International Compilation of Human Research Standards, 2021 Edition

The International Compilation of Human Research Standards (regular updates), lists over 1,000 laws, regulations and guidelines on the protection of research participants in more than 130 countries, plus standards from international and regional organisations. It is intended for researchers, institutional review boards or research ethics committees, sponsors and others overseeing human research. For investigator‑initiated, multi‑country clinical studies, it offers a structured route to identify applicable national and international human research protection standards, supporting feasibility assessment, ethics and regulatory planning, and training of research teams.

The document is organised by world region (Africa, Asia/Pacific, Europe, Latin America and the Caribbean, Middle East/North Africa, North America), with an initial section for international organisations. Within each region, countries and organisations are listed alphabetically, and users can jump directly to a country from the table of contents.

For every country or organisation, information is grouped into nine categories: general human subjects research; drugs, biologics and devices; clinical trial registries; research injury; social‑behavioural research; privacy and data protection; human biological materials; genetic research; and embryos, stem cells and cloning. Each category distinguishes key organisations from relevant standards, which may include laws, regulations, guidance and official opinions, whether mandatory or advisory.

Where possible, web links are provided to the original documents, often in English or accessible via online translation tools. A “Topics Not Covered” section clarifies that the Compilation generally excludes sub‑national rules, enabling legislation without substantive standards, disease‑specific regulations, professional ethics codes and draft or commentary documents.