National Health Medical Research Council, Australian Government, Direct-to-Consumer Genetic Testing: A Statement from the National Health and Medical Research Council, NHMIRC REF#G9, December 2014, available at <https://nhmrc.gov.au/about-us/publications/direct-consumer-genetic-testing-statement> (last visited Octover 10, 2019); National Health Medical Research Council, Australian Government, Understanding Direct-to-Consumer Genetic DNA Testing: An Information Resource for Consumers, NHMRC REF# G8, December 2014, available at <https://nhmrc.gov.au/sites/default/files/documents/reports/direct-consumer-genetic-testing.pdf> (last visited October 10, 2019); National Health Medical Research Council, Australian Government, Discussing Direct-to-Consumer Genetic DNA Testing with Patients: A Short Guide for Health Professionals, NHMRC REF#G7, December 2013, available at <https://nhmrc.gov.au/sites/default/files/documents/attachments/Discussing%20direct-to-consumer-genetic-dna-testing.pdf> (last visited October 10, 2019).+(last+visited+Octover+10,+2019);+National+Health+Medical+Research+Council,+Australian+Government,+Understanding+Direct-to-Consumer+Genetic+DNA+Testing:+An+Information+Resource+for+Consumers,+NHMRC+REF#+G8,+December+2014,+available+at++(last+visited+October+10,+2019);+National+Health+Medical+Research+Council,+Australian+Government,+Discussing+Direct-to-Consumer+Genetic+DNA+Testing+with+Patients:+A+Short+Guide+for+Health+Professionals,+NHMRC+REF#G7,+December+2013,+available+at++(last+visited+October+10,+2019).>Google Scholar

National Pathology Accreditation Advisory Council (NPAAC), Department of Health, Australian Government, The Provision of Direct to Consumer Genetic Tests: Guiding Principles for Providers, 2014, available at <http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-path-bestpractice> (last visited October 10, 2019).+(last+visited+October+10,+2019).>Google Scholar

Boughtwood, T., “Understanding Direct-to-Consumer Genetic Testing,” Australian Genomics Health Alliance, April 12, 2018, available at <http://www.australiangenomics.org.au/understanding-direct-to-consumer-genetic-testing/> (last visited December 10, 2019).Google Scholar

National Health and Medical Research Council, Australian Research Council, Universities Australia, Australian Government, National Statement on Ethical Conduct in Human Research 2007 (Updated 2018) (Canberra: Commonwealth of Australia, 2018).Google Scholar

Id. at 82.Google Scholar

Id. at 80.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id.Google Scholar

National Health and Medical Research Council, Australian Research Council, Australian Government, Australian Code for the Responsible Conduct of Research (Canberra: Commonwealth of Australia, 2018).Google Scholar

Department of Agriculture, Australian Government, Regulatory framework in Australia, available at <http://www.agriculture.gov.au/ag-farm-food/bio-technology/framework> (last visited October 10, 2019).+(last+visited+October+10,+2019).>Google Scholar

Therapeutic Goods Act 1989 (Cth) (Austl.).Google Scholar

Critchley, C. et al., “Public Reaction to Direct-to-Consumer Online Genetic Tests: Comparing Attitudes, Trust and Intentions Across Commercial and Conventional Providers,” Public Understanding of Science 24, no. 6 (2014): 731–750.CrossRefGoogle Scholar

Tiller, J. and Lacaze, P., “Regulation of Internet-based Genetic Testing: Challenges for Australia and Other Jurisdictions,” Frontiers in Public Health 6, no. 24 (2018): 1–6; Harvey, K. and Diug, B., “Short Note on Retail Genetics,” Australian Prescriber 40, no. 3 (2017): 86–87, available at <https://www.nps.org.au/australian-prescriber/articles/retail-genetics> (last visited October 10, 2019); National Pathology Accreditation Advisory Council (NPAAC), Department of Health, Australian Government, The Provision of Direct to Consumer Genetic Tests: Guiding Principles for Providers, 2014, available at <http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-path-bestpractice> (last visited October 10, 2019).CrossRefGoogle Scholar

National Pathology Accreditation Advisory Council (NPAAC), Department of Health, Australian Government, supra note 14.Google Scholar

Lei No. 8.142, de 28 Dezembro de 1990, COL.LEIS REP. FED. BRASIL, 6: 3583, Dezembro 1990 (Braz.) art. 1, para. 2.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 196, dated in October 10, 1996, available at <http://conselho.saude.gov.br/resolucoes/1996/Reso196.doc> (last visited October 11, 2019);+(last+visited+October+11,+2019);>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 196, dated in October 10, 1996, available at <http://conselho.saude.gov.br/resolucoes/1996/Reso196.doc> (last visited October 11, 2019); Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 466, dated in December 12, 2012, available at <http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf> (last visited October 11, 2019).+(last+visited+October+11,+2019);+Brazil,+Resolution+of+the+Conselho+Nacional+de+Saúde+(CNS)+n.+466,+dated+in+December+12,+2012,+available+at++(last+visited+October+11,+2019).>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 466, dated in December 12, 2012, available at <http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf> (last visited October 11, 2019), items VII and VII.1.+(last+visited+October+11,+2019),+items+VII+and+VII.1.>Google Scholar

Id.Google Scholar

Id.Google Scholar

Brazil, Operating Standard of the Conselho Nacional de Saúde (CNS) n. 1, dated in 2013, p. 8, available at <http://plataformabrasil.saude.gov.br/login.jsf> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 466, supra note 4.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 340, dated in July 8, 2004, available at <http://conselho.saude.gov.br/resolucoes/2004/Reso340.doc> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 441, dated in May 12, 2011, available at <http://conselho.saude.gov.br/resolucoes/2011/Reso441.pdf> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 340, dated in July 8, 2004, available at <http://conselho.saude.gov.br/resolucoes/2004/Reso340.doc> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 292, dated in July 8, 1999, available at <http://conselho.saude.gov.br/resolucoes/1999/Reso292.doc> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Id.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 340, supra note 9.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 466, supra note 4.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 340, supra note 9.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 292, supra note 12.Google Scholar

Brazil, Resolution of the Conselho Nacional de Saúde (CNS) n. 340, supra note 9.Google Scholar

Brazil, Resolution of the Agência Nacional de Vigilância Sanitária (ANVISA) n. 36, dated in August 26, 2015, available at <http://portal.anvisa.gov.br/documents/10181/2979365/RDC_36_2015_COMP.pdf/5ab916c1-108f-43d9-80b9-39984434c8aa> (last visited October 11, 2019).+(last+visited+October+11,+2019).>Google Scholar

Privacy Commissioner of Canada, “Direct-to-Consumer Genetic Testing and Privacy,” available at <https://www.priv.gc.ca/en/privacy-topics/health-genetic-and-other-body-information/02_05_d_69_gen/> (last visited July 29, 2019); Canadian Medical Association, “Direct-to-Consumer Genetic Testing,” CMA POLICY (May 2017), available at <https://policy-base.cma.ca/en/viewer?file=%2fdocuments%2fPolicypdf%2fPD17-05.pdf#phrase=false> (last visited October 15, 2019).+(last+visited+July+29,+2019);+Canadian+Medical+Association,+“Direct-to-Consumer+Genetic+Testing,”+CMA+POLICY+(May+2017),+available+at++(last+visited+October+15,+2019).>Google Scholar

See e.g. Healthcare (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181 [Healthcare (Consent) and Care Facility (Admission) Act]; An Act respecting clinical and research activities relating to assisted procreation, CQLR, c A-5.01, s 8; Art 20-21 Civil Code of Québec, RLRQ c CCQ-1991 [CCQ]; Health Information Act, SNWT 2014, c 2, s 68.Google Scholar

Private institutions that receive accreditation from Human Research Accreditation Canada are subject to its REB standards, which includes the TCPS2. Human Research Accreditation Canada, “Normative Documents,” available at <https://www.hracanada.org/find/normative-documents/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014, art 2.1 [TCPS2].Google Scholar

Government of Canada, Panel on Research Ethics, “TCPS2-Introduction,” available at <http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/introduction/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

In the case of private institutions, many have either explicitly adopted the TCPS2, or have adopted policies to supplement it. See, McGill Research and Innovation, “Forms and Guidelines,” available at <https://mcgill.ca/research/research/compliance/human/reb-i-ii-iii/forms-and-guidelines> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Zimmerman, S.V., “TCPS 2: Background and Selected Highlights Selected Highlights,” Panel on Research Ethics webinar for EHIL, presented May 2011, available at <http://www.ehealthinformation.ca/wp-content/uploads/2014/08/zimmerman.pdf> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Of note that the chief source relied upon to explain the following ethical rules are found in the TCPS2. Although not every REB will employ it, the TCPS2 can be said to represent Canada's normative ethical standards.Google Scholar

Reibl v. Hughes [1977] OJ No 2289, 78 DLR (3d) 35; Hopp v. Lepp, [1980] 2 SCR 192; Kita v. Braig [1992], 17 BCAC 55; Edwardson v. St Joseph›s Healthcare Hamilton, [2012] OJ No 5032, 2012 ONCA 719.Google Scholar

See e.g. Consent to Treatment and Healthcare Directives Act, RSPEI 1996, c 10, s 6(7); Art 10-11 CCQ, supra note 2; Healthcare (Consent) and Care Facility (Admission) Act, supra note 2; Medical Consent of Minors Act, SNB 1976, c M-6.1; Hospitals Act, RSNS 1989, c 208; Healthcare Consent Act, 1996, SO 1996, c 2, Sch A.Google Scholar

TCPS2, supra note 4, Chapter 2 § B.Google Scholar

Id. art 3.12.Google Scholar

Id. art 3.5.Google Scholar

Id. art 3.1. Additionally, the TCPS2 provides for certain rules in cases where the research participant lacks capacity to consent to research (TCPS2 art 3.9) taking into consideration the participant's best interests and trying to involve the participant as much as possible in the process (TCPS2 art 3.9-application).Google Scholar

Art 24 CCQ, supra note 2.Google Scholar

Aside from Québec, Alberta's Heath Information Act addresses electronic consent in the context of medical treatment. Alta Reg 70/2001 s 6. Federally, the Secure Electronic Signature Regulations recognize the validity of electronic signatures in the context of evidence, and establish the presumption that, absent of evidence to the contrary, a signature is presumed to be of the person identified in the digital signature certificate. Secure Electronic Signature Regulations, SOR/2005-30, § 5.Google Scholar

This refers to ensuring that the document or information contained therein was not altered and was maintained in its entirety. Kirby, E., Zawati, M.H., and Knoppers, B.M., “Electronic Consent to Health Research in Canada,” Canadian Bar Review 91, no. 2 (2013): 419–435, at 425.Google Scholar

This is typically established through an electronic signature. An Act to establish a legal framework for information technology, RSQ, c C-1.1, 2001.Google Scholar

Personal Health Information Protection Act, 2004, RSO 2004, c 3, Sch A; Electronic Commerce Act, 2000, RSO 2000, c 17; CCQ, supra note 2; Freedom of Information and Protection of Privacy Act, RSBC 1996, c 165; Freedom of Information and Protection of Privacy Regulation, RSBCReg 323/93; Electronic Transaction Act, RSBC 2001, c 10; Health Information Act, RSA 2000, c H-5; Health Information Regulation, Alta Reg 70/2001; Electronic Transaction Act, RSA 2001, c E-5.5; Freedom of Information and Protection of Privacy Act, SNS 1993, c 5; Freedom of Information and Protection of Privacy Regulations, NS Reg 105/94; Electronic Commerce Act, SNS 2000, c 26. See Kirby, supra note 17, at 423-425.Google Scholar

TCPS2, supra note 4, art 3.12-application.Google Scholar

Id. art 3.1-application.Google Scholar

The TCPS2 notes that incentives differ from reimbursements and compensation for injury. See TCPS2, supra note 4, art 3.2[j].Google Scholar

Id. art 3.1-application.Google Scholar

Id.Google Scholar

Id. art 3.2-application.Google Scholar

Id. art 3.2.Google Scholar

Id. art 12.2.Google Scholar

Id. art 3.3.Google Scholar

The exceptions to informed consent still require REB approval, and any alteration to the normal consent requirements should only be permitted to the extent necessary. The exceptions are: (1) the research only involves minimal risk to participants; (2) the alteration to consent is unlikely to adversely affect the welfare of participants; (3) it is impossible or impracticable to either carry out the research or address the research question if prior consent is sought; (4) alteration to consent is defined; (5) debriefing is provided, offering participants the opportunity to refuse consent or withdraw consent; and (6) cases of medical emergency. TCPS2, supra note 4, art 3.7-3.8.Google Scholar

Id. art 5.1.Google Scholar

Id. art 5.2.Google Scholar

Id. art 5.3.Google Scholar

Id. art 3.4.Google Scholar

Id. art 3.4-application.Google Scholar

I.e., causing undue hardship that jeopardizes the research.Google Scholar

Due to large quantities of data that are possibly de-identified or anonymized.Google Scholar

TCPS2, supra note 4.Google Scholar

Id. art 5.5A.Google Scholar

Id. art 5.5B.Google Scholar

Id. art 5.5B-application.Google Scholar

Id. art 5.7.Google Scholar

See above, “Consent” and “Secondary Uses.”Google Scholar

TCPS2, supra note 4, art 12.5(a).Google Scholar

Id. art 12.5(b).Google Scholar

Id. art 12.5-application.Google Scholar

Id. art 13.1.Google Scholar

Id. art 13.2.Google Scholar

Id. art 13.2-application. Importantly, this rule was developed because genetic research may reveal particularly sensitive information that can have implications for biological relatives, and may also affect eligibility for employment and insurance.Google Scholar

Id. art 13.3.Google Scholar

Id. art 9.1.Google Scholar

Id. art 9.3 and 9.8.Google Scholar

Id. art 9.19.Google Scholar

Id. art 8.1.Google Scholar

Id. art 8.3(b).Google Scholar

Government of Canada, Panel on Research Ethics, Scope, available at <http://www.pre.ethics.gc.ca/eng/policy-politique/interpretations/scope-portee/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Id.Google Scholar

Such as, privacy laws, informed consent, capacity, etc.Google Scholar

For example, privacy laws differ based on whether the organization under whose auspices the research is conducted is a public institution or a private one.Google Scholar

TCPS2, supra note 4, art 3.2 and 12.2Google Scholar

Thorogood, A., “Canada: Will Privacy Rules Continue to Favour Open Science?” Human Genetics 137, no. 8 (2018): 595–602, at 598.CrossRefGoogle Scholar

For example, the province of Québec generally legislates stricter rules in terms of private sector law. For instance, data custodians (in our case, researchers) must take all reasonable steps to ensure that the data will not be used for unrelated purposes without prior consent of the concerned individuals (Act respecting the Protection of personal information in the private sector, CQLR c P-39.1 s 17). Additionally, Québec law requires that where personal information is collected from an individual and a file is subsequently created from the information, the person concerned be notified of the place where the file is kept and of the access and rectification rights (Act respecting the Protection of personal information in the private sector, CQLR c P-39.1 s 8(3)). Further, British Columbia and Nova Scotia have data residency requirements, prohibiting the transfer of personal information held by public sector institutions outside the province (Freedom of Information and Protection of Privacy Act, RSBC 1996 c 165 s 33.2; Personal Information International Disclosure Protection Act SNS 2006 c 3 s 5(1)). The variation in legal requirements therefore have to be considered by foreign researchers prior to commencing DTP genomic research in Canada.Google Scholar

