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Normative Issues in Next Generation Sequencing Gene Testing.

Na-Kyoung Kim1

  • 1Department of Law, Sungshin Women's University, Seoul 02844, Korea.

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Next-generation sequencing (NGS) gene testing in Korea presents ethical challenges. This review examines normative issues in wet and bioinformatics analysis, applying bioethics and international guidelines for clinical practice.

Keywords:
AcetaminophenIncidental findingsInformed consentNext generation sequencing (NGS) gene testingPresumptive consentSecondary findingsUnsolicited findings

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Area of Science:

  • Genetics
  • Bioethics
  • Medical Law

Background:

  • Next-generation sequencing (NGS) gene testing is increasingly commercialized.
  • Ethical and legal issues surrounding NGS testing in Korea remain under-explored.
  • Normative challenges arise throughout NGS testing, from sample analysis to data interpretation.

Purpose of the Study:

  • To review ethical and legal problems in NGS gene testing in Korea.
  • To apply international guidelines and bioethical principles to clinical practice.
  • To address normative issues in both wet and bioinformatics analysis stages of NGS.

Main Methods:

  • Review of normative issues in NGS gene testing.
  • Application of international guidelines and bioethical principles.
  • Analysis of ethical considerations in wet and bioinformatics stages.

Main Results:

  • Presumptive consent may justify additional wet analysis if a medical relationship and gene correlation are established.
  • Unsolicited findings in bioinformatics analysis require careful consideration.
  • ACMG guidelines are crucial for evaluating unsolicited findings, especially regarding disease relevance and potential psychological harm.

Conclusions:

  • Ethical frameworks are needed for NGS gene testing in Korea.
  • Presumptive consent and clear correlation are key for additional testing.
  • Managing unsolicited findings requires adherence to guidelines like ACMG's to balance patient benefit and psychological impact.