What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

Abstract

Key points Informed assent/consent remains one of the most challenging issues in pediatric drug trials, with no trustworthy clue or guidance to determine what type of information and the extent of information to be provided in an informed assent/consent form. Based on our empirical data, risk–benefit aspects related to trial participation were perceived to be more important than general information or technical details of the trial, although all the elements are deemed useful, to a certain degree, to both child participants and their parents. Both child participants and their parents did not want to read an unduly long form, with the maximum acceptable page length of no more than 5–8 pages.

Keywords

• Informed consent
• Parental consent
• Assent
• Consent forms
• Ethics
• Clinical trials