- Ethical Standards and Procedures
- Animal Research
- Endangered Species and Biodiversity
- Data Privacy
- Tax Treaties
International Ethical Standards and Procedures for Research with Human Subjects
Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
The Declaration of Helsinki (DoH) is widely regarded as the cornerstone document on human subject research. It provides medical researchers a guide the ethical conduct of research involving human participants and specifically addresses protections for study participants with regard to the risks, burdens, and benefits of participating in studies as well as participants’ rights to privacy, confidentiality, and informed consent. The DoH was developed by the World Medical Association (WMA). The WMA is an international organization of over 95 medical associations and has published a number of guidelines and reports that address standards in medical education, ethics, and science.
ICH Guideline for Good Clinical Practice
The International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
International Ethical Guidelines for Health-related Research Involving Human Subjects
The International Ethical Guidelines for Health-related Research Involving Humans, sometimes informally referred to as CIOMS Guidelines, is a set of ethical principles regarding human experimentation created in 1993 by the Council for International Organizations of Medical Sciences (CIOMS) and updated in 2016. CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.
Ethical Consideration in Biomedical HIV Prevention Trials
Updated in 2012, the Ethical Consideration in Biomedical HIV Prevention Trials offers guidance on ethical considerations in HIV prevention research based on extensive consultation and lessons learned in biomedical HIV prevention research. Although the guidelines specifically address trials of biomedical HIV preventive interventions, they are also relevant to trials of behavioral HIV prevention methods.
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries: Report and Recommendations of the National Bioethics Advisory Commission
The Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries: Report and Recommendations of the National Bioethics Advisory Commission discusses ethical issues associated with international research subject to U.S. regulations in developing countries, where local technical skills and other key resources for protecting human participants are scarce.
Universal Declaration on Bioethics and Human Rights
The Universal Declaration of Bioethics and Human Rights, adopted by the United Nations Educational, Scientific, and Cultural Organization (UNESCO) in October 2005, addresses ethical issues related to medicine, life sciences, and associated technologies as applied to human beings. The aim of the declaration is to provide a universal framework of principles and procedures to guide states when they formulate policies in the field of bioethics, as well as to recognize the importance of scientific research and the benefits derived from scientific and technological development.
Fogarty International Center Bioethics Information and Resources
The Fogarty International Center Bioethics Information and Resources, part of the NIH, supports basic, clinical and applied research and training for U.S. and foreign investigators working in the developing world. Since its formation, Fogarty has served as a bridge between NIH and the greater global health community to facilitate exchanges among investigators, provide training opportunities, and support promising research initiatives in developing countries.
Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues, created by Executive Order 13521 on November 24, 2009, is an advisory panel to the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission oversaw a thorough review of current regulations and international standards to assess whether they adequately protect human participants in federally funded research. The Commission offers 14 recommendations to improve the current system, as provided in its report entitled Moral Science: Protecting Participants in Human Subjects Research.
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.
Office of Human Research Protections
Office for Human Research Protections (OHRP) International Compilation of Human Research Standards. The OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States. This site contains a compilation of over 1,000 laws, regulations, and guidelines on human subjects protection in over 100 countries.
