Conducting research in an international setting involves adhering to additional sets of regulations, policies, and customs. Not only must researchers follow the same ethical and regulatory standards for conducting human subjects research in another country as they do in the U.S., but researchers must also conform to the applicable local laws and norms of the host country and community as well.
PLANNING THE PROTOCOL
The HSC recommends submitting an application for review at a minimum of one month prior to the anticipated start date. Since international sites may have their own policies and procedures for allowing human subjects research to occur, planning your protocol in advance will help facilitate the review process.
Below are some items to consider when conducting research in an international setting:
- Research location(s): Identify cities, rural areas, spaces, and countries where the research will be conducted.
- Collaborator(s) and what the collaboration entails: Describe each collaborating site/agency/institution and define their role in the research (if applicable). Will these institutions be engaged in the research? Are they seeking their own IRB approval for the research activities?
- Local ethical review, permissions and requirements: Research in an international location often involves additional local ethical review, permissions, and may also require host country approval. A description of an appropriate local IRB or ethical review and how local permissions will be obtained should be documented in the ORahs protocol application. Consultation with community leaders (e.g., NGOs), stakeholders, or colleagues can aid in providing important insights about the local community in a research context. Note: Host country approval is different than a local ethical review and both may be required. The review should assess whether the project is culturally insensitive or offensive and whether participation could place the subjects at risk. The reviewer should be from the country or area targeted. The reviewer should also be able to understand the research. They should be independent of the research. For information on host country approvals, see OHRP's guidance on international research.
- Language and literacy: Language and literacy levels may vary by locale. What measures are taken to ensure subjects are informed about the research (i.e., informed consent) in a way that is appropriate to the cultural standards of the international location?
- Community and culture: Questions that may seem innocuous in the United States could be offensive and/or risky in another community or culture. An outline of the research team’s knowledge of the local community including the appropriateness of the research in context of the political and socio-economic climate, and societal norms should be described in the ORahs application.
- Payment to participants: Payments that are non-coercive in the United States could potentially be considered coercive in another community. Consider how you will ensure payment methods (if any), such as cash or goods, is non coercive and would be equivalent that what would be commonly available in the local community.
- Status of women: If the status of women in the international location(s) is different than the United States, what measures will be incorporated into the research to respect women’s autonomy to consent?
- Status of children: If the definition or guardianship of children in the targeted community is different than the United States, describe how your research team will adhere to these standards.
- Traumatized communities: Any risks and complications of conducting research with victims of violence or disasters should be discussed and a plan for minimizing any said risks should be included in the protocol application and consent process.
- Training: If your research team will be hiring individuals to conduct the research on your behalf (e.g., canvassing, recruiting participants, etc.) how are these individuals trained to conduct themselves in an ethical and non-coercive manner?
In most instances, federal regulations require documented (i.e., signed consent) from research participants unless a waiver of consent or documentation is requested, justified and approved by the HSC.
Below are some items to consider when obtaining informed consent in an international setting:
- Appropriate language: In many instances, there may be multiple spoken languages, such as an official state language, local language, and/or local dialects. Consent should be obtained using a language that is most understandable to the subject, which could mean having multiple consent forms in several languages.
- Oral or written consent: The spoken language may not be written, or the literacy level may vary from the spoken language. A signed consent form may have connotations or consequences and it may not be appropriate for the subject population.
- Translators: If your research team is not fluent in the local language, a translator or interpreter may be appropriate for the project. However, considerations for the relationship between the translator/interpreter and the subjects must be taken into account since a translator could be seen as an individual of power and subjects may feel undue pressure or influence to participate in the research.
- Additional permissions: Are there other individuals or groups whose permission must be sought before obtaining consent? For example, in some communities, a spouse, a head of the household, or permission from a group leader may be required before obtaining consent from subjects.
- Local contact: Some individuals may not have access to a telephone or email. Is there a local contact person in case subjects have questions or concerns that arise?
For more information on working in an international setting, see the UCSB HSC SOP 024 International Research.