Informed Consent in Pediatric Research

Abstract

Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in. Key PointsThe appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician.There is compelling evidence that most children younger than 9 years of age lack the capacity to consent for participation in clinical trials.In some jurisdictions, institutional review boards approve the participation in drug research of healthy volunteering children during early adolescence.

Knowledge and views of parents regarding ethical aspects of medical research among their children in Jordan

“…Information provided to this age group should be tailored to their developmental stage to accommodate their limited capabilities and experiences . Children do not have the legal capacity to give ‘consent’ to participate in medical research; instead, they can provide ‘assent’ after being fully informed by researchers who provide them with adequate material that suits their age . Different guidelines have been released by the European member states regarding the participation of children in research.…”

“…The main components and principles of consent that are generally acceptable in Western countries are also applied to other countries including Islamic regions. Generally, researchers decide whether to obtain assents and/or consents based on the onset of puberty; however, legal ages that mandate obtaining assents and/or consents may vary by geography, culture and legislative history in different countries …”

Parental Perceptions About Informed Consent/Assent in Pediatric Research in Jordan

“…Therefore, assent is an opportunity for children to decide whether or not to take part in a study (Giesbertz, Bredenoord, & van Delden, 2014). The guardian consent and child’s assent should be obtained prior to a child’s participation in research (Leibson & Koren, 2015; Unguru, 2011). This process is crucial to preserve children’s rights during their participation in research, including protection from possible harm, violation of privacy, legal risks, and psychological or emotional stress (De Lourdes Levy, et al, 2003; Ngui, Warner, & Roberts, 2014).…”

Investigator‐initiated randomized controlled trials in children with epilepsy: Mission impossible?

“…Even in our trial, with two established first‐choice AEDs, randomization was one of the reasons for parents to refuse participation. Obtaining informed consent is also an issue because in the Netherlands both parents need to give permission, and from 12 years of age the child must sign as well . As shown in the Informed Consent and Assent Tool kit, differences between national consent procedures exist in Europe .…”