Anticipatory Waivers of Consent for Pediatric Biobanking

Abstract

As pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research. Accordingly, bright‐line legal concepts of majority or competency do not accurately capture the emerging capacity for autonomous decision‐making of many pediatric research participants and unnecessarily complicate the issues about contacting participants at the age of majority to obtain consent for the continued or first use of their biospecimens that were obtained during childhood. We believe the proposed framework provides an ethically sound balance between the concern for potential exploitation of vulnerable populations, the impetus for the federal regulations governing research with children, and the need to conduct valuable research in the age of genomic medicine.

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

“…An implication of this research is that biobank assent materials given to teenagers can be written in a fashion similar to those given to adults for consent (15) 4 . Individual variation in capacity must also be taken into account-some adolescents will lack capacity, as will some adults-but in general this evidence suggests that many adolescents can meet the same minimal capacity threshold as young adults.…”

“…One possible strategy is to place conditions on consent waivers. For example, Hartsock et al (4) argue that consent waivers are appropriate for participants older than 12 if a good faith attempt has been made to recontact them (They suggest three attempts would be sufficient; children enrolled before 12 years of age would still require successful reconsent to remain in the biobank after reaching legal majority). These conditions on waivers would essentially require biobanks to demonstrate that recontact is indeed impracticable.…”

“…While biobanks may reconsent adolescent participants as a matter of policy, an increasingly popular option in the U.S. is to request that Institutional Review Boards (IRBs) waive the requirement to reconsent under certain conditions. Some commentators have argued in favor of IRBs granting such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18 (3,4). Nonetheless, the participation of minors in such research raises a number of ethical issues.…”

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance

“…Arguments in favor reason that given the systematic lack of benefit for the participating child [ 19 ], particularly following the Declaration of Helsinki’s broadening of pediatric participation to include children who would not be directly benefited but from whom research would benefit other children of the same age or with the same condition [ 32 ], the child ought to reap any therapeutic or informational benefit from participating in a biobank [ 3 ]. Yet children are vulnerable as dependents and are therefore more susceptible to harms arising from genetic discrimination, such as familial or public stigma due to undesirable traits or unknown genetic relations and false beliefs about genetic determinism [ 11 , 19 , 20 ]. It is also arguable that children have a right to an “open future” and should have the opportunity to consent themselves to being given any information upon maturity [ 21 ].…”