Responsible Conduct of Research

Resources for International Ethical Standards and Research Procedures

The following list contains a collection of resources specific to ethics and policy guidelines for
international research.

• UC Human Subject Research Policies
• ClinRegs, an online database of country-specific clinical research regulatory information
• 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 Ethical Guidelines for Health-related Research Involving Humans (pdf) The CIOMS Guidelines reflect the conditions and the needs of biomedical research internationally, and the implications for multinational or transnational research in which they may be partners.
• Office for Human Research Protection (OHRP) International Compilation of Human Research Standards: A compilation of over 1,000 laws, regulations, and guidelines on human subjects protection in over 100 countries
• OHRP International Activities
• Strategies for Protecting Human Research Subjects Globally
• Harvard Catalyst Novel Approaches to Post Approval Monitoring of Human Research in Developing Countries
• Fogarty International Center Bioethics Information and Resources

The Fogarty International Center at the U.S. NIH supports and facilitates global health research conducted by U.S. and international investigators, builds partnerships between health research institutions in the U.S. and abroad, and aids in training the next generation of scientists to address global health needs. Fogarty also aims to strengthen research bioethics expertise in developing countries by providing resources and information to bioethicists, research ethics committee members, researchers, students, and everyone else involved in international health research.

• International Ethical Guidelines for Biomedical Research Involving Human Subjects Ethical Considerations in biomedical HIV Prevention Trials (pdf)                             Published by United Nations AIDS 2007 (with additional information added in 2012). Translations available in Ch/Fr/Port/Sp/Viet International language editions. This is an excellent resource about conducting clinical trials internationally.
• Ethical and Policy Issues in Int'l Research: Clinical Trials in Developing Countries: Report and Recommendations of the National Bioethics Advisory Commission (pdf)

Discusses ethical issues that arise when research is sponsored or conducted in developing countries, where systems for protecting human participants equivalent to those of the U.S. have not yet been established.

• Presidential Commission for the Study of Bioethical Issues

President Obama requested the Commission to assess research standards following the October 2010 revelation that the U.S. Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent. The President gave the Bioethics Commission two assignments: to oversee a thorough fact-finding investigation into the specifics of the studies, reported in, "Ethically Impossible: STD Research in Guatemala from 1946 to 1948" and to assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally, with 14 changes to current practices to better protect research subjects, reported in Moral Science: Protecting Participants in Human Subjects Research.

• United Nations Education, Scientific, and Cultural Organization (UNESCO)

UNESCO’s Ethics of Science and Technology program works to assist Member States in developing sound policies and decisions on ethical issues in science and technology and released the International Declaration of Bioethics and Human Rights in 2005.  Of particular interest are two capacity-building initiatives:  Assisting Bioethics Committee and the Ethics Education Program. UNESCO’s Global Ethics Observatory (GEObs) is a set of databases containing information on all currently available ethics resources worldwide.

• World Health Organization (WHO). The WHO’s Ethics and Health Initiative examines a range of bioethical issues—such as access to health services, organ transplantation, and research with humans—raised by WHO’s own activities.
• The World Medical Association (WMA) is an international organization of over 95 medical associations. While it is best known for the Declaration of Helsinki, WMA has published a number of guidelines and reports that address standards in medical education, ethics, and science.

International Laws, Guidance, and Essential Country Data

OISE: International Integrity Resources, NSF

Office of International Science & Engineering (OISE) provides resources to assist in developing training and oversight plans for the responsible and ethical conduct of research in international contexts and understanding international codes of conduct.

OHRP Compilation of International Human Subject's Laws

The Office for Human Research and Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). The International Compilation of Human Research standards provide a listing of laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations.

World Bank Countries and Economies

The World Bank provides comprehensive national data for developing countries around the world. The data includes such measures as GDP, population growth, CO2 emission levels, poverty ratio, life expectancy, and others.

CIA World Fact Book

The World Factbook provides information on the history, people, government, economy, geography, communications, transportation, military, and transnational issues for 267 world entities.

World Health Organization Country Information

The World Health Organization Country Information webpage provides information and data on all countries that are members of the United Nations and World Health Organization. The data includes population statistics, information on national health systems, disease burden, and health profiles of each country.

Campus Directory of Research Compliance Offices