Version Date: August 15, 2010
Guidelines and considerations for researchers submitting IRB applications that involve sites outside the United States
Study teams should allow additional time for IRB review for studies involving site or personnel outside the United States, as these projects may require additional expert opinion, obtaining documentation of the qualifications of the individuals responsible for the translation of consent documents, and obtaining of documentation of review by an IRB or ethics committee in the country in which the research will be conducted.
- Investigators who intend to conduct international research should allow additional time for IRB review, as these projects usually require the IRB to obtain additional expert opinion regarding the culture in which the research will be conducted. In addition, the investigator generally will be asked to provide the IRB with documentation of the following:
- Review and approval by an IRB or ethics committee in the country in which the research will be conducted (a list of registered international IRB’s may be found on the OHRP web site. NOTE: UW-Madison will often not be able to serve as IRB of record for sites or personnel in countries outside the US.
- Letters of support from the appropriate official at the sites involved.
- A list of all personnel who will be engaged in human subjects research that indicates the role each person performs related to the research study should be clearly outlined in the application. Note: All key personnel are expected to complete the UW online human subjects protection training module or its equivalent. If an equivalent program will be used, this alternative should be described in some detail in the IRB application.
- The qualifications of the individuals responsible for the translation of consent documents.
- In the case of federally funded international research, investigators are required to ensure that any site at which the research is conducted has a current Federalwide Assurance (FWA) in place per Department of Health and Human Services requirements.
- In the IRB submission that describes research in a foreign country, the researcher should provide the IRB with sufficient background regarding the country and culture in which the research will be conducted so that it can determine:
- Whether the rationale for conducting the research in that context is adequate (e.g., researchers should indicate why the international site has been chosen rather than a domestic site).
- The nature and degree of risks, especially psychosocial, posed by the research.
- Whether the cultural, economic, or political conditions of the country or countries in which the research may be conducted would alter the risk for participants compared to the same research conducted within the U.S.
- How risks to subjects have been adequately minimized.
- Whether an IRB or Ethics Committee within the country in which the research will occur has reviewed the protocol.
- the consent process is appropriate for the research context and allows subjects to provide voluntary informed consent.
- If any remuneration is provided to subjects for their participation what the economic or social value of such would be to the subjects.
- The investigator should describe the consent process in the IRB application in detail. Some aspects of the consent process to consider when preparing your IRB application include:
- Ensure a copy of the proposed consent form or oral consent script is included with the application. Translated consent forms or consent scripts are not needed until the IRB has approved the English version of these documents because the IRB may require revisions to these documents. A translated version of the finalized documents can be provided to the IRB either in response to any modification requests the IRB has required or as an expedited change after IRB approval has been finalized.
- Describe who will translate any study documents, including consent forms and oral consent scripts, and their qualifications.
- Provide a detailed description of the consent process, including who will conduct the consent process and the training they will receive to obtain informed consent. The consent process should take into consideration the literacy level of the subjects and confidentiality concerns. In some cases, oral consent may be more appropriate than written consent because signing a consent form would put the participants at greater risk. Consent should always be obtained in the native language of the participants.
- The consent process must ensure participants are provided with local contacts for (1) someone representing the research team who can answer their questions and (2) someone outside the research team who can answer questions about participants’ rights as research subjects or to whom they can express concerns or complaints about the research (this can be an email address if participants are likely to have such access). In some cases the participants may have access to computers and an email address may be an acceptable method for them to communicate with the research team or the IRB in Madison. If the subjects do not have access to telephones or email, if they do not have the financial resources to make an international call, or if they do not speak English, it may not be helpful to provide the name and phone number for contacts in Madison. In those cases, providing the name and contact information for a person or organization in the location where the research will be conducted may be the best thing for subjects. This local contact must be willing to relay questions or complaints from subjects to the PI or the IRB and should be a stable person or organization that will be easily available to subjects.
Note: Research studies that fall under VA purview and will be conducted at international sites (i.e., sites not within the United States, its territories, or Commonwealths) or involve biological specimens or human data originating from international sites require permission from CRADO before the research is conducted. Multi-site trials must adhere to this requirement if the study is sponsored by the VA, the VA functions as the coordinating center, the VA subcontracts to an international site, or the principal investigator for the overall project is a VA investigator.