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  1. HHS
  2. OHRP
  3. International
  4. International Compilation of Human Resea…
  5. Human Research Standards in International Organizations
  • International Compilation of Human Research Standards
  • Ethical Codes & Research Standards
  • Equivalent Protections

Human Research Standards in International Organizations

Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.

This page provides an overview of standards for protecting research participants in International Organizations.

General

  • Council for International Organizations of Medical Sciences (CIOMS)
    • Research Involving Humans (2016)
  • International Committee of the Red Cross (ICRC)
  • Office of the United Nations High Commissioner for Human Rights (OHCHR)
    • International Covenant on Civil and Political Rights, Article 7 (1976)
  • The TRUST Code
    • Global Code of Conduct for Research in Resource-Poor Settings (2018)
  • UNAIDS
    • Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011)
    • Ethical Considerations in Biomedical HIV Prevention Trials (2012)
  • United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO)
    • Universal Declaration on Bioethics and Human Rights (2005)
  • World Health Organization (WHO)
    • Research Ethics Review Committee (ERC)
    • Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011)
    • Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
    • Managing Ethical Issues in Infectious Disease Outbreaks (2016)
    • WHO Guidelines on Ethical Issues in Public Health Surveillance (2017)
    • WHO Expert Group on Ethics and Governance of Artificial Intelligence for Health
    • Various Health Topic Resources
  • World Medical Association
    • Declaration of Helsinki (2013)

Drugs, Biologics, and Devices

Drugs

  • International Conference on Harmonization (ICH)
    • Guidelines for Good Clinical Practice E6 and Integrated Addendums (E6(R2)-(R3))
  • World Health Organization
    • Handbook for Good Clinical Research Practice: Guidance for Implementation (2005)
    • Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)

Devices

  • International Medical Device Regulators Forum (IMDRF)
    • Statement Regarding Use of ISO 14155:2011 (2015)
    • Archived Documents from the Global Harmonization Task Force (GHTF)
  • International Standards Organization
    • Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (ISO 14155:2011)

Clinical Trial Registries

  • International Committee of Medical Journal Editors
    • Clinical Trial Registration
  • United States National Institutes of Health – ClinicalTrials.gov
  • WHO International Clinical Trials Registry Platform
    • Resolution WHA 58.34 (2005)
  • European Medicines Agency, Clinical Trials Information System (CTIS)

Research Injury

  • Council for International Organizations of Medical Sciences
    • International Ethical Guidelines, Guideline 14 (2016)
  • International Conference on Harmonization
    • Good Clinical Practice E6 (R2)-(R3)
  • World Medical Association
    • Declaration of Helsinki, Paragraph 15 (2013)

Social-Behavioral Research

  • UNESCO
    • Code of Conduct and Ethical Guidelines for Social Science Research

Privacy/Data Protection

  • World Medical Association
    • Declaration of Helsinki, Paragraph 24 (2013)
    • Declaration of Taipei (2016)
    • Global Repository on National Digital Health Strategies (WHO)

Human Biological Materials

  • International Air Transport Association (IATA)
    • Infectious Substances Shipping Regulations (2005)
  • International Society for Biological and Environmental Repositories
    • ISBER Best Practices: Recommendations for Repositories (2019)
  • World Health Organization
    • Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997)

Genetic Research

  • World Medical Association
    • Human Genome Editing – Recommendations
    • Human Genome Editing (HGE) Registry
  • Human Genome Organization
    • Statement on the Principled Conduct of Genetic Research (1996)
    • Statement on DNA Sampling: Control and Access (1998)
    • Statement on Gene Therapy Research (2001)
    • Statement on Human Genomic Databases (2002)
  • UNESCO Bioethics Program
    • Universal Declaration on the Human Genome and Human Rights (1997)
    • International Declaration on Human Genetic Data (2003)

Embryos, Stem Cells, and Cloning

  • International Society for Stem Cell Research
    • Guidelines for the Conduct of Human Embryonic Stem Cell Research (2021)
Content last reviewed May 12, 2026
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