[1]- Text Size [2]
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[1] [3]Regulatory Framework in Health Research at the McGill University Health Centre [4] [.pdf]
Guidelines for the Management of Data and Tissue Banks [5] [.pdf]
McGill University Policy on the Ethical Conduct of Research Involving Human Subjects [6] [.pdf]
McGill University Ethical and Legal Aspects of Research Involving Human Subjects Conducted in the Faculty of Medicine and Affiliated Hospitals Policies and Proc [7] [.pdf]
Appendices to Faculty of Medicine Policy and Procedures [8][.pdf]
Glossary of Terms for Reviewing Human Subjects Research [9] [.pdf]
An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information [10]
An Act Respecting Health Services and Social Services [11]
An Act respecting the Health and Social Services Ombudsman [12]
An Act Respecting the Protection of Personal Information in the Private Sector [13]
Charter of human rights and freedoms [14]
(FRSQ) Background Document on Human Cloning [15] [.pdf]
(FRSQ) Code of Ethics and Professional Conduct [16] [.pdf]
(FRSQ) Guide d'éthique de la recherche et d'intégrité scientifique (2e édition) [17][.pdf]
(MSSS) Circulaire 2003-06-19 [18][.pdf]
(MSSS) Guide d'élaboration de normes sur la gestion des banques de données [19][.pdf]
MSSS Plan d’action Ministèriel [20] [.pdf]
CMQ code of ethics of physicians [21] [.pdf]
Civil Code of Quebec [22]
Assisted Human Reproduction Act [23]
CIHR "Best Practices for Protecting Privacy in Health Research" [24]
Clinical Trial Application [25]
Food and Drugs Act [26]
Food and Drugs Act Marijuana Exemption (Food and Drugs Act) Regulations [27]
Food and Drug Regulations - Division 5 [28]
Health Canada Addendum to the ICH Guidance E11: Clinical Investigation of Medicinal Products in the Pediatric Population [29]
Health Canada Adverse Reaction Information [30]
Health Canada Consolidation of the Food and Drugs Act and Food and Drug Regulations [31]
Health Canada Medical Devices Problem Reporting [32]
Natural Health Products
[33]Health Canada Regulatory Requirements Governing Drugs for Use in Clinical Trials in Canada [34] [.pdf]
Medical Devices Regulations [35]
Memorandum of Understanding - Tri-Councils [36]
Natural Health Products Regulations [37]
Personal Information Protection and Electronic Documents Act (PIPEDA) [38]
PIPEDA Organizations in the Province of Quebec Exemption Order [39]
TCPS 2 - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
[40]
Health Insurance Portability and Accountability Act (HIPAA) [41]
Guidance for Industry: Acceptance of Foreign Clinical Studies [42]
The Belmont Report [43]
US HHS Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection [44] [.pdf]
US Federalwide Assurance [45]
US Food and Drug Administration [46]
US 45 CFR 46 [47]
US 21 CFR
Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human Subjects [48]
Council for International Organizations of Medical Sciences (CIOMS)
International Guidelines for Ethical Review of Epidemiological Studies [49]
Council for International Organizations of Medical Sciences (CIOMS)
Human Genome Mapping, Genetic Screening and Gene Therapy [50]
Good Manufacturing Practices Guidelines [51] [.pdf]
(The) Declaration of Helsinki (2008) [52]
International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication [53]
International Compilation of Human Research Standards [54]
ICH Efficacy [55]
ICH GCP (Good Clinical Practice) Consolidated Guidelines [56]
(The) Nuremburg Code (1947) [57]
Advertising Standards Canada [58]
Code of Conduct (Canada’s Research-Based Pharmaceutical Companies) [59] [.pdf]
Links:
[1] http://muhc.ca/reo/textsize/decrease?destination=print%2F2741
[2] http://muhc.ca/reo/textsize/normal?destination=print%2F2741
[3] http://muhc.ca/reo/textsize/increase?destination=print%2F2741
[4] http://muhc.ca/sites/default/files/users/user139/MUHCRegulatoryFramework_Nov2010.pdf
