Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?
2016
Autori
Budin-Ljosne, IsabelleMascalzoni, Deborah
Soini, Sirpa
Machado, Helena
Kaye, Jane
Bentzen, Heidi Beate
Rial-Sebbag, Emmanuelle
D'Abramo, Flavio
Witt, Michal
Schamps, Genevieve
Katić, Višnja
Krajnović, Dušanka
Harris, Jennifer R.
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
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. Materials and 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.
Izvor:
Biopreservation and Biobanking, 2016, 14, 3, 241-248Izdavač:
- Mary Ann Liebert, Inc, New Rochelle
Finansiranje / projekti:
- Wellcome Trust - 096599/2/11/Z
- EU F7 project BIOSHARE
- Innovative Medicines Initiative project BTCure - 115142-1
- Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) program - European Union Seventh Framework Programme - 261433
- European Union Seventh Framework Programme - 305444
- BioBanking and Molecular Resource Infrastructure of Sweden project - Swedish Research Council (BBMRI) LPC - 313010
- European Research Council - 648608
- EU COST Action
- Biobank Norway - Norwegian Research Council - NFR 197443/F50
- LegRegPCM (Legal Regulation of Information Processing relating to Personalized Cancer Medicine) - Norwegian Research Council - NFR BIOTEK2021/238999/O30
- National Research and Innovation Platform for Personalized Cancer Medicine - Norwegian Research Council - NFR BIOTEK2021/ES495029
DOI: 10.1089/bio.2015.0115
ISSN: 1947-5535
PubMed: 27082461
WoS: 000377821800008
Scopus: 2-s2.0-84973348811
Institucija/grupa
PharmacyTY - JOUR AU - Budin-Ljosne, Isabelle AU - Mascalzoni, Deborah AU - Soini, Sirpa AU - Machado, Helena AU - Kaye, Jane AU - Bentzen, Heidi Beate AU - Rial-Sebbag, Emmanuelle AU - D'Abramo, Flavio AU - Witt, Michal AU - Schamps, Genevieve AU - Katić, Višnja AU - Krajnović, Dušanka AU - Harris, Jennifer R. PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2585 AB - 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. Materials and 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. PB - Mary Ann Liebert, Inc, New Rochelle T2 - Biopreservation and Biobanking T1 - Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe? VL - 14 IS - 3 SP - 241 EP - 248 DO - 10.1089/bio.2015.0115 ER -
@article{ author = "Budin-Ljosne, Isabelle and Mascalzoni, Deborah and Soini, Sirpa and Machado, Helena and Kaye, Jane and Bentzen, Heidi Beate and Rial-Sebbag, Emmanuelle and D'Abramo, Flavio and Witt, Michal and Schamps, Genevieve and Katić, Višnja and Krajnović, Dušanka and Harris, Jennifer R.", year = "2016", 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. Materials and 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.", publisher = "Mary Ann Liebert, Inc, New Rochelle", journal = "Biopreservation and Biobanking", title = "Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?", volume = "14", number = "3", pages = "241-248", doi = "10.1089/bio.2015.0115" }
Budin-Ljosne, I., Mascalzoni, D., Soini, S., Machado, H., Kaye, J., Bentzen, H. B., Rial-Sebbag, E., D'Abramo, F., Witt, M., Schamps, G., Katić, V., Krajnović, D.,& Harris, J. R.. (2016). Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?. in Biopreservation and Biobanking Mary Ann Liebert, Inc, New Rochelle., 14(3), 241-248. https://doi.org/10.1089/bio.2015.0115
Budin-Ljosne I, Mascalzoni D, Soini S, Machado H, Kaye J, Bentzen HB, Rial-Sebbag E, D'Abramo F, Witt M, Schamps G, Katić V, Krajnović D, Harris JR. Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?. in Biopreservation and Biobanking. 2016;14(3):241-248. doi:10.1089/bio.2015.0115 .
Budin-Ljosne, Isabelle, Mascalzoni, Deborah, Soini, Sirpa, Machado, Helena, Kaye, Jane, Bentzen, Heidi Beate, Rial-Sebbag, Emmanuelle, D'Abramo, Flavio, Witt, Michal, Schamps, Genevieve, Katić, Višnja, Krajnović, Dušanka, Harris, Jennifer R., "Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?" in Biopreservation and Biobanking, 14, no. 3 (2016):241-248, https://doi.org/10.1089/bio.2015.0115 . .