International research poses unique and complex ethical challenges. To review a study that is being conducted in an international setting and/or with international participants, the IRB HSR requires additional information about the study and its participants. Although we work to maintain a Board with a broad range of expertise, it is impossible to cover the diverse groups that are studied by our researchers. It is important to provide the IRB HSR with more details about the participants, appropriately identify risks to the participants, and describe how you will minimize those risks. Doing so will help the IRB HSR to accurately review your study and will demonstrate your preparedness for conducting your study. This section details specific information the IRB HSR needs to know as well as provides guidance for navigating and conducting research in an international setting and/or with international participants
- You must obtain IRB approval before your study can begin. Whether you are a UVA faculty member, staff or student, your research study must be approved by the IRB before it can begin. To reduce confusion, make sure you have the IRB's approval before you leave the country. We suggest you apply to the IRB at least 3-6 months before you leave to ensure adequate time for reviews. Bring your written IRB approval with you on your trip.
- Demonstrate cultural understanding and sensitivity. Is the typical process of signing an informed consent document culturally acceptable for your study? Are there other cultural barriers you might encounter once you arrive? The protocol should describe any anticipated cultural sensitivities of conducting your research and how you intend to overcome those barriers. The IRB will help you develop alternative methods for consent (or other issues) to ensure your research practices are ethically sound and respectful of the culture in which you are doing your research.
- Understand the research ethics guidelines of the host country. Investigators will be required to obtain IRB approval for research done internationally from the UVA IRB as well as from the local IRB/Ethics Committee within the country in which you will be doing your research. The approval from the local IRB/Ethics committee must be on file with the UVA IRB prior to the UVA IRB granting approval. The IRB strongly recommends you clearly understand the host country's requirements for reviewing and approving human subject research. Some countries have clear ethical guidelines that must be met for conducting domestic and/or international research. Other countries will not have a formal process but might rely on other neighboring countries to assist with the review. The Office for Human Research Protections (OHRP) has information on over 133 countries regarding their expectations for ethical committee review as well as information about human subject research laws. See the OHRP International Compilation of Human Research Standards for more resources on researching your international location. If you determine that you will need a local IRB/ethical committee review, you will need to provide the UVA IRB HSR with contact information for the other IRB as well as documentation of their approval.
- Please contact the IRB while abroad if you encounter any problems or need to change your IRB-approved protocol. If you find that upon arrival in the host country, some aspects of your research study must be modified for whatever reason, please notify the IRB office immediately. The IRB will do its best to quickly respond to your notification with further instructions and guidance. Please wait to hear back from the IRB before making any changes to your protocol!
Additional items to consider:
Traditionally, international research involves the researcher flying to a distant location to gather data from participants in that country. While those studies are still an important part of international research, it is possible to conduct international research and stay in Charlottesville as well. If your study includes any of the following, you will need to create at least one International Research Data Source:
- International Primary data source: data are collected by the principal investigator and/or the research team, and data are collected outside of the United States.
- International Secondary data source: data are collected by an individual or institution other than the principal investigator and/or research team, and data are collected outside of the United States.
If you are conducting the research in multiple international locations, particularly if the locations involve multiple IRB reviews and/or local researcher/mentors, please make this distinction in your IRB-HSR protocol/application.
Questions to Consider
Location
The location can be specific or broad, as needed (i.e. Munich, Germany vs Europe) as long as it makes sense with the study. If the study takes place in multiple locations, consider making multiple International Research Data Sources.
Is there a local researcher or local mentor associated with this site?
If you are student researcher (undergraduate/graduate) the board expects you to have a qualified local researcher or mentor who can guide you through the nuances of collecting data in your international location. This individual should be qualified to advise you about local customs, laws, and expectations regarding research, recruitment and consent processes, ethical reviews, and data collection/storage. If you are accessing data from an international source and not traveling abroad, there may be some instances in which a faculty sponsor with adequate experience can act as the “local mentor,” but you should contact our office first before making this determination. The local mentor should be listed on the protocol and needs to have CITI training or an equivalent human subject’s research training certification. Faculty are not required to have a local mentor.
Will you require a translator to interact with participants?
If you are conducting a study where the participants speak a language other than English and you are not fluent in the language, you will need a translator. When determining fluency, you should verify that your language skills are adequate for the technical information you will provide participants. For example, you may feel confident discussing weather or even politics, but do you feel confident that you can discuss the concepts in the consent form at a level that makes sense to the participants in their native language? In addition, are you confident that you can write appropriate recruitment and consent form materials? If not, you should have a translator.
Are recruitment/consent materials required for this site? / Will recruitment/consent materials be provided in a language other than English?
Briefly describe the process for translating the recruitment and consent materials. This may be somewhat redundant if you have already discussed use of a translator, but it is important for the board to understand this process as not all studies engage a translator.
GDPR - General Data Protection Regulation
If your study will take place in the European Union or United Kingdom or uses data from citizens of those regions, your study will be subject to the GDPR. Please review the GDPR section and access the GDPR Informed Consent Addendum to include with your consent materials at the time of initial review or with a modification.
GDPR applies to select data when collected from individuals located in the European Economic Area (EEA) and/or the United Kingdom (UK). GDPR regulates the collection, use, disclosure, or other processing of personal data. If you are collecting personal data in the EEA or UK, or if your participants reside in those areas, you are subject to the GDPR. If your participants are EEA or UK subjects but are outside of the EEA or UK when the data collection occurs, the data collected is not subject to the GDPR.
While many of the US federal regulations mirror the requirements in the GDPR, the GDPR requires researchers to provide additional consent form content and conduct specific processes related to data collection. While this section and the GDPR Informed Consent Addendum provides some guidance on what is required under the GDPR, please note that individual countries may have varied interpretations, etc. It is important that you familiarize yourself with the laws and regulations of the country(ies) in which you will conduct research and seek counsel if needed. Again, please refer to the OHRP International Compilation of Human Research Standards which provides a compilation of information on the GDPR and how it is interpreted in various countries. You will want to use the GDPR Informed Consent Addendum to ensure that you have provided participants with the appropriate information required by the GDPR.
Useful Website Links:
Consent Form Template for International Research
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
NIH: Global Clinical Regulations
International Compilation of Human Subject Protections
Harvard Global Research Ethics Map
Center for Global Health Opportunities
CITI Module
International Studies (ID 971)
Version Date 02-02-22