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Ethical Codes and Guidelines for the Protection of Human Subjects in Research

U.S. Codes and Guidelines

The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. United States Department of Health, Education, and Welfare. 1979-04-18. Available from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Report and Recommendations Research Involving Prisoners. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. United States Department of Health, Education, and Welfare. 1976. [DHEW Publication No. (OS) 76-131] Available from http://www.bioethics.gov/reports/past_commissions/Research_involving_prisoners.pdf. Accessibility verified on 2006-05-15.

Report and Recommendations Research Involving Children. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. United States Department of Health, Education, and Welfare. 1977. [DHEW Publication No. (OS) 77-0004] Available from http://www.bioethics.gov/reports/past_commissions/Research_involving_children.pdf. Accessibility verified on 2006-05-15.

Report and Recommendations Research on the Fetus. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. United States Department of Health, Education, and Welfare. 1975. [DHEW Publication No. (OS) 76-127] Available from http://www.bioethics.gov/reports/past_commissions/research_fetus.pdf. Accessibility verified on 2006-05-15.

Report and Recommendations Psychosurgery. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. United States Department of Health, Education, and Welfare. 1977. [DHEW Publication No. (OS) 77-0001] Available from http://www.bioethics.gov/reports/past_commissions/psychosurgery.pdf. Accessibility verified on 2006-05-15.

The reports and recommendations of the National Commission were codified (for the most part) in two sets of federal regulations. The Common Rule (45 CFR 46) is administered by the Office for Human Research Protections (OHRP), formerly the Office for Protection from Research Risks, and applies to research sponsored by the National Institutes of Health.

NB: This is neither a code nor a guideline but a number of codes and guidelines take it as a point of departure. The Nuremberg Code Directives for Human Experimentation. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law. No. 10. Vol. 2. Pp. 181-182. Washington, D.C.: U.S. Government Printing Office. (1949) Available from http://ohsr.od.nih.gov/guidelines/nuremberg.html

Follow this link for information about the Common Rule and the Office for Human Research Protections (OHRP)

Follow this link for information about the National Institutes of Health (NIH)

The second set of federal regulations, 21 CFR 50 Protection of Human Subjects and 21 CFR 56 Institutional Review Boards, is administered by the U.S. Food and Drug Administration (FDA) and applies to clinical investigations of drugs and medical devices.

Follow this link for information about 21 CFR 50, 21 CFR 56, and the Food and Drug Administration (FDA)

Follow this link to our collection of information on state legislation on human research protections.


International Codes and Guidelines

World Medical Association Helsinki Declaration. Ethical Principles for Medical Research Involving Human Subjects: http://www.wma.net/en/30publications/10policies/b3/index.html

International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organizations of Medical Sciences (CIOMS). November, 2002. Available from http://www.cioms.ch/frame_guidelines_nov_2002.htm

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH). Available from http://www.ich.org/LOB/media/MEDIA482.pdf

National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans. 1999. Available from http://www.nhmrc.gov.au/publications/synopses/e35syn.htm

National Health and Medical Research Council (NHMRC), Health and Human Research Ethics. Available from http://www.nhmrc.gov.au/ethics/human/index.htm

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002 and 2005 amendments). Available from http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm

Follow this link to find CIRCARE's collected information on research and human research protections in Canada: http://www.circare.org/CAindex.htm

International Resources

The International Compilation of Human Subject Research Protections. Office for Human Research Protections. 2005-10-01. Available from http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

World Health Organization (WHO) Ethics Resources. Available from http://www.who.int/health_topics/ethics/en/

Schuklenk U. HIV/AIDS: Ethical, Legal & Social Issues, Bioethics Information for the Developing World. Centre for Ethics in Public Policy and Corporate Governance, Witwatersrand University. Available from http://www.developing-world-bioethics.org/

Professional Codes, Guidelines, and Resources

Read the best first:

On Being a Scientist: Responsible Conduct in Research. National Academy of Science. 1994. National Academy Press. Available from http://www.nap.edu/readingroom/books/obas/index.html

AAAS Policy Brief: Human Research Subject Protections. American Association for the Advancement of Science, AAAS Center for Science, Technology, and Congress. Available from http://www.aaas.org/spp/cstc/briefs/humsub/humsublinks.shtml

AAAS Scientific Freedom, Responsibility, and Law Program. American Association for the Advancement of Science (AAAS). Available from http://www.aaas.org/spp/sfrl/

Ethical and Legal Aspects of Human Subject Research in Cyberspace. AAAS Scientific Freedom, Responsibility, and Law Program. Available from http://www.aaas.org/spp/sfrl/projects/intres/main.htm

The American Geriatrics Society. AGS Position Statement: The Responsible Conduct of Research. 2007. Accessed on 2007-11-01 at: http://www.americangeriatrics.org/products/positionpapers/respcondresearch.shtml

American Medical Association (AMA) Ethics Resource Center. Available from http://www.ama-assn.org/ama/pub/category/2732.html

American Medical Association (AMA) Index to the Code of Medical Ethics. Available from http://www.ama-assn.org/ama/pub/category/2498.html

American Medical Association (AMA) Federation Repository of Ethics Documents Online. Available from http://www.ama-assn.org/ama/pub/category/7665.html. (FRED, the collected codes of ethics from state and specialty medical association members of the AMA federation.)

