Broadening research consent in the era of genome-informed medicine

Genet Med. 2012 Apr;14(4):432-6. doi: 10.1038/gim.2011.76. Epub 2012 Mar 15.


Genetic variant associations and advances in research technologies are generating an unprecedented volume of genomic data. Whole-genome sequencing will introduce even greater depth to current data sets and will propel medical research and development. Yet as one area of biomedical research evolves, another stagnates: informed consent. As presently employed, informed consent is not entirely attuned to the era of whole-genome sequencing. The greatest value of genomic data lays in its accessibility over time; the current model of informed consent restricts the use of data and does not readily accommodate prospective basic and clinical research, a priori research, or opportunities to act upon incidental findings. It also disengages the research participant from the discovery process, discouraging the provision of research results that may have clinical value to that individual. A revisited informed consent approach-the Informed Cohort Oversight Board (ICOB)-has been proven successful at consenting individuals to a model which facilitates the simultaneous construction of longitudinal data with the return of results to participants as scientific knowledge and technology allows. The opportunity to sequence once and consult often is cost-effective, encourages scientific innovation, and provides the opportunity to quickly translate genomics into better clinical care.

Publication types

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

MeSH terms

  • Biomedical Research / ethics
  • Biomedical Research / statistics & numerical data*
  • Genetics, Medical / ethics
  • Genetics, Medical / statistics & numerical data
  • Genome, Human / genetics*
  • Genomics / ethics
  • Genomics / methods
  • Genomics / statistics & numerical data*
  • Humans
  • Informed Consent*
  • Medical Informatics / ethics
  • Medical Informatics / methods
  • Medical Informatics / statistics & numerical data
  • Sequence Analysis, DNA / ethics
  • Sequence Analysis, DNA / methods
  • Sequence Analysis, DNA / statistics & numerical data*