Thorogood, et al., “Protecting the Privacy of Canadians' Health Information in the Cloud,” Canadian Journal of Learning and Technology 14 (2016): 173–213, at 191.Google Scholar

Id. at 194.Google Scholar

McInerney v. MacDonald [1992] 2 SCR 138.Google Scholar

Saulnier, K.M., “Locating Biobanks in the Canadian Privacy Maze,” Journal of Law, Medicine & Ethics 44, no. 1 (2016):7–19, at 10.CrossRefGoogle Scholar

Charter of the French language, CQLR, c C-11, § 1.Google Scholar

Id. § 6.Google Scholar

This requirement is further established by the TCPS2, which requires that consent forms be provided in “plain language” for participants to understand. In Québec, this may mean that consent forms should also be provided in French. TCPS2, supra note 4, art 3.2.Google Scholar

Genetic Non-Discrimination Act, SC 2017, c 3.Google Scholar

Id. § 5.Google Scholar

Id. § 6.Google Scholar

Reference Re Genetic Non-Discrimination Act, 2018 QCCA 2193.Google Scholar

See Kirby, E., et al., Data Access and Sharing by Researchers in Genomics: Policy Brief, March 2018, available at <http://www.genomequebec.com/DATA/PUBLICATION/35_en~v~Data_Access_and_Sharing_by_Researchers_in_Genomics_-_Policy_Brief.pdf> (last visited October 15, 2019).+(last+visited+October+15,+2019).>Google Scholar

Id.Google Scholar

See TCPS2, supra note 4, chapter 9.Google Scholar

Id.Google Scholar

Id.Google Scholar

The benefits of international collaboration are widely accepted, as numerous publically funded data sharing platforms have been established, such as, CanDig (2018), Care4Rare SOLVE (2018), and the Canadian Open Neuroscience Platform (2018). See Thoro-good, supra note 60.Google Scholar

Knoppers, B.M., Abdul-Rahman, M.H., and Bédard, K., “Genomic Databases and International Collaboration,” King's Law Journal 18, no. 2 (2007): 291–311.CrossRefGoogle Scholar

See generally, Rahman, P. et al., “The Newfoundland Population: A Unique Resource for Genetic Investigation of Complex Diseases,” Human Molecular Genetics 12, no. 2 (2003): 167–172.CrossRefGoogle Scholar

See generally, Hamet, P. et al., “Quantitative Founder-Effect Analysis of French Canadian Families Identifies Specific Loci Contributing to Metabolic Phenotypes of Hypertension,” American Journal of Human Genetics 76, no. 5 (2005): 815–832.Google Scholar

Id.; Glazier, A.M., Nadeau, J.H., and Aitman, T.J., “Finding Genes that Underlie Complex Traits,” Science 298, no. 5602 (2002): 2345–2349.CrossRefGoogle Scholar

Office of the Privacy Commissioner of Canada, “Questions and Answers regarding the application of PIPEDA, Alberta and British Columbia's Personal Information Protection Acts,” available at <https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/r_o_p/02_05_d_26/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Personal Information Protection and Electronic Documents Act (SC 2000, c 5) schedule 1 Section 5 art 4.1 [PIPEDA].Google Scholar

Saulnier, supra note 65, at 12.Google Scholar

Office of the Privacy Commissioner of Canada, PIPEDA in brief, available at <https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/pipeda_brief/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

For example, Québec generally legislates stricter rules in terms of privacy, and the provinces of British Columbia and Nova Scotia have data residency requirements. Please refer to note 61.Google Scholar

Transportation of Dangerous Goods Regulations (SOR/2001-286) [TDG Regulations].Google Scholar

Human Pathogens and Toxins Act (SC 2009, c 24) [HPTA].Google Scholar

Government of Canada, Canadian Bio-safety Standard (CBS) Second Edition, available at <https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/second-edition.html#a2> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Transport Canada, Government of Canada, “Shipping Infectious Substances,” available at <http://www.tc.gc.ca/eng/tdg/page-1296.html> (last visited July 29, 2019); TDG Regulations, supra note 59, § 1.4.+(last+visited+July+29,+2019);+TDG+Regulations,+supra+note+59,+§+1.4.>Google Scholar

An infectious substance is defined as a substance known or reasonably believed to contain viable micro-organisms that are known or reasonably believed to cause disease in humans or animals. TDG Regulations, supra note 88, § 1.4.Google Scholar

Id. § 1.42.Google Scholar

Transport Canada, supra note 91.Google Scholar

Id. Furthermore, Transport Canada advises professionals to consider the medical history, symptoms, endemic local conditions, and individual circumstances of the participant to help assess whether a specimen is regulated.Google Scholar

HPTA, supra note 89, § 6 & 7.Google Scholar

Canadian Centre for Occupational Health and Safety, Government of Canada, “Transportation of Dangerous Goods (TDG)—Overview,” available at <https://www.ccohs.ca/oshanswers/legisl/tdg/tdg_overview.html> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

TCPS2, supra note 4, chapter 5.Google Scholar

Office of the Privacy Commissioner of Canada, supra note 86.Google Scholar

Privacy Act, RSC 1985, c P-21.Google Scholar

Id. § 2.Google Scholar

Office of the Privacy Commissioner of Canada, “Provincial legislation deemed substantially similar to PIPEDA,” available at <https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/r_o_p/provincial-legislation-deemed-substantially-similar-to-pipeda/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Government of Canada, supra note 5.Google Scholar

Office of the Privacy Commissioner of Canada, “Questions and Answers regarding the application of PIPEDA, Alberta and British Columbia's Personal Information Protection Acts,” available at <https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/r_o_p/02_05_d_26/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Id.; Thorogood, supra note 62, at 193.Google Scholar

Saulnier, supra note 65, at 12.Google Scholar

PIPEDA, in the case of commercial activity.Google Scholar

Thorogood, supra note 62, at 194; Lawson v. Accusearch Inc (c.o.b. Abika. com) [2007] FCJ No 164 [Lawson].Google Scholar

Lawson, supra note 108.Google Scholar

See Office of the Privacy Commissioner of Canada, Website that generates revenue by republishing Canadian court decisions and allowing them to be indexed by search engines contravened PIPEDA, available at <https://www.priv.gc.ca/en/opc-actions-and-decisions/investigations/investigations-into-businesses/2015/pipeda-2015-002/> (last visited July 29, 2019). These criteria were extracted from the PIPEDA Report Findings as they relate to international commercial entities holding data relevant to Canadians. Indeed, such a determination would be assessed on a case by case basis, yet indicia of a link with Canada can help determine the relevance of Canadian privacy law beforehand.+(last+visited+July+29,+2019).+These+criteria+were+extracted+from+the+PIPEDA+Report+Findings+as+they+relate+to+international+commercial+entities+holding+data+relevant+to+Canadians.+Indeed,+such+a+determination+would+be+assessed+on+a+case+by+case+basis,+yet+indicia+of+a+link+with+Canada+can+help+determine+the+relevance+of+Canadian+privacy+law+beforehand.>Google Scholar

TCPS2, supra note 4, art 3.4.Google Scholar

Id. at 32.Google Scholar

Sénécal, K., “Statement of Principles on the Return of Research Results and Incidental Findings,” Genome 57, no. 7 (2014): 541–548; Knoppers, B.M., Zawati, M.H. and Sénécal, K., “Return of Genetic Testing Results in the Era of Whole-Genome Sequencing,” Nature reviews, Genetics 16, no. 9 (2015): 553–559.Google Scholar

PIPEDA, supra note 84; (AB) Personal Information Protection Act, S.A. 2003, c. P-6.5; (BC) Personal Information Protection Act, SBC 2003, c 63; (QC) Act respecting the protection of personal information in the private sphere, CQLR c P-39.1.Google Scholar

Medical Devices Regulations (SOR/98-282). For example, where the genetic test is performed in Canada, it would be classified as a Class III in vitro diagnostic device as per the Medical Devices Regulation. Health Canada, Government of Canada, “Guidance for the risk-based classification system for in vitro diagnostic devices (IVDDs),” available at <https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

“Forsøgsperson,” available at <http://forsøgsperson.dk> (last visited July 30, 2019).+(last+visited+July+30,+2019).>Google Scholar

Act on Research Ethics Review of Health Research Projects, Consolidated Act no.1083 of September 15, 2017. The Act is availbale in English, available at <http://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects> (last visited October 17, 2019).+(last+visited+October+17,+2019).>Google Scholar

National Committee on Health Research Ethics, “Guidelines on Genomics Research,” adopted June 1, 2018, available at <http://en.nvk.dk/~/media/NVK-EN/General-guidelines/Guidelines-on-Genomics-Research.pdf> (last visited October 17, 2019).+(last+visited+October+17,+2019).>Google Scholar

Executive Order no. 498 of May 13, 2018 on Information and Consent to Participate in Health Research Projects as well as Notification and Monitoring of Health Research Projects (Danish title: Bekendtgørelse om information og samtykke til deltagelse i sundhedsvidenskabelige forskningsprojekter samt om anmeldelse af og tilsyn med sundhedsvidenskabelige forskningsprojekter).Google Scholar

National Committee on Health Research Ethics, “Guidelines on Genomics Research,” supra note 2.Google Scholar

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Apr. 4, 1997, C.E.T.S. No. 164; “Inimõiguste Ja Biomeditsiini Konventsioon: Inimõiguste Ja Inimväärikuse Kaitse Bioloogia ja Arstiteaduse Rakendamisel,” Riigi Teat, 1997, available at <https://www.riigiteataja.ee/akt/78570> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Tartu Ülikooli Inimuuringute Eetika Komitee, Tartu Ülikool, available at <https://www.ut.ee/et/teadus/eetikakomitee> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

BBMRI-ERIC, ELSI Helpdesk, available at <http://www.bbmri-eric.eu/606 journal of law, medicine & ethics The Journal of Law, Medicine & Ethics, 47 (2019): 582–704. © 2019 The Author(s) Estonia/Finland BBMRI-ERIC/elsi-helpdesk/> (last visited October 22, 20199).+(last+visited+October+22,+20199).>Google Scholar

Personal Data Protection Act, Riigi Teat, 2018, available at <https://www.riigiteataja.ee/en/eli/523012019001/consolide> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Apr. 4, 1997, C.E.T.S. No. 164; “Inimõiguste Ja Biomeditsiini Konventsioon: Inimõiguste Ja Inimväärikuse Kaitse Bioloogia Ja Arstiteaduse rakendamisel,” Riigi Teat, 1997, available at <https://www.riigiteataja.ee/akt/78570> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

“Adequacy Decisions: How the EU Determines if a Non-EU Country has an Adequate Level of Data Protection,” Eur. Comm, available at <https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Trinidad, S.B., Fullerton, S.M., Bares, JM, et al., “Genomic Research and Wide Data Sharing: Views of Prospective Participants,” Genetics in Medicine 12, no. 8 (2010): 486–495, at 486.CrossRefGoogle Scholar

Estonian Data Protection Inspectorate, available at: https://www.aki.ee/en/inspectorate.Google Scholar

Inimgeeniuuringute seadus. Riigi Teat, available at <https://www.riigiteataja.ee/akt/72581?leiaKehtiv> (last visited October 22, 2019); Human Genes Research Act, Riigi Teat, available at <https://www.riigiteataja.ee/en/eli/531102013003/consolide> (last visited October 22, 2019).+(last+visited+October+22,+2019);+Human+Genes+Research+Act,+Riigi+Teat,+available+at++(last+visited+October+22,+2019).>Google Scholar

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Apr. 4, 1997, C.E.T.S. No. 164.Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Sata, and Repealing Directive 95/46/EC (General Data Protection Regulation), 2016 O.J. (L 119), 1.Google Scholar

Leitsalu, L., “Communicating Genomic Research Results to Population-Based Biobank Participants,” PhD Dissertation, University of Tartu, 2016.Google Scholar

Human Genes Research Act, Riigi Teat, available at <https://www.riigiteataja.ee/en/eli/531102013003/consolide> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Leitsalu, L., Alavere, H., Jacquemont, S., et al., “Reporting Incidental Findings of Genomic Disorder-Associated Copy Number Variants to Unselected Biobank Participants,” Personalized Medicine 13, no. 4 (2016): 303–314; Alver, M., Palover, M., Saar, A., et al., “Recall by Geno-type and Cascade Screening for Familial Hypercholesterolemia in a Population-Based Biobank from Estonia,” Genetics in Medicine 21, no. 5 (2019): 1173–1180.CrossRefGoogle Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1.Google Scholar

Geenitestid, Terviseamet, available at <https://www.terviseamet.ee/et/meditsiini-seadmed/meditsiiniseadmed/kodanikule/geenitesti> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Medical Devices Act, Riigi Teat, available at <https://www.riigiteataja.ee/en/eli/ee/509012015001/consolide/current> (last visited October 22, 2019); Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU, 2017 O.J. (L 117), 1.+(last+visited+October+22,+2019);+Regulation+(EU)+2017/746+of+the+European+Parliament+and+of+the+Council+of+5+April+2017+on+In+Vitro+Diagnostic+Medical+Devices+and+Repealing+Directive+98/79/EC+and+Commission+Decision+2010/227/EU,+2017+O.J.+(L+117),+1.>Google Scholar

Human Genes Research Act, Riigi Teat, available at <https://www.riigiteataja.ee/en/eli/531102013003/consolide> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Pormeister, K., “Tarbijale Suunatud Geenitestid Eesti Oigusruumis,” Juridica 4 (2016): 263–270.Google Scholar

Personal Data Protection Act, Riigi Teat, 2018, available at <https://www.riigiteataja.ee/en/eli/523012019001/consolide> (last visited October 22, 2019); Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1.+(last+visited+October+22,+2019);+Regulation+(EU)+2016/679+of+the+European+Parliament+and+of+the+Council+of+27+April+2016+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+(General+Data+Protection+Regulation),+2016+O.J.+(L+119),+1.>Google Scholar

Medical Research Act (488/1999), available at <https://www.finlex.fi/fi/laki/kaannokset/1999/en19990488_20100794.pdf> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119) 1.Google Scholar

Act on Transport on Dangerous Goods (719/1994), available at <https://www.finlex.fi/fi/laki/kaannokset/1994/en19940719_20090388.pdf> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Act of the Medical Use of Human Organs and Tissues (101/2001), available at <https://www.finlex.fi/fi/laki/kaannokset/2001/en20010101_20130277.pdf> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Regulation (EU) 2016/679, of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119) 1.Google Scholar

Biobank Act (688/2012), available at <https://www.finlex.fi/fi/laki/kaannokset/2012/en20120688_20120688.pdf> (last visited October 22, 2019).+(last+visited+October+22,+2019).>Google Scholar

Kalokairinou, L., Howard, H.C., Slokenberga, S., et al., “Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape,” Journal of Community Genetics 9, no. 2 (2018): 117–132, at 117.Google Scholar

Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, 2017 O.J. (L 117), 1.Google Scholar

Ministry of Social Affairs and Health, Genomikeskus Genome Center, available at <http://www.genomikeskus.fi/en/frontpage.html> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Code de la santé publique [Public Health Code] art L 1121-1 (Fr.).Google Scholar

