IRB Guidance: International Research

This page outlines special considerations regarding international research.

International research can pose unique risks, specifically concerning the political, cultural or economic conditions of the research site, and the increased risk of traveling with research data. 

Risk
Identifying some element of risk associated with the research does not mean that it cannot be approved by the IRB. As most international research does pose some (minimal) risks to participants, it is important to identify those risks thoroughly - on both the protocol and consent documents - and describe the steps that the researcher will take to mitigate those risks.

Even if the research will be conducted by a graduate student, it is the expectation of the IRB that the PI will have reviewed and addressed the international aspects of the study, and in particular, any potential risks to participants.

Data Security
Provide details as to how the researcher(s) plan to protect the data while on site and during travel back to the US.  Address the storage and security of electronic data as well as any physical data, such as paper consent forms or surveys. It is likely that the IRB will request that all data be encrypted or be uploaded to a campus-approved site, such as a UW-Madison Box account, and then deleted from the physical site, hard drive, laptop, etc. 

Translations
All documents/instruments must be submitted to the IRB in English as well as in the language that they will be used. This includes consent forms, recruitment scripts, interview scripts, and surveys. Please note, the English versions may need edits, thus, translated documents can be provided after English versions have been reviewed.

On Site Personnel
All study team members, including personnel from outside the US, are required to have completed human subjects research training and be listed in the protocol application before engaging in any research activity (recruitment, consenting, data collection, answering questions, data analysis, etc.). Research assistants or other personnel hired at the site, possibly including translators, are considered non-UW collaborators on the study and must be added to the protocol by indicating in the application that the study is multi-site. Under certain unique international circumstances, it may be necessary for the Study Team to contact the IRB office to discuss human subjects research training for international personnel. If it is the intention of the study team to submit a New Change to add local personnel at a later date, this should be clearly outlined in the protocol application.

A local contact is generally required on consent documents.  This person should be someone who is willing to relay any questions that may come up after the researcher has left the region.  This contact, if not otherwise engaged in research activities, does not need to be listed on the study team. In situations where the researcher feels that, given the local context, a local contact is not a necessary step to protect the rights and welfare of participants (for example, benign study procedures that take place in a region where the general population all have cell phone coverage, internet access, etc.), it is the researchers responsibility to provide that justification as part of the application.

International IRB
If there is an IRB or ethics committee in the country, or at a collaborating institution, where the research will be conducted, 
AND review by that IRB/committee is required, please submit a copy of the approval with your protocol.

If there is no local IRB, site permission documentation may be required from a person with the authority to approve research at their site.

Informed consent
Consideration should be given to the most appropriate method of obtaining informed consent including:
  • Literacy level;
  • Confidentiality concerns; 
  • Cultural considerations.
In some cases, a waiver of documentation of written consent (oral consent and/or an information sheet) may be more appropriate. It is the responsibility of the researcher to provide an appropriate justification for any waivers of a written consent process. However, if the researcher intends to use identifiable information about the subject such as name, photos, or video, then documented consent will likely be required.

Consent should generally be obtained in the native language of the participants.

Be sure to include the following in the the protocol application:
  • Details about the political, social, cultural and economic environment, which will give the reviewer(s) a sense of how knowledgeable the study team is about the region of the world where the research is taking place;
  • Details about the source(s) of information that the researcher used to respond to the questions specific to international research.  For example, personal experience in the region, contacts on campus, or sources at the site.
Review & Timing
International research may require review by the Full IRB.  The IRB may also use consultants to ensure appropriate expertise when reviewing international projects.  Allow plenty of time for IRB review and approval. Protocol applications are often sent back to the researcher for modifications before final approval is granted.



Keywords:international, abroad, travel, local contact   Doc ID:42379
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-07-31 07:30 CSTUpdated:2018-09-28 13:42 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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