Local Context for International Research

When reviewing international research, the IRB is expected to obtain sufficient knowledge of the local context where the research will take place, including relevant laws and regulations. All international data collection requires consideration of any political, legal, and cultural considerations specific to the study under review.

  • Review the KSU European Union (EU) General Data Protection Regulation (GDPR) to determine if the country in which you will be conducting your research is involved. The Kennesaw State University EU General Data Protection Regulation Compliance Policy can be found in the KSU Policy Portal.

  • The IRB application should include a statement by the researcher that the GDPR has been reviewed, including whether the regulations apply. If the regulations do apply to your research, the application will need to include information relating to compliance with the provisions of the policy.

  • Review the International Compilation of Human Research Standards document (posted on the U.S. Dept. of Health & Human Services, Office for Human Research Protections website) in order to determine if there are specific procedures that you must follow for the country in which you will be conducting your research. The IRB application should include a statement by the researcher that the International Compilation of Human Research Standards document has been reviewed, including information on how any relevant standards are being met.

  • Documentation of “local approval” may be required when submitting KSU’s IRB application. IRBs may rely on researchers to provide essential information about the local research context.

Risk Level Identification from the Host Country

If the research presents no more than minimal risk to participants, a written statement from a local expert or community leader may suffice. This individual must be able to attest to the host country’s standards for human subject research protection and must confirm that the IRB protocol conforms to these standards.

If the research involves more than minimal risk to participants, all possible efforts must be made to confirm if a local IRB or ethics board/committee is available in the country where the research will take place. The approval letter from this body is required as an attachment to the IRB application.

If such a committee does not exist, a written statement from an individual who has the authority to ascertain that the research is ethical/acceptable within the context of that country’s culture must be obtained and reviewed by the IRB.

Other Points To Consider

  • The assessment of risk levels should be based on the cultural context.

  • Researchers need to have sufficient knowledge of the local context (laws, regulations, culture, and political and socio-economic factors) to enable the design and conduct of the research in ways that protect the rights and welfare of subjects. It is recommended that a local collaborator be included on the research team to ensure that the design and conduct of the research conforms to local regulations/customs.

  • Researchers should designate a contact within the country that would be available to speak to subjects as necessary about the research.

  • Researchers must provide a description of how data collected will be stored in the international location and how it will be transported to KSU. Also, researchers should be familiar with export control regulations.

  • IRB applications should provide a description of how the faculty sponsor will oversee the conduct of international research conducted by students.

  • Be prepared to provide the IRB with translations of your consent documents. (This may be provided after documents have been finalized following the review process.)

IRB review standards are based on federal regulations and guidelines.