Table 1.
National/subnational laws and guidelines governing research ethics, consent and capacity, and data protection.
| Jurisdiction | Research laws and ethical guidelines | Consent and capacity laws | Data protection laws |
|---|---|---|---|
| United Kingdom | |||
| England and WalesScotland | Medical Research Council Ethics Guide 2007, Medical research involving adults who cannot consent [MRC Ethics Guide]a | Mental Capacity Act 2005 (England and Wales) c9 [England MCA]. | |
| Adults with Incapacity Act, ASP 2000, c4 [Scotland AIA]. | Data Protection Act 1998 (UK), c. 29 [UK DPA] | ||
| Northern Ireland | Mental Capacity Act (Northern Ireland) 2016 (NI), c 18 [NI MCA]. | ||
| France | n/a | Civil Code [France CC] | Loi no 78-17 of 6 January 1978 on Information Technology, Data Files, and Civil Liberty |
| Code de la santé publique | |||
| Arts L1121-1 to L1121-16; L1122-1 to L1122-2; L1211-2 [France CS] | |||
| Finland | n/a | Guardianship Services Act, No. 442/1999 [Finland GSA] | No. 523/1999 Personal Data Act [Finland PDA] |
| Medical Research Act, No. 488/1999 [Finland MRA] | |||
| Canada | n/a | Privacy Act, RSC 1985, c. P-21 [Canada PA] | |
| Personal Information Protection and Electronic Documents Act, SC 2000, c 5b [PIPEDA] | |||
| Ontario | Substitute Decisions Act, 1992, SO 1992, c 30 [Ontario SDA] Health Care Consent Act SO 1996, c 2, Schedule Ac [Ontario HCCA] | PIPEDA applies to private sector. Freedom of Information and Protection of Privacy Act [Ontario FIPPA] Personal Health Information Protection Act [Ontario PHIPA] | |
| Québec | Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2014 (TCPS2) [TCPS2] | Civil Code of Quebec, CQLR c C-1991 [Quebec CCQ] | An Act Respecting the Protection of Personal Information in the Private Sector [Quebec ARPPIPS] |
| An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information, CQLR c A-2.1 [Quebec ARADHPBPPI] | |||
| An Act Respecting Health Services and Social Services, CQLR c S-4.2 [Quebec ARHSSS] | |||
| British Columbia | Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181 [BC HCCCFA] | Personal Information Protection Act [BC PIPA] Freedom of Information and Protection of Privacy Act [BC FIPPA] E-Health (Personal Health Information Access and Protection of Privacy) Act [BC PHIAPP] | |
| United States | n/a | ||
| Virginia | Virginia Code Title (2015) 32.1—Health, Chapter 5.1 Human Research [Va Code]. | ||
| District of Columbia | 45 CFR 46 Subpart A (2009) [US Common Rule] | District of Columbia Code (2014) Title 7 Human Health Care and Safety [DC Code]. | Health Insurance Portability and Accountability Act Privacy Rule, 45 CFR Part 160 and subparts A and E of Part 164 |
| Pennsylvania | Pennsylvania Consolidated Statutes (2015) Chapter 55—Incapacitated Persons; Chapter 58—Mental Healthcare [Pa CS] | ||
| Japan | Ethics Guidelines for Human Genome/Gene Analysis Research 2008d [Japan Guidelines] | n/a | Act on the Protection of Personal Information 2003 No. 57 |
| Singapore | Ethics Guidelines for Human Biomedical Research 2015 | Mental Capacity Act (Chapter 177A) (No 22 of 2008) [Singapore MCA] | Personal Data Protection Act 2012 (No. 26 of 2012) |
| Human Biomedical Research Act 2015 (No 29 of 2015) [Singapore HBRA] | |||
| Australia | n/a | Federal Privacy Act 1988 (Cth) and its Australian Privacy Principles | |
| New South Wales | National Statement on Ethical Conduct in Research Involving Humans 2007 [Australia Statement] | Guardianship Act 1877 (NSW) (No257) [NSW GA] Human Tissue Act 1983 (NSW) [NSW HTA] | Privacy and Personal Information Protection Act 1998 No. 133 (NSW). [NSW HRIPA] Health Records and Information Privacy Act 2002 No. 71 (NSW). |
| Victoria | Guardianship and Administration Act 1986 (Vic) [Victoria GAA] | Privacy and Data Protection Act 2014 No. 16 (Vic). [Victoria PDPA]. | |
| Human Tissue Act 1982 No. 9860 [Victoria HTA] | Health Records Act 2001 (Vic) [Victoria HRA]. |
aThe MRC is one guideline among many in the UK. For a list of discipline-specific texts, see UCL Research Ethics Committee, Codes of Conduct, https://ethics.grad.ucl.ac.uk/codes_of_conduct.php (accessed Dec. 19, 2016).
bThis is the default regime for the private sector in Canada. Provinces may enact private sector privacy legislation applicable within the province provided that it is deemed to be substantially similar to the federal legislation.
cThe act expressly excludes procedures whose primary purpose is research from its scope of application (s. 6). We include it here as the legal conditions of substitute consent in the care context provide a useful reference point for research.
dThe Ethics Guidelines for Human Genome/Gene Analysis Research is a ministerial order and not an operational guideline for a specific law. See Sosuke Iwae & Motomu Shimoda, Public Policy and Regulation System concerning Genetic Medicine in Japan 9 Formosan J Med. Human. 27 (2008).