed documentation is crucial
Record who provided consent/assent, the information disclosed, the patient's/guardian's understanding, their decision, and the date/time
For assent, document the child's agreement and any concerns expressed
Signed consent forms are standard for invasive procedures.
Management
Obtaining Consent For Treatment:
For children under the age of majority, informed consent is typically obtained from parents or legal guardians
Full disclosure of the medical situation, proposed treatment options (including risks, benefits, and alternatives), and prognosis is essential
The process should be collaborative, respecting the parents' role as primary decision-makers.
Obtaining Assent From Child:
For children who can understand, their assent should be sought and respected
This involves explaining the procedure or treatment in age-appropriate terms, allowing them to ask questions, and giving them a chance to agree or disagree
While not legally binding, a child's dissent should be carefully considered and explored, especially in cases of prolonged or burdensome treatments.
Emergency Situations:
In life-threatening emergencies where obtaining parental consent is impossible, treatment to preserve life or health can proceed under implied consent
Once the emergency is over and the parents are available, informed consent should be obtained for further management
If a child is deemed a mature minor, their assent or consent might override parental refusal in specific critical circumstances as per legal guidelines.
Refusal Of Treatment:
If parents refuse life-saving treatment for their child, healthcare providers have an ethical and legal obligation to advocate for the child's best interests
This may involve seeking legal intervention (e.g., court order) to authorize necessary treatment
Similarly, a mature minor's refusal must be carefully assessed and respected within legal parameters.
Key Points
Exam Focus:
Understand the legal and ethical basis of consent and assent in pediatrics
Differentiate between consent and assent and when each is applicable
Recognize the role of parental consent and the evolving autonomy of the child.
Clinical Pearls:
Always tailor your communication to the child's developmental stage and the parents' understanding
Be patient, honest, and empathetic
Document thoroughly
When in doubt, consult senior colleagues, ethics committees, or legal counsel.
Common Mistakes:
Failing to obtain informed consent from parents
Neglecting to seek assent from older children
Using medical jargon that patients/parents don't understand
Coercing decisions
Inadequate documentation of the consent/assent process
Assuming a child's wishes are irrelevant.