title: Returning individual research results for genome sequences of pancreatic cancer.
abstract: BACKGROUND
  Disclosure of individual results to participants in genomic research is a complex and contentious issue. There are many existing commentaries and opinion pieces on the topic, but little empirical data concerning actual cases describing how individual results have been returned. Thus, the real life risks and benefits of disclosing individual research results to participants are rarely if ever presented as part of this debate.
  
  
  METHODS
  The Australian Pancreatic Cancer Genome Initiative (APGI) is an Australian contribution to the International Cancer Genome Consortium (ICGC), that involves prospective sequencing of tumor and normal genomes of study participants with pancreatic cancer in Australia. We present three examples that illustrate different facets of how research results may arise, and how they may be returned to individuals within an ethically defensible and clinically practical framework. This framework includes the necessary elements identified by others including consent, determination of the significance of results and which to return, delineation of the responsibility for communication and the clinical pathway for managing the consequences of returning results.
  
  
  RESULTS
  Of 285 recruited patients, we returned results to a total of 25 with no adverse events to date. These included four that were classified as medically actionable, nine as clinically significant and eight that were returned at the request of the treating clinician. Case studies presented depict instances where research results impacted on cancer susceptibility, current treatment and diagnosis, and illustrate key practical challenges of developing an effective framework.
  
  
  CONCLUSIONS
  We suggest that return of individual results is both feasible and ethically defensible but only within the context of a robust framework that involves a close relationship between researchers and clinicians.
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia.
authors: Amber L
authors: AL
authors: Johns
authors: Queensland Centre for Medical Genomics, Institute for Molecular Biosciences, University of Queensland, St Lucia, QLD, 4072, Australia.
authors: David K
authors: DK
authors: Miller
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia.
authors: Skye H
authors: SH
authors: Simpson
authors: Department of Anatomical Pathology, Royal North Shore Hospital, Sydney Australia and University of Sydney, Sydney, NSW, 2065, Australia.
authors: Anthony J
authors: AJ
authors: Gill
authors: Queensland Centre for Medical Genomics, Institute for Molecular Biosciences, University of Queensland, St Lucia, QLD, 4072, Australia ; Genetic and Molecular Pathology, SA Pathology, Women's and Children's Hospital, North Adelaide, SA, 5006, Australia.
authors: Karin S
authors: KS
authors: Kassahn
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia.
authors: Jeremy L
authors: JL
authors: Humphris
authors: Department of Surgery, Royal North Shore Hospital, Sydney, NSW, 2065, Australia.
authors: Jaswinder S
authors: JS
authors: Samra
authors: Hereditary Cancer Clinic, Prince of Wales Hospital, Randwick, Sydney, NSW, 2031, Australia.
authors: Katherine
authors: K
authors: Tucker
authors: Hereditary Cancer Clinic, Prince of Wales Hospital, Randwick, Sydney, NSW, 2031, Australia.
authors: Lesley
authors: L
authors: Andrews
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia ; Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, Scotland, UK ; West of Scotland Pancreatic Unit, Glasgow Royal Infirmary, Glasgow, Scotland, UK.
authors: David K
authors: DK
authors: Chang
authors: Queensland Centre for Medical Genomics, Institute for Molecular Biosciences, University of Queensland, St Lucia, QLD, 4072, Australia.
authors: Nicola
authors: N
authors: Waddell
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia.
authors: Marina
authors: M
authors: Pajic
authors: Queensland Centre for Medical Genomics, Institute for Molecular Biosciences, University of Queensland, St Lucia, QLD, 4072, Australia.
authors: John V
authors: JV
authors: Pearson
authors: Queensland Centre for Medical Genomics, Institute for Molecular Biosciences, University of Queensland, St Lucia, QLD, 4072, Australia.
authors: Sean M
authors: SM
authors: Grimmond
authors: Cancer Research Program, Garvan Institute of Medical Research, the Kinghorn Cancer Centre, Sydney, NSW, 2010, Australia ; Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, Scotland, UK ; West of Scotland Pancreatic Unit, Glasgow Royal Infirmary, Glasgow, Scotland, UK ; Department of Surgery, Bankstown Hospital, Eldridge Road, Bankstown, Sydney, NSW 2200, Australia ; South Western Sydney Clinical School, Faculty of Medicine, University of New South Wales, Sydney, NSW, 2170, Australia ; Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Garscube Estate, Switchback Road, Bearsden, Glasgow, Scotland G61 1BD, UK ; Garvan Institute of Medical Research, 370 Victoria St, Darlinghurst, NSW, 2010, Australia.
authors: Andrew V
authors: AV
authors: Biankin
authors: St John of God Subiaco, Perth, WA, 6008, Australia ; School of Surgery, The University of Western Australia, Perth, WA, 6009, Australia.
authors: Nikolajs
authors: N
authors: Zeps