- Purpose and Applicability
- Questions and Answers
- When is IRB review required?
- What aspects of the study does the UW IRB review for International Research?
- What if I am a Fogarty Fellow?
- What if my study falls under the Single IRB mandate?
- What if my study is being reviewed by an external IRB?
- Are the regulations different for International Research?
- What additional regulatory reviews are needed?
- Where can I locate information on foreign research regulations?
- Is a local collaborator required?
- What if the local site cannot obtain local review?
- Are there special requirements if my study is funded by a U.S. government agency?
- What are the UW IRB’s requirements for translating information for enrolling non-English speaking participants?
- What if I want to pay or give a gift to participants in foreign countries?
- What information must I provide in my IRB application regarding the Local Research Context?
- What considerations are there for sending identifiable data or specimens to the U.S.?
- Do Certificates of Confidentiality apply to international research?
- What if I need to make a change to (modify) my research?
- Other UW International Travel Resources and Requirements
- Other Questions?
- Related Materials
- Regulatory References
- Version History
Purpose and Applicability
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 UW IRB is the IRB of record.
Questions and Answers
When is IRB review required?
All human subjects research conducted by University of Washington faculty, staff, or students regardless of funding source or research location, requires prospective submission to the UW IRB or reliance on another domestic or commercial IRB for the engagement of the UW. UW does not rely on international IRBs.
What aspects of the study does the UW IRB review for International Research?
Per HSD policy, for projects with an international component, UW IRB reviews all activities for the proposed research project, including those conducted at international sites, that the UW is engaged in. Additional review by a local “in country” IRB is usually required per 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.
What if I am a Fogarty Fellow?
In situations when the UW serves only as a passthrough of NIH funds for Fogarty Fellowships and there is NO other UW involvement, the UW will certify to the external funding agency that IRB approval has been (or is being) obtained, and from whom.
What if my study falls under the Single IRB mandate?
International sites are excluded from the Single IRB mandate. This means that international sites would not be required to rely on a Single IRB. If the UW 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 of the domestic sites will be reviewed by a non-UW IRB, you should obtain IRB review of the international components as described in that non-UW IRB’s policies and procedures relating to international research.
What if my study is being reviewed by an external IRB (for example, Advarra)?
You should follow that IRB’s policies and procedures about the IRB review of international research.
Are the regulations different for International Research?
The University of Washington 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 UW IRB). 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 UW 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.
What additional regulatory reviews are needed?
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.
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.
Where can I locate information on foreign research regulations for the specific country where I plan to conduct research?
Investigators can begin to educate themselves about applicable foreign research regulations for a specific country with the resources below:
- International Compilation of Human Research Standards
- Harvard School of Public Health Research Ethics Guidelines International Online Navigation map (REGION)
Is a local collaborator required?
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.
Based on study location and risk level, the IRB may require 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.
What if the local site cannot obtain local review?
There may be no local functioning review board. In these circumstances the UW 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 or a letter of invitation. This letter would need to be written by an individual completely independent of your study who is highly familiar with the culture of the region where the research will be conducted. Required elements:
- Reference the title of the study displayed in the IRB application
- Describe the expertise of the individual preparing the letter to address the local cultural and social norms
- Confirm they understand the intent of the research and activities to be performed
- Confirm the planned study does not conflict with local and cultural norms
- Document is signed and dated
Are there special requirements if my study is funded by a U.S. government agency (example: NIH, CDC)?
If the research is funded by the U.S. government, then each foreign institution that is engaged 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 UW 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.
These are common examples of when an institution is “engaged” in human research:
- Institutions whose employees or agents obtain the informed consent of human subjects for the research.
- Institutions whose employees or agents obtain for research purposes identifiable private information of identifiable biological specimens from any source for the research (even if the institution’s employees or agents do not directly interact or intervene with human subjects).
- Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures, or by manipulating the subject’s environment.
Information on FWAs can be found at OHRP’s Register IRBs & Obtain FWAs page.
Issues of engagement, FWAs, and local site requirements can be complex. Please contact email@example.com if you have specific questions or concerns.
