Beyond Biobanking: Future Use of Specimens and Data from Pediatric Participants

Singleton, Megan Kasimatis; Moon, Margaret; Jorgensen, E. Verena

doi:10.1016/j.jpeds.2020.01.021

Cited by 3 publications

(3 citation statements)

References 7 publications

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“…However, the challenge comes in determining the types of decisions appropriate to different stages of development. Singleton and colleagues explain, "Along the developmental trajectory, children move steadily from minimal autonomy to robust autonomy; respect for the developing autonomy of children is future-focused" (32). The assent process is meant to accommodate minors' growing decision-making capacity by reserving major or particularly demanding decisions until they are more cognitively capable.…”

Section: Developing Capacity To Make Consent Decisionsmentioning

confidence: 99%

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

Kasperbauer

Halverson

2021

Front. Med.

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Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.

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Section: Developing Capacity To Make Consent Decisionsmentioning

confidence: 99%

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

Kasperbauer

Halverson

2021

Front. Med.

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“…For example, pediatric biobanking is complicated by a child’s generally assumed lack of legal capacity to consent to the collection and ongoing storage of their samples, particularly prior to the teenage years [ 7 ]. Furthermore, given the varying ages and maturity of children involved, questions arise as to whether, and to what extent, child participants should be involved in the original consent process and their assent or refusal respected [ 8 – 10 ].…”

Section: Introductionmentioning

confidence: 99%

“…Given the ongoing nature of biobank storage, children also reach maturity and adulthood while the original research is ongoing or have reached maturity when new uses of the samples are proposed. Disagreement exists about gaining consent from a participant upon reaching adulthood due to the feasibility and costs of this process and whether human research ethics committees can waive this requirement [ 7 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

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

Prince,

Then,

O’Grady

2024

Eur J Pediatr

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Biobanking—the storage of human biological samples, including tissue, blood, urine, and genetic data—raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking—including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks. Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known:• Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues—in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New:• Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

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