Commission nationale de l'informatique et des libertés (CNIL), “Recherches dans le Domaine de la Santé : La CNIL Adopte de Nouvelles Mesures de Simplification,” available at <https://www.cnil.fr/fr/recherches-dans-le-domainede-la-sante-la-cnil-adopte-de-nouvellesmesures-de-simplification> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar

Gesetz über genetische Untersuchungen bei Menschen [GenDG] [German Genetic Diagnostics Act], July 31, 2009, BUNDESGESETZBLATT, Teil I at 2529.Google Scholar

Gesetz über den Verkehr mit Arzneimitteln [AMG] [Medicinal Products Act], Dec. 12, 2005, BUNDESGESETZBLATT, Teil I at 3394, §§ 40, 42.Google Scholar

Gesetz über Medizinprodukte [MPG] [Medical Devices Act], Aug. 7, 2002, BUNDESGESETZBLATT, Teil I at 3146, §§ 20, 22.Google Scholar

Based on the German IRB/REC Working Group recommendations, available at <https://www.ak-med-ethik-komm.de/index.php?option=com_content&view=article&id=147&Itemid=153&lang=d> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Gesetz über den Verkehr mit Arzneimitteln [AMG] [Medicinal Products Act], Dec. 12, 2005, BGBL. I at 3394, §§40, 42; Gesetz über Medizinprodukte [MPG] [Medical Devices Act], Aug. 7, 2002, BGBL. I at 3146, §§ 20, 22.Google Scholar

United Nations Economic Commission for Europe [UNECE], European Agreement concerning the International Carriage of Dangerous Goods by Road, ECE/TRANS/275, Vol. I and II, available at <http://www.unece.org/trans/danger/publi/adr/adr2019/19contentse.html> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Gesetz über die Beförderung gefährlicher Güter [GGBefG], Aug. 6, 1975, BUNDESGESETZBLATT, Teil I at 2121, § 3(1) No. 14; Verordnung über die Bestellung von Gefahrgutbeauftragten in Unternehmen [GbV], Mar. 11, BUNDESGESETZBLATT, Teil I at 304, § 3.Google Scholar

Bundesdatenschutzgesetz [BDSG], Jun. 30, 2017, BUNDESGESETZBLATT, Teil I at 2097, §1.Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 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 (General Data Protection Regulation). EUR-Lex Access to Eur. Union law, available at <https://eurlex.europa.eu/eli/reg/2016/679/2016-05-04> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

STRAFGESETZBUCH [StGB] [Criminal Code], §§ 5, 6 and 7, translation available at <https://www.gesetze-im-internet.de/englisch_stgb/index.html> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

BVerfG, 1 BvR 209, 269, 362, 420, 440, 484/83, Dec. 15, 1983, available at <https://www.bundesverfassungsgericht.de/SharedDocs/Entscheidungen/EN/1983/12/rs19831215_1bvr020983en.html> (last visited October 23, 2019); GRUNDGESETZ [GG] [BASIC LAW], § 1(1) translation available at <https://www.gesetze-im-internet.de/englisch_gg/> (last visited October 23, 2019).+(last+visited+October+23,+2019);+GRUNDGESETZ+[GG]+[BASIC+LAW],+§+1(1)+translation+available+at++(last+visited+October+23,+2019).>Google Scholar

Gesetz über genetische Untersuchungen bei Menschen [GenDG] [German Genetic Diagnostics Act], July 31, 2009, BGBI, L. at 2529, § 7.Google Scholar

Id., § 8, 9.Google Scholar

Id., § 11.Google Scholar

Id., § 17.Google Scholar

Technikfolgenabschätzung (TA) Aktueller Stand und Entwicklungen der Pränataldiagnostik, DEUTSCHER BUNDESTAG: Drucksache 19/9059, available at <http://dip21.bundestag.de/dip21/btd/19/090/1909059.pdf> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

DirectorateGeneral for Communications Networks, Content and Technology, “EU Countries will Cooperate in Linking Genomic Databases across Borders,” European Commission, April 10, 2019, available at <https://ec.europa.eu/digital-single-market/en/news/eu-countries-will-cooperate-linking-genomic-databases-across-borders> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Hellenic National Bioethics Commission, “Big Data in Health,” OPINION, translated by V. Antoniou, November 9, 2017, available at <http://www.bio-ethics.gr/images/pdf/GNOMES/OPINION_Big_Data_FINAL_EN.pdf> (last visited October 23, 2019); Hellenic National Bioethics Commission, “Incidental Findings in Research and Clinical Practice,” OPINION, translated by Matina Chatzigianni, Junes 26, 2015, available at <http://www.bioethics.gr/images/pdf/GNOMES/OPINION_Incidental_Findings_FINAL_.pdf> (last visited October 23, 2019); Hellenic National Bioethics Commission, “Direct-to-Consumer Genetic Testing,” OPINION, March 30, 2012, available at <http://www.bioethics.gr/images/pdf/ENGLISH/OPINIONS_REPORTS/Opinion_DTC_genetic_tests-Final-EN.pdf> (last visited October 23, 2019); Hellenic National Bioethics Commission, “The Use of Genetic Data in Private Insurance,” OPINION, January 11, 2008, available at <http://www.bioethics.gr/images/pdf/ENGLISH/OPINIONS_REPORTS/ins_opinion_eng.pdf> (last visited October 23, 2019); Hellenic National Bioethics Commission, “Bank of Biological Material of Human Origin (Biobanks) in Biomedical Research,” RECCOMENDATION, translated by C. Xanthopoulou, June 30, 2006, available at <http://www.bioethics.gr/images/pdf/ENGLISH/OPINIONS_REPORTS/biobanks_recom_eng.pdf> (last visited October 23, 2019); Hellenic National Bioethics Commission, “The Collection and Use of Genetic Data,” RECCOMENDATION, March 23, 2001, available at <http://www.bioethics.gr/images/pdf/ENGLISH/OPINIONS_REPORTS/recom_genetic_data_eng.pdf> (last visited October 23, 2019).+(last+visited+October+23,+2019);+Hellenic+National+Bioethics+Commission,+“Incidental+Findings+in+Research+and+Clinical+Practice,”+OPINION,+translated+by+Matina+Chatzigianni,+Junes+26,+2015,+available+at++(last+visited+October+23,+2019);+Hellenic+National+Bioethics+Commission,+“Direct-to-Consumer+Genetic+Testing,”+OPINION,+March+30,+2012,+available+at++(last+visited+October+23,+2019);+Hellenic+National+Bioethics+Commission,+“The+Use+of+Genetic+Data+in+Private+Insurance,”+OPINION,+January+11,+2008,+available+at++(last+visited+October+23,+2019);+Hellenic+National+Bioethics+Commission,+“Bank+of+Biological+Material+of+Human+Origin+(Biobanks)+in+Biomedical+Research,”+RECCOMENDATION,+translated+by+C.+Xanthopoulou,+June+30,+2006,+available+at++(last+visited+October+23,+2019);+Hellenic+National+Bioethics+Commission,+“The+Collection+and+Use+of+Genetic+Data,”+RECCOMENDATION,+March+23,+2001,+available+at++(last+visited+October+23,+2019).>Google Scholar

See Hellenic National Bioethics Commission, “Direct-to-Consumer Genetic Testing,” supra note 2.Google Scholar

International Health Division, Indian Council of Medical Research, Guidelines for International Collaboration/Research Projects in Health Research; MoUs & HMSC Prodecure, available at <https://www.icmr.nic.in/content/guidelines> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Genetic Information Law, 5761-2000, (Isr.), § 13, available at <https://www.jewishvirtuallibrary.org/jsource/Health/GeneticInformationLaw.pdf> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar

Ministry of Health: Clinical Trials Department, “Procedure for Medical Experiments in Humans 5775-2014, at 80, available at <http://research.telhai.ac.il/sites/default/filesfiles/%D7%A0%D7%95%D7%94%D7%9C%20%D7%9C%D7%A0%D7%99%D7%A1%D7%95%D7%99%D7%99%D7%9D%20%D7%A8%D7%A4%D7%95%D7%90%D7%99%D7%99%D7%9D%20%D7%91%D7%9-1%D7%A0%D7%99%20%D7%90%D7%93%D7%9D_%D7%AA%D7%A9%D7%A2%D7%93%20(1).pdf> (in Hebrew only) (last visited October 25, 2019).+(in+Hebrew+only)+(last+visited+October+25,+2019).>Google Scholar

Siegal, G., “Genomic Databases and Bio-banks in Israel,” Journal of Law, Medicine and Ethics 43, no. 4 (2015): 766–775.Google Scholar

Comitato Nazionale di Bioetica (CNB), “Opinions & Responses,” available at <http://bioetica.governo.it/en/opinions/opinions-responses/> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Comitato Nazionale per la Biosicurezza, le Biotecnologie e le Scienze della Vita (CNBBSV), Pareri (Opinions), available at <http://cnbbsv.palazzochigi.it/it/documenti/pareri/> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Comitato Nazionale di Bioetica (CNB), “ICB-CNBBSV Joint Group,” available at <http://bioetica.governo.it/en/opinions/icb-cnbbsv-joint-group/>..>Google Scholar

Ministero della Salute, Piano per l'innovazione del Sistema Sanitario Basata Sulle Scienze Omiche (Plan for innovation of the health system based on omics sciences) Annex A, sub A, para. 8.b, available at <http://www.salute.gov.it/imgs/C_17_notizie_3270_lista-File_itemName_0_file.pdf> (last visited October 23, 2019); see also Intesa 5 giugno 2003, n. 176/CSR, G.U. Jan. 17, 2018, n. 13 (It.). In execution of the Plan, the Istituto Superiore di Sanità instituted a working group on genomics known as Table for genomics (Tavolo per la genomica). On July 11, 2018 an “Inter-institutional Coordination” was set up at the Directorate-General for Health Prevention of the Ministry of Health, with the task of implementing the Plan. (last visited October 23, 2019); see also Intesa 5 giugno 2003, n. 176/CSR, G.U. Jan. 17, 2018, n. 13 (It.). In execution of the Plan, the Istituto Superiore di Sanità instituted a working group on genomics known as Table for genomics (Tavolo per la genomica). On July 11, 2018 an “Inter-institutional Coordination” was set up at the Directorate-General for Health Prevention of the Ministry of Health, with the task of implementing the Plan.' href=https://scholar.google.com/scholar?q=Ministero+della+Salute,+Piano+per+l'innovazione+del+Sistema+Sanitario+Basata+Sulle+Scienze+Omiche+(Plan+for+innovation+of+the+health+system+based+on+omics+sciences)+Annex+A,+sub+A,+para.+8.b,+available+at++(last+visited+October+23,+2019);+see+also+Intesa+5+giugno+2003,+n.+176/CSR,+G.U.+Jan.+17,+2018,+n.+13+(It.).+In+execution+of+the+Plan,+the+Istituto+Superiore+di+Sanità+instituted+a+working+group+on+genomics+known+as+Table+for+genomics+(Tavolo+per+la+genomica).+On+July+11,+2018+an+“Inter-institutional+Coordination”+was+set+up+at+the+Directorate-General+for+Health+Prevention+of+the+Ministry+of+Health,+with+the+task+of+implementing+the+Plan.>Google Scholar

Società Italiana di Genetica Umana (SIGU), Linee Guida (Guidelines), available at <https://www.sigu.net/show/documenti/5/1/linee%20guida> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Fondazione Smith Kline (FSK), Linee Guida per i protocolli clinici di ricerca genetica. Raccomandazioni per la realizzazione e la valutazione dei protocolli di ricerca clinica in campo gene-tico (Guidelines for clinical protocols of genetic research. Recommendations for the implementation and evaluation of genetic clinical research protocols), available at <http://www.fsk.it/gruppidi-lavoro-fsk/i-gruppi-conclusi/lineeguida-in-genetica-umana#gdl-documenti> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Decreto Legislativo 24 giugno 2003, n. 211, G.U. Aug. 9, 2003, n. 184 (It.). After the reorganization of the Ethics Committees in 2006 (Decreto Ministeriale 12 maggio 2006, G.U. Aug. 22, 2006, n. 194 (It.)), the Law n. 189 of November 8, 2012 (Legge 8 novembre 2012, n. 189, G.U. Oct. 10, 2012, n. 263 (It.)) established that, by June 30, 2013, each Region should arrange to reorganize the Ethics Committees of its territory. The latest revision of the system was regulated by Law no. 3 of January 11, 2018, so-called Law Lorenzin, and implementing Legislative decree no. 52 of May 14, 2019 (Legge, 11 gennaio 2018, n. 3, G.U. Jan. 31, 2018, n. 25 (It.)).Google Scholar

Decreto Legislativo 14 maggio 2019, n. 52, G.U. June 12, 2019, n. 136 (It.).Google Scholar

Regulation (EU) 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, 2014 O.J. (L 158), 1.Google Scholar

Fondazione Smith Kline (FSK), supra note 6. See especially the chapter “Check list for drafting and assessment of a genetic research protocol and the informed consent.”Google Scholar

Decreto Legislativo 30 giugno 2003, n. 196, G.U. Jul. 30, 2003, n. 174 (It.).CrossRefGoogle Scholar

Decreto Legislativo 10 agosto 2018, n. 101, G.U. Sep. 4, 2018, n. 205 (It.).Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1.Google Scholar

The Garante per la protezione dei dati personali (<https://www.garanteprivacy.it/web/guest/home>) is an independent administrative authority established by Law no. 675 of December 31, 1996 (Legge 31 dicembre 1996, n. 675, G.U. Jan. 8, 1997, n. 5 (It.)) and regulated by the Personal Data Protection Code. Legislative decree no. 101/2018 (D.Lgs. 101/2018) established that the Authority would be responsible for monitoring the application of the GDPR.)+is+an+independent+administrative+authority+established+by+Law+no.+675+of+December+31,+1996+(Legge+31+dicembre+1996,+n.+675,+G.U.+Jan.+8,+1997,+n.+5+(It.))+and+regulated+by+the+Personal+Data+Protection+Code.+Legislative+decree+no.+101/2018+(D.Lgs.+101/2018)+established+that+the+Authority+would+be+responsible+for+monitoring+the+application+of+the+GDPR.>Google Scholar

Garante per la protezione dei dati personali, Main Decisions by the Italian Data Protection Authority, available at <https://www.garanteprivacy.it/web/guest/home_en/main-decisions> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

See General authorizations for the processing of genetic data nos. 8/2012, 8/2014 and 8/2016.Google Scholar

Provvedimento che individua le prescrizioni contenute nelle Autorizzazioni generali nn. 1/2016, 3/2016, 6/2016, 8/2016 e 9/2016 che risultano compatibili con il Regolamento e con il d.lgs. n. 101/2018 di adeguamento del Codice - 13 dicembre 2018; Registro dei provvedimenti n. 497 del 13 dicembre 2018.Google Scholar

Comitato Nazionale di Bioetica (CNB), “Managing ‘Incidental Findings’ in genomic investigations with new technology platforms,” available at <http://bioetica.governo.it/en/opinions/opinions-responses/managing-incidental-findings-in-genomic-investigations-with-new-technology-platforms/> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

FSK, supra note 6, at 69.Google Scholar

Decreto legislativo 8 settembre 2000, n. 332, G.U. Nov. 17, 2000, n. 189 (It.).Google Scholar

