title: Expect the unexpected: screening for secondary findings in clinical genomics research.
abstract: Due to decreasing cost, and increasing speed and precision, genomic sequencing in research is resulting in the generation of vast amounts of genetic data. The question of how to manage that information has been an area of significant debate. In particular, there has been much discussion around the issue of 'secondary findings' (SF)-findings unrelated to the research that have diagnostic significance.
  
  
  
  The following includes ethical commentaries, guidelines and policies in respect to large-scale clinical genomics studies.
  
  
  
  Research participant autonomy and their informed consent are paramount-policies around SF must be made clear and participants must have the choice as to which results they wish to receive, if any.
  
  
  
  While many agree that clinically 'actionable' findings should be returned, some question whether they should be actively sought within a research protocol.
  
  
  
  SF present challenges to a growing field; diverse policies around their management have the potential to hinder collaboration and future research.
  
  
  
  The impact of returning SF and accurate estimates of their clinical utility are needed to inform future protocol design.
authors.affiliation: Radcliffe Department of Medicine, University of Oxford, Level 6 West Wing, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Mackley
authors.affiliation: Department of Bioethics, Faculty of Medicine, Dalhousie University, 5849 University Avenue, Room C-312, CRC Bldg, PO Box 15000, Halifax NS, Canada B3H 4R2.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Capps
mesh_terms: D035843:Biomedical Research; D002755:Choice Behavior; D023281:Genomics / Q000941:ethics / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D033162:Incidental Findings; D019451:Information Management; D007258:Informed Consent
keywords: clinical genomics; genome sequencing; genomics research; informed consent; secondary findings