SELECTED HUMAN RESEARCH ETHICS NORMS, ORGANIZATIONS & RESOURCES This page collects a sampling of links to (I) selected human research ethics norms, (II) selected organizations involved in the ethics or human research, and (III) other resources. Each section begins with a sampling from Canada, and then surveys selected nations and the international community. The international dimension is intended to assist the Interagency Advisory Panel on Research Ethics (PRE) in its mandate to advise on the evolution of the Tri-Council Policy Statement, Ethical Conduct of Research Involving Humans, 1998 (TCPS) in both a national and international context. I. SELECTED HUMAN RESEARCH ETHICS NORMS: POLICIES, LAWS & GUIDELINES This section generally collects governmental policy statements, laws or guidelines on the ethics of research involving humans from Canada and the international community. Selected guidelines from international non-governmental organizations are also noted. In general, however, reports and guidelines from professional or non-governmental groups are collected under the works of selected organizations in section II, below. 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) 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 (1987) 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) 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) Fonds de la recherche en santé du Québec (FRSQ): - Guide d' éthique de la recherche et d' intégrité scientifique, (August 2003) (pdf document) Fonds de Recherche sur la Société et la Culture, - Ethique de la Recherche Sociale, (November 2002) (draft) (pdf document) Quebec, Minister of Health and Social Services - Ministerial Action Plan — Ethics of Research and Scientific Integrity (1998) - Conditions d’exercice des comités d’éthique de la recherche désignés ou institués, published in the official Québec Gazette, no 35 (29/08/1998) (pdf document) 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) 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) INTERNATIONAL & OTHER NATIONS Association of Social Anthropologists of the UK & the Commonwealth Ethical Guidelines for Good Research Practice (1999) (pdf document) Australia Aboriginal and Torres Strait Islander Commission Australian Health Ethics Committee (AHEC) of the National Health & Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999) (pdf document) AHEC, Values and Ethics in Aboriginal and Torres Strait Islander Health Research concerning Aboriginal and Torres Strait Islander Peoples (2003) (pdf document), replaces AHEC’s Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (1991) AHEC, When Does Quality Assurance in Health Care Require Independent Ethical Review? (February 2003) (pdf document) Australian Institute of Aboriginal and Torres Strait Islander Studies, Guidelines for Ethical Research in Indigenous Studies (2000) (pdf document) Australia, Commonwealth Department of Health, Therapeutic Goods Administration, Human Research Ethics Committees and the Therapeutic Goods Legislation (June 2001) (pdf document) Council for International Organization of Medical Societies (CIOMS) International Ethical Guidelines for the Ethical Review of Epidemiological Studies, (1991) International Ethical Guidelines for Biomedical Research Involving Human Subjects, (2002) Council of Europe 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) Denmark 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) European Union Directive on the Protection of Individuals with Regard to the Processing of Personal Data (1995), especially arts.7-8,13 Charter of Fundamental Rights of the European Union. (2000), arts. 3, 7-8 Directive on Good Clinical Practice in Clinical Trials of Medicinal Products (2001, effective 2004) (pdf document) Ethical review Under the Quality of Life Programme (July 2001) (pdf document) 6th Framework Programme for Research 2003-2008 (2002), art. 3 Finland Medical Research Act, 1999 (pdf document) France Law 88-1138 of 20 décembre 1988 relative to the Protection of Persons Involved in Biomedical Research (Loi Huriet), Code de la Santé Publique, art.L.1121 et seq, as amended Helsinki - See World Medical Association Human Genome Organization (HUGO) Statement on Principled Conduct of Genetics Research (1996) Statement on DNA Sampling: Control and Access (1998) Statement on Cloning (1999) Statement on Benefit Sharing (April 2000) Statement on the Human Genetic Databases (2002) Statement