Informed assent
ThemesInformed 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].
- ↑ 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.
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 [1].
- ↑ Poston RD. Assent Described: Exploring Perspectives From the Inside. J Pediatr Nurs. 2016;31(6):e353-e65.
For whom is this important?
The Embassy Editorial team, Iris Lechner, Rosie Hastings contributed to this theme. Latest contribution was Oct 20, 2020
