The OSU IRB must review all international research projects involving human subjects to ensure that the appropriate provisions are in place to protect the rights and welfare of study subjects. The safeguards must be at least equivalent to the protections afforded by the U.S. regulations pertaining to the protection of human subjects in research (45 CFR 46).
Research studies are considered to have an international component when investigators travel abroad to collect data or investigators use or collect data from participants who are outside of the U.S. Examples include (1) a researcher traveling to Brazil to conduct a survey with a Brazilian population, (2) a researcher analyzing identifiable biological specimens that were collected in India, or (3) researchers in the United States conducting an online survey in which subjects who live in other countries may respond.
Note: Research with international populations that occurs within the borders of the United States is not considered international research as the U.S. IRB regulations apply. However, many of the considerations below may be relevant as they relate to cultural sensitivity and/or language barriers.
Applications for international research should identify whether there is a local IRB, ethics committee, or government entity that must be consulted or that will perform a review within the host country. A copy of the approval notice or supporting documents for the local review should be included in the OSU IRB application.
If the research is funded by the U.S. government, then each foreign site that is “engaged” in the research must hold and/or obtain a valid Federal Wide Assurance (FWA) with OHRP and these sites must review and conduct research in compliance with the applicable U.S. federal regulations.
Additional Considerations for International Research
- The consent documents must be in a language understandable to the proposed participants. The IRB will not verify the accuracy of translated document. Therefore, a back translation may be required unless this requirement can be waived based on the qualifications of the translator. For more information about how the IRB defines who is a qualified translator, please refer to section 10.4(d) of the OSU Policies and Procedures. Translated consent documents and any applicable back translations must be provided to the IRB along with the credentials of the translator detailed in the Investigator Qualifications section of the IRB protocol. Translated documents will be processed (stamped) in a manner consistent with documents presented in English.
- There may be circumstances under which verbal consent is more appropriate than written consent. For more information, please refer to the section pertaining to Waiver of Documentation of Informed Consent in the OSU Policies and Procedures.
- As with all compensation, investigators must take care to avoid unduly influencing subjects. Investigators should consider local context when determining the amount, type, and/or method of payment.The remuneration should be described in the compensation section of the protocol in terms of its value in the U.S. and local context. This section of the protocol should also include a description of payment in relative terms (i.e., payment equates to a day’s work, hourly salary, or another local reference) (Duke University, 2011).Compensation need not be monetary and can include items such as food, gift cards, transportation reimbursement, household supplies, etc.
Local Contact Information
- The consent form should include local contact information that is appropriate and feasible for the subject populations. Examples include phone and/or email for local co-investigators, name of community leader, Ministry of Health, coordinator for a non-governmental organization (NGO), and local IRB or ethics committee.
- Note: The consent form does not have to include the OSU IRB contact information on studies where that is not a reasonable requirement, e.g. participants do not speak English and/or they do not have access to international calling or email.
- Translations of consent documents, recruitment materials, test instruments, and/or other materials that will be seen by the participant must be submitted to the IRB for review in addition to the English version of the documents.
- To ensure that the translations are accurate for the specific community of study, it is recommended that a local contact person verify the translations.
- If local translators will be used to facilitate the research, the Training and Oversight section of the protocol should include details about how translators are trained in confidentiality and protocol adherence.
- In instances where the data to be collected have the potential to cause social stigmatization, researchers and other study personnel should use care in selecting an appropriate field assistant or on-site translator to ensure that participant confidentiality is maintained. In some cases, local customs may require that the translator/field assistant be drawn from the community. In this case, the researcher/study personnel should also train the assistant about not unduly influencing a participant to respond to questions that s/he may otherwise not wish to answer (Seattle University, 2014). This training should also be outlined in the Training and Oversight section of the protocol.
- Every effort should be made to save research data to the OSU server.
- If it not immediately feasible to save data to the OSU server, a description of how data will be securely stored electronically and/or in paper format while both on site and in transit should be included in the Anonymity or Confidentiality section of the IRB protocol. Please refer to the OSU Data Security Guidance for additional requirements.
- Once back in the United States, data should be saved in accordance with OSU data security guidance.
Export Control/Embargoed Countries
Relevant local context information should be included in the IRB protocol. This includes, but it not limited to, the following:
- A description of the research team’s knowledge of or experience in the host country as well as any relevant qualifications for conducting the proposed research within the international setting should be included in the Investigator Qualifications and/or Training and Oversight sections of the IRB protocol.
- Cities, regions countries where research will be conducted
- Scientific/ethical justification for conducting the research in an international setting
- Economic status of the country/community
- Current events or socio-political environment in the country that may impact research conduct or alter the risks or benefits to subjects
- Societal and cultural beliefs in the country that may impact research conduct or alter the risks or benefits to subjects
- If women and children are part of the subject population, their role in the society, including their autonomy and legal capacity to make decisions.
- If there are circumstances in which women or community members do not have the autonomy to make decisions for themselves, the plan for obtaining informed consent from both the study subject and any additional authority figures should be included in the Consent Process section of the IRB protocol.
- Literacy rate of the potential subject population
- Languages and dialects of the potential subject population
- Involvement of organizations, community leaders, or experts in engaging the subject population or conducting the research
- Relevance of the research to the area’s health, economic, educational, or other needs
- Distribution of risks and current and future benefits (Tufts University, 2014).
- A description of how the plan for recruitment and subject selection will avoid undue influence or favoritism within the subject population.
- If it is possible that researchers might witness child abuse or neglect in an international setting, the following information about mandatory reporting should be included in the Anonymity and Confidentiality section of the protocol:
- Indicate what local laws govern reporting of child abuse in the country of study, if applicable.
- Indicate what is culturally 'normal' and what would fall outside of 'normal' punishment for children.
- Provide a plan if you encounter a situation that is outside 'normal' practices.
- Indicate in the consent form your plan for reporting to local authorities for situations outside ‘normal’ practices, if applicable.
- NOTE: Under Oregon Law, employees of the University are required to report instances of child abuse to Oregon Authorities regardless of where the child abuse occurred. However, the IRB has had multiple conversations with Oregon authorities and it is unclear what would happen with that information. Therefore, while it is still required, disclosure to Oregon Authorities does not need to be added to the consent form, as it is unlikely to pose a risk to participants within the country of study.
- Additional information about mandatory reporting can be found on the OSU Human Resources Website and on the Oregon Department of Human Services website.
- All revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s) regardless of the location of research. Changes that are required by local IRBs or communities must be submitted to the OSU IRB prior to initiation.
Lab Tests in an International Setting
- If lab tests will be performed in an international setting, additional information may be required. Please see the Guidance for CLIA Certification for additional Information.
International Travel Resources on the OSU Campus
While the personal safety of OSU employees and students conducting research outside the United States is outside the purview of the IRB, there are relevant resources available on campus.
Cornell University (2014), Human Research Participant Protection Program: Guidance on IRB Review of International Research
Duke University (2011), International Research
Seattle University (2014), Research in International Settings
Tufts University (2014), International Research Guidance & Checklist