title: Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?
abstract: BACKGROUND
  There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges.
  
  
  METHODS
  A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach.
  
  
  RESULTS
  Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process.
  
  
  CONCLUSIONS
  Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants.
authors.affiliation: 1 Centre for Medical Ethics, Institute of Health and Society, University of Oslo , Oslo, Norway .|2 Norwegian Cancer Genomics Consortium , Kreftgenomikk.no, Oslo, Norway .
authors.forename: Isabelle
authors.initials: I
authors.lastname: Budin-Ljøsne
authors.affiliation: 3 Center for Research Ethics and Bioethics, Uppsala University , Uppsala, Sweden .|4 Center for Biomedicine , EURAC, Bolzano, Italy .
authors.forename: Deborah
authors.initials: D
authors.lastname: Mascalzoni
authors.affiliation: 5 Helsinki Biobank, Helsinki University Hospital , Helsinki, Finland .
authors.forename: Sirpa
authors.initials: S
authors.lastname: Soini
authors.affiliation: 6 Centre for Social Studies, University of Coimbra , Coimbra, Portugal .
authors.forename: Helena
authors.initials: H
authors.lastname: Machado
authors.affiliation: 7 Nuffield Department of Population Health, Centre for Health, Law and Emerging Technologies (HeLEX), University of Oxford , Oxford, United Kingdom .
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.affiliation: 1 Centre for Medical Ethics, Institute of Health and Society, University of Oslo , Oslo, Norway .|2 Norwegian Cancer Genomics Consortium , Kreftgenomikk.no, Oslo, Norway .|8 Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo , Oslo, Norway .
authors.forename: Heidi Beate
authors.initials: HB
authors.lastname: Bentzen
authors.affiliation: 9 UMR 1027, Inserm, Université de Toulouse , Toulouse, France .
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
authors.affiliation: 10 Charité-Universitätsmedizin Berlin , Berlin, Germany .
authors.forename: Flavio
authors.initials: F
authors.lastname: D'Abramo
authors.affiliation: 11 Institute of Human Genetics , Polish Academy of Sciences, Poznań, Poland .
authors.forename: Michał
authors.initials: M
authors.lastname: Witt
authors.affiliation: 12 Centre for Medical and Biomedical Law, Université Catholique de Louvain , Leuven, Belgium .
authors.forename: Geneviève
authors.initials: G
authors.lastname: Schamps
authors.affiliation: 13 School of Medicine, University of Rijeka , Rijeka, Croatia .
authors.forename: Višnja
authors.initials: V
authors.lastname: Katić
authors.affiliation: 14 Faculty of Pharmacy, Belgrade University , Belgrade, Serbia .
authors.forename: Dusanca
authors.initials: D
authors.lastname: Krajnovic
authors.affiliation: 16 Department of Genetics and Bioinformatics, Norwegian Institute of Public Health , Oslo, Norway .
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Harris
mesh_terms: D033002:Duty to Recontact / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000458:organization & administration; D005060:Europe; D036281:Genetic Research / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D033162:Incidental Findings; D011795:Surveys and Questionnaires