References
- Alberta Heritage Foundation for Medical Research (AHRMR). (2005). AHFMR Programs. Edmonton. Online. www.ahfmr.ab.ca/programs.php
- Article 21, Civil Code of Quebec, S.Q. 1991, c 64. http://www.msss.gouv.qc.ca/ministere/ethique/comite_regles.html
- Brody , B. A. 1998 . The Ethics of Biomedical Research: An International Perspective , New York : Oxford University Press .
- Canada Corporations Act, R.S. 1970, c. C-32.
- Canadian Institute of Health Research (CIHR). (2004). About CIHR. Ottawa. Online. http://www.cihr-irsc.gc.ca/e/24418.html#3
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada (CIHR, NSERC, and SSHRC). (1998). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Medical Research Council. Online. http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm
- Canadian Patient Safety Institute (CPSI). (2005). Edmonton. Online. www.patientsafetyinstitute.ca
- Canadian Public Accountability Board (CPAB). (2004). Toronto. Online. www.cpab-ccrc.ca
- Carty, B. (2003). Tragic Trials. CBC Radio. Online. www.ottawa.cbc.ca/regional/servlet/View?filename=ot_cartycheotrials
- College of Physicians and Surgeons of Alberta (CPSA). (2005). Edmonton. Online. www.cpsa.ab.ca
- College of Physicians and Surgeons or Manitoba (CPSM). (2005). Winnipeg. Online. http://www.cpsm.mb.ca/
- Commission on the Future of Health Care in Canada (Commission). (2002). Building on Values: The Future of Health Care in Canada. Online. http://www.hc-sc.gc.ca/english/care/romanow/hcc0086.html
- Corman , J. , Blajchman , M. and Knight , A. 2002 . Placebo Tribulations . Can Med Assoc J , 167 : 455 – 456 . [CSA]
- Craig , P. P. 2003 . Administrative Law , 5th , 92 London : Thomson .
- Deyo , R. 2004 . Gaps, tensions and conflicts in the FDA approval process: Implications for clinical practice . J Amer Board of Family Practice , 17 : 142 – 149 . [CSA]
- Downie , J. 2006, forthcoming . “ Grasping the nettle: Confronting competing issues and obligations in health research policy ” . In Frontiers of Fairness: How Decisions are Made About the Public Coverage of Health Care , Edited by: Flood , C. Toronto : University of Toronto Press .
- Downie , J. 2004 . Dying Justice , Toronto : University of Toronto Press .
- Downie , J. 2003 . Contemporary health research: A cautionary tale . Health Law J , : 1 – 20 . [CSA]
- Downie , J. , Baird , P. and Thompson , J. 2002 . Industry and the Academy: Conflicts of interest in contemporary health research . Health Law J , 10 : 103 – 122 . [INFOTRIEVE] [CSA]
- Downie , J. and McDonald , F. 2004 . Revisioning the oversight of research involving humans in Canada . Health Law J , 12 : 159 – 181 . [INFOTRIEVE] [CSA]
- Downie , J. and McDonald , F. 2003 . An international comparative review of research ethics bodies . Clinical Researcher , 3 ( 11 ) : 14 – 25 . [CSA]
- Durham, G. (2005). E-mail communication from Gillian Durham, Deputy Director-General, Sector Policy Directorate. New Zealand: April 12, 2005
- Emanuel , E. J. , Wood , A. , Fleischman , A. , Bowen , A. , Getz , K. , Grady , C. , Levine , C. , Hammerschmidt , D. E. , Faden , R. , Eckenwiler , L. , Muse , C. T. and Sugarman , J. 2004 . Oversight of human participants research: identifying problems to evaluate reform proposals . Ann Internal Med , 141 : 282 – 291 . [CSA]
- Federman , A. , Hanna , K. E. and Rodrigues , L. L. , eds. 2002 . Responsible Research: A Systems Approach to Protecting Research Participants , Washington, DC : National Academy Press .
- Flynn , S. 2000 . The cost of getting approval . British Med J , 320 : 1183 [CSA]
- Fonds de la recherché en sante Quebec (FRSQ). (2005). Montreal. Online. www.frsq.gouv.qc.ca
- Food and Drug Regulations (1985), C.R.C., c.870, ss.G05.003(5), G.05.002
- Government of Canada. (2005). Governance Structure for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Government of Canada. Online. www.pre.ethics.gc.ca/english/aboutus/termsofreference.cfm
- Government of Canada Privy Council Office (GCPCO). (2000). Remuneration Guidelines for Part-time Governor in Council Appointees in Agencies, Boards and Commissions. Ottawa: Privy Council Office. Online. http://www.pco-bcp.gc.ca/default.asp?Language=E&Page=Publications&doc=MPSP/guideabc_e.htm
- Hadskis, M., and Carver, P. (2005). The long arm of administrative law: Applying administrative law principles to research ethics boards. Health Law Review 13: 19–33
- Health Canada. 2003 . Submission—Federal Department Report—Innovation and Health , Ottawa : Health Canada .
- Health Information Act, R.S.A. 2000, c. H-5, s.27
- Health Information Protection Act, S.S. 1999, c. H-0.021, s.29
- Health Products and Food Branch Inspectorate (HPFBI). (2004). Summary Report of the Inspections of Clinical Trials Conducted in 2003/2004. Ottawa: Health Canada. Online. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/2003-2004_tc-tm_e.html
- Hirtle , M. 2003 . The governance of research involving human participants in Canada . Health Law J , 11 : 137 – 152 . [INFOTRIEVE] [CSA]
- Humphreys , K. , Trafton , J. and Wagner , T. H. 2003 . The cost of Institutional Review Board procedures in multicenter observational research . Ann Internal Med , 139 ( 1 ) : 77 [CSA]
- Jones, D. (2002). Issue Identification Paper: Governance of Research Involving Human Subjects. Report submitted to Health Canada.
