University of Minnesota
Institutional Review Board

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Guidance & FAQs

IRB Review of International Research

Research conducted by University investigators in foreign countries remains under University purview and guidelines.

While we 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 formats.

In some instances it may be appropriate for the IRB to waive some or all requirements for written consent.

Research proposals for which this may be reasonable should include explanations of cultural norms or conditions requiring such as waiver. (eg. societies where no written language is used, societies where signatures represent the surrender of spirit or soul to the researcher)

Research projects must have been approved by the local equivalent of an IRB before they are presented to the University IRB.

Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The IRB requires documentation of this "local approval" before it gives approval.

Include Appendix K with IRB applications for international research projects.

Cross-Cultural Issues and the Consent Process

The requirements for documenting informed consent vary among cultures. The IRB does not exempt projects conducted in foreign countries or with other cultural groups here from the consent requirement, but it can waive the requirement for written documentation of consent.

Also see:

4.11 Consent and language barriers in the Protecting Human Subjects Guide

Center for Cross-Cultural Health
Integrate cultural competency into health and human services by providing information, training, research and consulting to health and human service providers in Minnesota and beyond.

Family Health International
Training Curricula for Research Ethics
The site is a global network of persons and institutions interested in various fields of applied ethics. It offers access to a large number resources on ethics, especially through its leading global digital ethics library.

Indiana University
Center for Bioethics
International Research Ethics Subject Guide

BioEthics around the World


OHRP International Issue Links
More Information

Reports and Articles

Policy Issues in International Research: Clinical Trials in Developing Countries
April 2001
Report and Recommendations of the National Bioethics Advisory Commission (NBAC)

Ethics of Clinical Research in the Developing World
Mar. 2002
Nature Reviews Immunology

International Ethical Guidelines for Biomedical Research Involving Human Subjects
Oct. 2002
by the Council for International Organizations of Medical Sciences

Report: The ethics of research related to healthcare in developing countries
24 April 2002

Commentary: Putting International Research Ethics Guidelines to Work for the Benefit of Developing Countries
Lavery, James V.