Ministero della Salute, Nuove Linee guida del 28 marzo 2013, in merito alla pubblicità sanitaria concernente i dispositivi medici, dispositivi medico-diagnostici in vitro e presidi medico-chirurgici (New Guidelines for health advertising of medical devices, in vitro diagnostic medical devices and medical-surgical devices) (Dec. 20, 2017), available at <http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=PUB&idSrv=A01&flag=P> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

NBC-NBBLSC, “Test genetici di suscettibilità e medicina personalizzata,” (Genetic Susceptibility Testing and Personalised Medicine), July 14, 2010, available at <http://cnbbsv.palazzochigi.it/media/1562/3-gm_genetic-susceptibility-testing-and-personalised-medicine.pdf> (last visited October 23, 2019).+(last+visited+October+23,+2019).>Google Scholar

Id. at 6.Google Scholar

Id. at 31-33.Google Scholar

Id. at 43-45.Google Scholar

MYCODE, available at <https://mycode.jp/survey/research.html?src=information_20160831> (last visited October 24, 2019) (in Japanese only).+(last+visited+October+24,+2019)+(in+Japanese+only).>Google Scholar

RIKEN Center for Brain Science, available at <http://www.brain.riken.go.jp/labs/mdmd/genome_research.html#topics4> (last visited October 24, 2019) (in Japanese only).+(last+visited+October+24,+2019)+(in+Japanese+only).>Google Scholar

National Hospital Organization, available at <https://www.ehs-mcs-jp.com/> (in Japanese only) (last visited October 24, 2019).+(in+Japanese+only)+(last+visited+October+24,+2019).>Google Scholar

Ministry of Health, Labour and Welfare (MHLW), “Ethical Guideline of Human Genome and Genomic Analysis Study,” available at <https://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/genome/0504sisin.html> (last visited October 24, 2019), s. 4(2) (in Japanese only).+(last+visited+October+24,+2019),+s.+4(2)+(in+Japanese+only).>Google Scholar

MYCODE, supra note 1.Google Scholar

Id., s. 11(1).Google Scholar

Ministry of Economy, Trade and Industry (METI), “Personal Information Protection Guidelines,” available at <https://www.meti.go.jp/policy/mono_info_service/mono/bio/Seimeirinnri/guideline_20170329.pdf> (last visited October 24, 2019) (in Japanese only).+(last+visited+October+24,+2019)+(in+Japanese+only).>Google Scholar

Japanese Committee for Clinical Laboratory Standards (JCCLS), “Best Practice Guideline,” available at <http://www.jccls.org/techreport/bestpractice_guideline.pdf> (in Japanese only); Council for the Handling of Personal Genetic Information (CPIGI), “Voluntary Standards that Companies Dealing with Personal Genetic Information Should Comply With (Voluntary Standards for Individual Genetic Information Handling Companies),” available at <http://www.cpigi.or.jp/jisyu/img/sin_jisyu.pdf> (last visited October 24, 2019) (in Japanese only).+(in+Japanese+only);+Council+for+the+Handling+of+Personal+Genetic+Information+(CPIGI),+“Voluntary+Standards+that+Companies+Dealing+with+Personal+Genetic+Information+Should+Comply+With+(Voluntary+Standards+for+Individual+Genetic+Information+Handling+Companies),”+available+at++(last+visited+October+24,+2019)+(in+Japanese+only).>Google Scholar

Japanese Association of Medical Sciences (JAMS), “Guidelines for Genetic Tests and Diagnoses in Medical Practice,” available at <http://jams.med.or.jp/guideline/genetics-diagnosis_e.pdf> (last visited October 24, 2019).+(last+visited+October+24,+2019).>Google Scholar

Al Hussaini, M. and Abu Hmaidan, A., “Use of Human Surplus Biospecimens in Research: A Survey from a Cancer Centre,” Eastern Mediterranean Health Journal 20, no. 6 (2014): 378–384.Google Scholar

Statute No. 10 of 2014 on Stem Cells (Jordan).Google Scholar

Dajani, R., “Jordan's Stem-Cell Law can Guide the Middle East,” Nature 510, no. 7504 (2014): 189–189.Google Scholar

See Al Hussaini and Abu Hmaidan, supra note 1.Google Scholar

Ruiz de Chávez, M. and Piña Jiménez, R., eds., Bioética y Nuevas Fronteras de la Genética, (Mexico: Fontamara/Conbioética, 2018); Jim, G. Sánchez, énez, et al., “La Medicina Genómica en México: Los Primeros Pasos y el Camino por Recorrer,” Genome Research 18, no. 8 (2008): 1191–1198.; Oliva Sánchez, P.F., et al., “La Medicina Genómica en las Políticas de Salud Pública: Una Perspectiva de Investigadores Mexicanos del área Biomédica,” Salud Pública de México 55, no. 1 (2013): 16–25.Google Scholar

Ley General de Salud [LGS] Diario Oficial de la Federación [DOF] 07-02-1984, últimas reformas DOF 07-12-2018 (General Health Law) (Mex.); Reglamento de la Ley General de Salud en materia de Investigación para la Salud [RLGS-mIS], Diario Oficial de la Federación [DOF] 04-02-2014, últimas reformas DOF 07-12-2018 (Regulations of the General Health Law on Health Research); Acuerdo por el que se Emiten las Disposiciones Generales para la Integración y Funcionamiento de los Comites de Etica en Investigacion y se Establecen las Unidades Hospitalarias que Deben Contar con Ellos, de Conformidad con los Criterios Establecidos por la Comision Nacional de Bioetica, Diario Oficial de la Federación [DOF] 10-31-2012 (General Rules for the Integration and Operation of Research Ethics Committees and the Health Care Units that must Estabish Them, Acording to the Criteria of the National Bioethics Commission) (Mex.); National Bioethics Commission Mexico, Guía Nacional para la Integración y el Funcionamiento de los Comités de Ética en Investigación, [National Guidelines for the Integration and Operation of Research Ethics Committees] 5th edition, 2016.Google Scholar

Ley General de Salud [LGS], Diario Oficial de la Federación [DOF] 07-02-1984, últimas reformas DOF 07-12-2018 (General Health Law); Reglamento de la Ley General de Salud en materia de Investigación para la Salud [RLGS-mIS], Diario Oficial de la Federación [DOF] 04-02-2014, últimas reformas DOF 07-12-2018 (Regulations of the General Health Law on Health Research) (Mex.).Google Scholar

Ley General de Protección de Datos Personales en Posesión de Sujetos Obligados [LGPDPPSO], Diario Oficial de la Federación [DOF] 01-26-2017; Ley Federal de Transparencia y Acceso a la Información Pública [LFTAIP], Diario Oficial de la Federación [DOF] 05-09-2016, últimas reformas DOF 01-27-2017 (Federal Law of Transparency and Access to Public Government Information) (Mex.); Ley Federal de Protección de Datos Personales en Posesión de los Particulares [LFPDPPP] Diario Oficial de la Federación [DOF] 07-05-2010 (Federal Law on the Protection of Personal Data held by Private Parties)(Mex.).Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1Google Scholar

The Council of the Federation of Medical Scientific Societies, FMWV Code of Conduct for Health Research, available at <https://www.federa.org/sites/default/files/bijlagen/coreon/code_of_conduct_for_medical_research_1.pdf> (last visited October 28, 2019).+(last+visited+October+28,+2019).>Google Scholar

Autoriteit Persoonsgegeven, available at <https://www.autoriteitpersoonsgegevens.nl/en> (last visited October 28, 2019).+(last+visited+October+28,+2019).>Google Scholar

Federation of Dutch Medical Scientific Societies, code Goed Gedrag, available at <https://www.federa.org/code-goedgedrag> (last visited October 28, 2019), English version, available at <https://www.federa.org/codes-conduct> (last visited October 28, 2019).+(last+visited+October+28,+2019),+English+version,+available+at++(last+visited+October+28,+2019).>Google Scholar

van den Berg, M. and van Kranen, H.J., “Public Health Genomics: Wat Zijn de Kansen voor Preventie?,” Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Report 270524001/2013, available at <https://www.rivm.nl/bibliotheek/rapporten/270524001.pdf> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Jansen, B. and Baart, R.I.C., “Van wie is mijn geamputeerde been?” Neder-lands Tijdschrift voor Geneeskunde 162 (2018): D2301, available at <https://www.ntvg.nl/artikelen/van-wie-mijngeamputeerde-been/artikelinfo> (last visited October 28, 2019).Google Scholar

Wet zeggenschap lichaamsmateriaal, Ministerie van Volksgezondheid, Welzjin en Sport, April 24, 2017, available at <https://www.internetconsultatie.nl/zeggenschaplichaamsmateriaal> (last visited October 28, 2019).+(last+visited+October+28,+2019).>Google Scholar

Rijksdienst voor Ondernemend Nederland, “Projects IOP Genomics (English),” available at <https://www.rvo.nl/subsidies-regelingen/iops/iop-genomics/projects-english> (last visited October 28, 2019).+(last+visited+October+28,+2019).>Google Scholar

Netherlands Organisation for Health Research and Development (ZonMw), “Personalised Medicine Program,” available at <https://www.zonmw.nl/nl/onderzoek-resultaten/geneesmiddelen/programmas/programma-detail/personalised-medicine/> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices, 1998 O.J. (L 331), 1.Google Scholar

Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC ad Commission Decision 2010/227/EU, 2017 O.J. (L 117), 176.Google Scholar

Wet medisch-wetenschappelijk onderzoek met mensen februari 26, 1998, Stb. 1998.Google Scholar

See Centrale Commisie Mensgebonden Onderzoek (CCMO), Erkende METC's, available at <https://www.ccmo.nl/metcs/erkende-metcs> (last visited October 28, 2019); Committee Finder, available at <https://pauljanssenfuturelab.eu/tools/clinical_research_in_the_netherlands/committee_finder/?user_id=0&token> (last visited October 28, 2019). (last visited October 28, 2019); Committee Finder, available at (last visited October 28, 2019).' href=https://scholar.google.com/scholar?q=See+Centrale+Commisie+Mensgebonden+Onderzoek+(CCMO),+Erkende+METC's,+available+at++(last+visited+October+28,+2019);+Committee+Finder,+available+at++(last+visited+October+28,+2019).>Google Scholar

Besluit verplichte verzekering bij medisch-wetenschappelijk onderzoek met mensen 2015 November 24, 2014, Stb. 2014, 477.Google Scholar

Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001 on the Community ode relating to medicinal products for human use, 2001 O.J. (L 311), 28, 67.Google Scholar

Uitvoeringswet Algemene verordening gegevensbescherming Mei 25, 2018, Stb. 2018, 145.Google Scholar

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights Biomedicine, C.E.T.S. no. 164 (April 4, 1997).Google Scholar

Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, C.E.T.S. No. 203 (November 27, 2008).Google Scholar

Additional Protocol to the Convention on Human Rights nd Biomedicine, concerning Biomedical Research, C.E.T.S. no. 195 (January 1, 2005).Google Scholar

Wet medisch-wetenschappelijk onderzoek met mensen Februari 26, 1998, Stb. 1998.Google Scholar

Wet op het bevolkingsonderzoek Oktober 29, 1992, Stb. 1992, 611.Google Scholar

Raad voor de Volksgezondheid and Zorg (Council for Public Health & Care), Screening en de rol van de overheid (2008) (no longer available online); Health Council (Gezondheidsraad): Screening: tussen hoop en hype (2008), available at <https://www.gezondheidsraad.nl/documenten/adviezen/2008/04/01/screening-tussen-hoop-en-hype> (last visited October 28, 2019); Health Council (Gezondheidsraad): Doorlichten door-gelicht (2015), available at <https://www.rijksoverheid.nl/documenten/rapporten/2015/03/05/doorlichten-doorgelicht-gepast-gebruik-van-health-checks> (last visited October 28, 2019).+(last+visited+October+28,+2019);+Health+Council+(Gezondheidsraad):+Doorlichten+door-gelicht+(2015),+available+at++(last+visited+October+28,+2019).>Google Scholar

Wet op het bevolkingsonderzoek, Oktober 29, 1992, Stb. 1992, 611.Google Scholar

National Health Act (2014) SB. 215, § 26, available at <http://www.ilo.org/dyn/natlex/docs/ELECTRONIC/104157/126947/F-693610255/NGA104157.pdf> (last visited Octover 29, 2019).+(last+visited+Octover+29,+2019).>Google Scholar

Federal Ministry of Health (FMoH), National Code of Health Research Ethics, August 13, 2007, at 28 — 31, 37 — 40, [hereinafter cited as National Code of Health Research Ethics].Google Scholar

Nnamuchi, O., “Biobank/Genomic Research in Nigeria: Examining Relevant Privacy and Confidentiality Frameworks,” Journal of Law, Medicine & Ethics, 43, no. 4 (2015): 776–786, at 776.Google Scholar

Id. at 776.Google Scholar

See National Code of Health Research Ethics, supra, note 2 at 24.Google Scholar

Id.Google Scholar

Id. at 37 — 42.Google Scholar

FMoH/NHREC, Policy Statement on Storage of Human Samples in Bio-banks and Biorepositories in Nigeria (PS1.02013), Nov. 1, 2013, available at <http://nhrec.net/nhrec/NHREC_Policy_Statement_on_Biobanks_FINAL.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

See National Health Act, (2014) SB. 215, §§ 31 — 34 (Nigeria).Google Scholar

See FMoH/NHREC, supra, note 8, at ¶ D(i).Google Scholar

Ley Nº 30309 — Ley Que Promueve La Investigación Científica, Desarrollo Tecnológico E Innovación Tecnológica (2015); Reglamento de la Ley Nº 30309, Ley que promueve la investigación científica, desarrollo tecnológico e innovación tecnológica — Decreto Supremo N° 188-2015-EF (2015); Ley Nº 26842 — Ley General De Salud (1997) y sus modificaciones (2017).Google Scholar

Reglamento de Ensayos Clínicos Decreto Supremo N° 021-2017-SA; Ley Nº 26842, Ley General de Salud (2017).Google Scholar

Ley Nº 30309 — Ley Que Promueve La Investigación Científica, supra note 1.Google Scholar

Reglamento de Ensayos Clínicos Decreto Supremo N° 021-2017-SA; Ley, Ley General de Salud (2017)Google Scholar

Lineamientos Para Garantizar El Ejercicio De La Bioética Desde El Reconocimiento De Los Derechos Humanos Decreto Supremo N° 011-2011-JUSGoogle Scholar

Reglamento de Ensayos Clínicos Decreto Supremo N° 021-2017-SA; Ley Nº 26842, Ley General de Salud, (2017); Lineamientos Para Garantizar El Ejercicio De La Bioética Desde El Reconocimiento De Los Derechos Humanos Decreto Supremo N° 011-2011-JUS; Ley Nº 30309 — Ley Que Promueve La Investigación Científica, Desarrollo Tecnológico E Innovación-Tecnológica (2015); Reglamento de la Ley Nº 30309, Ley que promueve la investigación científica, desarrollo tecnológico e innovación tecnológica — Decreto Supremo N° 188-2015-EF (2015); Ley Nº 26842 — Ley General De Salud (1997) y sus modificaciones (2017).Google Scholar