American College of Physicians Ethics Manual. 4th Ed. 1998-04-01. Available from http://www.acponline.org/ethics/ethicman.htm

Federation of State Medical Boards Policy Documents. Available from http://www.fsmb.org/grpol_policydocs.html

Mann H. ASSERT: A Standard for the Scientific and Ethical Review of Trials. Available from http://www.assert-statement.org/

American Psychological Association Ethical Principles of Psychologists and Code of Conduct. 2002. Available from http://www.apa.org/ethics/code2002.html

The Center For the Study of Ethics in the Professions maintains an extensive public repository of ethical codes:

Health Care Codes of Ethics Online. Center For the Study of Ethics in the Professions. Illinois Institute of Technology. Available from http://www.iit.edu/departments/csep/codes/codes_index.html

American Association of Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. Available from http://www.aamc.org/research/coi/start.htm

American Association of Medical Colleges / Medical Research. Available from http://www.aamc.org/research/start.htm

Association of American Universities / Research Issues. Available from http://www.aau.edu/research/research.cfm


Working List 2006-09

First Clinical Research Regulatory Database search (Search 300+ CFR, FDA, NIH, OHRP, ICH, EU and other regulatory documents.)

European Union

Directive 2001/20/EC of The European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [2010-02-06]: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0020:EN:HTML


Australian Therapeutic Goods Administration. Available from http://www.tga.gov.au/

Australia New Zealand Therapeutic Products Authority. Available from http://www.anztpa.org.nz/

Australian Medical Association. Available from http://www.ama.com.au/web.nsf?opendatabase

Australian Medical Council. Available from http://www.amc.org.au/

Licensure (by state or territory):   Australian Medical Council / State & Territory Medical Boards. Available from http://www.amc.org.au/board.asp

New South Wales Medical Board. Available from http://www.nswmb.org.au/

Medical Board of the Northern Territory. Available from http://www.nt.gov.au/health/org_supp/prof_boards/prof_licensing_auth.shtml

The Medical Board of Queensland. Available from http://www.medicalboard.qld.gov.au/

Medical Board of South Australia. Available from http://www.medicalboardsa.asn.au/

The Medical Council of Tasmania. Available from http://www.medicalcounciltas.com.au/

Medical Practitioners Board of Victoria. Available from http://medicalboardvic.org.au/

Medical Board of Western Australia. Available from http://www.wa.medicalboard.com.au/

Or try: HealthInsight / Health Districts. Available from http://www.healthinsite.gov.au/topics/Health_Services

CHOICE (where to complain). Available from http://www.choice.com.au/viewArticle.aspx?id=100901&catId=100392&tid=100008&p=4

HealthInsight Quality Health Information for Australians. Available from http://www.healthinsite.gov.au/

New Zealand

New Zealand Regional Ethics Committees: http://www.ethicscommittees.health.govt.nz/

New Zealand Good Clinical Research Practice: http://www.medsafe.govt.nz/profs/RIss/clinical.asp

New Zealand Medsafe (New Zealand Medicines and Medical Devices Safety Authority): http://www.medsafe.govt.nz/

New Zealand Adverse Reaction Reporting and IMMP: http://www.medsafe.govt.nz/profs/adverse.asp

New Zealand Gene Technology Advisory Committee: http://www.hrc.govt.nz/root/pages_regulatory/Gene_Technology_Advisory_Committee.html

Licensure: Medical Council of New Zealand: http://www.mcnz.org.nz/

Discipline: Medical Practitioners Disciplinary Tribunal: http://www.mpdt.org.nz/

Discipline: (phasing in) New Zealand Health Practitioners Disciplinary Tribunal: http://www.hpdt.org.nz/Default.aspx?tabid=1

New Zealand Guidelines Group: http://www.nzgg.org.nz/

United Kingdom

Statutory Instrument 2004 No. 1031 The Medicines for Human Use (Clinical Trials) Regulations 2004 (=Directive 2001/20/EC). Available from http://www.opsi.gov.uk/si/si2004/20041031.htm

National Health Service Central Office for Research Ethics Committees (COREC). Available from http://www.corec.org.uk/index.htm

Medicines and Healthcare products Regulatory Agency (MHRA). Available from http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5

Licensure and Discipline:   UK General Medical Council. Available from http://www.gmc-uk.org/

National Health Service England (NHS). Available from http://www.nhs.uk/

Critical Appraisal Tools, Critical Appraisal Skills Programme (CASP) and Evidence-based Practice. National Health Service. Available from http://www.phru.nhs.uk/casp/critical_appraisal_tools.htm


Last Updated: 2010-02-08

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