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Purpose:  

Special considerations apply for human subjects research with participants located outside the United States. This guidance aims to inform 91̽�� researchers about what other resources to consult when preparing protocol submissions involving participants abroad and in participant-facing materials to minimize the potential to break other countries’ data protection laws. OU researchers planning international research should allow for longer review time for IRB protocols.

Scope:  

This guidance applies to all studies that meet both the federal definition of “human subject” and “research” that involve participants who are physically located outside of the United States during study procedures. This guidance applies to both in-person and remote human subjects research, in which an investigator might be physically located in the United States while conducting procedures remotely with participants outside of the United States. If you’re not sure if your study meets the federal definitions of “human subject” and “research,” and/or you’re not sure if your research site qualifies as an international location, please contact the Office of Research Compliance at compliance@ohio.edu.

Definitions:

• Human subject means a living individual about whom an investigator (whether professional or student) conducting research:           

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

• Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Investigator Responsibility:  

Investigators submitting protocols for OU IRB review are responsible for compliance with all applicable human subjects research and data privacy regulations for the countries where their participants are located.

OU investigators planning human subjects research with participants outside of the United States should consult the Office of Human Research Protections before submitting a protocol for IRB review.

• Some countries may require that researchers planning work within their boundaries obtain an approval from a local Ethics Committee (EC) and/or from a local university. These approvals would be in addition to, not a substitute for, an approval from the OU IRB. Researchers based in institutions in the United States may or may not need to affiliate with a local university in other countries to obtain these additional approvals.
• Generally speaking, the physical location of the participants will dictate the regulations that will apply to the collection of data in a human subjects research study. If, for example, an OU researcher wants to interview people in both Canada and Japan via Microsoft Teams from their office in Athens, then that researcher should expect Canadian law to apply to participants completing an interview from Canada and Japanese law to apply to participants completing an interview from Japan. In most cases, regulations will apply regardless of citizenship. So in the above example, data collection from a Saudi Arabian citizen completing an interview from Canada would be subject to Canadian law.
• Investigators should review sections on their planned research sites in the OHRP’s   to determine if additional local approvals and compliance with specific data regulations will be required.

OU investigators planning human subjects research with collaborators outside of the United States should consult with the Office of Research Compliance once you have formalized your research questions and have a general idea of your methods AND before you submit in Cayuse.

Risk for Research in Other Countries:  

The OU IRBs expect investigators to think carefully about the context of risks involved in research participation in other countries and to provide sufficient additional details for the IRBs to assess risks to participants that may be specific to those countries. Study procedures that would not be risky or sensitive for US-based participants may be for participants in other countries. For example:  interviewing political scientists who are US citizens located in the United States about their perceptions of political unrest abroad would most likely not constitute greater than minimal risk to participants. Interviewing political scientists who are citizens residing in the country where the unrest is taking place could constitute considerably greater risk to those participants. If the IRB feels that there is study specific risk to researchers who plan to travel to other countries, they may refer the concern to Legal Affairs or other OHIO institutional offices. In IRB protocol submissions, OU researchers should provide sufficient detail about their target participant populations for international locations to allow the OU IRBs to assess location-specific risks to participants.

Verification of Translation:  

If conducting study procedures with participants in languages other than English, OU researchers must provide participant-facing documents in both English and the other language as part of their IRB protocol submissions. Complete the Verification of Translation for Human Subjects Research Studies form and upload the completed form as an attachment with your IRB protocol application.

Additional Reviews:

The OU IRBs reserve the right to consult with additional experts about planned international research. For example, additional experts may review protocol submissions describing work with participants in countries that follow the - European Union states, plus Iceland, Liechtenstein, and Norway. Additional experts may also review protocols describing work with participants deemed to be vulnerable subjects in applicable countries or work with participants who are afforded other special legal protections.

 Revised: 10/22/2024