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Human subjects research conducted by University of Iowa or VAHCS investigators (faculty, staff or students) in foreign countries typically remains under the UI purview and guidelines. Procedures normally followed outside the United States for research involving human subjects may differ from those set forth in federal and University policies. These may result from differences in language, cultural and social history, and social mores. In addition, national policies such as the availability of national health insurance, philosophically different legal systems, and social policies may make forms and procedures inappropriate. While the UI IRB cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent process.
Special attention should be given to local customs and to local cultural and religious norms in drafting written consent documents or proposing alternative consent procedures. Protections afforded subjects must be equivalent to those provided to subjects in the United States.
For some research proposals, it may be appropriate to request a waiver of consent or the elements of consent. Such proposals should include explanations of cultural norms or conditions requiring such a waiver. For example, societies where no written language is used or societies where signatures might represent something quite different than what they represent in the United States.
The first step in the review process is to make a determination about whether or not the project meets the definition of human subjects research. If unsure about whether the project constitutes human subjects research, the investigator should submit a Human Subjects Research Determination (HSRD) form in HawkIRB to receive a documented determination from the IRB Chair.
If the project does involve human subjects research, the investigator will be required to submit a New Project application in HawkIRB for IRB review and approval prior to the conduct of the research. In federally funded research, research activities in a foreign country may be approved if the procedures proscribed by a foreign institution are equivalent to those in the U.S. Research projects must have been approved by the local equivalent of an IRB before they are given final approval by the UI IRB. OHRP provides a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world. Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval of the project. The UI IRB will require documentation of this “local approval” using the International Research Local Context Review Form before it gives final approval of the project. This form is available on the attachments page in the HawkIRB application.