- Kondro , W. 2004 . Drug company experts advised staff to withhold data about SSRI use in children . Can Med Assoc J , 170 ( 5 ) : 783 [CSA]
- Lemmens , T. 2004 . Leopards in the temple: Restoring scientific integrity to the commercialized research scene . Journal of Law, Medicine, and Ethics, International and Comparative Health Law and Ethics: A 25-year Retrospective , 32 ( 4 ) : 641 – 657 . [CSA]
- Lemmens , T. 2002 . Report to the three Granting Agencies from the Ethics Review Committee regarding the assessment of institutional policies with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans , On file with the author. .
- Lin, M. H. and Meschino, J. A. (1993). Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID). Letter. Online. http://www.hhs.gov/ohrp/humansubjects/guidance/hsdcsep93.htm
- Llewellyn , J. , Downie , J. and Holmes , R. 2003 . Protecting human research subjects: A jurisdictional analysis . Health Law J , : 207 – 242 . [CSA]
- Loh , E. D. and Meyer , R. E. 2004 . Medical schools’ attitudes and perceptions regarding the use of central institutional review boards . Academic Medicine , 79 ( 7 ) : 644 – 51 . [INFOTRIEVE] [CSA]
- McDonald , M. 2005 . Special Issue: Canadian Governance for Ethical Research Involving Humans . Health Law Review , 13 ( 2&3 ) : 5 – 12 . at 8[CSA]
- McDonald , M. 2000 . The Governance of Health Research Involving Human Subjects , Ottawa : Law Commission of Canada .
- Ministry of Health (NZ) (MOHNZ). (2005). Guidelines for Completion of the National Application Form for Ethical Approval of a Research Project (NAF-2005 v1) Online. http://www.newhealth.govt.nz/ethicscommittees/documents/nafg.pdf
- National Bioethics Advisory Commission (NBAC). (2001). Ethical and Policy Issues in Research Involving Humans. Washington DC U.S.: Government Printing Office. Online. http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.html
- National Council on Ethics in Human Research (NCEHR). (2005). Options for the Development of an Accreditation System for Human Research Protection Programs: Request for Comments. Circulated by e-mail, on file with author.
- National Placebo Working Committee. (2004). Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada. Ottawa: Health Canada. Online. http://www.cirh-irsc.gc.ca/e/25139.html
- National Research Council of Canada (NRCC). (2005). About the Research Ethics Boards. Ottawa. Online. www.nrc-cnrc.gc.ca/randd/ethics/about-reb_e.html
- National Science and Engineering Research Council (NSERC). (2005). For Institutions. Ottawa. Online. http://www.nserc.gc.ca/inst_e.htm
- Nova Scotia Health Research Foundations (NSHRF). (2005). Halifax. Online. www.nshrf.ca
- Office of the Inspector General Department of Human and Health Services (DHHS). (1998). Institutional Review Boards: A Time for Reform. Washington DC: US Government Printing Office. Online. http://www.oig.hhs.gov/oei/reports/oei-01-97-00193.pdf
- Panel on Research Ethics (PRE). (2005). Ottawa: Government of Canada. Online. www.pre.ethics.gc.ca
- Personal Health Information Act S.M. 1997, c. P33.5, s.24.
- Personal Health Information Protection Act, 2004, S.O. 2004, c.3 Sched. A, s.37.
- Social Sciences and Humanities Research Ethics Special Working Committee (Social Sciences). (2004). Giving Voice to the Spectrum. Online. http://www.pre.ethics.gc.ca/english/workgroups/sshwc/reporttopre.cfm
- Thompson, J. (2004). Statistics Canada Estimates of Canadian research and development expenditures (GERD), Canada, 1993 to 2004, and by province 1993 to 2002. Catalogue no. 88F0006XIE – No. 020. Ottawa: Science, Innovation, and Electronic Information Division.
- Thompson , J. , Baird , P. and Downie , J. 2001 . The Olivieri Report: The Complete Text of the Report of the Independent Inquiry Commissioned by the Canadian Association of University Teachers , Toronto : James Lorimer and Company .
- Tully , J. , Ninis , N. , Booy , R. and Viner , R. 2000 . The new system of review by multicentre research ethics committees: prospective study . British Med J , 320 ( 7243 ) : 1179 – 82 . [CSA]
- Wagner , T. H. , Cruz , A. M. and Chadwick , G. L. 2004 . Economies of scale in Institutional Review Boards . Medical Care , 42 ( 8 ) : 817 – 823 . [INFOTRIEVE] [CSA]
- Wainwright , P. and Saunders , J. 2004 . What are the local issues? The problem of the local review of research . J Med Ethics , 30 : 313 – 317 . [INFOTRIEVE] [CSA]
- Weijer , C. 2002 . Placebo tribulations . Can Med Assoc J , 167 : 456 – 457 . [CSA]
- Weijer , C. 2001 . Continuing review of research approved by Canadian research ethics boards . Can Med Assoc J , 164 : 1305 – 1306 . [CSA]
- Whittington , C. J. , Kendall , T. , Fonagy , P. , Cottrell , D. , Cotgrove , A. and Boddington , E. 2004 . Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data . Lancet , 363 ( 9418 ) : 1341 – 1345 . [PUBMED] [INFOTRIEVE] [CSA]
- Wood , A. , Grady , C. and Emanuel , E. 2004 . Regional ethics organizations for protection of human research participants . Nature Medicine , 10 ( 12 ) : 1283 – 1288 . [INFOTRIEVE] [CSA]