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Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot?

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Columns: Currents in Contemporary Bioethics
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

De Vries, J. et al., “Ethical Issues in Human Genomics Research in Developing Countries,” BMC Medical Ethics 12, no. 5 (2011), available at < https://doi.org/10.1186/1472-6939-12-5> (last visited April 26, 2019).CrossRefGoogle Scholar
Kolata, G., “The Struggle to Build a Massive ‘Biobank’ of Patient Data,” New York Times, March 19, 2018, available at <https://www.nytimes.com/2018/03/19/health/nih-biobank-genes.html> (last visited April 26, 2019).Google Scholar
Popejoy, A.B. and Fullerton, S.M., “Genomics Is Failing on Diversity,” Nature 538, no. 7624 (2016): 161-164.CrossRefGoogle Scholar
Kinkorova, J., “Biobanks in the Era of Personalized Medicine: Objectives, Challenges and Innovation,” EPMA Journal 7, no. 1 (2015): 4.CrossRefGoogle Scholar
Capocasa, M. et al., “Samples and Data Accessibility in Research Biobanks: An Explorative Survey,” PeerJ 4 (2016): e1613.CrossRefGoogle Scholar
Graham, C.E. et al., “Current Trends in Biobanking for Rare Diseases: A Review,” Dovepress 2 (2014): 49-61.Google Scholar
International Rare Diseases Research Consortium (2018), available at <http://www.irdirc.org> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
See De Vries et al., supra note 1; Kinkorova, supra note 4; Capocasa et al., supra note 5.Google Scholar
See Popejoy and Fullerton, supra note 3.Google Scholar
Zawati, M.H. et al., “Barriers and Opportunities in Consent and Access Procedures in Low- and Middle-Income Country Biobanks: Meeting Notes from the BCNet Training and General Assembly,” Biopreservation & Biobanking 16, no. 3 (2018): 171-178.CrossRefGoogle Scholar
Goebel, J.W. et al., “Legal and Ethical Consequences of International Biobanking from a National Perspective: The German BMB-EU Coop. Project,” European Journal of Human Genetics 18, no. 5 (2010): 522-525.CrossRefGoogle Scholar
Internet World Stats, available at <www.internetworldstats.com/stats.htm> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
“Letter From the Editor,” MIT Technology Review 120, no. 1 (2017): 2Google Scholar
The Broad Institute and Dana-Farber Cancer Institute, “Metastatic Breast Cancer Project,” available at <https://www.mbcproject.org/about> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Sleeboom, M., “The Harvard Case of Xiu Xiping: Exploitation of the People, Scientific Advance, or Genetic Theft?” New Genetics & Society 24, no. 1 (2005): 7-78.CrossRefGoogle Scholar
Kaye, J. et al., “Including All Voices in International Data-sharing Governance,” Human Genomics 12, no. 13 (2018): 1-9; M.A. Rothstein et al., “Comparative Approaches to Biobanks and Privacy,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 167-172.CrossRefGoogle Scholar
Jones, K.H. et al., “The Other Side of the Coin: Harm Due to the Non-use of Health-related Data,” International Journal of Medical Informatics 97 (2017): 43-51.CrossRefGoogle Scholar
See Zawati et al., supra note 10.Google Scholar
Genomics England (2018), available at <https://www.genomicsengland.co.uk> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive), General Data Protection Regulation, Regulation EU 2016/679.Google Scholar
Apple, “ResearchKit and CareKit” (2017), available at <http://www.apple.com/researchkit> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Research Stack (2018), available at <http://researchstack.org> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Sync for Science (2018), available at <https://github.com/sync-for-science> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Genome Connect, “The ClinGen Patient Portal” (2018), available at <https://www.genomeconnect.org/> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
DNA Land (2017), available at <https://dna.land> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
National Geographic, “The Genographic Project” (2018), available at <https://genographic.nationalgeographic.com> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Global Alliance for Genomics and Health, “Global Alliance Framework for the Responsible Sharing of Genomic and Health Related Data” (2014), available at <https://genomicsandhealth.org/about-the-global-alliance/key-documents/framework-responsible-sharing-genomic-and-health-related-data> (last visited September 25, 2018).+(last+visited+September+25,+2018).>Google Scholar
Dove, E.S. et al., “Ethics Review for International Data-Intensive Research,” Science 351, no. 6280 (2016): 1399-1400.CrossRefGoogle Scholar
Council for International Organizations of Medical Sciences, “International Ethical Guidelines for Health-related Research Involving Humans” (2017), available at <https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMSEthicalGuidelines.pdf> (last visited April 26, 2019); J.J.M. VanDelden and R. Van der Graf, “Revised CIOMS International Ethical Guidelines for Health-related Research Involving Humans,” Journal of the American Medical Association 317, no. 2 (2017): 135-136.CrossRef+(last+visited+April+26,+2019);+J.J.M.+VanDelden+and+R.+Van+der+Graf,+“Revised+CIOMS+International+Ethical+Guidelines+for+Health-related+Research+Involving+Humans,”+Journal+of+the+American+Medical+Association+317,+no.+2+(2017):+135-136.>Google Scholar
See Zawati et al., supra note 10.Google Scholar
Declaration of Helsinki (2008), available at <https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/> (last visited April 26, 2019); Belmont Report, available at <https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/> (last visited April 26, 2019).+(last+visited+April+26,+2019);+Belmont+Report,+available+at++(last+visited+April+26,+2019).>Google Scholar
Food and Drug Administration, U.S. Department of Health and Human Services, “Use of Electronic Informed Consent, Questions and Answers, Guidance for Institutional Review Boards, Investigators, and Sponsors” (2016), available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM436811.pdf> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
McConnell, M.V. and Ashley, E.A., “Mobile Health Research–App-Based Trials and Informed Consent,” New England Journal of Medicine 376, no. 9 (2017): 861-863.Google Scholar
Knoppers, B.M. et al., “Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority,” IRB: Ethics and Human Research 36, no. 6 (2016): 1-9.Google Scholar
OECD Council on Health Data Governance, “The Next Generation of Health Reforms” (2017), available at <https://www.oecd.org/health/health-systems/Recommendation-of-OECD-Council-on-Health-Data-Governance-Booklet.pdf> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Sleeboom, supra note 15.Google Scholar
HUGO Ethics Committee, Statement on Benefit Sharing, 2000, available at <http://www.hugo-international.org/Resources/Documents/CELS_Statement-BenefitSharing_2000.pdf> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
UNESCO, International Declaration on Human Genetic Data (2003), available at <http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar
Editorial, “Our Shared History,” Nature Genetics 50, no. 2 (2018): 159, available at <https://doi.org/10.1038/s41588-018-0049-4> (last visited April 26, 2019).+(last+visited+April+26,+2019).>Google Scholar