Reglamento de la Ley Nº 30309, Ley que promueve la investigación científica, desarrollo tecnológico e innovación tecnológica — Decreto Supremo N° 188-2015-EF (2015), art. 8; Ley que promueve la investigación científica, desarrollo tecnológico e innovación tecnológica — Decreto Supremo N° 188-2015-EF (2015).Google Scholar

Reglamento de Ensayos Clínicos Decreto Supremo N° 021-2017-SA; Ley Nº 26842, Ley General de Salud (2017); Lineamientos Para Garantizar El Ejercicio De La Bioética Desde El Reconocimiento De Los Derechos Humanos Decreto Supremo N° 011-2011-JUS; Ley Nº 30309 — Ley Que Promueve La Investigación Científica, Desarrollo Tecnológico E Innovación Tecnológica (2015); Reglamento de la Ley Nº 30309, Ley que promueve la investigación científica, desarrollo tecnológico e innovación tecnológica — Decreto Supremo N° 188-2015-EF (2015); Ley Nº 26842 — Ley General De Salud (1997) y sus modificaciones (2017); Directiva para Muestras Biológicas en Ensayos Clínicos Directiva N° INS/OGAT-V.01.Google Scholar

Ley Nº 26821 Ley Orgánica para el aprovechamiento sostenible de los recursos naturales (1997).Google Scholar

Directiva para Muestras Biológicas en Ensayos Clínicos Directiva N° INS/OGAT-V.01.Google Scholar

Directiva para Muestras Biológicas en Ensayos Clínicos Directiva N° INS/OGAT-V.01, art. 5.7.f.Google Scholar

Directiva para Muestras Biológicas en Ensayos Clínicos Directiva N° INS/OGAT-V.01., art. 5.6.6.-5.7.Google Scholar

Ustawa o Wyrobach Medycznych [Act on medical devices], Dz. U. 2010, nr 107, poz. 679, art. 45; According to art. 2(4), a clinical trial is designed and planned for a systematic human research, undertaken to verify the safety or performance of a specific medical device, medical device or active medical device for implantation.Google Scholar

Ustawa o o Zawodach Lekarza i Lekarza Dentysty [Act on the Professions of Physician and Dentist], Dz.U. 1997, nr 28, poz. 152, art. 29. According to art. 21, a medical experiment conducted on people may be a therapeutic or research experiment. The therapeutic experiment is the introduction by the doctor of new or only partially tested diagnostic, therapeutic or prophylactic methods in order to achieve a direct benefit for the health of the person being treated. It can be carried out if the previously used medical methods are not effective or if their effectiveness is not sufficient. The research experiment is aimed primarily at expanding medical knowledge. It can be carried out both on sick and healthy people. Conducting a research experiment is permissible if participation in it is not associated with risk or the risk is small and does not remain in disproportion to the possible positive results of such an experiment. There for genetic testing cannot be treated as medical experiment.Google Scholar

Najwyższa Isba Kontroli [Supreme Audit Office], available at <https://www.nik.gov.pl/en/> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), at 1.Google Scholar

Ustawa o Pobieraniu, Przechowywaniu i Przeszczepianiu Komórek, Tkanek i Narzżdów [Act on the collection, storage and transplantation of cells, tissues and organs], Dz.U. 2005, nr 169, poz. 1411Google Scholar

Ministry of Public Health, Department of Research, State of Qatar, Guidance for the Design, Ethical Review, and Conduct of Genomic Research in Qatar, POLICY, 2017-2018, available at <https://www.moph.gov.qa/about-us/Documents/research/Guidance%20for%20the%20Design,%20Ethical%20Review,%20and%20Conduct%20of%20Genomic%20Research%20in%20Qatar.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Human Biomedical Research Act 2015 (No. 29 of 2015), available at <https://sso.agc.gov.sg/Act/HBRA2015> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Ministry of Health Singapore, Human Biomedical Research Act: Reflection on Transition, March 2, 2018, available at <https://www.moh.gov.sg/docs/librariesprovider5/legislation/reflection-on-transition.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Human Biomedical Research Act 2015 (No. 29 of 2015) at 3rd sch.Google Scholar

Id., § 3(3). This sub-section identifies these materials as human gametes or human embryos, cytoplasmic hybrid embryos, human-animal combination embryo and human stem cells or neural cells.Google Scholar

Id. § 3(2)(a)-(c).Google Scholar

Id. § 3(2)(i)-(iii).Google Scholar

Id., 2^nd sch, para. 1, 2, 6, 7. Other research excluded from the statutory definition of human biomedical research include minimal risk studies and tests that relate to normal human psychological responses and behaviours or measurement of human intelligence, as well as activities that are already governed under a different statutory regime.Google Scholar

Id. § 3(5).Google Scholar

Bioethics Advisory Committee Singapore, Ethical Guidelines for Human Biomedical Research, June 2015: at 28–29, available at <https://www.bio-ethics-singapore.org/files/publications/reports/ethics-guidelines-for-human-biomedical-research-full-report.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Id. para. 2.13. As the BAC explains, the principle of beneficence is not considered to be distinct from the principle of respect for persons for many research endeavors, and is hence not set apart as a standalone principle.Google Scholar

Human Biomedical Research (Restricted Research) Regulations 2017, S 621/2017, available at <https://sso.agc.gov.sg/SL/HBRA2015-S621-2017?DocDate=20171030> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Wong, M.L., Chia, K.S., Yam, W.M., Teodoro, G.R., and Lau, K.W., “Willingness to Donate Blood Samples for Genetic Research: A Survey from a Community in Singapore,” Clinical Genetics 65, no. 1 (2004): 45–51.Google Scholar

Bioethics Advisory Committee Singapore, Genetic Testing and Genetic Research, November 2005, available at <https://www.bioethics-singapore.org/files/publications/reports/genetic-testing-and-genetic-research-full-report.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Bioethics Advisory Committee Singapore, Human Tissue Research, November 2002, para 9.6, available at <https://www.bioethics-singapore.org/files/publications/reports/human-tissue-research-full-report.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Chan, T.W. and Ho, C.W.L., “A Ten-Year Retrospective Analysis of Consent for the Donation of Residual Human Tissue in Singapore Healthcare Institution: Reflections on Governance,” Asian Bio-ethics Review 9, no. 4 (2017): 335–351.CrossRefGoogle Scholar

See: Biological Agents and Toxins Act 2006, available at <https://sso.agc.gov.sg/Act/BATA2005> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

See: Protected Areas and Protected Places Act (1987), available at <https://sso.agc.gov.sg/Act-Rev/PAPPA1959/Published/20131231?DocDate=19870330> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Bioethics Advisory Committee Singapore, supra note 13.Google Scholar

Ministry of Health Singapore, Code of Practice: Standards for the Provision of Clinical Genetic/Genomic Testing Services; Standards for the Provision of Clinical Laboratory Genetic, enomic Testing Services, 2018, available at <https://elis.moh.gov.sg/elis/publishInfo.do?task=download&pkId=295> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Bioethics Advisory Committee Singapore, supra note 9.Google Scholar

Human Biomedical Research Act 2015 (No. 29 of 2015), § 6.Google Scholar

Id. § 7, 8.Google Scholar

Id. § 12(1).Google Scholar

Id. § 26.Google Scholar

Id. § 27-29.Google Scholar

Id. § 2.Google Scholar

Ministry of Health Singapore, Human Biomedical Research Bill: Public Consultation Nov-Dec 2014 (2014), available at <https://www.moh.gov.sg/content/dam/moh_web/e-Consultation/HBR%20Bill_Public%20Consultation_Slides.pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Human Biomedical Research Act 2015 (No. 29 of 2015), § 32.Google Scholar

Id. § 33.Google Scholar

Id. § 38.Google Scholar

Id. § 2.Google Scholar

Id. § 6.Google Scholar

Id. § 9.Google Scholar

Id. § 10.Google Scholar

Id. § 11.Google Scholar

Id. § 12(2).Google Scholar

Id. 5th sch, pt 2.Google Scholar

Bioethics Advisory Committee Singapore, supra note 14.Google Scholar

See: Ministry of Health Singapore, Singapore Government, Online Consultation on Draft Subsidiary Legislation for Human Biomedical Research Act — Tissue Banking Regulations, available at <https://www.moh.gov.sg/e-consultation/online-consultation-on-draft-subsidiary-legislation-for-human-biomedical-research-act—tissue-banking-regulations> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Human Biomedical Research Act 2015 (No. 29 of 2015) § 31.CrossRefGoogle Scholar

Bioethics Advisory Committee Singapore, supra note 9.Google Scholar

Personal Data Protection Commission, Advisory Guidelines on Key Concepts in the PDPA, July 27, 2017, available at <https://www.pdpc.gov.sg/-/media/Files/PDPC/PDF-Files/Advisory-Guidelines/the-transfer-limitation-obligation—ch-19-(270717).pdf> (last visited October 29, 2019).+(last+visited+October+29,+2019).>Google Scholar

Staunton, C. and Moodley, K., “Data Mining and Biological Sample Exportation from South Africa: A New Wave of Bioexploitation under the Guise of Clinical Care?” South African Medical Journal 106, no. 2 (2016): 136–138; Pepper, M.S. et al., “ASSAf Consensus Study on the Ethical, Legal and Social Implications of Genetics and Genomics in South Africa,” South African Journal of Science 114, no. 11/12 (2018): 1–3.Google Scholar

Dandara, C. et al., “Direct-to-Consumer Genetic Testing: To Test or Not to Test, That is the Question,” South African Medical Journal 103, no. 2 (2013): 510–512.Google Scholar

National Department of Health, “Ethics in Health Research: Principles, Processes and Structures,” March 1, 2015, available at <http://nhrec.health.gov.za/index.php/grids-preview> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

National Department of Health (DoH), “Policy Framework for Ethics Approval and Endorsement of Health Research,” available at <http://www.health.gov.za/index.php/2014-03-17-09-09-38/policies-and-guidelines/category/90-2012p> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

DoH, supra note 3, para 3.3.9.Google Scholar

Health Professions Council of South Africa HPCSA, Guidelines for Good Practice in the Health Care Professions, Booklet 13 (2016).Google Scholar

South African Medical Research Council (MRC), “Guideline Documents,” available at <http://www.mrc.ac.za/research/ethics/guideline-documents> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

Human Sciences Research Council, “Guidance For External Applicants Applying For Ethical Review by the HRSC Research Ethics Committee (REC),” January 2018, para. 7, available at <http://www.hsrc.ac.za/uploads/pageContent/5498/Guidance%20for%20external%20applicants%20applying%20for%20ethical%20review%20by%20the%20HSRC%20REC%2020182.pdf> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

MRC, “Guidelines on Ethics for Medical Research: Ethical Principles,” Book 1, par. 11.4.2, available at <http://www.mrc.ac.za/sites/default/files/attachments/2016-06-29/ethicsbook1.pdf> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

DoH, supra note 3, para. 3.3.9.Google Scholar

DoH, supra note 3; para. 2.3.8.Google Scholar

National Department of Health, National Health Act: Regulations Relating to Import and export of human tissue, blood, blood products, cultured cells, embryos, foetal tissue, zygotes and gametes, March 2, 2012.Google Scholar

Material transfer agreement of human biological materials to be used by providers and recipients of biological material for use in research or clinical trials under the auspices of the Health Research Ethics Committees, GN 719 of GG 41781, July 20, 2018.Google Scholar

Protection of Personal Information Act 4 of 2013 § 72 (S. Afr.).Google Scholar

Promotion of Access to Information Act 2 of 2000 (S. Afr.).Google Scholar

Protection of Personal Information Act 4 of 2013 (S. Afr.).Google Scholar

Academy of Science of South Africa (ASSAF), “Human Genetics and Genomics in South Africa: Ethical, Legal and Social Implications. Consensus Study,” November, 2018, p. 20, available at <http://research.assaf.org.za/bitstream/handle/20.500.11911/106/2018_assaf_ethical_genetics_genomics_consensus.pdf?sequence=1&isAllowed=y> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

DoH, supra note 3, para. 3.3.8.Google Scholar

MRC, supra note 7, s. 11.Google Scholar

Nienaber, A., “Consent to and Authorisation of the Export and use of Human Biological Specimens for Future Research — Perspectives from Three African Countries,” Comparative and International Law Journal of Southern Africa 44, no. 2 (2011): 225–254.Google Scholar

ASSAF, supra note 17¸p. 20. s. 2.1.CrossRefGoogle Scholar

Id., p. 38, R3.Google Scholar

Id.¸p. 90, para 5.6.Google Scholar

Id.¸p. 91, para 5.7.Google Scholar

Id.¸pp. 93-94.Google Scholar

ASSAF, supra note 17.Google Scholar

Bioethics and Biosafety Act, Act No. 9100, Jan. 1, 2005, art. 36-40 (S. Kor.), translated in Ministry of Government Legislation, available at <http://moleg.go.kr/english/korLawEng?pstSeq=47518> (last visited October 30, 2019).+(last+visited+October+30,+2019).>Google Scholar

Id. art 36, para 1.Google Scholar

Id. art 36, para 2. However, a DTP genomic research will not be able to meet any of the exemption criteria.Google Scholar

Id. art 37, para 1-3.Google Scholar

Id. art 37, para 4. However, a DTP genomic research will not be able to meet any of the exemption criteria.Google Scholar

Minister's Decree under the Bioethics and Biosafety Act of Korea, Schedule 34, art. 34, para. 2. This form was mentioned in my previous article “Biobank Regulation in South Korea,” Journal of Law, Medicine & Ethics 44, no. 2 (2016): 342–351 Regardless of whether the researcher preserves the biospeci-mens in a repository or simply discards them after sequencing, the Regulatory Framework for “Non-Bank” Repositories will apply to DTP genomic research, as the framework is geared towards bio-specimens research. I refer to Figure 1 of the article that contains word-for-word translation of the informed consent template.Google Scholar

The Korea National Institute for Bioethics Policy is a policy research institute that is funded by the Ministry of Health and Welfare, the equivalent to the Department of Health and Human Services of the U.S. As such, although the institute does not have any legal authority to issue interpretive guidance, many researchers turn to the institute for guidance and its guidance often becomes de facto standards.Google Scholar

Minister's Decree under the Bioethics and Biosafety Act of Korea, supra note 6, art 34, para 1.Google Scholar

Ulsan Metropolitan City, Ulsan National Institute of Science and Technology, Ulsan University Hospital, “Ulsan 10k Genome Project,” available at <http://www.10000genomes.org/> (last visited July 30, 2019).+(last+visited+July+30,+2019).>Google Scholar

Real Decreto 1716/2011, de 18 de noviembre, por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica y del tratamiento de las muestras biológicas de origen humano, y se regula el funcionamiento y organización del Registro Nacional de Biobancos para investigación biomédica art. 31 (B.O.E. 2011, 290) (Spain).Google Scholar

Real Decreto 65/2006, de 30 de enero, por el que se establecen requisitos para la importación y exportación de muestras biológicas (B.O.E. 2006, 32) (Spain).Google Scholar

Real Decreto-ley 9/2014, de 4 de julio, por el que se establecen las normas de calidad y seguridad para la donación, la obtención, la evaluación, el procesamiento, la preservación, el almacenamiento y la distribución de células y tejidos humanos y se aprueban las normas de coordinación y funcionamiento para su uso en humanos (B.O.E. 2014, 163) (Spain).Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1, art. 46, 47 and 49.Google Scholar

