Substitute consent to data sharing: A way forward for international dementia research?

Journal of Law and the Biosciences

Volumn 4, Issue 1, 2017, Pages 133-158

  Thorogood, Adrian ^a   St Pierre, Constance Deschênes ^a   Knoppers, Bartha Maria ^a  

^a MCGILL UNIVERSITY   (Canada)

Author keywords

Best interests; Capacity; Data sharing; Research ethics; Substitute consent

Indexed keywords

EID: 85052109035     PISSN: None     EISSN: 20539711     Source Type: Journal    
DOI: 10.1093/jlb/lsw063     Document Type: Article

References (30)

1. World Health Organization, Dementia: Fact Sheet (April 2016), http://www.who.int/mediacentre/ factsheets/fs362/en/ (accessed Dec. 19, 2016)
2. ULRIKE DEETJEN, ERIC T. MEYER & RALPH SCHROEDER, BIG DATA FOR ADVANCING DEMENTIA RESEARCH: AN EVALUATION OF DATA SHARING PRACTICES IN RESEARCH ON AGE-RELATED NEURODEGENERATIVE DISEASES 86-87, 93
3. Bengt Winblad et al., DefeatingAlzheimer's Disease and OtherDementias:APriority for European Science and Society, 15LANCET NEUROL. 455, 456 (2016)
4. WILLIAM W. LOWRANCE, LEARNING FROMEXPERIENCE: PRIVACY AND THE SECONDARYUSE OFDATA INHEALTH RESEARCH 19 (The Nuffield Trust, 2002)
5. American Psychiatric Association'sTask Force on Research Ethics, Ethical Principles and Practices for Research Involving Human Participants with Mental Illness, 57PSYCHIATRIC SERVICES 552, 553 (2006)
6. Genomics England, 100,000 Genomes Project, Participants Information Sheets and Consent Forms, (Aug. 5, 2016, 3:30 PM) http://www.genomicsengland.co.uk/taking-part/patient-information-sheets-and-consentforms/ (accessed Dec. 19, 2016)
7. Willem van Panhuis, A Systematic Review of Barriers to Data Sharing in Public Health, 14 BMCPUB. HEALTH 1144 (2014)
8. Jillian Oderkirk, Elettra Ronchi & Niek S. Klazinga, International Comparisons of Health System Performance among OECD Countries: Opportunities and Data Privacy Protection Challenges, 112HEALTH POLICY 9 (2013)
9. ABA Commission on Law and Aging, Health Care Decision-Making Authority: What is the Decision-Making Standard? (July 2015) www.americanbar.org/aging (accessed Dec. 19, 2016)
10. Elyn R. Saks et al., Proxy Consent to Research:The Legal Landscape, 8 YALE J. HEALTH POL'YÐICS 37 (2008)
11. www.coe.int (accessed Dec. 19, 2016))
12. World Medical Association, Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, June 1964, arts 1, 19-20 and 28 (updated October 2013) http://www.wma.net/en/30publications/10policies/b3/ (accessed Dec. 19, 2016)
13. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidelines 9, 13-15 (2002) http://www.cioms.ch/publications/layout guide2002.pdf (accessed Dec. 19, 2016)
14. Angela Campbell & Kathleen Cranley Glass, The Legal Status of Clinical and Ethics Policies, Codes, and Guidelines inMedical Practice and Research, 46MCGILL L.J. 473, 482 (2001)
15. Shimon Tashiro, Unintended Consequences of 'Soft' Regulations:The Social Control of Human Biomedical Research in Japan, 19 INT. J. JAPANESE SOCIOLOGY 4 (2010)
16. Gina Bravo et al., Comparison of Provincial andTerritorial Legislation Governing Substitute Consent for Research, 24 CAN. J. AGING 237, 245 (2005)
17. Tom Archibald & Trudo Lemmens, Data Collection from Legally Incompetent Subjects: A Paradigm Legal and Ethical Challenge for Population Databanks, HEALTH L.J. (SPEC. ED.) 145, 156 (2008)
18. National Institutes of Health (NIH) Office of Extramural Research, Research Involving Individuals with Questionable Capacity to Consent: Points to Consider (November 2009), http://grants.nih.gov/grants/policy/questionablecapacity.htm (accessed Dec. 19, 2016)
19. Kyoko Wada, The Concept ofMinimal Risk:The Need for Better Guidance on the Ethics Review Process, 11AM. J. BIOETHICS 27 (2011)
20. Seema Shaw, The Dangers of Using a Relative Risk Standard for Minimal Risk, 11 AM. J BIOETHICS 22 (2011)
21. Bartha M. Knoppers et al., Questioning the Limits of Genomic Privacy, 91 AM. J HUM. GENET. 577 (2012)
22. Ann Cavoukian & Daniel Castro, Big Data and Innovation, Setting the Record Straight: De-identification Does Work, (Information and Privacy Commissioner Ontario, June 16, 2014) https://www.ipc.on.ca/images/Resources/pbd-de-identification ITIF.pdf (accessed Dec. 19, 2016)
23. Khaled El Emam, Methods for the de-identification of electronic health records for genomic research, 3 GENOME MED. 25 (2011)
24. Arvind Narayan & Edward W. Felten, No Silver Bullet: De-identification Still Doesn't Work (Manuscript, 2014), http://randomwalker.info/publications/no-silver-bullet-de-identification.pdf (accessed Dec. 19, 2016)
25. Erika Check Hayden, The Genome Hacker: Yaniv Erlich shows how research participants can be identified from 'anonymous' DNA, 497 NATURE 172 (2013)
26. Organisation for Economic Co-operation and Development, OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data at para 52 (23 September 1980) http://www.oecd.org/ sti/ieconomy/oecdguidelinesontheprotectionofprivacyandtransborderflowsofpersonaldata.htm (accessed Dec. 19, 2016)
27. http://www.oecd.org/sti/ieconomy/ (accessed Dec. 19, 2016)
28. Adrian Thorogood et al., Protecting the Privacy of Canadians' Health Information in the Cloud, 14 CAN. J LAW TECH. 173 (2016)
29. Jorge L. Contreras & Jerome H. Reichman, Sharing by design: Data and decentralized commons, 350 SCIENCE 1312 (2015)
30. Global Alliance for Genomics and Health, Ageing and Dementia Task Team https://genomicsandhealth. org/working-groups/our-work/ageing-and-dementia (accessedDec. 19, 2016)