on Stem Cell Research (2004) India Indian Council of Medical Research, Ethical Guidelines for Biomedical Research on Human Subjects (2000) (pdf document) Indian National Committee for Ethics in Social Science Research in Health,Ethical Guidelines For Social Science Research In Health (2000) International Conference on Harmonization. Good Clinical Practice: Consolidated Guideline (1997) (pdf document) International Society of Ethnobiology Guidelines for Research, Collections, Databases and Publications (1998) Netherlands Medical Research Involving Human Subjects Act (2000) (pdf document) New Zealand Health Research Council, Health Research Ethics Committee, Guidelines on Ethics in Health Research (Oct. 2002) (pdf document) Health Research Council, Maori Health Committee, Guidelines for Researchers on Health Research Involving Maori (1998) (pdf document) Health Research Council, Operational Standards for Ethics Committees (2002) Health Information Privacy Code 1994 (amended to 12 February 1996), adopted under the Privacy Act Nuremberg Code From the Doctors Trial of the International War Crimes Tribunal Judgement (Nuremberg, Germany, 1947) Norway The National Committee for Research Ethics in the Social Sciences and the Humanities, Guidelines for Research Ethics in the Social Sciences, Law and the Humanities (2001) Organisation for Economic Cooperation and Development (OECD) Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (1981) Pan American Health Organization Research Grants Program, Ethical Guidelines for Research Involving Human Subjects (2002) (pdf document) South Africa Human Sciences Research Council of South Africa. Code of Reseach Ethics (1997) UNESCO Ethical Guidelines for International Comparative Social Science Research in the Framework of MOST (1994) Universal Declaration on the Human Genome and Human Rights (1997) UNESCO World Conference on Science, Declaration on Science and the Use of Scientific Knowledge (1999) International Declaration on Human Genetic Data (2003) Universal Declaration on Bioethics and Human Rights (2005) (pdf document) United Kingdom 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 - Research involving Human Participants in Developing Societies: Ethical Guidelines for MRC - sponsored Studies (1998) (pdf document)   - Personal Information in Medical Research (2000) (pdf document) - Human Tissue and Biological Samples for use in Research - Operational and Ethical guidelines (2001) (pdf document)   - MRC interim guidance on ethics of research involving human material derived from the nervous system (June 2003) (pdf document) Medical research involving children (2004) (pdf document) Medical Research Council position statement on research regulation and ethics (2005) (pdf document) United Nations International Covenant on Civil & Political Rights, art. 7 (1976) UN General Assembly, Resolution 45/95 of 14 December 1990: Guidelines for the Regulation of Computerized Personal Data Files (1990) UN General Assembly, Resolution 59/280 of 8 March 2005: United Nations Declaration on Human Cloning (2005) (pdf document) UNAIDS, Ethical consideration in HIV preventive vaccine research: UNAIDS Guidance Document (May 2000) (pdf document) See also UNESCO, WHO and Pan American Heath Organization United States 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) (adopted by 15+ US federal departments: e.g., health, education, defense, veteran affairs, justice, etc.) (pdf document). 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, 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. 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 World Health Organization Operational Guidelines for Ethics Committees that Review Biomedical Research (2000). World Medical Association Declaration of Helsinki (1964, as revised and clarified, 2004) Declaration on Ethical Considerations Regarding Health Databases, arts. 3,5,21 (2002). II. SELECTED ORGANIZATIONS, SELECTED PUBLICATIONS This section of the links page collects national and international organizations involved in the ethics of research involving humans. The selection thus generally profiles the activities, advisory opinions, repor ts or publications of selected professional, non-governmental, governmental organizations. CANADIAN ORGANIZATIONS Alberta College of Physicians and Surgeons, Research Ethics Review Program Association of Canadian Universities of Northern Studies - Ethical Principles for the Conduct