[5] http://muhc.ca/sites/default/files/users/user136/Data%20bank%20guidelines%20-%20FINAL%208-3-2007.pdf
[6] http://www.mcgill.ca/files/secretariat/Ethical-Conduct-Research-Human-Policy.pdf
[7] http://www.mcgill.ca/files/medresearch/PandP2007_FINAL.pdf
[8] https://secureweb.mcgill.ca/medresearch/sites/mcgill.ca.medresearch/files/PandP2007_AppendicesAtoM.pdf
[9] http://muhc.ca/sites/default/files/users/user136/glossary_v7.pdf
[10] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=%2F%2FA_2_1%2FA2_1_A.htm
[11] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=%2F%2FS_4_2%2FS4_2_A.htm
[12] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=%2F%2FP_31_1%2FP31_1_A.htm
[13] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=%2F%2FP_39_1%2FP39_1_A.htm
[14] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=%2F%2FC_12%2FC12_A.htm
[15] http://www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/fiches_media_english.pdf
[16] http://www.frsq.gouv.qc.ca/fr/ethique/pdfs_ethique/code_ethique_ang.pdf
[17] http://www.frsq.gouv.qc.ca/fr/ethique/pdfs_ethique/GUIDE2003.pdf
[18] http://msssa4.msss.gouv.qc.ca/fr/document/d26ngest.nsf/6bf0324580595c9c8525656b0015cbc3/30a38ca94589138985256d4a0050b784/$FILE/2003-012.pdf
[19] http://ethique.msss.gouv.qc.ca/site/download.php?549227f54d1fc514c247671e75b3bea3
[20] http://ethique.msss.gouv.qc.ca/site/fr_pam.phtml
[21] http://www.cmq.org/~/media/132E0C657730482DBEE837D7473D439D.ashx
[22] http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/CCQ_1991/CCQ1991_A.html
[23] http://laws-lois.justice.gc.ca/eng/acts/A-13.4/FullText.html
[24] http://www.cihr-irsc.gc.ca/e/29072.html
[25] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/notice_cta_dec_avis2-eng.php
[26] http://laws.justice.gc.ca/en/F-27/index.html
[27] http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-261/page-1.html
[28] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/consultation/clini-rev-exam/ctrf_dd_eccr_dt_2007-03-26-eng.php
[29] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/e11_addendum-eng.php
[30] http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react-neg/index-eng.php
[31] http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/index-eng.php
[32] http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/md_prob_rep-rap_incident_im-eng.php
[33] http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php
[34] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_background-eng.php
[35] http://laws.justice.gc.ca/en/F-27/SOR-98-282/index.html
[36] http://www.nserc.ca/institution/mou_e.htm
[37] http://laws.justice.gc.ca/en/F-27/SOR-2003-196/index.html
[38] http://laws-lois.justice.gc.ca/eng/acts/P-8.6/index.html
[39] http://gazette.gc.ca/archives/p2/2003/2003-12-03/html/sor-dors374-eng.html
[40] http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
[41] http://www.hhs.gov/ocr/hipaa/
[42] http://www.fda.gov/RegulatoryInformation/Guidances/ucm124932.htm
[43] http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
[44] http://www.hhs.gov/ohrp/policy/fguid.pdf
[45] http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html
[46] http://www.fda.gov/default.htm
[47] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
[48] http://www.cioms.ch/publications/layout_guide2002.pdf
[49] http://www.cioms.ch/publications/guidelines/1991_texts_of_guidelines.htm
[50] http://www.cioms.ch/publications/guidelines/1990_texts_of_guidelines.htm
[51] http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/index-eng.php
[52] http://www.wma.net/en/30publications/10policies/b3/index.html
[53] http://www.icmje.org/index.html
[54] http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html
[55] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/index-eng.php
[56] http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e6-eng.pdf
[57] http://www.frsq.gouv.qc.ca/fr/ethique/pdfs_ethique/nuremberg_a.pdf
[58] http://www.adstandards.com/en/
[59] https://www.canadapharma.org/