International Research Policy
The following information, from the Berkeley Human Research Protection Program, supplies relevant information to research projects conducted internationally. The following policies also apply to our policies at Smith College.
“When conducting human subjects research in an international setting, investigators must consider not only the ethical and regulatory standards applied to domestic research, but also the ethical and regulatory standards of the setting in which the research will be conducted. Investigators are responsible for paying special attention to local laws, culture, tradition, and language, as well as to the current political and social climate. They must comply with the relevant laws protecting human subjects in the host country as well as any requirements for local IRB approval. Investigators should consider partnering with local researchers in order to ensure understanding of local context and regulations."
In addition to the standard IRB proposal requirements, the IRB requires a clear explanation of how the investigator plans to obtain local permission (in the host country) to conduct the study. This permission would be in addition to the Smith College IRB review.
Local IRB Review
This is the best way to ensure that the study is set up in a way that is culturally appropriate. As you plan your research, find out if the place in which you plan to recruit participants has a local IRB or IRB equivalent. Explain your plan for working with them in your IRB proposal.
If there is no established mechanism for local ethical review or if local regulations do not require a formal review of your research, explain this to the Smith College IRB. The IRB may request a letter from an individual in the host country confirming that there is no formal review process available or needed, and that the research is acceptable according to local context.
Letter from an Administrator
If you are collaborating with a local organization (e.g., research institute, hospital, college or university), you will be asked to submit a signed letter confirming the support of an administrator in charge of research at the organization or institution. If there is no local IRB or IRB equivalent, this letter may be accepted as a substitute for that requirement.
Investigators proposing an international research project will be asked to explain their expertise with the subject population and how their research protocol is sensitive to cultural norms. Investigators may provide a letter from an expert to verify the cultural appropriateness of their study if they do not have personal experience with the subject population.
Field research done outside of the United States, especially in non-western societies or places where the participants do not speak English poses some problems in obtaining written documentation of informed consent. In these situations, it is sometimes impossible, for a variety of reasons, to obtain written consent. If that is the case, the investigator must provide the IRB with a statement of the reasons why it should waive written consent, and also provide an acceptable alternative method of obtaining informed consent, which is appropriate to both the participants and their culture. See “Waivers of Written Informed Consent” for more information about making this request.
All study documents should be submitted to the IRB in English. Investigators are responsible for making sure all translated documents accurately reflect what is approved by the IRB.
If you are hiring a translator or guide to help with communication during interviews, they must sign a confidentiality agreement in order to protect the information disclosed by participants.