Hostname: page-component-848d4c4894-75dct Total loading time: 0 Render date: 2024-05-16T18:20:42.724Z Has data issue: false hasContentIssue false
  • English
  • Français

Return of Results: Towards a Lexicon?

Published online by Cambridge University Press:  01 January 2021

Bartha Maria Knoppers  and
Amy Dam
Get access Rights & Permissions [Opens in a new window]

Extract

The last few years have witnessed the growth of large-scale, population genomics biobanks, which serve as longitudinal, gene-environment databases for future yet unspecified research. An international consortium, the Public Population Project in Genomics (P3G), builds harmonization tools for such biobanks and has catalogued numerous studies — at least 139 with over 10,000 banked participants and 34 with over 100,000. As their potential use for translational, clinical research draws near, it is opportune to clarify the duties of such biobanks to communicate results to participants. To identify the potential obligations, some demystification of the terminology surrounding the return of results as found in international and national norms on biobanking generally is essential. On the whole, our proposed lexicon is based on a study of norms as found in national and international policies but excludes debates found in the literature.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 4 , Winter 2011 , pp. 577 - 582
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

See Public Population Project in Genomics (P3G), “Study Catalogue,” available at <http://www.p3gobservatory.org/studylist.htm> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See World Medical Association (WMA), World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, Seoul, 2008, at Recommendation 30, available at <http://www.wma.net/en/30publications/10policies/b3/index.html> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Centre for Society and Genomics, Always Expect the Unexpected: Legal and Social Aspects of Reporting Biobank Research Results to Individual Research Participants, Nijmegen, 2009, at 18, available at <http://www.society-genomics.nl/uploads/media/Always_expect_the_unexpected.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See UK10K, Wellcome Trust Sanger Institute, Ethical Governance Framework, Hinxton, 2010, available at <http://www.uk10k.org/assets/EF_UK10K_v21.pdf> (last visited September 9, 2011).+(last+visited+September+9,+2011).>Google Scholar
See UK Biobank, UK Biobank Ethics and Governance Council: Review 2009, London, 2010, at 7.Google Scholar
See UK10K, supra note 4, at 7.Google Scholar
Id.Google Scholar
See National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1, Rockville, MD, 1999, at 72, available at <http://bioethics.georgetown.edu/nbac/hbm.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002, at 38, available at <http://www.cioms.ch/publications/layout_guide2002.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Renegar, et al, “Returning Genetic Research Results to Individuals: Points to Consider,” Bioethics 20, no. 1 (2006): 24–36, at 31, available at <http://onlinelibrary.wiley.com/doi/10.1111/j.1467–8519.2006.00473.x/pdf> (last visited August 29, 2011); Medical Research Council and Wellcome Trust, Access to Collections of Data and Materials, London, 2006, at 11, available at <http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_grants/documents/web_document/wtx030842.pdf > (last visited August 29, 2011); German National Ethics Council, Biobanks for Research, Berlin, 2004, at 59, available at <http://www.ethikrat.org/_english/publications/Opinion_Biobanks-for-research.pdf> (last visited August 29, 2011).CrossRefGoogle Scholar
See Centre for Society and Genomics, supra note 3, at 18; Id. (German National Ethics Council), at 59; Interagency Advisory Panel on Research Ethics, Revised Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Ottawa, 2009, at 162, available at <http://www.pre.ethics.gc.ca/pdf/eng/Revised%20Draft%202nd%20Ed%20PDFs/Revised%20Draft%202nd%20Edition%20TCPS_EN.pdf> (last visited August 29, 2011); Department of Health, Department of Western Australia, Guidelines for Human Biobanks, Genetic Research Databases and Associated Data (Australia Biobank), East Perth, 2010, at 33, available at <http://www.genomics.health.wa.gov.au/publications/docs/guidelines_for_human_biobanks.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011);+Department+of+Health,+Department+of+Western+Australia,+Guidelines+for+Human+Biobanks,+Genetic+Research+Databases+and+Associated+Data+(Australia+Biobank),+East+Perth,+2010,+at+33,+available+at++(last+visited+August+29,+2011).>Google Scholar
