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:
- Explanation of Purpose: Why the study is being done (e.g., “to find a better way to treat cough”).
- Description of Procedures: What will happen (e.g., “a small prick,” “drinking a sweet medicine”).
- Disclosure of Risks/Discomforts: Honest appraisal of pain or time involved.
- Voluntariness: Explicitly stating the child can say “no” even if parents said “yes.”
- 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.