Real Decreto 1716/2011, supra note 1, art. 31.Google Scholar

Ley 14/2007, de 3 de julio, de Investigación biomédica (B.O.E. 2007, 159) (Spain).Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation), 2016 O.J. (L 119), 1.Google Scholar

Ley 14/2007, de 3 de julio, de Investigación biomédica (B.O.E. 2007, 159), art. 46-57 (Spain).Google Scholar

Howard, H.C. et al., “The Convergence of Direct-to-Consumer Genetic Testing Companies and Biobanking Activities: The Case of 23andme,” in Wein-roth, M. and Rodrigues, E., eds., Knowing New Biotechnologies: Social Aspects of Technical Convergence (London: Routledge, 2015): 59–74; Slokenberga, S. and Howard, H.C., “The Right to Science and Human Germline Editing. Sweden, its External Commitments and the Ambiguous National Responses under the Genetic Integrity Act,” Förvaltningsrättslig tidskrift 2 (2019): 199–222Google Scholar

Swedish Government Official Report 2018: 4 (SOU 2018:4).Google Scholar

At the Centre for Research Ethics and Bioethics, at Uppsala University, Heidi C. Howard and her team are working on ELSI issues, including direct-to-participant research/testing. Howard is a leading ELSI expert on genetics and genomics. The team's publications are not generally focused on Swedish law. See Uppsala University Publications, “Howard, Heidi Carmen,” available at <http://uu.diva-portal.org/smash/person.jsf?pid=authority-person%3A19956&dswid=827> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

See “Ethikprövnings myndigheten,” Swedish Ethical Review Authority, available at <https://etikprovningsmyndigheten.se> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

See “Överklagandenämnden för etikprövning,” (Ethics Review Appeals Board), available at <https://www.onep.se/en/start/> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

According to the SCER, all planned research that meets legal requirements according to Sec 3-4 is subject to ethical review, as long as that research is to take place within Sweden's geographical boundaries (Sec. 5). Thus, a research project must undergo ethical review in Sweden even if it has been approved elsewhere.Google Scholar

The Head of Research can be either a physical or a legal person who runs the organization within which the research is to be performed. The Head of Research is the person with the formal responsibility for the research, and thus the one who must apply for ethical review.Google Scholar

The research may be based at a commercial, governmental, or academic entity. A research project is generally subject to Swedish ethical review based on its content, not on how it is funded or otherwise set up logistically. A project involving DTP genome research is handled the same way regardless of organizational form, as long as the content of the research is the same.Google Scholar

Heeney, C., Hawkins, N., de Vries, J., Boddington, P., and Kaye, J., “Assessing the Privacy Risks of Data Sharing in Genomics,” Public Health Genomics 14, no. 1 (2011): 17—25.CrossRefGoogle Scholar

The Press Act and the Public Access to Information and the Secrecy Act (both of which are part of the constitutional framework in Sweden).Google Scholar

Centre for Research Ethics & Bioethics, Uppsala University, “Mind the Risk: Managing Genetic Risk Information,” available at <https://www.crb.uu.se/mind-the-risk/> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Entre for Research Ethics & Bioethics, Uppsala University, “Welcome to CRB,” available at <https://www.crb.uu.se> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Läkemedelsverket (Swedish Medical Products Agency), “Certificate of a Pharmaceutical Product (CPP),” available at <https://lakemedelsverket.se/malgrupp/Foretag/Lakemedel/Export-certifikat-CPP/> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

Datainspektionen (Swedish Data Protection Authority), “Transfer of Data to a Third Country: When Personal Data is Made Available Outside the EU/EEA,” available at <https://www.datainspektionen.se/other-lang/in-english/the-general-data-protection-regulation-gdpr/transfer-of-data-to-a-third-country/> (last visited August 2, 2019).+(last+visited+August+2,+2019).>Google Scholar

On the topic on return of genetic risk information, see Stjernschantz Forsberg, J., Biobank Research — Individual Rights and Public Benefit, Uppsala University Dissertation, 2012.Google Scholar

On the EU level as well, there is currently a lack of legislation specifically targeting DTC genetic testing. Genetic self-testing kits are usually classified as “in vitro diagnostic medical devices,” and they are considered to fall under Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices, 1998 O.J. (L 331) 1.Google Scholar

Loi fédérale relative à la recherche sur l'être humain (LRH), Federal Act on Research involving Human Beings (HRA), September 30, 2011, RS 810.30, art. 45(2) (Switz.).Google Scholar

Ordonnance relative à la recherche sur l'être humain à l'exception des essais cliniques (ORH), Ordinance on Human Research with the Exception of Clinical Trials [HRO], September 20, 2013, RS 810.301 (Switz.).Google Scholar

Loi fédérale sur l'analyse génétique humaine [LAGH], Federal Act on Human Genetic Testing [HGTA], October 8, 2004, RS 810.12 (Switz.).Google Scholar

Loi fédérale sur l'analyse génétique humaine [LAGH], entrera en vigueur en 2021 (FF 2018 3627), Federal Act on Human Genetic Testing [HGTA], will come into force in 2021 (FF 2018 3627).Google Scholar

Loi fédérale sur l'analyse génétique humaine (LAGH), Federal Act on Human Genetic Testing [HGTA], October 8, 2004, RS 810.12, art. 14(1) (Switz.).Google Scholar

World Medical Association [WMA], “Declaration of Helsinki,” June 1964, available at <https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/> (last visited October 31, 2019).+(last+visited+October+31,+2019).>Google Scholar

World Medical Association [WMA], “Declaration of Taipei,” October 2002, available at <https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/> (last visited October 31, 2019).+(last+visited+October+31,+2019).>Google Scholar

Ordonnance relative à la recherche sur l'être humain à l'exception des essais cliniques (ORH), Ordinance on Human Research with the Exception of Clinical Trials (HRO), September 20, 2013, RS 810.301, art. 6-23 (Switz.).Google Scholar

Id. art 14 et seq.; HRA, supra note 1, art. 45(1) ff; HRO, supra note 2, art. 14 ff.Google Scholar

HRA, supra note 1, art. 45; HRO, supra note 2, art. 14 ff.Google Scholar

Loi fédérale sur la protection des données (LPD), Federal Act on Data Protection (FADP), June 19, 1992, RS 235.1.Google Scholar

HRA, supra note 1, art. 19.Google Scholar

OBLIGATIONENRECHT (OR), CODE DES OBLIGATIONS (CO), CODICE DELLE OBLIGAZIONI (CO) (Code of Obligations), March 30, 1991, SR 220, RS 220, art. 97.Google Scholar

Id., art. 41.Google Scholar

FADP, supra note 11.Google Scholar

Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 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 (General Data Protection Regulation). EUR-Lex Access to Eur. Union law, available at <https://eurlex.europa.eu/eli/reg/2016/679/2016-05-04> (last visited October 31, 2019).+(last+visited+October+31,+2019).>Google Scholar

FADP, supra note 15, art. 6(1).Google Scholar

HRA, supra note 2, art. 62 ff.Google Scholar

Convention on Biological Diversity (CBD), “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity,” October 29, 2010, available at <https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf> (last visited October 31, 2019).+(last+visited+October+31,+2019).>Google Scholar

HRA, supra note 2, art. 8.1.Google Scholar

Id., art. 42(2); FADP, supra note 15, art. 6.Google Scholar

FADP, supra note 15, art. 6.Google Scholar

Loi fédérale sur la lutte contre les maladies transmissibles de l'homme (LEp), Epidemics Act (EpidA), September 28, 2012, RS 818.101, art. 27 (Switz.).Google Scholar

Ordonnance sur les mouvements transfrontières des organismes génétiquement modifiés (OCart), Ordinance on the Transboundary Movements of Genetically Modified Organisms (CartO), November 3, 2004, RS 814.912.21, art. 1 (Switz.).Google Scholar

Id., art. 3.Google Scholar

Id., art. 6(1).Google Scholar

Id., art. 6(3).Google Scholar

HRA, supra note 2, art. 8.Google Scholar

HGTA, supra note 3, art. 10(1).Google Scholar

Id., art. 13.Google Scholar

Regulations for Organization and Operation of Human Research Ethics Review Board, Fawubu Quanguo Fagui Ziliaoku, available at <https://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCode=L0020179> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Human Subjects Research Act, Fawubu Quanguo Fagui Ziliaoku, art. 19, available at <https://law.moj.gov.tw/ENG/Law-Class/LawAll.aspx?pcode=L0020176>. (last visited December 11, 2019)..+(last+visited+December+11,+2019).>Google Scholar

Id., art. 9.Google Scholar

Taiwan Food and Drug Administration, “Biospecimen Input and Output,” available at <https://www.fda.gov.tw/TC/siteListContent.aspx?sid=1245&id=5705> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Personal Information Protection Act, Fawubu Quanguo Fagui Ziliaoku, available at <https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=I0050021> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Id., art. 6.Google Scholar

Uganda National Council for Science and Technology (UNCST), National Guidelines for Research Involving Humana as Research Participants, July 2014, at 2–8, available at <https://www.swarthmore.edu/sites/default/files/assets/documents/institutional-review-board/Human_Subjects_Protection_Guidelines_July_2014.pdf> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Id. at 28.Google Scholar

Id. at 2-3.Google Scholar

Id. at 29.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id. at 29-30.Google Scholar

Genomics England, “The 100,000 Genomes Project,” available at <https://www.genomicsengland.co.uk/about-genomics-england/the-100000-genomes-project/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Biobank UK, available at <https://www.ukbiobank.ac.uk> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Human Genetics Commission, Genes Direct: Ensuring The Effective Oversight Of Genetic Tests Supplied Directly To The Public (Department of Health, 2003), available at <http://webarchive.nation-alarchives.gov.uk/20120504102222/ http://www.hgc.gov.uk/Client/document.asp?DocId=34&CAtegoryId=10> (last visited October 30, 2018); Human Genetics Commission, More Genes Direct (Department of Health, 2007), available at <http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_053238.pdf> (last visited October 22, 2018); Human Genetics Commission, A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services (Department of Health, 2010), available at <https://ukgtn.nhs.uk/resources/library/article/human-genetics-commission-a-common-framework-of-principles-for-direct-to-consumer-genetic-testing-services-70/> (last visited October 22, 2018).+(last+visited+October+30,+2018);+Human+Genetics+Commission,+More+Genes+Direct+(Department+of+Health,+2007),+available+at++(last+visited+October+22,+2018);+Human+Genetics+Commission,+A+Common+Framework+of+Principles+for+Direct-to-Consumer+Genetic+Testing+Services+(Department+of+Health,+2010),+available+at++(last+visited+October+22,+2018).>Google Scholar

Government of the United Kingdom, “Emerging Science and Bioethics Advisory Committee,” available at <https://www.gov.uk/government/groups/emerging-science-and-bioethics-advisory-committee> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Human Tissue Authority, Code A: Guiding Principles and The Fundamental Principle of Consent (version updated 3 April 2017), para 40, available at <https://www.hta.gov.uk/hta-codes-practice-and-standards-0> (last visited October 25, 2018). The previous version of this code was substantially similar. Please see Human Tissue Authority, Code of Practice 1 — Consent (Version 14.0, updated July 2014), para. 33 and 35, available at <https://www.hta.gov.uk/sites/default/files/Code_of_practice_1_-_Consent.pdf> (last visited May 12, 2016).+(last+visited+October+25,+2018).+The+previous+version+of+this+code+was+substantially+similar.+Please+see+Human+Tissue+Authority,+Code+of+Practice+1+—+Consent+(Version+14.0,+updated+July+2014),+para.+33+and+35,+available+at++(last+visited+May+12,+2016).>Google Scholar

In accordance with World Medical Association [WMA], “Declaration of Helsinki,” June 1964, available at <https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

See for example, Genomics England, “Ethical Approval for 100,000 Genomes Project,” available at <https://www.genomicsengland.co.uk/100k-genomesprojectp-gains-ethical-approval-to-offernhs-patients-further-information-about-their-genomic-results/> (last visited November 1, 2019); Genomics England, “Protocol and Related Policies,” available at <www.genomicsengland.co.uk> (last visited November 1, 2019).+(last+visited+November+1,+2019);+Genomics+England,+“Protocol+and+Related+Policies,”+available+at++(last+visited+November+1,+2019).>Google Scholar

See Health Research Authority, “Governance Arrangements for Research Ethics Committees,” available at <https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

See Health Research Authority, “What Approvals and Decisions do I Need?” available at <https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Please see the forthcoming chapter Phillips, A.M. and Hervey, T.K., “Brexit and Biobanking: GDPR Perspectives,” in Individual Rights, Public Interest and Biobank Research. Article 89 GDPR and European Legal Responses, edited by Slokenberga, S., Tzortzatou, O., and Reichel, J. (Springer, forthcoming).Google Scholar

Health Research Authority, “Legal Basis for Processing Data,” available at <https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-detailed-guidance/legal-basis-processing-data/> (last visited Apr. 24, 2019).+(last+visited+Apr.+24,+2019).>Google Scholar

Human Tissue Authority, “About Us,” available at <https://www.hta.gov.uk/about-us> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Health Research Authority, “About Us,” available at <https://www.hra.nhs.uk/about-us/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

Health Research Authority, “What We Do,” available at <https://www.hra.nhs.uk/about-us/what-we-do/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

See A.M. Phillips and T.K. Hervey, supra note 10, citing Health Research Authority, “Consent in Research,” available at <https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/what-law-says/consent-research/> (last visited Apr. 24, 2019).+(last+visited+Apr.+24,+2019).>Google Scholar

Joint Research Centre, Overview of EU National Legislation on Genomics (JRC Science for Policy Report 2018), at 71.Google Scholar

Id., ch. 1.Google Scholar

Phillips, A.M., Buying Your Self on the Internet: Wrap Contracts and Personal Genomics (Edinburgh: Edinburgh University Press, 2019), ch. 3, citing Human Tissue Authority, “Analysis of DNA under the HT Act FAQs,” available at <https://www.hta.gov.uk/faqs/analysis-dna-under-ht-act-faqs> (last visited October 27, 2018). Note: The Human Tissue Authority has not altered its stance on this.CrossRefGoogle Scholar

Ray, T., “23andMe Gets CE Mark, Launches PGS Offering in UK for £125,” GenomeWeb, December 1, 2014, available at <https://www.genomeweb.com/microarrays-multiplexing/23andme-gets-ce-mark-launches-pgs-offering-uk-1255> (last visited Oct. 22, 2018); Gibbs, S., “DNA-Screening Test 23andMe Launches in UK after US Ban,” The Guardian, December 2, 2014, available at <https://www.theguardian.com/technology/2014/dec/02/google-genetic-testing-23andme-uk-launch> (last visited Oct. 22, 2018).Google Scholar

A.M. Phillips, supra note 18, ch. 1.Google Scholar

UK Parliament, Science and Technology Committee (Commons), at <https://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/inquiries/parliament-2017/commercial-genomics-17-19/> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

HM Government & Association of British Insurers, Code on Genetic Testing and Insurance, available at <https://www.abi.org.uk/globalassets/files/publications/public/genetics/code-on-genetic-testing-and-insurance_embargoed.pdf> (last visited November 1, 2019).+(last+visited+November+1,+2019).>Google Scholar