See CARTaGENE, Information Brochure for Participants, at 10, available at <http://www.cartagene.qc.ca/images/stories/cartagene_brochure.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Knoppers, B. M. Kharaboyan, L., ‘“Deconstructing’ Biobank Communication of Results,” SCRIPTed 6, no. 3 (2009): 677–684, at 680, available at <http://www.law.ed.ac.uk/ahrc/script-ed/vol6–3/knoppers.pdf> (last visited August 29, 2011).Google Scholar
See UK Biobank, UK Biobank Ethics and Governance Framework, Manchester, 2007, at 8, available at <http://www.ukbiobank.ac.uk/docs/EGF20082.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Wellcome Trust Case Control Consortium, available at <http://www.wtccc.org.uk/index.shtml> (last visited August 29, 2011); Corriell Institute, available at <http://ccr.coriell.org/Default.aspx> (last visited August 29, 2011).+(last+visited+August+29,+2011);+Corriell+Institute,+available+at++(last+visited+August+29,+2011).>Google Scholar
See Genetic Alliance Biobank, Registry and Biorepository Bulletin, available at <http://www.geneticalliance.org/biobank.bulletin#section2> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See CARTaGENE, Samples and Data Access Policy, at 8, available at <http://www.cartagene.qc.ca/images/stories/pdf_en/6_sdapjanv2010_eng.pdf> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Knoppers, Kharaboyan, , supra note 13, at 682.Google Scholar
See Knoppers, B. M. Laberge, C., “Return of Accurate and Actionable Results: Yes,” American Journal of Bioethics 9, nos. 6–7 (2009): 36–43.CrossRefGoogle Scholar
See National Heart, Lung and Blood Institute (NHLBI), NHLBI Working Group on Reporting Genetic Results in Research Studies, Meeting Summary, Bethesda, MD, 2004, available at <http://www.nhlbi.nih.gov/meetings/workshops/gene-results.htm#guidelines> (last visited August 29, 2011).+(last+visited+August+29,+2011).>Google Scholar
See Australia Biobank, supra note 11, at 33.Google Scholar
See NHLBI, supra note 20, at recommendation 3.Google Scholar
See Australia Biobank, supra note 11, at 11.Google Scholar
World Health Organization (WHO), Genetic Database: Assessing the Benefits and Impact on Human and Patient Right, Geneva, 2003, at 13.Google Scholar
See NBAC, supra note 8, at 72.Google Scholar
See UK10K, supra note 4, at 8.Google Scholar
See Australia Biobank, supra note 11, at 11.Google Scholar
See TCPS, supra note 11, at 136.Google Scholar
Id., at 162.Google Scholar
See NHLBI, supra note 20.Google Scholar
German National Ethics Council, supra note 10, at 58.Google Scholar
See WHO, supra note 24, at 13.Google Scholar
Quebec Network of Applied Genetic Medicine, Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations, Montreal, 2003, at 3.Google Scholar
See NBAC, supra note 8, at 72.Google Scholar
National Cancer Institute, Office of Biorepositories and Biospecimen Research, Workshop on Release of Research Results to Participants in Biospecimen Studies July 8–9 2010, Bethesda, MD, 2011, at Recommendation 2.5.Google Scholar
See UK10K, supra note 4, at 7.Google Scholar
Beskow, L. M. et al, “Informed Consent for Population-Based Research Involving Genetics,” JAMA 286, no. 18 (2001): 2315–2321, at 2319, available at <http://jama.ama-assn.org/cgi/reprint/286/18/2315> (last visited August 29, 2011).CrossRefGoogle Scholar
See UK10K, supra note 4, at 10 (emphasis added).Google Scholar
Organisation for Economic Co-Operation and Development, OECD Guidelines on Human Biobanks and Genetic Research Databases, Paris, 2009, at 34, available at <http://www.oecd.org/dataoecd/41/47/44054609.pdf> (last visited September 14, 2011).+(last+visited+September+14,+2011).>Google Scholar
Lévesque, E. Joly, Y. Simard, J., “Return of Research Results: General Principles and International Perspectives,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 583–592.CrossRefGoogle Scholar