Important Note: All IRB protocols for research to be conducted in a foreign country — including survey-only research — must include a completed international research addendum. The international research addendum is embedded in the initial protocol protocol.
Human subjects research conducted under the auspices of Brandeis University and in a foreign country must adhere to the applicable standards, policies, laws and norms of Brandeis University, the United States and the foreign country in which the research is to take place (the host country).
Just as Brandeis University requires approval from the Brandeis University Institutional Review Board, foreign countries often require approval from an IRB or ethics committee in their country. Many countries have a single IRB or ethics committee for the entire country, while other countries have many IRBs and ethics committees affiliated with many institutions scattered throughout the country, just as in the United States.
Many foreign countries use the same or similar standards as the United States (the Belmont Report, Common Rule and/or 45 CFR 46), and it is easy to dismiss the necessity of acquiring approval from the host country on these grounds. It is important, however, to recognize that similar standards do not equate to approval from both countries.
The Brandeis University IRB is not and cannot be familiar with the cultural norms, social mores and local laws of every country, which vary tremendously around the globe. The Brandeis University IRB may depend on the host country's IRB or ethics committee's knowledge, then, of what might put human subjects at risk in their particular country.
While it may be the case that the host country does not require approval from the/an IRB or ethics committee in their country, the Brandeis University IRB may still require that approval be obtained. In cases where the Brandeis University IRB does not feel competent in its ability to judge what might put human subjects at risk, not obtaining this approval could be detrimental to the human subjects.
Research studies supported by US federal funds require each international site engaged in research to undergo local IRB review by an Ethics committee that holds a Federal Wide Assurance (FWA). Investigators of US federally funded research studies can search the OHRP Database for Registered IORGs and IRBs, Approved FWAs and for Documents Received by OHRP in the Last 60 days to locate foreign IRBs that hold an FWA:
Non-federally funded studies can use this same search to locate and contact a foreign ethics committee/IRB.
It may also be the case that the host country has no official IRB or ethics committee. It is often necessary, in such situations, to obtain approval from local experts or leaders of the country or community in which the research will be conducted. It is important, however, that the individual(s) granting the approval be as independent as possible from the human subjects, as well as the research, to avoid the appearance of coercion or undue influence.
In addition, international laws and export controls regulations must be considered when conducting human subjects research abroad, as they may limit the movement of research data out of the country, both physically and electronically. The principal investigator must know the applicable laws and regulations of the country in which the research will be conducted before embarking on any research and, if needed, arrangements and agreements must be in place to ensure compliance.
Please Note: If research will be conducted in a language other than English, all translated materials, along with a translation certification, must be submitted to the IRB for approval prior to their use. Consider submitting your translated documents and certifications as a modification after the protocol has been approved, as documents often require revisions necessitating an updated certification along with the revised documents.
Things to Consider When Doing Research in Foreign Countries
Some insurance policies cover medical and evacuation services while abroad. If yours does not, consider purchasing additional coverage.
Unless you are conducting low-risk ethnographic research, it is generally important that both you and your subjects are fluent in any language(s) in which you interact. If you are not fluent, it can impact your recruitment of subjects, the informed consent process and your data.
Keep in mind that you will need to include all paperwork (recruitment materials, informed consent script/form, research instruments) in translation, as well as in English, in your Institutional Review Board protocol.
If neither you nor any researchers involved in your study are fluent in the language(s) of the host community, you may have to utilize interpreters. Do not rely on family members or friends of the subjects: hire a professional with whom you can discuss the study in detail. It is important that interpreters fully understand your research or they may not communicate the information accurately. In addition, it is important that the subjects feel comfortable answering and/or asking questions freely.
Example: You are conducting research in a language you do not speak and ask a subject's daughter to interpret, which she agrees to do. The daughter is not familiar with your research and does not understand all the terminology, but is anxious to be done so does not ask for clarification. In addition, your subject finds some of your questions embarrassing to answer through her daughter and does not give complete answers.
Conducting international research can be complicated, and collaborating with researchers at a local institution can be extremely helpful. For example, a local collaborator may know from whom to get local IRB approval (perhaps through his/her institution) and be able to facilitate the process, which could be daunting to a foreign researcher. In addition, a local collaborator can help with cultural nuances that may have implications for your research — or for you.
Example: You are a sociologist planning to conduct research in a country with one national institutional review board. You carefully prepare and submit your IRB protocol, only to be told by the IRB it is interested in reviewing protocols for clinical studies only and will not review a protocol for social scientific research.
