UI faculty, staff, and students must receive UI Institutional Review Board (IRB) approval for all human subjects research conducted outside the United States. For international research, additional approvals may be needed before the UI IRB can approve the research. This page outlines those additional approvals, the process to obtain them and general guidelines for conducting research in another country.

The regulations, standards, and norms for conducting human subjects research in other countries may differ from the United States. Language or communication issues, cultural and social norms, and national laws and regulations vary by country. Investigators must design their study to comply with these requirements for the country (or countries) where they will conduct the research.

Getting Started

The study design and procedures must comply with the norms, standards, and regulations for conducting human subjects research in the country where the research will take place. Educate yourself about the requirements for conducting research in that location. Consult with someone who has experience conducting research in that country. This may be a researcher in that country or someone in the U.S. who has conducted research in that location.

Determine if IRB Review is Needed

Investigators who are unsure about whether their project meets the definition of human subjects research should submit a Human Subjects Research Determination (HSRD) form in HawkIRB. Visit the “Do I Need IRB Approval” web page for more information.

International Ethics Committee Review Requirement

Many countries have laws and regulations regarding human subjects research. The first step is to determine whether there is a requirement for the study to be reviewed by an in-country ethics committee. This review would be in addition to the review of the study by the UI IRB. If there is an ethics committee review requirement in the host country, investigators must obtain approval from the in-country ethics committee before the research can be approved by UI IRB. Review the UI IRB Standard Operating Procedures and Researchers Guide (Section 2, Part 8.C) for the UI IRB policy on International research.

The Office of Human Research Protections (OHRP) in the US Department of Health and Human Services (HHS) maintains two compilations of ethical standards for the conduct of human subjects research in other countries:

  • The International Compilation of Human Research Standards outlines over 1,000 laws, regulations, and guidelines for human subjects research in over 130 countries. There is a main pdf document and separate region-specific compilations. The majority of countries in the compilation have regulations only related to biomedical research. This compilation also includes countries like the U.S. that have laws and regulations regarding social/behavioral/educational research.

Investigators are advised to use these resources to make sure their proposed research complies with the laws and ethical standards in the host country.

Local Context Review Requirement

When there is no regulatory requirement to have an in-country ethics review committee approve human subjects research, investigators will need to rely on local experts or community leaders from the country to provide a local context review of the study. There is a Local Context Review form on the Attachment page of the HawkIRB application. See below for more information.

Other Laws and Regulations that Effect International Human Subjects Research

There are other international laws that are not specific to human subjects research, but impact research when it is conducted within the borders of some countries. Additionally, some federal funding agencies have additional requirements that must be met when researchers are conducting human subjects research in international countries.


The European Union General Data Protection Regulation (GDPR) regulates the processing of personal data, in any format, of a living individual residing within the European Union. This applies to all data, including research data that is collected during a study. the UI policy related to GDPR is outlined in the UI Operations Manual (V. Administrative, Financial, and Facilities Policies, Chapter 46).


The National People’s Congress of the People’s Republic of China has also passed a Personal Information Protection Law of the People’s Republic of China (PIPL) for the protection of personal information for people that are from China.  This regulation applies to all data, including data collected for human subjects research. 

International Research Funded by the US Department of Defense

Department of Navy-sponsored international research requires permission of the host country and an ethics review and approval by the host country, or the Naval IRB with host country representation.

Completing the HawkIRB Application for International Research

UI investigators must submit a HawkIRB application for an international research project that involves human subjects, even if approval is obtained from an in-country ethics board. Incorporate all changes or requirements from the in-country ethics committee into the HawkIRB application.

Best Practice: Draft the HawkIRB New Project form prior to submission to the in-country ethics board. But submit the HawkIRB application to the UI IRB after the in-country ethics board approves the project. If the project requires a local context review, obtain that documentation before submitting the HawkIRB application.

Relevant Sections of the HawkIRB Application

Provide specific information regarding off-campus research in the following sections:

