The University requires all investigators/students to ensure that human subjects who participate in research projects outside of the United States receive the same level of protections as research participants inside the United States. Research conducted by University and affiliate researchers in foreign countries remains under University purview and guidelines.
The Institutional Review Board (IRB) believes that culturally appropriate procedures are an important aspect of protecting participants in research. The review of foreign site research presents several challenges to the IRB. The IRB is required to have and document knowledge of the "local research context" and generally requires additional information from investigators before final approval of foreign site projects can be given, including information about local laws and customs, local IRBs, agencies, or "gatekeeper" organizations, and informed consent alternatives. The FDA requires compliance with "the laws and regulations of the country in which the research is conducted."
International research activities must have academic merit; they may not violate pertinent laws or professional principles of conduct; and only competent and qualified individuals may be involved in the conduct of such research. All international research studies must adhere to recognized Ethics Codes such as Title 45 CFR 46, the Declaration of Helsinki, the Nuremberg Code, or the Belmont Report. Investigators are encouraged to contact the Chair of the IRB or RIO staff to discuss issues related to International Research.
OHRP publishes The International Compilation of Human Research Standards, a listing of over 1,000 laws, regulations, and guidelines on human subject protections in over 100 countries and from several international organizations. This document should be consulted to determine country level guidelines on human subject research. Many of the listings embed hyperlinks to the source document. These laws, regulations, and guidelines are classified into six categories:
- General, i.e., applicable to most or all types of human subjects research
- Drugs and Devices
- Research Injury
- Privacy/Data Protection
- Human Biological Materials
- Embryos, Stem Cells, and Cloning
University and affiliate researchers conducting or overseeing research conducted outside the United States must complete the CITI module for International Research or equivalent training approved by the Director of Research Integrity.
International research projects must have been approved by the local equivalent of an IRB before they are presented to the University IRB.
Research projects must provide documentation of approval by the local equivalent of an IRB where required by country, province, or local laws or by a suitable alternative before international projects will be approved by the University IRB.
Many international universities have Ethics Committees that can review and approve research. If a study involves minimal risk, documentation that is equivalent to an IRB approval letter or a permission letter from the research site may be acceptable. Where there is no equivalent board or group, the IRB requires investigators to apply a good-faith effort to secure local cooperation for the research and to document those efforts as part of the application. In such cases, investigators should consult with local experts or community leaders about the project and secure their support for the conduct of the research.
Research conducted by University and affiliate investigators in foreign countries remains under University purview and guidelines, including requirements for informed consent.
While we cannot impose our standards for written documentation of consent for other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent process. In some instances it may be appropriate for the IRB to waive some or all requirements for written consent, for example for cultural or religious reasons.
When culturally appropriate, the IRB will consider alternative consent formats and processes.
Special attention should be given to local customs, and local cultural and religious norms in drafting written consent documents or proposing alternative consent processes. Research proposals for which alternative consent formats or processes are preferable should include explanations of cultural norms or conditions requiring alternatives to written, informed consent. (e.g., societies where no written language is used, societies where signatures represent the surrender of spirit or soul to the researcher). Local customs with regard to minors are often in conflict with standards used in the United States. With all due sensitivity for local customs, minors who are treated as adults in their own country will be treated a minors for the purpose of protection in research. However, the definition of who may provide 'parental permission' to participate may appropriately be adjusted based on cultural norms. It is possible that grandparents or even tribal leaders may be the cultural head of household and may ethically serve as the designated guardian for a minor participating in research.