Research Consent at the Age of Majority: Preferable but not Obligatory

Abstract

In this issue of , Berkman et al argue that parental permission to obtain samples is sufficient to continue storing them and using them for research after the pediatric participant reaches the age of majority. In this Ethics Rounds, we argue that there are important ethical reasons for obtaining consent from participants when they reach majority. However, these reasons must be balanced with the aim of efficiently and economically conducting research that benefits children. Given current guidance from the relevant regulatory bodies, it remains necessary to obtain consent for the continued use of identified pediatric samples when participants reach the age of majority unless the institutional review board grants a waiver of consent. However, we argue that waivers of consent should more frequently be granted by institutional review boards and used for this purpose.

Whither Health Research

“…Medical maturity may occur before the legal age of majority and grants children certain decision-making rights (Knoppers et al, 2016;Dalpé et al, 2019). In both cases, many authors and ethical guidelines favour re-contacting the participant to obtain their consent for their continued participation or for the continued use of their data and biological specimens (Giesbertz et al, 2014;Knoppers et al, 2016;Brothers and Wilfond, 2018;Patrinos et al, 2022). Participants should be asked to provide their own informed consent or should be notified of their participation or storage of their data and specimens and given the option to opt-out of the research and destroy their information (Giesbertz et al, 2014;Knoppers et al, 2016;Patrinos et al, 2022).…”

The Promise of Patient-Derived Preclinical Models to Accelerate the Implementation of Personalised Medicine for Children with Neuroblastoma

“…The decision from the ethics committees stems from the definition of human research subject (some have argued that if the samples are completely anonymized, consent is no longer needed) and of parental responsibility. Most ethics committees have taken a cautious approach of recommending an attempt at confirming consent [ 29 , 30 ]. Of note, when adult survivors of children cancer were asked if they thought it was important for consent to be confirmed, their responses varied greatly, but all granted consent to use their historical samples for research [ 29 ].…”

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

“…This means, in principle, that biobanks can seek to waive reconsent for all adolescent participants when they reach the age of majority. In commenting on the issue of reconsent both before and after the revisions to the Common Rule, Kyle Brothers and colleagues have argued that there should be a presumption in favor of pursuing reconsent but that there is no affirmative duty to do so [i.e., reconsent does not amount to a moral obligation (3,15,16)]. They reason that allowing consent waivers while still making an attempt to reconsent promotes both adolescents' autonomy and progress in medical research.…”

“…Analyses of the ethics of assent and reconsent have focused on adolescents' developing capacity to make decisions for themselves, especially regarding their bodies and personal information (16,(28)(29)(30)(31). Providing opportunities to make independent decisions in the context of medical research can perhaps help facilitate the development of these capacities.…”