Consent and assent in research on children
ThemesConsent and assent in research on children
What is this about?
Research involving children presents unique ethical challenges, especially regarding obtaining consent for participation.
Two approaches must be followed to ensure that research involving children is transparent. The first is consent, which requires complete and informed consent from adults who understand all aspects of the research; the second is assent, which is not legally binding but reflects the children’s agreement, as their age prevents them from giving fully informed consent.Why is this important?
Providing assent alongside consent in research involving children is essential for several reasons.
Assent protects participants' rights by ensuring that the child's views are acknowledged and respected, even though the child is not legally able to give fully informed consent.
Upholding the principles of consent and assent is essential for conducting research ethically, honoring both autonomy and dignity.
Applying these principles ensures that all parties involved in the research are adequately informed and that the interests of all participants, especially when dealing with vulnerable groups such as children, are protected.For whom is this important?
What are the best practices?
Protecting the rights and well-being of children and adolescents is a key reason for requiring parental consent and child assent in research.
According to the International Ethical Guidelines for Health-related Research Involving Humans, prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), published in 2016.
Children and adolescents should take part in health-related research unless there is a strong scientific rationale for excluding them. Their unique physiology and health needs require special attention from researchers and ethics committees. However, their developing emotional and cognitive abilities may render them more vulnerable; without proper support, they might not be able to fully protect their interests. Therefore, additional protections are essential to ensure their rights and well-being in research.
Before undertaking research involving children and adolescents, the researcher and the research ethics committee must ensure that: a parent or a legally authorized representative of the child or adolescent has given permission; and that the agreement (assent) of the child or adolescent has been obtained in keeping with the child’s or adolescent’s capacity, after having been provided with adequate information about the research tailored to the child’s or adolescent’s level of maturity.
In general, a child or adolescent's refusal to participate or continue in the research must be respected unless, in exceptional circumstances, research participation is considered the best medical option for the child or adolescent.In Detail
Legally, minor children and adolescents cannot give legally valid informed consent, but they can actively participate in research discussions—this is called assent.
This means that, with age-appropriate information, they are involved in the decision-making process based on their capacities rather than merely not expressing dissent. Obtaining assent must consider age, individual circumstances, life experiences, emotional and psychological maturity, and the family situation.
As adolescents approach the age of majority, their agreement may be ethically equivalent to consent, with parental consent regarded as "co-consent." If adolescents reach the legal age of majority during the research and become capable of independent informed consent, their written consent for continued participation must be obtained.contributed to this theme. Latest contribution was Feb 23, 2025
