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I. VÁLOGATÁS A HUMÁN KÍSÉRLETEKKEL KAPCSOLATOS ETIKAI NORMÁKBÓL: POLITIKÁK, TÖRVÉNYEK ÉS IRÁNYELVEK
Canada
- Aboriginal Healing Foundation, Ethics Guidelines for Aboriginal Communities Doing Healing Work (pdf files) (2000)
- Alberta, Health Information Act (1999) (pdf document), arts. 27(1)(d), 48-56
- Canadian Institutes of Health Research, Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research (2002, updated 2005, 2006)
- Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council NSERC), and the Social Sciences and Humanities Research Council (SSHRC), Interim Tri-Agency Measures for Human Pluripotent Stem Cell Research
- Correctional Services Canada, Commissioner's Research Directives: DCOO9 (2004)
- Health Canada, (clinical trials regulations) Regulations Amending the Food and Drug Regulations: 1024, (2001), especially arts. C.05.001 C.05.006, C.05.010(d), C.05.012; see also, the Health Canada Therapeutic Products Directorate Guidelines, which incorporate standards of the International Conference on Harmonization (see below)
- Health Canada, Medical Device Regulations (revised, 1998), sections 1,32, 79-88
- Health Canada, Proposed Assisted Human Reproduction (Section 8) Regulations (September 2005)—regarding consent, inter alia, for use of an in vitro embryo for any purpose (e.g., for research purposes)—based on sections 8, 65 of the Assisted Human Reproduction Act, 2004, Laws of Canada, ch. 2
- Health Canada, Therapeutic Products Directorate Guidelines. Inclusion of Women in Clinical Trials During Drug Development (Sept. 1996) (pdf document)
- Manitoba, The Personal Health Information Act, sections 22-24 (1997)
- National Homelessness Initiative, Ethical Guidelines for Conducting Research Involving Homeless People (2004)
- National Defence, Research Involving Human Subjects: DAOD 5061-0,5061-1 (1998)
- Newfoundland, Health Research Ethics Authority Act (2006)
- Northwest Territories: Scientist Act, RSNWT, c.S-4
- Personal Information Protection & Electronic Documents Act (PIPEDA) (2000), especially arts.5,7
- Privacy Commissioner of Canada, Privacy Act, sections 7-8
- Quebec, Civil Code of Quebec, sections 10-11, 20-24 (Book One)
- Québec, Fonds de la recherche en santé du Québec (FRSQ):
- Québec, Fonds de Recherche sur la Société et la Culture,
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Ethique de la Recherche Sociale, (November 2002) (draft) (pdf document) |
- Quebec, Minister of Health and Social Services
- Royal Commission on Aboriginal Peoples, Ethical Guidelines for Research (1993) (pdf document)
- Saskatchewan, The Health Information Protection Act (HIPA) (overview) (1997)
- Statistics Canada. Statistics Canada Act, especially arts.12,17-18, and the Companion Guide to the Statistics Act (1999)
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002 and 2005 amendments). of the Canadian Institutes of Health Research (CIHR), Social Sciences and Humanities Research Council of Canada (SSHRC), and Natural Sciences and Engineering Research Council of Canada (NSERC)
- Yukon, Council of Yukon First Nations, Traditional Knowledge Research Guidelines: A Guide for Researchers in the Yukon (2000)
- Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data, (Jan.1981, effective Jan. 1985)
- Recommendation No (83) 10 on the Protection of Personal Data Used for Scientific Research and Statistics (23 September 1983)
- Council of Europe, Recommendation No R(90)3 of the Committee of Ministers on Medical Research Involving Humans (Feb. 1990)
- Recommendation No (97) 5 on the Protection of Medical Data (13 February 1997)
- Convention on Human Rights & Biomedicine (Oviedo, 1997), especially arts. 1-2, 5-6,10, 13,15-18, 28.
- Additional Protocol on the Prohibition of Cloning Human Beings to the Convention on Human Rights & Medicine (Paris, 1998)
- Additional Protocol on Biomedical Research to the Convention on Human Rights & Medicine, (2005)
- Law No. 503 of 24 June 1992 on the Scientific Ethical Committee System and the Examination of Biomedical Research Projects
- Danish Central Scientific Ethical Committee, Guidelines on Biomedical Experiments (Nov. 2000)
- See World Medical Association
- Department of Health, Governance Arrangements for NHS Research Ethics Committees (2001)
- Data Protection Authority, Data Protection Act of 1998, arts.1-4, 33 (data for research purposes), and Schedule 3, art.8 (medical research). See also, The Data Protection (Processing of Sensitive Personal Data) Order 2000: Statutory Instrument 2000 No. 417. London, Feb. 2000, para. 9.
- Economic and Social Research Council, Research Ethics Framework (2005) (pdf document)
- Human Fertilisation and Embryology Authority, Human Fertilisation and Embryology Act 1990, especially arts.3, 11, 15
- Welcome Trust, Research Involving People Living in Developing Countries (2005)
- Medical Research Council, Ethics Series
- Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects Research (1979)
- Federal (Common Rule) Policy for the Protection of Human Subjects: (June 1991, June 2005) (adopted by 14 US federal departments: e.g., health, education, defense, veteran affairs, justice, etc.)
