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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

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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

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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

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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

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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

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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

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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

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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

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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

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

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Id. art 12.5(b).Google Scholar

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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

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Id. art 9.3 and 9.8.Google Scholar

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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

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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

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