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Human Subjects Ethical Issues Guidelines in Canada Rules Offices and Programs Ethical Issues • Ethical Issues in Research Involving Human Participants (CBM 99-3) http://www.nlm.nih.gov/archive//20061214/pubs/cbm/hum_exp.html • Protecting Human Subjects Department of Energy http://www.er.doe.gov/production/ober/humsubj/ • Office for Human Research Protections (OHRP) - IRB Guidebook http://www.hhs.gov/ohrp/irb/irb_guidebook.htm • Ethical, Legal and Social Implications Program National Human Genome Research Institute http://www.genome.gov/page.cfm?pageID=10001618 Human Subjects Guidelines in Canada • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 1998 (with 2000, 2002 updates) http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm • National Council on Ethics in Human Research http://www.ncehr-cnerh.org/english/home.php Rules • Belmont Report (1979) http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm • Helsinki declaration (1964-2004) The World Medical Association's statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Revised October 2004 2004: http://www.wma.net/e/policy/63.html • Nuremberg Code (1949) http://www.hhs.gov/ohrp/references/nurcode.htm • DHHS (2001): Protection of Human Subjects, Title 45 Part 46 http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html • FDA (2001): Institutional Review Boards, Title 21 Part 56 http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.html • FDA (2001): Protection of Human Subjects, Title 21 Part 50 http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html • NIH (2000): Required education in the protection of human research participants. Notice OD-00-039, June 5, 2000 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html • Office for Human Research Protections (OHRP) - IRB Guidebook http://www.hhs.gov/ohrp/irb/irb_guidebook.htm Offices and Programs • Human Research Protection Program, UCSD http://irb.ucsd.edu • OHRP Office for Human Research Protections, Dept. of Health and Human Services http://www.hhs.gov/ohrp/ update: 12/22/2006 |
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