of Research in the North (2003) (pdf document) Association of Universities and Colleges of Canada (AUCC) Canadian Association of University Teachers (CAUT) Canadian Association of Research Ethics Boards (CAREB) Canadian Association of University Research Administrators (CAURA) Canadian Biotechnology Advisory Committee (CBAC) Canadian Bioethics Society Canadian Institutes of Health Research (CIHR) Canadian Psychological Association, Canadian Code of Ethics for Psychologists (2000) Canadian Sociology & Anthropology Association (CSAA) Genome Canada Health Canada - Therapeutic Products Directorate Health Canada - A Canadian System of Oversight Health Canada - Research Ethics Board National Aboriginal Health Organization (NAHO) - Aboriginal Research National Council on Ethics in Human Research (NCEHR) National Research Council (NRC), Institute of Biodiagnostics Natural Sciences and Engineering Research Council of Canada (NSERC) Social Sciences and Humanities Research Council of Canada (SHHRC) Quebec, College of Physicians of Quebec - Code of Ethics of Physicans (2002) (pdf document), arts. 28-31,45,48,61,78, 87. Quebec, Fonds de la Recherche en Santé du Québec (FRSQ) - Central Research Ethics Committee (see ethics) - Rapport d'enquête concernant les activités des comités d'éthique de la recherche au Québec (Sept. 1999) (pdf document)   Quebec, Fonds de Recherche sur la Société et la Culture Quebec, Ministry of Research, Science & Technology, Committee on the Ethics of Science and Technology, - The Ethical Issues of Genetic Data Bases: Towards Democratic Responsible Regulation of -- Position Statement (February 2003)   INTERNATIONAL & NATIONAL ORGANIZATIONS Australia Aboriginal and Torres Strait Islander Commission Australian Institute of Aboriginal and Torres Strait Islander Studies Australian Law Reform Commission (ALRC) - Discussion Paper 66 Protection of Human Genetic Information (Apr. 2000) Australian Research Council (ARC) Australian & New Zealand Society of Criminology - Code of Ethics (Apr. 2000) Australian Health Ethics Committee (AHEC) National Health and Medical Research Council (NHMRC) - Human Research Ethics Handbook - When Does Quality Assurance in Health Care Require Independent Ethical Review? (2003) Therapeutic Goods Administration (TGA) Council of Europe Steering Committee on Bioethics Denmark Danish Council of Ethics European Forum for Good Clinical Practice European Union European Group on Ethics in Science and New Technologies (EGE) RESPECT: Professional and Ethical Codes for Technology-related Socio-Economic Research, An EU Code of Ethics for Socio-Economic Research (2004) (document pdf) Finland National Advisory Board on Research Ethics France Centre national de la recherche scientifique (CNRS), Comité d'éthique pour les sciences (COMETS) National Consultative Committee on Bioethics for Health and Life Sciences (CCNE) - Opinion on sampling of dead human embryonic and fetal tissue for therapeutic, diagnostic, and scientific purposes (1984)   - Opinion on the testing of new treatments on humans. Considerations and proposals (1984) - Opinion on experimentation on patients in a chronic vegetative state - Report (1986) - Opinion on research and use of in vitro human embryos for scientific and medical purposes - Report (1986) - Recommandations regarding local Ethics Committees - Report (1988) - Opinion concerning the dissemination of DNA analysis identification techniques (genetic fingerprinting) (1989) - Opinion on embryo research aiming to achieve pre-transfer genetic diagnosis for wich a moratorium was declared in 1986 (1990) - Opinion regarding the application of genetic testing to individual studies, family studies and population studies. (Problems related to DNA "banks", cell "banks" and computerisation) (1991) - Opinion that the human genome should not be used for commercial purposes - Thoughts relating to ethical problems of human genome research (1991) - Opinion on the ethics of research in the sciences of human behaviour (1993) L'Institut National de la Santé et de la Recherche Médicale (INSERM) National Assocation of Regional Research Ethics Committees New Zealand Health Research Council - Guidelines for Researchers on Health Research Involving Maori - Operational Standards for Ethics Committees (2002) Nordic Committee on Bioethics Norway National Research Ethics Committees - National Committee for Medical Research Ethics - National Committee for Research