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Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

Laura M Beskow1, Carrie B Dombeck2, Cole P Thompson2

  • 11] Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA [2] Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.

Genetics in Medicine : Official Journal of the American College of Medical Genetics
|August 22, 2014
PubMed
Summary
This summary is machine-generated.

Experts defined key information for adequate comprehension in biobanking informed consent. This research clarifies essential knowledge for participants to provide valid consent for biobank research.

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Area of Science:

  • Biomedical Ethics
  • Biobanking Research
  • Informed Consent

Background:

  • Federal regulations and guidelines mandate specific information for biobank participant consent.
  • Uncertainty exists regarding the level of participant understanding required for valid informed consent.

Purpose of the Study:

  • To define "adequate comprehension" for biobanking informed consent.
  • To identify specific information participants must understand for valid consent.

Main Methods:

  • A Delphi process involving three online surveys with 51 diverse experts.
  • Experts included scientists, biobank managers, ethicists, and community representatives.
  • Consensus (>70% agreement) was sought on 16 biobank consent topics.

Main Results:

  • Consensus was reached on 15 out of 16 consent topics.
  • The Genetic Information Nondiscrimination Act was the sole topic without consensus on required comprehension.
  • A core set of essential knowledge points for biobanking consent was identified.

Conclusions:

  • The Delphi process successfully defined key comprehension points for valid biobanking consent.
  • This provides a standard for improving consent forms and processes.
  • Offers a metric to evaluate interventions aimed at enhancing participant comprehension.