- Department of Education, Protection of Human Subjects in Research, 34 Code of Federal Regulations (CFR) 97 (common rule)
- Food & Drug Administration (FDA), 21 CFR 50,56: Protection of Human Subjects (under the Federal Food & Drug Act)
- FDA, Guidance for Institutional Review Boards and Clinical Investigators: Medical Devices (1998 Update)
- FDA, Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients (1998), 21 CFR 201.23,based on the Food, Drug Administration Modernization Act of 1997/, Section 505(A) of the Federal Food, Drug, and Cosmetic Act: (The so-called paediatric rule was suspended by court judgement (pdf document) in autumn 2002) and complemented by the Best Pharmaceuticals for Children Act (2002)
- Department of Health & Human Services: 45 CFR 46.101 et seq. (common rule)
- Department of Health & Human Services: Institutional Review Boards: Registration Requirements (July 2004) (pdf document)
- Department of Health & Human Services, Centers for Disease Control and Prevention (CDC), Guidelines for Defining Public Health Research and Public Health Non-Research (1999)
- Department of Health & Human Services, Standards for Privacy of Individually Identifiable Health Information (HIPPA, 2002), especially arts.,164.501-502,164.512(i), 164.514
- Department of Justice, Regulations on Protection of Human Subjects (common rule), 28 CFR 46; Regulations on Confidentiality of Identifiable Research and Statistical Information, 28 CFR 22.
- Environmental Protection Agency, Expanded Protections for Subjects in Human Studies Research, Federal Register 6 Feb 2006; 71(24):6137-76 (human pesticide testing)
- Environmental Protection Agency, Protections for Subjects in Human Research; Nursing Women. Federal Register 23 June 2006; 71(121)36171-76
- Indian Health Service (federal), Guidelines for the Collection & Use of Research Specimens (Sept. 1998) (pdf document)
- Office of Human Research Protection (OHRP) -Guidance Documents e.g.,: continuing review, IRB written procedures, etc.
- National Aeronautics and Space Administration (NASA), Protection of Human Subjects under the Federal Common Rule, 14 CFR 1230 et seq.;
- NASA, Policy Directive 7100.8D: Protection of Human Research Subjects (30 May 2002)
- National Science Foundation, 45 CFR 690 (common rule) and FAQs: Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research
- National Institutes of Health (NIH), Office of Human Subjects Research, Guidelines for Conduct of Research Involving Human Subjects at NIH
- National Institutes of Health, (Amendments) Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (Oct. 2000)
- Presidential Memorandum, Strengthened Protections for Human, Subjects of Classified Research (27 Mar.1997) Federal Register: 13 May 1997; 62 (92): 26367-26372
II. KIVÁLASZTOTT SZERVEZETEK ÉS PUBLIKÁCIÓIK
A kiválasztott szakmai szervezetek, nem kormányzati és kormányzati szervezetek működése, tanácsadói tevékenysége, jelentései és tanulmányai
- Accreditation of Human Research Protection Programs (AAHRPP)
- Advisory Committee on Human Radiation Experiments - Final Report (1995)
- American Anthropological Association (AAA), Statement on Ethnography and Institutional Review Boards (2004)
- American Association for the Advancement of Science (AAAS)
- American Association for Public Opinion Research (AAPOR)
- American College of Epidemiology, Ethics Guidelines (2000)
- American Educational Research Association, Ethical Standards of the American Educational Research Association 1992, revised 2000.
- American Indian Law Center, Model Tribal Research Code (Sept. 1999) (pdf document)
- American Psychological Association (APA)
- Ethical Principles of Psychologists and Code of Conduct 2002 (pdf document)
- American Sociological Association (ASA)
- Department of Health and Human Services (HHS)
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HHS, FDA - Center for Drug Evaluation and Research (CDER) |
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HHS, FDA - Bioresearch Monitoring Program Coordination |
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HHS, Food and Drug Administration (FDA) |
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HHS, Indian Health Service Research Program, Area/Tribal IRB Chairs |
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HHS, National Institutes of Health (NIH) |
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HHS, NIH - Behavioral and Social Sciences Research Coordinating Committee |
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HHS, Office for Human Research Protections (OHRP) |
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HHS, Office of Inspector General, Office of Evaluation and Inspections (See clinical Research):
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HHS, Secretary's Advisory Committee on Human Research Protections |
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IRB Handbook (OHRP) |
- National Academies of Science, Institute of Medicine
- National Academies of Science, National Research Council
- National Bioethics Advisory Commission (NBAC, 1995-2001)
- National Human Research Protections Advisory Committee (NHRPAC) (2000-2002)
Reports:
- President's Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry (July 2002)
White Paper: Alternative Sources of Pluripotent Stem Cells (May 2005)
- Public Responsibility in Medicine and Research (PRIM&R)
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