International Compilation of Human Research Standards

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.

The International Compilation of Human Research Standards is a listing of over 1,000 standards on human subjects protections in 131 countries and from many international organizations. These standards may include laws, regulations, and/or guidelines. First published in 2005, the Compilation is intended for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in the conduct or oversight of research involving human participants around the world.

Compilations of Human Research Standards by World Region

Human Research Standards by International Organizations

This information is organized by world region in alphabetical order: Africa, Asia/Pacific, Europe, Latin America and the Caribbean, Middle East/North Africa, and North America. Under each section, you will find the countries or international organizations organized also in alphabetical order. For each country or international organization, the information is then categorized into nine categories:

  1. General, i.e., applicable to most or all types of human subjects research
  2. Drugs and Devices
  3. Clinical Trial Registries
  4. Research Injury
  5. Social-Behavioral Research
  6. Privacy/Data Protection
  7. Human Biological Materials
  8. Genetic
  9. Embryos, Stem Cells, and Cloning

These nine categories often overlap, so it may be necessary to review other categories for a more complete understanding of a country’s standards. The information under these nine categories is divided into Key Organizations and Relevant Standards. Key Organizations may include governmental and non-governmental organizations. Relevant Standards may include laws, legislations, regulations, guidance, official opinions or positions, etc. Since the meaning of these terms often vary significantly by county, they all have been grouped together under Relevant Standards, regardless to whether they include mandatory requirements or voluntary guidelines. 

Where possible, a link has been provided to specific key organizations and relevant standards. In many cases, the documents and webpages are available in English. When the URL links to a non-English website or document, an online language translator usually can render an English version. Many operating systems may also be able to translate a document or webpage.

In order to focus its scope to human research protections, the International Compilation of Human Research Standards attempts to not include:

  1. Standards from the state, provincial, or local levels
  2. Enabling legislation, i.e., laws that only authorize an agency to promulgate standards, but that themselves do not include substantive standards
  3. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical ethics, products liability, clinical trial inspection procedures, intellectual property, good manufacturing practice, bioequivalence testing, informed consent in clinical practice, radiation or environmental safety, etc.
  4. Ethics codes of academic, medical, or other professional organizations
  5. Working papers, drafts, commentaries, or discussion papers

Public Input and Comments

To request that we include a new standard or a new country in the International Compilation, or to let us know of changes to these standards or broken links, please email us at OHRP-Edu@hhs.gov.

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