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Related Experiment Videos

Informed consent for genetic research on stored tissue samples

E W Clayton1, K K Steinberg, M J Khoury

  • 1Department of Pediatrics, Vanderbilt University, Nashville, Tenn, USA.

JAMA
|December 13, 1995
PubMed
Summary

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Informed consent is crucial for genetic research on stored tissue samples, with specific guidelines for linkable versus anonymous samples. Further ethical and legal considerations are warranted for future studies.

Area of Science:

  • Genomic Medicine
  • Bioethics
  • Legal Medicine

Background:

  • Genetic research utilizing stored human tissue samples presents complex ethical and legal challenges.
  • Balancing research benefits with individual privacy rights is paramount in genomic studies.
  • Existing frameworks for informed consent require adaptation for future genetic research applications.

Framework:

  • Recommendations developed through a multi-stakeholder consensus process involving scientists, ethicists, lawyers, and consumers.
  • The framework addresses informed consent for both future tissue collection and the use of existing stored samples.
  • Key considerations include the distinction between linkable and anonymous samples and conditions for waiver or limitation of consent.

Implementation:

  • Informed consent is mandatory for genetic research on linkable stored samples, with defined exceptions.
Keywords:
Biomedical and Behavioral ResearchCenters for Disease Control and PreventionGenetics and ReproductionNational Institutes of HealthProfessional Patient Relationship

Related Experiment Videos

  • Genetic research on anonymous samples generally does not require informed consent, though re-identification protocols may warrant consideration.
  • Institutional Review Boards (IRBs) should review all protocols involving stored samples for genetic research.

    • Implications:

    • Establishing clear guidelines for informed consent in genetic research protects participants and facilitates ethical scientific advancement.
    • This framework supports responsible innovation in genomics while upholding individual autonomy and privacy.
    • Further research and societal dialogue are necessary to address evolving ethical and legal landscapes in genetic research.