The Broad Institute and Dana-Farber Cancer Institute, “About Us,” Meta-static Breast Cancer Project website, available at <https://www.mbcproject.org/about> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

National Geographic, “The Geno-graphic Project,” available at <https://genographic.nationalgeographic.com/about/> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

23andMe, Global Genetics Project website, available at <https://www.23andme.com/global-genetics/> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

23andMe, African Genetics Project website, available at <https://www.23andme.com/africa-project/> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

23andMe, “23andMe Populations Collaborations Program,” 23andMe website, available at <https://research.23andme.com/populations-collaborations/#howitworks> (last visited August 31, 2019).+(last+visited+August+31,+2019).>Google Scholar

45 C.F.R. § 46.Google Scholar

21 C.F.R. pts. 50, 56.Google Scholar

45 C.F.R. § 46.101(a).Google Scholar

45 C.F.R. § 46.101(a).Google Scholar

Department of Health and Human Services, “Revised Common Rule Q&As,” available at <https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-qand-a/index.html> (last visited June 6, 2019).+(last+visited+June+6,+2019).>Google Scholar

45 C.F.R. § 46.102(e)(1).Google Scholar

45 C.F.R. § 46.102(e)(2).Google Scholar

45 C.F.R. § 46.102(e)(6).Google Scholar

45 C.F.R. § 46.110(b)(2).Google Scholar

45 C.F.R. § 46.102(j).Google Scholar

45 C.F.R. § 46.110(b)(2).Google Scholar

Id.Google Scholar

HHS Office of Human Research Protections, “Expedited Review Procedures Guidance (2003),” available at <https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-expedited-review-procedures/index.html/> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Id.Google Scholar

HHS Office of Human Research Protections, “OHRP Expedited Review Categoriesd (1998),” available at <https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Id.Google Scholar

Personal correspondence from representatives from the Vanderbilt IRB, OHRP to author.Google Scholar

The Broad Institute and Dana-Farber Cancer Institute, supra note 1.Google Scholar

HHS Office of Human Research Protections, supra note 19.Google Scholar

Id. Expedited category four provides for “[c]ollection of additional data and biological specimens, excluding blood specimens, for research purposes during procedures already being performed for clinical purposes, provided the additional collection does not entail more than a minimal increase in risk, pain or discomfort.”Google Scholar

Id. Expedited category five provides for “[c]ollection of data through noninvasive or minimally invasive procedures (not requiring the addition of general anesthesia or sedation for research purposes) routinely employed in clinical practice.”Google Scholar

45 C.F.R. § 46.104(4). “Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospeci-mens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 C.F.R. pts. 160 and 164, sub pts. A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 C.F.R. 164.501 or for “public health activities and purposes” as described under 45 C.F.R. 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.” 45 C.F.R. § 46.104(7).Google Scholar

45 C.F.R. § 46.104 (8).Google Scholar

According to the informed consent requirements found in 45 C.F.R. § 46.116(2), “[a]n investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.” See also Department of Health and Human Services, Office of the Inspector General, “Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (June 2000),” available at <https://oig.hhs.gov/oei/reports/oei-01-97-00195.pdf> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Department of Health and Human Services, Secretary's Advisory Committee on Human Research Protections, Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revision (March 2013), available at <https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-may-20-letter-attachment-b/index.html> (last visited June 6, 2019). (last visited June 6, 2019).' href=https://scholar.google.com/scholar?q=Department+of+Health+and+Human+Services,+Secretary's+Advisory+Committee+on+Human+Research+Protections,+Considerations+and+Recommendations+Concerning+Internet+Research+and+Human+Subjects+Research+Regulations,+with+Revision+(March+2013),+available+at++(last+visited+June+6,+2019).>Google Scholar

Food and Drug Administration and HHS Office for Human Research Protections, Use of Electronic Informed Consent, Questions and Answers, Guidance for Institutional Review Boards, Investigators, and Sponsors (December 2016), available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM436811.pdf> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Id.Google Scholar

Under 45 C.F.R. § 46.116(a)(5)(i), “[i] nformed consent [forms] must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”Google Scholar

45 C.F.R. § 46.116(b)(9)(i-ii).Google Scholar

45 C.F.R. § 46.116(c)(7).Google Scholar

45 C.F.R. § 46.116(c)(8).Google Scholar

45 C.F.R. § 46.116(c)(9).Google Scholar

45 C.F.R. § 46.116(g).Google Scholar

45 C.F.R. § 46.Google Scholar

HHS Office for Human Research Protections, “International,” available at <https://www.hhs.gov/ohrp/international/index.html> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

HHS Office for Human Research Protections, “International Compilation of Human Research Standards,” available at <https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Food and Drug Administration, Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices (Feb. 21, 2018), 83 Federal Register 7366-7388, available at <https://www.federalregister.gov/documents/2018/02/21/2018-03244/human-subject-protection-acceptance-of-data-from-clinical-investigations-for-medical-devices> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Northwestern Institutional Review Board Office, “IRB Review of International Research,” available at <https://irb.northwestern.edu/sbs/review-international> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

University of Southern California, Office for the Protection of Research Subjects, “International Research,” available at <https://oprs.usc.edu/irb-review/international-research/> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Department of Health and Human Services, Protection of Human Subjects: Interpretation of Assurance Requirements (July 7, 2006), 71 Federal Register 130, available at <https://www.govinfo.gov/content/pkg/FR-2006-07-07/pdf/E6-10511.pdf> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Department of Health and Human Services, Office for Human Research Protections, Engagement of Institutions in Human Subjects Research, October 2008, available at <https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html> (last visited June 5, 2019). See also Department of Health and Human Services, Office for Human Research Protections, “Determining When Institutions are Engaged in Research,” January 2009, available at <https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html> (last visited June 5, 2019).+(last+visited+June+5,+2019).+See+also+Department+of+Health+and+Human+Services,+Office+for+Human+Research+Protections,+“Determining+When+Institutions+are+Engaged+in+Research,”+January+2009,+available+at++(last+visited+June+5,+2019).>Google Scholar

National Institutes of Health, “Compliance and Reporting,” February 11, 2016, available at <https://www.hhs.gov/ohrp/compliance-and-reporting/index.html> (last visited August 1, 2019). See 45. C.F.R. § 46.+(last+visited+August+1,+2019).+See+45.+C.F.R.+§+46.>Google Scholar

Food and Drug Administration, “Reporting Complaints Related to FDA-Regulated Clinical Trials,” July 31, 2018, available at <https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/reporting-complaints-related-fda-regulated-clinical-trials> (last visited August 1, 2019). See 21 C.F.R. pts. 50, 56 (2018).+(last+visited+August+1,+2019).+See+21+C.F.R.+pts.+50,+56+(2018).>Google Scholar

See National Human Genome Research Institute, “Genome Statute and Legislation Database,” available at <https://www.genome.gov/about-genomics/policy-issues/Genome-Statute-Legislation-Database> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Popejoy, A.B. and Fullerton, S.M., “Genomics Is Failing on Diversity,” Nature 538, no. 7624 (2016): 161–164.CrossRefGoogle Scholar

See, e.g., Sleeboom, M., “The Harvard Case of Xiu Xiping: Exploitation of the People, Scientific Advance, or Genetic Theft?” New Genetics and Society 24, no. 1 (2005): 57–78.CrossRefGoogle Scholar

15 C.F.R. § 730 et seq.Google Scholar

Under 49 C.F.R. § 173.134(4), “patient specimen” is defined as “human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media.”Google Scholar

49 C.F.R. § 173.134(1) (2018); 49 C.F.R. pts. 171-177.Google Scholar

49 C.F.R. § 173.134(1)(i).Google Scholar

United States Postal Service, “Publication 52 — Hazardous, Restricted, and Perishable Mail,” June 2018, available at <https://pe.usps.com/text/pub52/pub52apxc_019.htm> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

49 C.F.R. § 173.134(1)(ii).Google Scholar

United States Postal Service, “USPS Packaging Instruction 6H,” June 2018, available at <https://pe.usps.com/text/pub52/pub52apxc_024.htm> (last visited June 5, 2019); IATA Dangerous Good Regulation, supra note 55, at 3.6.2.2.3.8.+(last+visited+June+5,+2019);+IATA+Dangerous+Good+Regulation,+supra+note+55,+at+3.6.2.2.3.8.>Google Scholar

International Air Transport Association, “Dangerous Good Regulation,” January 2017, available at <https://www.iata.org/whatwedo/cargo/dgr/Documents/infectious-substance-classification-DGR56-en.pdf> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

United States Postal Service, supra note 57; IATA Dangerous Good Regulation, supra note 55, at 3.6.2.2.3.8.Google Scholar

Customs and Border Patrol, Info Center, “Importing Biological Materials into the United States”, Customs and Border Patrol website, available at <https://help.cbp.gov/app/answers/detail/a_id/3681/kw/non%20commercial%20shipment> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Id.Google Scholar

Id.Google Scholar

Food and Drug Administration, Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research, available at <https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/ucm390716.htm> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Id. “In addition, to avoid possible delays with importation of specimens for testing or research, it is recommended that the labeling of each specimen container include the following information to make clear that the specimens do not fall under FDA regulation: An accurate description of the biological specimens. For example: human blood specimen, human tissue specimen, human DNA specimen. [2] A statement regarding the intended use of the specimen. For example: “Human Blood For Testing in a Clinical Laboratory,” or “Human DNA Specimen for Basic Scientific Research.” [3] If the biological specimen has been tested for infectious agents such as the hepatitis B surface antigen (HBsAg) and/or the antibody to human immunodeficiency virus (anti-HIV), a statement relative to the test results should be included.”Google Scholar

Under 42 C.F.R. § 71.54(a), “Diagnostic specimen” is broadly defined as “[s] pecimens of human and animal matter (including tissue, blood, body discharges, fluids, excretions or similar material), or environmental samples.”Google Scholar

Under 42 C.F.R. § 71.54(a), “Genomic material” is defined as “Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA) comprising the genome or organism's hereditary information, that may be single-stranded or double-stranded, and in a linear, circular, or segmented configuration and may be positive sense (same polarity as mRNA), negative sense, or ambisense (mixture of the two).”Google Scholar

Centers for Disease Control and Prevention, “FAQ,” available at <https://www.cdc.gov/cpr/ipp/faq.htm> (last visited June 4, 2019) (indicating that the certification may be included by either the importer or the sender).+(last+visited+June+4,+2019)+(indicating+that+the+certification+may+be+included+by+either+the+importer+or+the+sender).>Google Scholar

Id. According to CDC policy, “To facilitate clearance of materials that do not require a CDC import permit, each shipment must be accompanied by a certification statement, on an official letterhead, from the sender or the recipient of this material. The certification statement must include: A detailed description of the material and Statements affirming: 1. The material is not known or suspected to contain an infectious biological agent, and 2: One of the following: How the person knows that the material does not contain an infectious biological agent, or Why there is no reason to suspect that the material contains an infectious biological agent, or A detailed description of how the material was rendered noninfectious.”Google Scholar

42 C.F.R. § 71.54(f).Google Scholar

42 C.F.R. § 71.54; see Centers for Disease Control and Prevention, “Import Permit Program,” available at <https://eipp.cdc.gov> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

National Research Council, Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys, Conducting Biosocial Surveys: Collecting, Storing, Accessing, and Protecting Biospeci-mens and Biodata (2010), available at <https://www.ncbi.nlm.nih.gov/books/NBK50729/> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

21 C.F.R. § 50.1.Google Scholar

21 C.F.R. § 812.3(p).Google Scholar

21 C.F.R. § 11.Google Scholar

21 C.F.R. § 50.Google Scholar

21 C.F.R. § 56.Google Scholar

45 C.F.R. § 46.Google Scholar

Food and Drug Administration and HHS Office for Human Research Protections, supra note 31.Google Scholar

Food and Drug Administration, Office of Good Clinical Practice, Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators (January 1998), available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recruiting-study-subjects> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Id.Google Scholar

45 C.F.R. § 164.506.Google Scholar

45 C.F.R. § 164.512(a-l).Google Scholar

45 C.F.R. § 164.512(i)(1)(i).Google Scholar

Clayton, E.W. et al., “The Law of Genetic Privacy: Applications, Implications, Limitations,” Journal of Law and Biosciences 6, no. 1 (2019): 1–36, doi.org/10.1093/jlb/lsz007; see 45 C.F.R. § 160.103.Google Scholar

45 C.F.R. §§ 164.502(d)(2), 164.514(a-b).Google Scholar

Id.Google Scholar

The Genetic Information Nondiscrimination Act of 2008, Pub. L. 110-233, 122 Stat. 881 (2008), available at <https://www.gpo.gov/fdsys/pkg/PLAW-110publ233/html/PLAW-110publ233.htm> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Id. at §§ 102, 105.Google Scholar

42 U.S.C. § 12101 et seq.; see Clayton, E. W, “Why the Americans with Disabilities Act Matters for Genetics,” Journal of the American Medical Association 313, no. 22 (2014): 2225—2226, at 2225.Google Scholar

42 U.S.C. §§ 18001-18122.Google Scholar

U.S. Department of Commerce, “Privacy Shield Framework,” available at <https://www.privacyshield.gov/eu-us-framework> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Id.Google Scholar

Id.Google Scholar

Department of Commerce, International Trade Administration, The EU U.S. and Swiss-U.S. Privacy Shield Frameworks, available at <https://www.privacyshield.gov/ps-overview-businesses> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Id.Google Scholar

The Privacy Act of 1974, Pub.L. 93-579, 88. Stat. 1896 (1974), available at <https://www.gpo.gov/fdsys/pkg/STATUTE-88/pdf/STATUTE-88-Pg1896.pdf> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Department of Justice, Office of Privacy and Civil Liberties, Privacy Act of 1974, available at <https://www.justice.gov/opcl/privacy-act-1974> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

5 U.S.C. § 552a(a).Google Scholar

5 U.S.C. § 552a(d).Google Scholar

5 U.S.C. § 552a(b).Google Scholar

Health Information Technology for Economic and Clinical Health Act, The American Recovery and Reinvestment Act of 2009, Pub.L, 111—5, 123 Stat. 115 (2009), available at <https://www.govinfo.gov/content/pkg/PLAW-110publ233/pdf/PLAW-110publ233.pdf> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

A comprehensive list of state statutes and bills is maintained by the National Human Genome Research Institute (NHGRI). See National Human Genome Research Institute, Genome Statute and Legislation Database, available at <https://www.genome.gov/about-genomics/policy-issues/Genome-Statute-Legislation-Database> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

See, e.g., Moore v. Regents of the University of California, 51 Cal. 3d. 120 (Cal. 1990); Greenberg v. Miami Children's Hospital Research Institute, Inc., 264 F. Supp. 1064 (S.D. Fla. 2003); Washington University v. Catalona, 490 F.3d 667 (8th Cir. 2007). See McGuire, A.L., “Who Owns the Data in a Medical Information Commons,” Journal of Law, Medicine, and Ethics 47, no. 1 (2019): 62–69.CrossRefGoogle Scholar

See, e.g,. Alaska Stat. § 18.13.010(a) (2); Colo. Rev. Stat. § 10-3-1104.7(1) (a); Fla. Stat. § 760.40(2)(a); Ga. Code Ann. § 33-54-1(1); La. Rev. Stat. Ann. § 22:213.7(E).Google Scholar

