Human Subjects Regulations

You must include the Initial protocol application and associated documents (e.g., surveys, questionnaires, study information). The application must list all international locations involved in the study, and the research plan must indicate that this is an international protocol. All foreign investigators collaborating in the research study must be listed on the IRB application. Include any aliases or alternate spellings and affiliation information.

Informed consent document(s) in English. Informed consent documents should be translated into the local language after IRB approval. Translated documents should state who performed the translation services.

Investigators must comply with both U.S. regulations and local policies and regulations governing the international research sites. All studies must have evidence of local approval by an IRB, Ethics Board, or Independent Ethics Committee (IEC) familiar with the local research context and local law, or a letter explaining why such a review is not possible. If no local ethics approval is in place, at a minimum, there must be endorsement of the project by the local authority/institution involved in the research. No research can begin until local approval has been obtained and submitted to the UC IRB. It is important to do your homework early and, if possible, enlist a local collaborator to help you address the site’s requirements to obtain local ethics reviews and permissions to conduct research at that international site.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

The International Compilation of Human Research Standards contains more than 1,000 laws, regulations, and guidelines on human subject protections in 130 countries, as well as standards issued by a number of international and regional organizations.

Information stored on your laptop can be at great risk for theft or corruption, or confiscation by authorities. Encryption software is contraband when crossing some borders. If you are encrypting patient information, be sure your software will not alarm border patrol. This may be in direct contrast to your human studies requirements. Visit Data Security to learn more.

The US government requires that clinical trials be registered on ClinicalTrials.gov.

Research ethics have a human and a scientific component. They are complex, and you may need advice when you are in remote areas. Work with your CHR and develop a resource for accessing that ethical perspective when you are abroad.