{"id":18736,"date":"2017-05-04T10:06:09","date_gmt":"2017-05-04T17:06:09","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=18736"},"modified":"2025-05-01T07:14:21","modified_gmt":"2025-05-01T14:14:21","slug":"international-research","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/international-research\/","title":{"rendered":"International Research"},"content":{"rendered":"
This web page provides guidance to researchers conducting international research and alerts investigators to the additional review requirements and considerations for such activities when the 91探花IRB is the IRB of record.<\/p>\n
All human subjects research conducted by 91探花 faculty, staff, or students regardless of funding source or research location, requires prospective submission to the 91探花IRB or reliance on another domestic or commercial IRB for the engagement<\/a> of the UW. 91探花does not rely on international IRBs.<\/p>\n Per HSD policy<\/strong>, for projects with an international component, 91探花IRB reviews all activities for the proposed research project, including those conducted at international sites, that the 91探花is engaged in. For the international sites, as a courtesy the 91探花IRB generally reviews the in-country protocol to ensure it complies with U.S. regulations. Additional review by a local “in country” IRB is usually required per local regulations and the local IRB is responsible for reviewing the study for compliance with local regulations. Local review boards may be referred to as an Institutional Review Board (IRB), an Independent Ethics Committee (IEC), an Ethical Review Board (ERB) or Research Ethics Board (REB). In other words, international projects generally have review by two or more IRBs.<\/p>\n International sites are excluded from the Single IRB mandate<\/a>. This means that international sites would not be required to rely on a Single IRB. If the 91探花IRB will be the IRB of record for all the domestic sites in a project, you should obtain IRB review of the international components as described in this guidance. If all the domestic sites will be reviewed by a non- 91探花IRB, you should obtain IRB review of the international components as described in that non- 91探花IRB\u2019s policies and procedures relating to international research. However, if the non- 91探花IRB will not review the international aspects of the study for compliance with U.S. regulations the 91探花IRB can review the international aspects for compliance with the U.S. regulations as a courtesy for 91探花investigators. <\/p>\n You should follow that IRB’s policies and procedures about the IRB review of international research. However, if the external IRB will not review the international aspects of the study for compliance with U.S. regulations the 91探花IRB can review the international aspects for compliance with the U.S. regulations as a courtesy for 91探花investigators.<\/p>\n The 91探花 IRB applies the U.S. “Common Rule” human subjects regulations (i.e., 45 CFR 46) to all projects, international and domestic, except as allowed by the HSD Flexibility Policy (GUIDANCE Authority and Responsibilities of HSD and 91探花IRB<\/a>). Other U.S. regulations are applied as required (e.g., FDA, EPA, DoD). The IRB applies the same ethical and regulatory standards to international research as to domestic research as well as the same 91探花policies and procedures for the conduct of research. This is separate, and in addition to any regulatory or other reviews (e.g., local IRB, government agency) required at the location where research is conducted.<\/p>\n When research is conducted outside the United States, investigators must comply with both the U.S. regulations and with the local policies, permissions and regulations governing the international research site.<\/p>\n It can take time to identify and navigate the local requirements. If possible, enlist a local collaborator to help you address that site’s requirements and assist in identifying who to contact and what is required to obtain ethics reviews and permissions to conduct research at that international site.<\/p>\n Investigators can begin to educate themselves about applicable foreign research regulations for a specific country with the resources below:<\/p>\n Investigators are strongly encouraged to collaborate with an individual or organization with expertise in the region. This collaboration will greatly assist in identifying appropriate research sites, navigating the local regulations and policies, understanding culture, local infrastructure, overcoming language barriers and increasing community partnership.<\/p>\n Based on study location and risk level, the IRB may require<\/strong> documentation of a local site collaborator. This may be necessary to ensure the project meets the IRB approval criteria related to adequate resources and expertise, appropriate subject protections, and an adequate consent process.<\/p>\n There may be no local functioning review board. In these circumstances the 91探花IRB may require, depending upon study location and risk level, a letter of cooperation or permission from an appropriate local institutional or oversight official. This is sometimes called site permission<\/em> or a letter of invitation<\/em>. This letter needs to be written by an individual completely independent of your study<\/strong> who is highly familiar with the culture of the region where the research will be conducted. Required elements:<\/p>\n If the research is funded by the U.S. government, then each foreign institution that is engaged<\/a> in the research must hold and\/or obtain a valid Federal Wide Assurance (FWA) with OHRP and these institutions must review and conduct research in compliance with the applicable U.S. federal regulations. The 91探花investigator is responsible for ensuring that all engaged international sites hold an FWA and that the research is approved by an IRB or Ethics Committee.<\/p>\n These are common examples of when an institution is “engaged” in human research:<\/p>\n Information on FWAs can be found at OHRP’s Register IRBs & Obtain FWAs<\/a> page.