See, e.g., Alaska Stat. Ann. § 18.13.010(a) (2); Ariz. Rev. Stat. § 20-448.02; Del. Code tit. 16, §1201 et seq.; Fla. State. Ann. § 760.40(2)(a).Google Scholar

See, e.g., Ark. Code §20-35-101 et seq.; Colo. Rev. Stat. § 10-3-1104.6); Ga. Code § 33-54-1 et seq.; Me. Stat. tit. 22, § 1711C; N.M. Stat. § 24-21-1 et seq.Google Scholar

See, e.g., Fla Stat. §7 60.40); Ky. Rev. Stat. §61.931 et seq.; Me. Stat. tit. 22, § 1711C.Google Scholar

See e.g. Del. Code tit. 16, §1201 et seq.; Nev. Rev. Stat. §629.101 et seq.; N.J. Rev. Stat. §10:5-43 et seq.; Tex. Bus. & Com. Code § 546.001 et seq.; Wyo. Stat. § 35-31-101 et seq.Google Scholar

See, e.g., Cal. Health and Safety Code § 24170 et seq.; Md. Health Code §13-2001 et seq.; NY Public Health Code §2440 et seq.; Code of Va. § 32.1-162.16. See also supra notes 93, 97, 98.Google Scholar

National Institutes of Health, All of Us Research Program, available at <https://www.nih.gov/research-training/allofus-research-program> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

Genomics England, available at <https://www.genomicsengland.co.uk> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

See, e.g., Long, C.R. et al., “Health Research Participants' Preferences for Receiving Research Results,” Clinical Trials 13, no. 6 (2016): 582–591; Thorogood, A. et al., “APPLaUD: Access for Patients and Participants to Individual Level Uninterpreted Genomic Data,” Human Genomics 12, no. 1 (2018): 1–7.CrossRefGoogle Scholar

Wolf, S.M. and Evans, B. J, “Return of Results and Data to Study Participants,” Science 362, no. 6411 (2018): 159–160, 159. See 45 C.F.R. §§ 164.501, 164.524.CrossRefGoogle Scholar

42 U.S.C. § 263a(a).Google Scholar

Wolf and Evans, supra note 114, at 160.Google Scholar

National Human Genome Research Institute (NHGRI), Return of Research Results, available at <https://www.genome.gov/27569049/return-of-research-results/> (last visited June 5, 2019). The NHGRI notes that “[a] lthough some scientists have obtained CLIA certification for their laboratories, most research laboratories are not CLIA-certified, and not all research laboratories have the resources to enable re-testing in a CLIA-certified laboratory.”+(last+visited+June+5,+2019).+The+NHGRI+notes+that+“[a]+lthough+some+scientists+have+obtained+CLIA+certification+for+their+laboratories,+most+research+laboratories+are+not+CLIA-certified,+and+not+all+research+laboratories+have+the+resources+to+enable+re-testing+in+a+CLIA-certified+laboratory.”>Google Scholar

Wolf and Evans, supra note 114, at 159-160. See also Burke, W., Evans, B.J., and Jarvik, G.P., “Return of Results: Ethical and Legal Distinctions Between Research and Clinical Care,” American Journal of Medical Genetics 166, no. 1 (2014): 105–111.Google Scholar

Wolf and Evans, supra note 114, at 159-160; W. Burke et al., supra note 118.Google Scholar

Wolf and Evans, supra note 114, at 160.Google Scholar

Id.; See GINA §§ 102, 105.Google Scholar

45 C.F.R. § 46.116(c)(8) requires additional elements of informed consent including “[a] statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.”Google Scholar

45 C.F.R. § 46.116(d)(6) requires that “[u]nless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject.”Google Scholar

45 C.F.R. § 46.104(d)(8)(iii); See Department of Health and Human Services, Office for Human Research Protections, “Revised Common Rule Q&As,” available at <https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Id.Google Scholar

Green, R.C. et al., “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574; Kalia, S.S. et al., “Recommendations for Reporting of Secondary Findings in Clinical Exome and Genome Sequencing, 2016 Update (ACMG SFv.2.0): A Policy Statement of the American College of Medical Genetics and Genomics,” Genetics in Medicine 19, no. 2 (2017): 249–255.CrossRefGoogle Scholar

Fabsitz, R.R. et al., “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group,” Circulation: Cardiovascular Genetics 3, no. 6 (2010): 574–580.Google Scholar

Weiner, C., “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues),” American Journal of Epidemiology 180, no. 6 (2014): 562–564.CrossRefGoogle Scholar

National Academies of Sciences, Engineering, and Medicine, Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (Washington, DC: The National Academies Press, 2018), doi.org/10.17226/25094.Google Scholar

Id.Google Scholar

Clinical Laboratory Improvement Amendments of 1988, Pub. L. No. 100-578, 102 Stat. 2903 (1988) (codified at 42 U.S.C. § 263a).Google Scholar

Under CLIA, a laboratory is defined as “a facility for the biological, microbio-logical, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” 42 C.F.R. § 493.2.Google Scholar

42 U.S.C. § 263a(a).Google Scholar

See, e.g., 23andMe, “Genetic Science,” available at <https://www.23andme.com/genetic-science/> (last visited June 5, 2019); FamilyTreeDNA, available at <https://www.familytreedna.com> (last visited June 5, 2019).+(last+visited+June+5,+2019);+FamilyTreeDNA,+available+at++(last+visited+June+5,+2019).>Google Scholar

42 U.S.C. § 263a(a).Google Scholar

See Barker, J., “‘DNA day’ Planned for Ravens' Game Undergoes Federal and State Scrutiny,” Baltimore Sun, September 18, 2017, available at <http://www.baltimoresun.com/business/bsbz-ravens-dna-day-20170918-story.html> (last visited June 5, 2019); Stone, J., “Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues,” Dark Daily, January 10, 2018, available at <https://www.darkdaily.com/federal-regulators-issue-notice-to-dtc-test-company-orig3n-that-its-purchase-of-interleukin-genetics-could-involve-clia-compliance-issues/> (last visited June 5, 2019).Google Scholar

Id.Google Scholar

The Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1939) (codified at 21 U.S.C. ch. 9 § 301); Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified at U.S.C. §360c-360k).Google Scholar

Food and Drug Administration, “Press Announcements,” “FDA Permits Marketing of First Direct-to-Consumer Genetic Carrier Test for Bloom Syndrome” (Feb. 19, 2015), Food and Drug Administration website, available at <https://wayback.archiveit.org/7993/20170111191740/ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Food and Drug Administration, “Press Announcements,” “FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions,” April 6, 2017, Food and Drug Administration website, available at <https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-tests-provide-genetic-risk-information-certain-conditions> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Food and Drug Administration, “FDA Authorizes, with Special Controls, Direct-to-Consumer Test that Reports Three Mutations in the BRCA Breast Cancer Genes,” Press Announcements, March 6, 2018, available at <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Food and Drug Administration, Press Announcements, “FDA Authorizes First Direct-to-Consumer Test for Detecting Genetic Variants that May Be Associated with Medication Metabolism,” Oct. 31, 2018, Food and Drug Administration website, available at <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

Food and Drug Administration, “501(k) Clearances,” Food and Drug Administration website, available at <https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

23andMe, “23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test on a Hereditary Colorectal Cancer Syndrome,” Press Release, Jan. 22, 2019, 23andMe website, available at <https://mediacenter.23andme.com/press-releases/23andme-receives-fda-clearance-for-direct-to-consumer-genetic-test-on-a-hereditary-colorectal-cancer-syndrome/> (last visited June 5, 2019).+(last+visited+June+5,+2019).>Google Scholar

FDA Press Release, supra note 141.Google Scholar

Food and Drug Administration, Press Announcements, “Statement from FDA Commissioner Scott Gottlieb, M.D. on Implementation of Agency's Streamlined Development and Review Pathway for Consumer Tests that Evaluate Genetic Health Risks” (Nov. 6, 2017), Food and Drug Administration web-site, available at <https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-implementation-agencys-streamlined-development-and> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

15 U.S.C. §§ 41-58 (2018).CrossRefGoogle Scholar

See Federal Trade Commission, “Commissioners,” Federal Trade Commission website, available at <https://www.ftc.gov/about-ftc/commissioners> (last visited June 5, 2019) (describing that “[t]he Commission is headed by five Commissioners, nominated by the President and confirmed by the Senate, each serving a seven-year term. No more than three Commissioners can be of the same political party. The President chooses one Commissioner to act as Chairman.”).+(last+visited+June+5,+2019)+(describing+that+“[t]he+Commission+is+headed+by+five+Commissioners,+nominated+by+the+President+and+confirmed+by+the+Senate,+each+serving+a+seven-year+term.+No+more+than+three+Commissioners+can+be+of+the+same+political+party.+The+President+chooses+one+Commissioner+to+act+as+Chairman.”).>Google Scholar

15 U.S.C. § 45.Google Scholar

15 U.S.C. §§ 52-55.Google Scholar

15 U.S.C. § 45.Google Scholar

See Hazel, J. W and Slobogin, C., “Who Knows What, and When?: A Survey of the Privacy Policies Proffered by U.S. Direct-to-Consumer Genetic Testing Companies,” Cornell Journal of Law and Public Policy 28, no. 1 (2018): 35–66, at 42. The most prominent example of FTC action against a DTC-GT company occurred in January 2014, when the agency filed an administrative complaint against Genelink, Inc. and its subsidiary, Foru International Corporation, makers of an at-home genetic test kit that purported to match consumers to products in its line of dietary and skincare supplements. The FTC took issue with Genelink's representations “that genetic disadvantages identified through the companies' DNA assessments [were] scientifically proven to be mitigated by or compensated for with the companies' nutritional supplements.” The FTC also claimed that “the companies' acts and practices related to data security were unfair and deceptive” because, in contradiction to the companies' posted privacy policies, it had “failed to provide reasonable and appropriate security for consumers' personal information,” including genetic information and social security, credit card, and bank account numbers. Genelink ultimately entered into a consent agreement with the FTC to settle the complaint, which required the company to “have at least 2 [randomized human clinical trials] before making disease prevention, treatment, and diagnosis claims”, “prohibited [the company] from mis-representing [its] privacy and security practices,” and required the company to “establish and maintain comprehensive data security programs and submit to security audits by independent auditors every other year for twenty years” (citations omitted).Google Scholar

Federal Trade Commission, Consumer Information, “Direct-to-Consumer Genetic Tests” (February 2018), Federal Trade Commission website, available at <https://www.consumer.ftc.gov/articles/0166-direct-consumer-genetic-tests> (last visited June 5, 2019); Federal Trade Commission, “DNA Test Kits: Consider the Privacy Implications,” Consumer Information, December 2017, Federal Trade Commission website, available at <https://www.consumer.ftc.gov/blog/2017/12/dna-test-kits-consider-privacy-implications> (last visited June 5, 2019).+(last+visited+June+5,+2019);+Federal+Trade+Commission,+“DNA+Test+Kits:+Consider+the+Privacy+Implications,”+Consumer+Information,+December+2017,+Federal+Trade+Commission+website,+available+at++(last+visited+June+5,+2019).>Google Scholar

Jillson, Elisa, Federal Trade Commission, Business Blog, “Selling genetic testing kits? Read on,” March 2019, available at <https://www.ftc.gov/news-events/blogs/business-blog/2019/03/selling-genetic-testing-kits-read> (last visited June 5, 2019).Google Scholar

Federal Trade Commission, “Mobile Health App Developers: Best Practices,” April 2016, available at <https://www.ftc.gov/slideshow-items/best-practices-mobile-health-app-developers> (last visited June 5, 2019); Federal Trade Commission, “Mobile Health Apps Interactive Tool,” available at <https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool> (last visited June 5, 2019).+(last+visited+June+5,+2019);+Federal+Trade+Commission,+“Mobile+Health+Apps+Interactive+Tool,”+available+at++(last+visited+June+5,+2019).>Google Scholar

Baram, M., “The FTC is Investigating DNA Firms like 23andMe and Ancestry over Privacy,” Fast Company, June 5, 2018, available at <https://www.fastcompany.com/40580364/the-ftc-is-investigating-dna-firms-like-23andme-and-ancestry-over-privacy> (last visited June 4, 2019).Google Scholar

Dick, H.C., “Risk and Responsibility: State Regulation and Enforcement of the Direct-to-Consumer Genetic Testing Industry,” Saint Louis University Journal of Health Law & Policy 6, no. 2 (2012): 167–200, at 174-184.Google Scholar

Id.Google Scholar

See, e.g., Social Media Privacy Protection and Consumer Rights Act of 2018, available at <https://www.congress.gov/bill/115th-congress/senate-bill/2728/text?format=txt> (last visited August 31, 2019); Information Transparency & Personal Data Control Act, available at <https://www.congress.gov/bill/116th-congress/house-bill/2013/text> (last visited August 31, 2019); Algorithmic Accountability Act of 2019, available at <https://www.congress.gov/bill/116th-congress/house-bill/2231/text> (last visited August 31, 2019); Balancing the Rights of Web Surfers Equally and Responsibly Act of 2019, available at <https://www.congress.gov/bill/116th-congress/senate-bill/1116/text> (last visited Aug. 31, 2019); Protecting Personal Health Data Act, available at <https://www.congress.gov/bill/116th-congress/senate-bill/1842/text> (last visited August 31, 2019); Do Not Track Act, available at <https://www.congress.gov/bill/116th-congress/senate-bill/1578/text> (last visited August 31, 2019); Designing Accounting Safeguards to Help Broaden Oversight and Regulations on Data Act, available at <https://www.scribd.com/document/414097245/Data-Value-Transparency-SIL19753> (last visited August 31, 2019).+(last+visited+August+31,+2019);+Information+Transparency+&+Personal+Data+Control+Act,+available+at++(last+visited+August+31,+2019);+Algorithmic+Accountability+Act+of+2019,+available+at++(last+visited+August+31,+2019);+Balancing+the+Rights+of+Web+Surfers+Equally+and+Responsibly+Act+of+2019,+available+at++(last+visited+Aug.+31,+2019);+Protecting+Personal+Health+Data+Act,+available+at++(last+visited+August+31,+2019);+Do+Not+Track+Act,+available+at++(last+visited+August+31,+2019);+Designing+Accounting+Safeguards+to+Help+Broaden+Oversight+and+Regulations+on+Data+Act,+available+at++(last+visited+August+31,+2019).>Google Scholar

See id.Google Scholar

California Consumer Privacy Act of 2018, available at <https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB1121> (last visited August 31, 2019). See Rothstein, M.A. and Tovino, S.A., “California Takes the Lead in Data Privacy Act,” Hastings Center Report 49, no. 5 (2019).Google Scholar

New York Privacy Act, available at <https://legislation.nysenate.gov/pdf/bills/2019/S5642> (last visited August 31, 2019).+(last+visited+August+31,+2019).>Google Scholar

National Public Radio & Truven Health Analytics, Health Poll: Genetic Testing (March 2018), available at <https://truvenhealth.com/Portals/0/Assets/NPR-Truven-Health-Poll/TRU_18842_0318_NPR_Poll_GeneticTesting.pdf> (last visited August 1, 2019).+(last+visited+August+1,+2019).>Google Scholar