Feedback of individual genetic results to research participants: in favor of a qualified disclosure policy

Hum Mutat. 2011 Aug;32(8):861-7. doi: 10.1002/humu.21518. Epub 2011 Jun 30.

Abstract

This article discusses whether and when researchers have a moral obligation to feedback individual genetic research results. This unsettled debate has rapidly gained in urgency in view of the emergence of biobanks and the advances in next-generation sequencing technology, which has the potential to generate unequalled amounts of genetic data. This implies that the generation of many known and unknown genetic variants in individual participants of genetics/genomics research as intentionally or collaterally obtained byproducts is unavoidable. As we conclude that valid reasons exist to adopt a duty to return genetic research results, a qualified disclosure policy is proposed. This policy contains a standard default package, possibly supplemented with (one or more of) three additional packages. Whereas the default package, containing life-saving information of immediate clinical utility, should be offered routinely and mandatory to all research participants, offering (one of) the three additional packages is context-specific. Such a qualified disclosure policy in our opinion best balances the potential benefits of disclosure with the potential risks for research participants and the harms of unduly hindering biomedical research. We appeal to the genetics community to make a joint effort to further refine the packages and set thresholds for result selection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Beneficence
  • Comprehension
  • Disclosure / ethics*
  • Disclosure / legislation & jurisprudence
  • Genetic Research / ethics*
  • Humans
  • Moral Obligations
  • Personal Autonomy
  • Professional Autonomy
  • Research Personnel / ethics*
  • Research Subjects*