Ethics in Science and Technology - National Committee for Research Ethics in the Social Sciences and the Humanities Norwegian Biotechnology Advisory Board Sweden Swedish Research Councils (Medicine, Social Sciences, Engineering)    United Kingdom Association of Social Anthropologists of the United Kingdom and the Commonwealth Ethical Guidelines for Good Research Practice (1999) British Society of Criminology. Code of Ethics for Researchers in the Field of Criminology (March 2003) Department of Health, Central Office for Research Ethics Committees Department of Health, Governance Arrangements for Health and Social Care (2001) (pdf document) Department for Work & Pensions, Doing the Right Thing. Outlining the Department for Work and Pensions approach to ethical and legal issues in social research (2003) Economic and Social Research Council - Research Ethics Framework - Working Papers - Crossing boundaries: social science, health and bioscience research and the process of ethics review' (Feb. 2004, pdf document)   - The international dimension to research ethics: the significance of international and other non-UK frameworks for UK social science' (Feb. 2004, pdf document)   - Social science research ethics in developing countries and contexts' (Feb 2004, pdf document)   - Implementing the ESRC Research Ethics Fram ework: The Case for Research Ethics Committees (Feb 2004, pdf document)   Engineering and Physical Sciences Research Council Medical Research Council Nuffield Council on Bioethics - Discussion Paper: The ethics of clinical research in developing countries (2001) - Discussion Paper: Stem cell therapy: the ethical issues (2001) - Report: The ethics of research related to healthcare in developing countries (Apr. 2002) Social Research Association, Ethical Guidelines (2003) United States 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) - Code of Professional Ethics and Practices (2002) - Protection of Human Participants in Survey Research:  A Source Document for Institutional Review Boards (May 2003)  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) - HHS, FDA - Center for Drug Evaluation and Research (CDER) - HHS, FDA - Bioresearch Monitoring Program Coordination - HHS, Food and Drug Administration (FDA) - HHS, Indian Health Service Research Program, Area/Tribal IRB Chairs - HHS, National Institutes of Health (NIH) - HHS, NIH - Behavioral and Social Sciences Research Coordinating Committee - HHS, Office for Human Research Protections (OHRP) - HHS, Office of Inspector General, Office of Evaluation and Inspections (See clinical Research): - Report: Protecting Human Research Subjects: Status of Recommend ations (April 2000) (pdf document)   - Report :Institutional Review Boards: Their Role in Reviewing Approved Research (June 1998) (pdf document)   - Report: Institutional Review Boards: Promising Approaches (June 1998) (pdf document) - Report: Institutional Review Boards: A Time for Reform (June 1998) (pdf document) - HHS, Secretary's Advisory Committee on Human Research Protections - IRB Handbook (OHRP) National Academies of Science, Institute of Medicine - Preserving Public Trust: Accreditation and Human Research Participant (2001) - Responsible Research: A Systems Approach to Protecting Research Participants (2003) - - Ethical Conduct of Research Involving Children (2004) Guidelines for Human Embryonic Stem Cell Research (2005) National Academies of Science, National Research Council -Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003)   National Bioethics Advisory Commission (NBAC, 1995-2001) - Cloning Human Beings (June 1997) - Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (December 1998)   - Ethical Issues in Human Stem Cell Research (September 1999, pdf document) - Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (April 2001)   - Ethical and Policy Issues in Research Involving Human Participants (August 2001) National Human Research Protections Advisory Committee (NHRPAC) (2000-2002) Reports: - Clarification of the Status of Third Parties When Referenced by Human Subjects in Research (April 2002, pdf document) - Recommendations on Public Use Data Files (Jan 2002, pdf document)   - Recommendations on Confidentiality and Research Data Protections (July 2002, pdf document) President's Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry (July 2002) Public Responsibility in Medicine and Research (PRIM&R) III. OTHER SELECTED RESOURCES Under construction.