Themes

Informed assent

What is this about?

Informed assent is a process through which minors agree to participate in clinical trials. This is different from informed consent, because minors cannot provide consent in the full meaning of the word, as they don’t meet the legal age requirements. For minors, consent is provided by parents or legal guardians, and this process of acquiring both consent and assent is called a dual consent procedure (1).

Why is this important?

In order to conduct clinical research in an ethical manner, informed assent from children and informed consent from their legal guardians must be sought. Respecting both children’s wishes and asking parents’ permission is necessary in order to respect laws and rules of good clinical practice, and to respect patients’ autonomy, despite the fact that the patient is a minor (2).

For whom is this important?

Research subjects, Ethics committee members, Researchers, Health care professionals, Junior researchers, Senior researchers, General public

What are the best practices?

Throughout the world, different practices have been developed to protect the interest of children participating in clinical trials. In the United States, researchers have to ask permission from both minors and their parents or legal guardians. Permission from minors has to be definitive and the lack of objections cannot be defined as assent. When asking for assent, researchers should present all relevant information in a simple and understandable language, according to the child’s level of understanding (1). In the European Union, different practices exist, and some countries provide different legal and mandatory or recommended ages for assent (review of practices provided in tools section). In some situations, giving informed consent is not necessary. For example, when the only treatment for a disease is only available through clinical trials (3).

References

1. Hein IM, De Vries MC, Troost PW, Meynen G, Van Goudoever JB, Lindauer RJ. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research. BMC Med Ethics. 2015;16(1):015-0067.

2. Poston RD. Assent Described: Exploring Perspectives From the Inside. J Pediatr Nurs. 2016;31(6):e353-e65.

3. American Academy of Pediatrics Committee on Bioethics: Guidelines on foregoing life-sustaining medical treatment. Pediatrics. 1994;93(3):532-6.

Marin Viđak contributed to this theme.

Latest contribution was May 29, 2019