Informed Consent for Genetic Research

Jeffrey R. Botkin1

1 University of Utah, Salt Lake City, Utah
Publication Name:  Current Protocols in Human Genetics
Unit Number:  Unit 1.16
DOI:  10.1002/0471142905.hg0116s66
Online Posting Date:  July, 2010
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Genetic research often utilizes or generates information that is potentially sensitive to individuals, families, or communities. For these reasons, genetic research may warrant additional scrutiny from investigators and governmental regulators, compared to other types of biomedical research. The informed consent process should address the range of social and psychological issues that may arise in genetic research. This paper addresses a number of these issues, including recruitment of participants, disclosure of results, psychological impact of results, insurance and employment discrimination, community engagement, consent for tissue banking, and intellectual property issues. Points of consideration are offered to assist in the development of protocols and consent processes in light of contemporary debates on a number of these issues. Curr. Protoc. Hum. Genet. 66:1.16.1‐1.16.13 © 2010 by John Wiley & Sons, Inc.

Keywords: consent; regulatory; disclosure; ethics; genetic testing

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Table of Contents

  • Introduction
  • Exceptions to Informed Consent
  • Regulatory Requirements for Informed Consent in Research
  • Genetic Exceptionalism
  • Risks of Genetic Research
  • Community Consent and Engagement
  • Research with Biological Samples
  • Intellectual Property Issues
  • Conclusions
  • Literature Cited
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Literature Cited

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Internet Resources
  Federal Regulation 45CFR46.
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