<\/p>\n Issues of engagement, FWAs, and local site requirements can be complex. Please contact hsdinfo@uw.edu<\/a> if you have specific questions or concerns.<\/p>\n Researchers must have a plan to manage communications with non-English-speaking participants during all phases of study participation. Because participants may have questions or concerns at any time, investigators must be prepared to manage communication beyond the consent process and data collection.<\/p>\n Review the section on\u00a0Anticipated involvement of subjects with limited English proficiency<\/a> in HSD’s Consent\u00a0guidance for full details.<\/p>\n Researchers should first find out whether the laws and regulations of the foreign country permit research participants to receive gifts or monetary compensation for research participation. If yes, researchers must describe in their 91探花IRB application the planned amount of compensation in both 91探花and foreign currency. To prevent undue influence from inappropriately high levels of compensation, as well as inappropriately low levels of compensation, information about the average daily wage in the country must also be provided. For more information, review HSD’s guidance on Subject Payment<\/a>.<\/p>\n “Local context” means information about the local regulations, policies, relevant cultural norms, and relevant local cultural\/religious\/social sensitivities. The 91探花IRB must be provided with sufficient knowledge about the local research context to ensure that adequate protections are in place and ethical research conduct occurs in that geographic location. Local context information is provided to the IRB in the IRB Protocol form<\/a>.<\/p>\n Researchers are strongly encouraged to collaborate with an individual or organization with expertise in this topic.<\/p>\n Some countries place restrictions on bringing identifiable data into\/out of the country. The European Union, for example, has laws surrounding what kind of identifiable information can be provided by participants in Europe and brought to the United States. Data export laws and U.S. export control laws [https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/compliance-requirements-non-financial\/export-control-measures\/<\/a>] may also affect your research in countries with which the U.S. has embargoes or trade restrictions, such as Iran. These laws may also affect which technology you can bring into the country.<\/p>\n U.S. federal Certificates of Confidentiality will be issued to researchers for applicable research regardless of the country where the investigator or the protected information resides. However, Certificates of Confidentiality may not be effective for data held in foreign countries. Review the guidance on Certificate of Confidentiality<\/a> for more information and the 91探花Consent templates<\/a> for appropriate consent form language.<\/p>\n All revisions or modifications to an approved study must be reviewed and approved by all reviewing IRBs prior to implementing the change(s), regardless of the location of research. Changes that are required by local IRBs or communities must be submitted to the 91探花IRB prior to implementing the changes.<\/p>\n The only exception is for changes or actions that are “necessary to eliminate apparent immediate hazards to the subject”. If this does happen, regulations require you to report the actions taken to the IRB within 10 working days (Guide to Reporting New Information<\/a>).<\/p>\n While the personal safety of 91探花employees and students conducting research outside the United States is not the responsibility of the IRB, there are relevant resources available on campus that can be helpful for other institutional requirements. For example, if students will conduct research in other countries, they must register with the 91探花Office of Global Affairs.<\/p>\n A 91探花Travel Waiver may be required for travel to certain countries: list of countries<\/a>.<\/p>\n Contact HSD Info hsdinfo@uw.edu<\/a> if you have questions about preparing your IRB application or about conducting International Research.<\/p>\n APPLICATION IRB Protocol<\/a>What aspects of the study does the 91探花IRB review for International Research?<\/h3>\n
What if my study falls under the Single IRB mandate?<\/h3>\n
What if my study is being reviewed by an external IRB (for example, Advarra)?<\/h3>\n
Are the regulations different for International Research?<\/h3>\n
What additional regulatory reviews are needed?<\/h3>\n
Where can I locate information on foreign research regulations for the specific country where I plan to conduct research?<\/h3>\n
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Is a local collaborator required?<\/h3>\n
What if the local site cannot obtain local review?<\/h3>\n
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Are there special requirements if my study is funded by a U.S. government agency (example: NIH, CDC)?<\/h3>\n
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What are the 91探花IRB’s requirements for translated and\/or interpreted information and documents for enrolling non-English speaking participants?<\/h3>\n
What additional information must I provide in my IRB application if I want to pay or give a gift to participants in foreign countries?<\/h3>\n
What information must I provide in my IRB application regarding the Local Research Context?<\/h3>\n
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What considerations are there for sending identifiable data or specimens to the U.S.?<\/h3>\n
Do Certificates of Confidentiality apply to international research?<\/h3>\n
What if I need to make a change to (modify) my research?<\/h3>\n
Other 91探花International Travel Resources and Requirements<\/h2>\n
What if I have questions?<\/h2>\n
Related Materials<\/h2>\n
\nGLOSSARY Engagement<\/a>
\nGUIDANCE Authority and Responsibilities of HSD and 91探花IRB<\/a>
\nGUIDANCE Certificate of Confidentiality<\/a>
\nGUIDANCE Consent<\/a>
\nGUIDANCE Subject Payment<\/a>
\n 91探花Consent Templates<\/a>
\nWEBPAGE Guide to Reporting New Information<\/a>
\nWEBPAGE Single IRB<\/a><\/p>\n