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International Research

Research conducted in international settings must be reviewed using both the MSU Denver standards (US federal, institutional, etc.) as well as the standards adopted by the country in which the research is being conducted. 45 CFR 46 states the following regarding international research:

§46.101 To what does this policy apply?

(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures.

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Investigators conducting international research must provide the IRB with sufficient information on the setting(s) including any cultural or language considerations of the research and demonstrate to the IRB that they have the necessary permissions to conduct the research in that setting.  This may include approval from one or more local ethics review boards and permissions from country or local level entities (e.g. Ministry of Health, local school officials, etc.).  In many cases, ethics review boards would expect that international researchers have local collaborators involved in their studies (as co-investigators, interpreters, community liaisons, etc.). 

Research that requires oversight of multiple review boards should be appropriately planned for in your study timeline.  Often, these review processes can occur concurrently; but, it is ultimately the researcher's responsibility to ensure that all review boards are informed of any modifications, additions, and final determinations, so that approved research materials remain consistent.

The Office for Human Research Protections (OHRP) provides a reference guide for researchers: OHRP International Compilation of Human Research Standards


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