International Research Reviews

The IRB also reviews many projects that take place internationally, which have some special considerations. When doing international research (whether as a student or as faculty), it is important to begin the IRB process as soon as possible. If the research will be using study sites outside the U.S. then in most cases a letter of permission from each site is required. If there is no local IRB that will be reviewing the study, then a letter of cultural context may also be required. Additional information on both of these can be found in the links below. For international research, HIPAA rules will not apply unless identifiable data will be brought back to the US for analysis.

Local ethical approval for the research may be needed, and this can take quite a while in some cases. Please see our Policies and Procedures (PDF), in the chapter entitled "Local Research Context; Research Conducted At Non-Emory Sites" for more detailed information.

Q and A

QuestionsAnswers
Is the IRB submission and review process at Emory any different than it would be for a US-based study?In general, no. The eIRB application smart form is the same as it would be for a US-based study. There are, however, additional considerations that you must address in your protocol document. It might require additional language in the consent form as well. 
Are there any special protocol/consent templates for international research?No. You will need to tailor both document types to reflect the study as you will conduct it, but there are no separate templates specifically for use in international studies.
Do I need in-country IRB/Ethics Committee approval in addition to Emory IRB approval?

If you will conduct your study in collaboration with an in-country institution that has access to an IRB, they must approve the study before you can commence in-country study activities.

If you will conduct a study that includes any more-than-minimal risk activities, an in-country IRB or equivalent should approve the study before you can commence in-country study activities.

If you will conduct a clinical trial of a drug, device, or biologic, an in-country IRB must approve the study before you can commence in-country study activities.

If you will have no collaborators in-country that have their own IRB/Ethics Committee and there are no more-than-minimal risk activities, we can accept a letter of cultural context in lieu of local IRB approval.

What are the requirements of a letter of cultural context? Who needs to write it, and what do they need to state in the letter?Ideally, the author should be:

       i. Unengaged in the proposed study activities

       ii. Knowledgeable of the cultural landscape of the areas/populations being explored.

       iii. Experienced in conducting human subjects research in the proposed area.

       iv. An academic, health care provider, humanitarian organization administrator, educational administrator, or governmental official, but it should be someone with an intuitive connection to the population and concepts at hand.

The letter should be:

     i. On institutional letterhead if applicable

     ii. An attestation to the cultural appropriateness of the study protocol, processes, instruments, and consent forms. This is what we will use as our basis for our review of in-country study activities.

These letters are subject to review on case-by-case basis.

Template example of a cultural context letter 

If I will enroll non-English speakers, do I need to provide Emory IRB with translated consent documents, recruitment materials, and things like surveys/questionnaires/interview guides?

At initial review, we generally ask that study teams not yet submit translated consent documents, though it is fine to submit any translated recruitment materials and study instruments. It is likely that we will request revisions to consent forms, and this prevents having to translate the same document twice. Please note that we need English copies of all documents so that we can review them.

If the consent form was originally written in a non-English language, please translate it into English so we can review it and provide the English copy in the submission.

