IRB Review of International Research
Research conducted by University investigators in foreign countries remains under University purview and guidelines.
We do not relax our standards for ethical conduct of research or for a meaningful consent process for research that will be done outside the United States.
When drafting written consent documents or proposing alternative consent formats, special attention should be given to local customs and to local cultural and religious norms.
If the research includes enrollment of children in other countries, the principal investigator is responsible for providing the IRB with sufficient information to verify the age at which participants in such jurisdictions have the ability to consent to participation in research.
In some instances it may be appropriate for the IRB to waive some or all requirements for written consent.
Research proposals for which this may be reasonable should include explanations of cultural norms or conditions that would justify a waiver (eg. societies where no written language is used, societies where signatures represent the surrender of spirit or soul to the researcher).
You must consider what data security protections should be in place and are allowed in the localities to which you will be traveling. Here are tips on collecting, transmitting, and storing research data securely:
• Take steps to protect from loss from theft or otherwise, any electronic devices or documents that might have participant data.
• Understand export and customs laws that govern computing devices and data in the country, and those of any country through which you will be passing; and take steps to manage and protect your data in compliance with those requirements. For tips from UChicago’s IT Services on using electronic devices safely and productively while traveling, see https://uchicago.service-now.com/it?id=kb_article&sys_id=4004ba4d1327be0027255eff3244b0d3
B. To prevent the possibility of data loss of paper files, field notes, recordings, or other records:
• Transcribe and electronically store notes as quickly as possible.
• Keep a back‐up copy of the electronic files in UChicago Box (with restricted
We recommend that you create any UChicago Box folders needed for your research and share them as needed with research colleagues (e.g., your faculty advisor) before you leave the United States. Review folder security settings to be sure that data stored there is only shared as you intend.
UChicago Box is free to UChicago personnel. For more information on UChicago Box, see https://uchicago.service-now.com/it?id=kb_article&sys_id=54d64a921387760027255eff3244b0a6
C. To prevent exposure of data that was obtained under a promise of confidentiality:
• Collect the minimum amount of identifiable data needed
• Use systems to mask the identities of participants
• Minimize the number of local research staff members who have access to identifiable data
• Transcribe, encrypt, and electronically store notes as quickly as possible and destroy physical files if possible. Otherwise keep them secure under your control.
• Protect computers and all electronic devices, and individual files, with ‘complex’ passwords. Guidance on creating good passwords is available at https://answers.uchicago.edu/page.php?id=16276
• Encrypt all data -- see information about encryption methods on the IT Services website at https://uchicago.service-now.com/it?id=kb_article&sys_id=0a28651edb188b00432f7f8cbf961906 If you do not have full disk or device-level encryption enabled, and you will be storing sensitive research data in Microsoft Word or Excel files, use Word or Excel to encrypt those individual files.
· Do not store identifiable data in personal Cloud file share services
· Do not transmit identifiable data via e‐mail
· Store identifiable data on mobile devices only when the device is encrypted and only as long as it takes to access a secure internet connection and upload encrypted data to UChicago Box
· Always upload to UChicago Box and erase files from mobile devices before crossing international borders
NOTE: UChicago Box can be used to store student education records (FERPA) data. UChicago Box cannot be used to store Patient Health Information (PHI), or Credit Card or Payment Card Industry (PCI) data.
Helpful information on traveling abroad is also available on the UChicago International Travel Resources webpage at http://internationaltravel.uchicago.edu/
NOTE: Special rules apply to travel and other transactions related to Cuba, Iran, North Korea, the Republic of the Sudan (aka “North Sudan”) or Syria. For further information, see the UChicago Memo on Export Controls and International Travel at https://uchicago.app.box.com/s/1sehc56ug4j3w75k8sb2y72923ptmhmn
Useful Links to Information about Doing International Research
HHS Office for Human Research Protections International Compilation of Human Research Standards: http://www.hhs.gov/ohrp/international/
OHRP Listing of Social-Behavioral Research Standards: https://www.hhs.gov/ohrp/international/social-behavioral-research-standards/index.html
University of Michigan International Human Subjects Research Resources: http://www.hrpp.umich.edu/policies/international.html
Ethical Approaches to Gathering Information from Children and Adolescents in International Settings: Guidelines and Resources: http://www.popcouncil.org/uploads/pdfs/horizons/childrenethics.pdf