title: Navigating social and ethical challenges of biobanking for human microbiome research.
abstract: Biobanks are considered to be key infrastructures for research development and have generated a lot of debate about their ethical, legal and social implications (ELSI). While the focus has been on human genomic research, rapid advances in human microbiome research further complicate the debate.
  
  
  
  We draw on two cystic fibrosis biobanks in Toronto, Canada, to illustrate our points. The biobanks have been established to facilitate sample and data sharing for research into the link between disease progression and microbial dynamics in the lungs of pediatric and adult patients. We begin by providing an overview of some of the ELSI associated with human microbiome research, particularly on the implications for the broader society. We then discuss ethical considerations regarding the identifiability of samples biobanked for human microbiome research, and examine the issue of return of results and incidental findings. We argue that, for the purposes of research ethics oversight, human microbiome research samples should be treated with the same privacy considerations as human tissues samples. We also suggest that returning individual microbiome-related findings could provide a powerful clinical tool for care management, but highlight the need for a more grounded understanding of contextual factors that may be unique to human microbiome research.
  
  
  
  We revisit the ELSI of biobanking and consider the impact that human microbiome research might have. Our discussion focuses on identifiability of human microbiome research samples, and return of research results and incidental findings for clinical management.
authors.affiliation: Department of Psychology, University of Guelph, Guelph, ON, N1G 2W1, Canada.
authors.forename: Kim H
authors.initials: KH
authors.lastname: Chuong
authors.affiliation: Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Canada.|University Health Network, Toronto, Canada.
authors.forename: David M
authors.initials: DM
authors.lastname: Hwang
authors.affiliation: Adult Cystic Fibrosis, University of Toronto, Toronto, Canada.|Toronto Adult Cystic Fibrosis Centre, St Michael's Hospital, Toronto, Canada.
authors.forename: D Elizabeth
authors.initials: DE
authors.lastname: Tullis
authors.affiliation: Department of Paediatrics, University of Toronto, Toronto, Canada.|Division of Infectious Diseases, Hospital for Sick Children, Toronto, Canada.
authors.forename: Valerie J
authors.initials: VJ
authors.lastname: Waters
authors.affiliation: Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Canada.|Department of Paediatric Laboratory Medicine, Hospital for Sick Children, Toronto, Canada.
authors.forename: Yvonne C W
authors.initials: YC
authors.lastname: Yau
authors.affiliation: Department of Cell & Systems Biology, Centre for the Analysis of Genome Evolution & Function, University of Toronto, Toronto, Canada.
authors.forename: David S
authors.initials: DS
authors.lastname: Guttman
authors.affiliation: Department of Psychology, University of Guelph, Guelph, ON, N1G 2W1, Canada. kieran.odoherty@uoguelph.ca.
authors.forename: Kieran C
authors.initials: KC
authors.lastname: O'Doherty
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D002170:Canada; D003219:Confidentiality; D003550:Cystic Fibrosis / Q000382:microbiology; D030881:Disclosure; D032984:Ethics, Research; D006801:Humans; D033162:Incidental Findings; D033181:Information Dissemination; D008168:Lung / Q000382:microbiology; D064307:Microbiota; D018907:Privacy; D011634:Public Health; D011639:Public Opinion
keywords: Biobank; Cystic fibrosis; Identifiability; Incidental findings; Microbiome; Research ethics; Return of results