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

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  • 1Indiana University Center for Bioethics, Indiana University School of Medicine, Indianapolis, IN, United States.

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Reconsenting minors in research biobanks upon reaching adulthood presents ethical and regulatory hurdles. This paper reviews these challenges and proposes evidence-based policies for enrolling minors in biobank research.

Keywords:
assentautonomybiobankinginformed consentlearning health systems

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Area of Science:

  • Bioethics
  • Genomic Research
  • Clinical Research

Background:

  • Research biobanks enrolling minors face complex challenges regarding reconsent at age 18.
  • US federal regulations offer limited guidance, permitting practices like reconsent waivers.
  • Ethical debates persist regarding adolescent autonomy in research decision-making.

Purpose of the Study:

  • To review the practical, ethical, and regulatory issues of reconsenting minors in research biobanks.
  • To describe the current ethical discourse surrounding adolescent consent.
  • To outline evidence-based policies for research biobank enrollment of minors.

Main Methods:

  • Literature review of ethical and regulatory frameworks.
  • Analysis of current practices in research biobanks.
  • Synthesis of ethical arguments on adolescent autonomy.

Main Results:

  • Federal regulations allow for reconsent waivers in research biobanks.
  • Arguments for waivers cite low research risks and practical difficulties in recontacting participants.
  • Significant ethical considerations surround the age of autonomous decision-making for adolescents.

Conclusions:

  • Developing clear, evidence-based policies is crucial for ethically enrolling minors in research biobanks.
  • Addressing reconsent challenges requires balancing participant protection with research feasibility.
  • Further ethical deliberation is needed on adolescent capacity for research participation.