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:
Choose the "FWAs" tab
Press the “Advanced Search” link
Select the appropriate country & Search
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.