IRB Corner: Human Subjects Protections in International Studies

IRB Corner: Human Subjects Protections in International Studies

In this month’s IRB Corner, we discuss human subjects protections in international studies. We explain why an international study may require additional reviews and approvals. We present resources to support researchers who intend to conduct an international study, including explaining how a researcher can locate contact information for international research reviews. We outline how obtaining an international research review impacts an investigator’s UOPX IRB review. Finally, we address other considerations for researchers proposing to conduct research outside of the United States.

Why do international studies involving human subjects require additional reviews and approvals?

The U.S. federal regulations for the protection of human research subjects (45 CFR 46) are based primarily on principles from the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/). The ethical principles underlying the U.S. regulations are not always aligned with local norms and standards for other nations and cultural communities. The U.S. guidelines stipulate that when a study takes place outside of the United States, the research must also be reviewed based on local human research ethical standards. UOPX researchers (faculty and students) are required to educate themselves on the local human research ethical standards and regulatory requirements.

What human research resources are available to support researchers conducting international research?

The U.S. Office of Human Research Protection (OHRP) publishes the International Compilation of Human Research Standards to help researchers locate local regulations (see http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html.) The Compilation of Human Research Standards is updated annually by OHRP and lists over 1,000 local laws, regulations, and guidelines from over 100 countries. OHRP also provides links to a number of national and international ethical codes and research standards, including the Belmont report, Declaration of Helsinki, and Nuremberg Code (http://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html). The Declaration of Helsinki and the Nuremberg Code are two very important human subject protection documents for those who are conducting research outside of the United States; UOPX faculty and student researchers should familiarize themselves with both before conducting international research.

How does obtaining an international research review impact a UOPX IRB review?

University of Phoenix researchers conducting a study outside of the United States are required to present verification to the UOPX IRB that they have had their study reviewed by an equivalent human research ethics board in the area where the study will be conducted. In some cases, the local standards or regulations may not require a review. In cases where the local standards or regulations do not require a human subjects review, UOPX researchers must provide the UOPX IRB a copy of the local regulations or a written statement from a member of the local ethics board indicating that the research study does not require a human subjects review based on local standards or regulations. For more on other types of permissions the UOPX IRB considers, see our GUIDANCE – Permissions document.

Are there other considerations for a researcher proposing to conduct a study outside of the United States?

UOPX researchers who intend to conduct their research abroad should be aware of current travel alerts and warnings published by the U.S. State Department (https://travel.state.gov/content/passports/en/alertswarnings.html). To protect our researchers’ safety, if there is a U.S. Travel Warning for the location where a study will be conducted, we ask that all U.S. citizens and U.S. nationals (including those who hold dual citizenship) enroll in the U.S. Department of State’s Smart Traveler Enrollment Program (STEP) (https://step.state.gov/step/). In addition, researchers should also have the local U.S. Embassy contact information available at all times while out of the United States and conducting research. UOPX researchers can also contact the STEP program to determine if any items, such as cameras, cell phones, laptop computers, or other technology items, require additional clearance for traveling to and from the research location.

All guidance documents, templates, and forms are available in the IRBNet Forms and Templates library (accessible from the left menu within IRBNet). After reviewing the guidance materials recommended in this article, please contact The University of Phoenix IRB Office at IRB@phoenix.edu if you have a question about international studies

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