Many cultural differences are obvious and/or easy to ascertain by the researcher. However, if you are not already acquainted with the culture of your host community, it is easy to make assumptions about similarities between their culture and yours. You must be extremely vigilant and make no assumptions, as they can put your subjects at greater risk.
Example: You are conducting research in a community that has recently undergone a natural disaster. You are prepared for your subjects to be emotional and obviously traumatized by the events; however, the culture in which you are working regards displays of emotion negatively. Because your subjects do not display signs of traumatization as you understand it, your questions dig deeper than they would otherwise have and your lack of understanding may, in fact, traumatize your subjects further.
To engage in research in a foreign country or community, you must understand the context in which you will be conducting the research. For example, if the community has recently been through a natural disaster or war, there may be additional psychological, political or legal risks to be considered.
Example: You are conducting research in a country that has recently been at war. They do not have good internet connectivity and you are unable to store your data in the cloud. You are interested in the effects the war has had on the poor — those on whom the war has had the biggest impact. Your subjects answer your questions and then share with you that they believe the government is corrupt, but that they cannot speak out without serious consequences. As you attempt to leave the country, you are accused of being a spy and your computer is confiscated.
It is easy to assume that the laws you are familiar with — the laws of the United States — will apply to your international research. Be sure to familiarize yourself with the local, state and national laws that may pertain to your research in any way.
Example: In Massachusetts — in fact, in the majority of states and countries around the globe — the age of majority is 18; however, you are working in a country in which the age at which individuals may consent to participate in research is 16. Your 16- and 17-year-old prospective subjects may feel insulted if you ask their parents for consent. Alternatively, you may be breaking the law if you do not obtain parental consent for your 18- to 20-year-old prospective subjects if the age of majority in the country in which you are conducting your research is 21.
If your research is being conducted in, or if you are transferring data from, at least one European Union or other European Economic Area state, your research may be subject to the General Data Protection Regulation (GDPR).
For information on the requirements of the GDPR, see What Investigators Need to Know About the GDPR and/or contact the HRPP office.
Current European Union states include Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
Current European Economic Area states include Iceland, Liechtenstein and Norway.
Be aware that, as is the case with research involving children, there are many societies and communities in which consent must first be obtained from someone other than your prospective research subject.
Example: You are conducting research in a remote village, where you find prospective subjects to be polite but reticent to answer questions relating to your research. You mention the difficulty you are having to a colleague who has conducted research in the village previously. Your colleague asks whether you discussed the research first with the village elders and explains that the villagers will only participate in research the village elders have approved.
Note that consent in such cases does not take the place of the subject's own voluntary informed participation — every prospective subject must also then be given the opportunity to give or refuse to give their informed consent to participate in the research.
While obtaining documented informed consent is the default expectation, it may not be realistic or culturally appropriate in all environments. In these cases, you will need to obtain oral consent and request a waiver of documented informed consent in your IRB protocol.
Example: You are conducting research in a society with no written language, making obtaining written informed consent impossible, or in a culture where verbal contracts are considered sufficient, and where requesting a signature is insulting.
Will your subjects be able to read your consent documents/information sheets and/or research instruments?
Example: You are working within a community with a low literacy rate; some subjects may have difficulty reading your informed consent form and/or research instruments, but may not inform you of this because they do not want to disappoint you, the investigator.
Coercion is the overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.
Example: You are conducting medical research and tell your prospective subjects that they will be denied treatment if they do not participate in your research.
The appearance of coercion can exist when investigators may not feel that they are threatening harm, but when the prospective subjects are put into a situation in which they may feel threatened if they do not participate in the research.
Example: You are conducting research in a community for which prior consent from the community leader or council of elders must be obtained. Prospective subjects may feel that this consent to proceed with the research implies that community members are required to participate.
When providing compensation to subjects for participating in your research, you must be careful of the potential for unduly influencing prospective subjects with excessive or inappropriate remuneration. The value of the compensation must be appropriate to both the subjects' participation and the local economy.
Example: You are conducting research for which subjects must participate in a two-hour interview, and you are offering the equivalent in local currency of $25 as compensation. In the United States, this may be appropriate (compensating your subjects at a rate of $12.50/hour); however, in many countries $25 may be worth a week's or even a month's pay, making it extremely difficult for the prospective subjects to decline participation.