International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

Genet Med. 2012 Apr;14(4):484-9. doi: 10.1038/gim.2012.13. Epub 2012 Feb 16.


Managers of genomic biobanks constantly face ethical and legal challenges ranging from issues associated with the informed consent process to procedural concerns related to access by researchers. Yet, with the availability of next-generation sequencing technologies, one topic is emerging as the focus of ongoing debate: the return of individual research results and incidental findings to participants. This article examines this topic from an international perspective, where policies and guidelines discussing the matter in the context of genomic biobanks and genomic research are analyzed and commented. This approach aims to highlight the shortcomings of these international norms, mainly the danger arising from both the therapeutic misconception and the conflation of research results with incidental findings. This article suggests some elements to consider in order to complement available guidance at the international level.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Genomics / ethics*
  • Genomics / methods
  • Genomics / statistics & numerical data
  • Humans
  • Incidental Findings*
  • Internationality
  • Medical Informatics / ethics*
  • Medical Informatics / methods
  • Medical Informatics / statistics & numerical data
  • Research Subjects*
  • Researcher-Subject Relations / ethics
  • Tissue Banks / ethics*
  • Truth Disclosure / ethics