In order to review a study that is being conducted in an international setting and/or with international participants, the Board 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 Board 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 Board to accurately review your study and will demonstrate your preparedness for conducting your study. This section details specific information the Board needs to know as well as provides guidance for navigating conducting research in an international setting and/or with international participants.
An international setting involves any location outside of the legal jurisdiction of the United States. An international population could be a tight-knit community living within the borders of the U.S., such as the Hmong, or a broader group such as non-native Latinos. These groups generally have (though are not limited to) a distinct cultural identity that is different from mainstream American culture, speak a different language, and in some cases may not be U.S. citizens or could be undocumented.
If you are conducting a study in another country, it is important that you understand the legal implications of your study and how they might affect your participants. If you are collecting information about illegal behaviors, you need to understand what power the government has to take this information from you and use it against your participant. If this is an issue, participants need sufficient warning. In some cases, it may be necessary to waive documenting consent in order to protect a participant’s identity. Some participants may have a delicate political position because of refugee status or opposition to current political powers. It is important to understand how your involvement with the participants will affect their political standing, which can often impact personal well-being, employment status, etc. It is also important to investigate any laws that might affect how you should conduct your study. For example, in the U.S., there are specific laws governing how medical records and student records can be used by researchers. Similar laws may apply in other countries as well. As another example, the definition of a minor (i.e. child unable to legally consent) varies in different countries and even in the different U.S. states. You will be obligated to follow the local laws for the location in which you conduct your study and it is important that you are familiar with any laws that are pertinent to your study.
International participants may have different perspectives on legal documents, consent forms, etc, and may be wary of signing a consent form, whether of whether an actual risk exists. Documents like consent forms that appear to be legal in nature may be inappropriate in some cultural contexts. Although the Board has some restrictions on what it can allow, they will consider alternative consent scenarios that are culturally appropriate. For more information, see Oral Consent.
When writing your protocol, describe your procedures and then explain why they are culturally appropriate. For example, if you are using an oral consent process, explain why it is culturally appropriate for you to do so (i.e. the participants are offended when approached with a form, it is more appropriate to talk to them casually first before talking about the research process). This information will help the Board to understand the cultural environment in which you are working and will demonstrate to them that you are prepared to go forward.
In addition to understanding the local legal ramifications of your study and the cultural context, you will need to investigate the local IRB requirements. The IRB-SBS expects international participants to be treated the same as participants from the US and we review a protocol as such. However, our review does not supercede the authority of an IRB that governs an international location; depending on the circumstances of your study, you may be subject to both the UVA IRB-SBS review and a local IRB review as well. For more resources on international human subjects regulations, see International from OHRP's website (check out the Listings of Social-Behavioral Research Standards specifically).
The Board expects you to provide the participants with a consent process that is in their native language (or the language in which they usually read and converse). This includes not only providing a consent document written in the participant’s language but also providing a translator that the participant can talk to if he or she has questions if you are not able to speak the language sufficiently. The translator will be considered part of the research team and is obligated to follow the protocol for protecting confidentiality. In some situations, the Board may require a separate consent process for the translator.
In order for a participant to be informed, it is necessary that the consent process be conducted in a language the participant can understand. If you anticipate recruiting non-English speaking participants, the Board asks that you provide a version of the consent form in the language that is appropriate for the participants, as well as arrange for an individual who can talk with the participants (if you do not speak the language). The interpreter must understand confidentiality issues and should be a trusted member of the research team.
As stated in the "Legal Preparedness" section, consent forms may not be appropriate for some international settings and it may be more appropriate to use an oral consent procedure. For more information, see Oral Consent.
In the consent templates, we ask that you provide the participant with your contact information as well as the IRB-SBS contact information. Depending on your location and population, it may not be feasible or realistic for your participants to contact our IRB if they have questions. Thus it is important for you to provide a local contact who can be available to answer questions and provide support if a problem should arise. For undergraduate and graduate students, this person can be your local advisor (please note that you are required to have a local advisor when you are conducting a study abroad. Please see Student Researchers for more information). Other options may include (but are not limited to) a qualified individual in a local research facility, IRB, or hospital.