Research conducted in international settings must be reviewed using both the MSU Denver standards 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.
Investigators conducting international research must complete the addendum for Research in International Settings and the International Research CITI training module (beginning September 1st).
OHRP International Standards ( 1,166 KB)