BC IRB – International Research Policy
International research may pose special concerns for the IRB and for research teams. PIs are responsible for understanding and complying with the ethical and legal aspects of conducting human subjects research in an international setting. This often requires additional consideration for international participants’ rights and welfare within different cultural context and local regulations.
PIs should consider the following issues when evaluating local context and address them in their IRB protocol:
- Scientific/ethical justification for conducting research in an international setting, including how the research will benefit the local population
- Societal and cultural beliefs that may impact the research
- Role of women and children in the society and their autonomy to make decisions
- iteracy rate of the population
- Details of the political, cultural, and economic environment, how these details impact the research in terms of design and special challenges, and the resources available to the research team for guidance on these topics
The HHS Office for Human Research Protections maintains an online compilation of international laws and regulations pertaining to human research protections. Additional resources on international research are also available. Before submitting an IRV application, PIs should first consult this compilation to determine whether there is a specific local review process in the country where data collection will occur.
If no local laws, regulations, or standards of practice require review by a local IRB or similar local review body, the PI* must include with their IRB application a letter from someone with knowledge of the local context stating that:
a) there is no formal local review process in the country, and
b) that the individual has reviewed the protocol and can attest to its cultural appropriateness and safety.
The PI should also provide information describing the person’s qualification to comment on such matters.
If a specific local review is required in the country of study, the approval from that local governing board must be included in the BC IRB application. Please note that international approval processes often move slowly, so you should plan ahead and build potential delays into your timeline.
Regardless of whether local review is required, research conducted at or in collaboration with a specific site, such as a school, university, hospital, or clinic, the PI must include with their submission a letter signed by an appropriately authorized representative of the site indicate the site’s support for the research to go forward.
The content, language, and method of consent should be carefully considered to ensure that it is culturally and contextually appropriate. A local contact must be included on the consent form with an appropriate contact method so that participants can reach out with concerns or questions. For example, if internet access is limited at the site, providing an email address would not be appropriate.
All personnel on the project, including those outside of the United States, must have human subjects training. Research assistants hired at the site are considered collaborators and must be included on the study protocol in most cases. If the BC-required CITI training is not culturally appropriate for local research team members, please contact the IRB to determine another training method that will meet the team’s needs.