Assent for a study involving children

1. Definition of Assent

Assent is a child’s affirmative agreement to participate in research. It is not the mere absence of an objection. Unlike "Consent," which is a legally valid agreement given by an adult (Parental Informed Consent), Assent is an ethical requirement reflecting the child's developing capacity for autonomy.

2. Ethical Basis and Guidelines

• Beneficence and Non-maleficence: Protecting the child from harm while allowing potential benefits.
• Respect for Persons: Acknowledging the child as an individual with evolving maturity.
• Regulatory Frameworks: Governed by the ICMR National Ethical Guidelines (2017) and the Declaration of Helsinki.

3. Age Thresholds for Assent (ICMR Guidelines)

While maturity varies, the following age-based approach is generally practiced in India:

• Below 7 years: Assent is generally not required; only parental consent is obtained. Observations of the child's dissent (crying, resisting) must be respected.
• 7 to 12 years: Oral/Verbal assent is obtained in the presence of a witness, documented by the investigator.
• 13 to 18 years: Written assent is mandatory using a simplified "Assent Form" in addition to parental consent.

4. Components of the Assent Process

The process must be tailored to the child's developmental stage using age-appropriate language:

1. Explanation of Purpose: Why the study is being done (e.g., "to find a better way to treat cough").
2. Description of Procedures: What will happen (e.g., "a small prick," "drinking a sweet medicine").
3. Disclosure of Risks/Discomforts: Honest appraisal of pain or time involved.
4. Voluntariness: Explicitly stating the child can say "no" even if parents said "yes."
5. Right to Withdraw: The child can stop at any time without any penalty or loss of care.

5. The Concept of "Dissent"

• Definition: A child’s explicit refusal or negative expression toward participation.
• Ethical Priority: In most non-therapeutic research, the child’s dissent overrides parental consent.
• Exceptions: Dissent may be overruled only if the research intervention is potentially life-saving or offers a direct health benefit unavailable outside the trial.

6. Documentation Requirements

• Assent Form: Must be distinct from the Parental Informed Consent Form (PICF).
• Language: Local language, simple words, short sentences, and use of pictorial aids or comics where applicable.
• Signatures: The child signs (if literate), along with the investigator.

7. Waiver of Assent

The Institutional Ethics Committee (IEC) may grant a waiver if:

• The child is incapable of providing assent (due to age, mental status, or unconsciousness).
• The research involves minimal risk and is of great importance to child health.
• The research is conducted in emergency/life-threatening situations where the child is unstable.