What are the UW IRB’s requirements for translated and/or interpreted information and documents for enrolling non-English speaking participants?
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.
The initial UW IRB application should only include the English version of documents that will be used with research subjects (such as recruitment materials, consent documents, questionnaires, and data collection materials).
Consent, assent, and parental permission must be communicated in a language understood by the subjects. This may require interpretation and/or translation services for research intended, or likely, to involve subjects who are not fluent in English. To reduce the number of changes required, HSD recommends that translations only occur after the content of the English documents has been approved by the IRB. All translated materials must be reviewed and approved by the IRB prior to using them with subjects.
For all studies, the UW IRB expects that translated documents will meet the following requirements:
- Linguistically accurate;
- At an appropriate reading level for the subject population; and
- Culturally sensitive for the location they will be used.
Researchers are required to inform the IRB how they will ensure that these translation and interpretation requirements will be met. A qualified translator/interpreter should be able to ensure that the tone, meaning, and content of the translated documents remain consistent with the IRB-approved English version(s).
An attestation of translation is required for consent forms for more than minimal risk studies (TEMPLATE Translation Attestation) and may be required by the IRB in other circumstances, where appropriate.
What additional information must I provide in my IRB application if I want to pay or give a gift to participants in foreign countries?
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 UW IRB application the planned amount of compensation in both UW 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.
See: GUIDANCE Subject Payment.
What information must I provide in my IRB application regarding the Local Research Context?
“Local context” means information about the local regulations, policies, relevant cultural norms, and relevant local cultural/religious/social sensitivities. The UW 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 APPLICATION IRB Protocol.
- Research Sites. Identify all countries where the research will be conducted.
- Cultural Context. Describe site-specific cultural issues, customs, beliefs, sensitivities, or values that may affect the research, how it is conducted, or how consent is obtained or documented.
- Local Rules and Requirements. Describe any local laws and requirements that may affect the research (especially the research design, consent procedures, and use of biospecimens). The most common examples are laws about:
- Specimens – for example, some countries will not allow biospecimens to be taken out of the country.
- Age of consent – laws about when an individual is considered old enough to be able to provide consent vary from country to country.
- Legally authorized representative – laws about who can serve as a legally authorized representatives (and who has priority when more than one person is available) vary between countries.
- Mandatory reporting – some countries have laws requiring reporting of specific conditions or behaviors (for example, child abuse or serious criminal behaviors) to local authorities.
- Language and Literacy. The IRB reviews the process that will be used to ensure that: (1) the oral and written information provided to participants during the consent process and throughout the study will be in a language readily understandable to them; and (2) at an appropriate reading/comprehension level for written materials (e.g., consent forms, questionnaires). Also see: GUIDANCE Consent Subjects With Limited English Proficiency.
- Subject payment. How your planned payments or gifts to subjects compare with the local economic situation and average wage.
What considerations are there for sending identifiable data or specimens to the U.S.?
Researchers are strongly encouraged to collaborate with an individual or organization with expertise in this topic.
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/] 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.
Do Certificates of Confidentiality apply to international research?
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. See the GUIDANCE Certificate of Confidentiality for more information and the TEMPLATE Consent for appropriate consent form language.
What if I need to make a change to (modify) my research?
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 UW IRB prior to implementing the changes.
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).
Other UW International Travel Resources and Requirements
While the personal safety of UW 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 UW Office of Global Affairs.
A UW Travel Waiver may be required for travel to certain countries: list of countries.
What if I have questions?
Contact HSD Info firstname.lastname@example.org if you have questions about preparing your IRB application or about conducting International Research.
APPLICATION IRB Protocol
GUIDANCE Authority and Responsibilities of HSD and UW IRB
GUIDANCE Certificate of Confidentiality
GUIDANCE Subject Payment
TEMPLATE Consent Form, Standard
TEMPLATE Translation Attestation
WEBPAGE Guide to Reporting New Information
WEBPAGE Single IRB
45 CFR 46
Open the accordion below for version changes to this guidance.
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Key Words: Non-UW sites