  • Section II.2: Add the translator/interpreter as a non-UI research team member if they are engaged in research (independently interacting with subjects for any aspect of the study activities). If the translator/interpreter is only providing interpreter and/or translation services and UI researchers will be conducting the study procedures with the translator’s assistance for communication, they do not need to be added to the research team.
  • Section III.1: The IRB will expect to see a funding source listed if an investigator is traveling internationally to conduct human subjects research and if there are any other costs associated with the research (i.e., subject compensation). The drop down menu under “Internal” funding includes an options for UI institutional grant/award, departmental/PI discretionary funds, and PI personal funds.
  • Section VI.16: Describe how you will communicate with non-English speaking subjects. If research team members are neither fluent in, nor a native speaker of, the language spoken by the intended subject population, a translator may be necessary for written communications and an interpreter may be necessary for verbal communications. The recruitment process, consent process and all study procedures must be conducted in a language the subject readily understands. Investigators must specify who will complete document translations and/or who will be acting as the interpreter during interactions with the subjects. If the translator/interpreter is not a member of the research team, the investigator must provide a resume or the credentials of the translator/interpreter in the ‘Miscellaneous’ section of the attachments page on the HawkIRB application.
  • Section VII.A.1: Investigators must provide all locations where study activities will take place. This includes locations outside the U.S. and on- or off-campus in the U.S. Study procedures include recruitment, consent procedures, all study activities and data collection, data storage and analyses.
  • Section VII.D: Investigators must describe all methods that will be used to recruit subjects into the study and how these recruited volunteers will indicate their consent to participate in the study. 
    • Recruitment procedures should be feasible, culturally appropriate and conducted in a language that the potential subjects can understand.  
    • The consent process should be appropriate to the subject population and the local culture. For instance, it may be the norm to approach a village elder before directly approaching potential subjects in some cultures.
    • Additionally, it may not be appropriate to ask for a written consent. Citizens of counties with a history of government or police violence may feel uncomfortable signing any official documents. If written consent is not the norm in the country where the research will be conducted, investigators must request a waiver of documentation of consent in Section VII.D.16. Review the UI IRB Standard Operating Procedures and Researcher Guide (Section 2, Part 11.C) for more information regarding a waiver of documentation of consent.
  • Section X.4: The IRB will expect a thorough, detailed plan to protect subject privacy and confidentiality. Privacy protections protect the person, allowing them to keep personal information to themselves. Confidentiality protections protect data, including paper and electronic records and biospecimens. Describe how you will secure study materials while in the host country and when traveling back to the UI. Describe physical protections for any devices holding electronic data. In most cases, simply storing electronic data on a password-protected laptop is not adequate. Additional protections, such as encryption and uploading to UI managed servers (OneDrive), may be necessary depending on the sensitivity of data.  
    More information is available on the Data Security page.

Relevant Attachments to the HawkIRB Application

Additional attachment may be required for human subjects research conducted outside of the United States.

  • Local Ethics Committee Approval or Local Context Review: Investigators must attach documentation of either the in-country ethics committee submission and approval or a local context review in the ‘Miscellaneous’ section of the attachments page in the HawkIRB application. If a local ethics committee declines to review the study, the investigator must attach documentation of this decision. If any of this documentation is not written in English, the investigator must attach both the original document and the English translation of the document.
  • Letter of Agreement: Investigators must attach a letter of agreement from the organization or entity where they will conduct their research to the HawkIRB application, if applicable. If research is not conducted in a location that would require permission (such as a public space or in subject’s homes), the letter of agreement is not required.
  • Informed Consent Documents: Consent documents must be written in the language or dialect of the intended study population. Many countries speak different languages/dialects across regions, which means citizens in one area may not speak or read the country’s most common or “official” language. It is important to also consider the reading level of the potential participants. If literacy is low in the intended population, it may be more appropriate for the investigator to conduct a verbal consent process and use the IRB-approved consent document as the script.  It may also be appropriate given the context of the research and the cultural context to request a waiver of documentation of consent in the IRB application. Use the UI IRB Informed Consent Document, Consent Letter or Exempt Information Sheet, available on the Attachments page of the HawkIRB application.
  • English and Translated Versions of Attachments: The IRB must review all documents that subjects will see (e.g., recruitment materials, consent documents, data collection forms that will be completed by the subjects). This includes the English versions (that the IRB will use to review and approve the actual content) and the final, translated versions. At the time of the initial HawkIRB application submission, attach documents in English. After the IRB has reviewed the content of the attachments, and as the final step before the application is approved, the form will be returned through Workflow to attach translated versions of all pertinent study documents. Any documents that normally require the IRB approval stamp must include the approval stamp on the translated versions.

Collaboration with International Researchers and/or Institutions

When UI researchers collaborate with researchers in another country, the UI IRB oversees UI researcher activities and the in-country ethics board oversees the research activities of non-UI collaborators. The UI IRB does not rely on an international ethics board to oversee UI researchers. The HawkIRB application should only describe the research activities of UI researchers. Describe the collaboration in Section VII.A.

For multi-site research, collaborating international institutions, directly receiving federal funding must have a federalwide assurance. UI Investigators must provide documentation of the FWA and either the in-country IRB or ethics committee approval.