Animal Research
The International Guiding Principles for Biomedical Research Involving Animals was developed by the Council for International Organizations of Medical Sciences (CIOMS) and reflects current best practices and standards of care in laboratory animal medicine and science. It provides a framework of responsibility and oversight to ensure the appropriate use of animals. It also serves as a benchmark for advancing international collaboration in biomedical sciences. The World Organization for Animal Health (OIE) Terrestrial Animal Health Code (Terrestrial Code) sets forward standards for improving terrestrial animal health and welfare, and veterinary public health worldwide, including through standards for safe international trade in terrestrial animals (mammals, birds and bees) and their products. The health measures in the Terrestrial Code should be used by the Veterinary Authorities of importing and exporting countries to provide for early detection, reporting and control agents pathogenic to terrestrial animals and, in the case of zoonoses, for humans, and to prevent their transfer via international trade in terrestrial animals and terrestrial animal products, while avoiding unjustified sanitary barriers to trade. The NIH Office of Laboratory Animal Welfare (OLAW) oversees Public Health Service (PHS)-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals that states: "Institutions in foreign countries receiving PHS support for activities involving animals shall comply with this Policy, or provide evidence to the PHS that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met." IACUC approval is not required of foreign grantees; however, OLAW encourages foreign grantees to use the standards in the Guide for the Care and Use of Laboratory Animals. The Guide is recognized worldwide as a resource for laboratory animal research facilities. When the grantee is a domestic institution and performance sites are foreign (i.e., domestic grant with a foreign component), PHS Policy requirements are applicable. Accordingly, the prime domestic grantee remains responsible for animal activity conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activity as conducted at the foreign performance site is acceptable to the prime grantee). The prime grantee IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the prime grantee IACUC remains responsible for the review. Additionally, the foreign site must obtain a Foreign Assurance. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is an international agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival. CITES works by subjecting international trade in specimens of selected species to certain controls. All import, export, re-export and introduction of species covered by the Convention has to be authorized through a licensing system. Each Party to the Convention must designate one or more Management Authorities in charge of administering that licensing system and one or more Scientific Authorities to advise them on the effects of trade on the status of the species. The species covered by CITES are listed in three Appendices, according to the degree of protection they need. For additional information on the number and type of species covered by the Convention, click here. AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. More than 950 companies, universities, hospitals, government agencies and other research institutions in 41 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research. Furthermore, per UC C&G Manual 18-440, all facilities housing animals must be fully accredited by AAALAC. The AAALAC website also provides links to various international resources. The One Health Initiative is the collaborative effort of multiple disciplines — working locally, nationally,and globally — to attain optimal health for people, animals and the environment. The importance of One Health is promoted by scientists in many countries and supported by prominent organizations including the World Health Organization, Food and Agriculture Organization, World Organization for Animal Health, The International Federation for Animal Health, Global Alliance for Rabies Control, New Zealand Centre for Conservation Medicine (NZCCM), Hubnet in Asia the One Health Global Network, the University of California One Health Center, Academic Hospital Utrecht and Utrecht Life Sciences and the Infection Ecology and Epidemiology Network, Uppsala, Sweden.International Guiding Principles for Biomedical Research Involving Animals
Terrestrial Animal Health Code
Animal Research Funded by NIH
Convention on International Trade in Endangered Species of Wild Fauna and Flora
AAALAC International
One Health Initiative
Endangered Species and Biodiversity
Convention on International Trade in Endangered Species of Wild Fauna and Flora
The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is an international agreement between 80 countries. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival.
International Treaty on Plant Genetic Resource for Food and Agriculture (ITPGRFA)
The International Treaty on Plant Genetic Resource for Food and Agriculture (ITPGRFA) is a legal instrument in the fight against hunger and poverty, particularly in an era of climate change that also affects food production. ITGRFA facilitates the exchange and conservation of crop genetic resources amongst member nations, as well as the fair sharing of benefits arising from their use.
Convention on Biological Diversity (CBD)
The Convention on Biological Diversity (CBD) is a comprehensive, binding agreement signed by 193 governments covering the use and conservation of biodiversity. The CBD sets out commitments for maintaining the world's biodiversity that directly supports the livelihoods of billions.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the CBD. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources.
EU-U.S. Privacy Shield
The EU-U.S. Privacy Shield is designed by the U.S. Department of Commerce and European Commission to provide companies on both sides of the Atlantic with a mechanism to comply with EU data protection requirements when transferring personal data from the European Union to the United States. The EU-U.S. Privacy Shield replaces the International Safe Harbor Privacy Principles that were established in 2000, but declared invalid in October 2015 by the European Court of Justice.
The EU-U.S. Privacy Shield requires the U.S. to monitor and enforce more robustly, and cooperate more with European Data Protection Authorities. It includes, for the first time, written commitments and assurance regarding access to data by public authorities.
Additional Resources
Tax Treaties
The United States has income tax treaties with a number of foreign countries. Under these treaties, residents (not necessarily citizens) of foreign countries are taxed at a reduced rate, or are exempt from U.S. income taxes on certain items of income they receive from sources within the United States. These reduced rates and exemptions vary among countries and specific items of income. Under these same treaties, residents or citizens of the United States are taxed at a reduced rate, or are exempt from foreign taxes, on certain items of income they receive from sources within foreign countries.
The United States Income Tax Treaties – A to Z provides links to tax treaties between the United States and particular countries. For further information on tax treaties refer to the IRS U.S. Tax Treaties publication.