The IRB Process

Design Issues

International Research

Introduction

It is important that all research with human subjects adequately protect the rights and welfare of the subjects. All human subjects research in which American investigators are involved, and which would be subject to the federal regulations if it were conducted wholly within the United States, must comply with the federal regulations for the protection of human subjects in all material respects.

IRB Considerations

Federal Regulations recognize that "the procedures normally followed in the foreign countries [in which the research will take place] may differ from those set forth in this policy." Research may be approved, therefore, if "the procedures prescribed by the [foreign] institution afford protections that are at least equivalent to those provided in this policy." The foreign country's procedures may then be substituted for the procedures required by the federal regulations. Approval of the substitution is to be given by the IRB after review of the foreign procedures.

One difficult issue is determining what constitutes "protections that are at least equivalent" to the federal regulations. This determination may need to be made by the Office for Human Research Protections. The broad policy outlines of international standards, such as the Declarations of Helsinki or the Nuremberg Code, are a starting place, but are not alone sufficient. Written descriptions of the specific procedural implementation of such policies that have been adopted by the foreign institution are required.