I will conduct my project in multiple countries. Do I need to provide IRB approval or cultural context letters for all involved countries?It depends, but if you will conduct a study that needs local IRB review according to the earlier question, you will need approval for every country in which you will conduct those applicable activities.
Nobody from the Emory study team will travel outside the US, and we will not interact with any participants. Do we still need in-country IRB approval/cultural context?It depends. If Emory is a grant awardee and we will sub-contract in-country personnel to conduct human subjects research activities, we would review the study as if we conducted them ourselves. If instead you will conduct a collaborative study where Emory does not fund in-country activities, we might need to review the study only for Emory personnel’s activities, and we would not need local IRB review/cultural context to conduct our portion of the study.
I or someone from my team will receive a grant/contract to perform a study. We will not interact/intervene with participants, but we will sub-contract collaborators to do so. Do I still need Emory IRB review?If the study qualifies as human subjects research, we will need both Emory IRB review and in-country IRB review.
I will conduct an analysis using data, including identifiers, from a non-US source. Does this qualify as “international research?”No. You do not need cultural context or in-country IRB review to conduct a secondary analysis of identifiable data collected outside the US.
I will conduct an online survey study that will include non-US respondents but is focused on a particular country or region. Do I need IRB approval/cultural context from all countries to be included?Yes. We can discuss if you feel like you cannot provide letters for all countries, but the expectation is that we you have every country covered by IRB approval or cultural context letter.
I will conduct an online survey study that will include non-US respondents but is NOT focused on any particular country or region. Do I need IRB approval/cultural context from all countries to be included?No
I am a native of the non-US country in which I propose to conduct research. Do I still need to provide in-country IRB approval/cultural context letter?Yes. We need an entity/someone not affiliated with the study or part of the study team to provide an unbiased characterization of the study activities and documents.
I will conduct my study on certain entities’ premises (schools, clinics, community orgs, businesses) or I will enroll their employees, patients, or students. Do I need “site permission” from an authoritative source at that entity?In most cases, yes. If you will enroll or conduct study activities at places like the ones listed above, we usually need to know that you have that place’s permission to conduct the study or enroll “their” people.
I will conduct my study in a setting where the concepts of permission, consent, and assent differ from those in the US. What do I need to consider?The concepts of minority vs. majority, personal consent, and assent can differ across cultures. Literacy levels and existence of multiple local languages can be important considerations as well. It is the researcher’s responsibility to learn the laws and customs regarding permission, consent, and assent. You should speak to these in the protocol and use them to justify any kind of consent/assent processes that differ from our usual processes.
My in-country enumerators/study team do not have reliable internet, or the CITI training is not provided in a language they can understand. Is there another option for human subjects research protections training? 

We suggest using FHI360, but we are open to discussions about other solutions if this does not work either: https://www.fhi360.org/expertise/ethical-standards-and-training/

I will conduct ethnographic participant observations, is this research?While projects in this field are often examinations of quite unique places and cultures, the work is usually done in order to gain knowledge about human behavior more generally, to generalize to a larger theory, or to contribute to the academic field. While many of these projects may meet the exempt review criteria, they usually require at least an initial IRB submission. Anthropological research can be a gray area. Some is like a case study (not “research”), but some explicitly develops generalizable knowledge (“research”) Use our determination tool or contact an IRB staff member to inquire.
While I am in country conducting my research activities, do I need to have any special licenses or registrations to conduct my study?Please contact Chris Rapalje in the Office of Global Strategy and Initiatives at  rapalje@emory.edu with any questions or if you need assistance with other aspects of your proposed international activity.
Do I need to consider Export Controls prior to traveling to the country I will conduct my research in?Export Control Assessment Form
I will enroll participants in Europe or China, or I will obtain data about persons living in Europe. Do I need to be concerned with GDPR or PIPL 21?
If you will obtain data from persons who live in the European Economic Area (EEA), the General Data Protection Regulation (GDPR) will apply. There are heavy restrictions upon collecting individual data in Europe, and you should familiarize yourself with what is allowed under the regulation.
If you will collect data from persons living in China, the Personal Information Protection Law of the People’s Republic of China (PIPL) will apply. Proper conduct of research under this law includes notifying participants that the Chinese government may have access to study records.

Other International Research Considerations:

Other laws and regulations, both U.S. and foreign, may apply to your international work. Completing the Export Control Assessment Form helps ensure compliance with rules related to sending materials and technology outside of the US or sharing information with foreign nationals. The International Project Review tool can help with other project planning and compliance-related considerations. 

Please contact Chris Rapalje in the Office of Global Strategy and Initiatives at christine.rapalje@emory.edu with any questions or if you need assistance with other aspects of your proposed international activity.

For Undergraduates: If your project involves travel abroad, and you will be receiving Emory funds and/or credit for it, your travel must be registered with Emory's Center for International Programs Abroad (CIPA).

Helpful Links: