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International Human Subject Research Resources

U-M Resource

The International Research Risks Report from ORCR (formerly OHRCR) provides recommendations for mitigating the risks in conducting international human subjects research. 

Note: The articles linked below may require a subscription to a publication database, have a cost to download from that database/website, or require additional software to view.  

The external informational resources linked below address important areas for the development, approval, training for and conduct of international human subjects research. Investigators and IRB members may find these resources helpful when considering the multitude of unique and complex issues related to international human subjects research. This list was compiled by the U-M Office of Research Compliance Review (ORCR).

Resources for Developing Programs

The following organizations provide information about International Research Ethics Committee (REC) and IRB standards for accreditation and capacity building:

  • SIDCER - The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of independently established regional forums for ethical review committees, health researchers, and invited partner organizations with an interest in the development of ethical review.
  • AAHRPP - The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), helps organizations worldwide strengthen their human research protection programs and provides a list of accredited organizations both nationally and internationally.
  • FERCAP - Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP), aims to improve understanding and implementation of ethical review for behavioral and biomedical researchers in Asia and the Western Pacific region.
  • CIOMS - The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.

International Laws, Guidance, and Essential Country Data

These resources represent a compilation of research laws and regulations in most countries in the world along with essential country information that is useful for IRB members who are reviewing studies being conducted abroad.

  • OHRP Compilation of International Human Subject's Laws - Web page containing a downloadable document listing over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations compiled by the HHS Office of Human Research Protections (OHRP).
  • OISE: International Integrity Resources - National Science Foundation (NSF) Office of International Science & Engineering (OISE) provides resources to assist in the development of training and oversight plans for the responsible and ethical conduct of research in international contexts and understanding international codes of conduct.
  • World Bank Countries and Economies - Comprehensive national data for developing countries around the world; e.g., Agriculture & Rural Development, Aid Effectiveness, Climate Change, Economic Policy & External Debt, Education, Gender, Health, Infrastructure, Labor & Social Protection, Poverty, and more.
  • CIA World Fact Book - Provides information on the history, people, government, economy, geography, communications, transportation, military, and transnational issues for 267 world entities.
  • World Health Organization Country Information - A webpage listing all the countries that are members of the United Nations and the World Health Organization. Includes population statistics, information on national health systems, mortality, disease burden, and the health profile of each country.

International Ethical Standards and Procedures

Resources that describe the ethical issues and standards in conducting international research.

Informed Consent Approaches

Resources that describe issues related to written consent and alternate consent formats (e.g., oral, pictorial).

​Clinical Trials

Training

Resources that provide training on the ethical principles, standards, and procedures associated with human subjects research.