International Research

If you are planning to do research outside of the United States, you must comply with any existing research requirements of the country.

OHRP page on International Human Subjects Protection
The OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States.

The "International Compilation of Human Research Protections" is a resource you may consult for known international research protections.

"Listing of Social-Behavioral Research Standards"

https://www.hhs.gov/ohrp/international/social-behavioral-research-standards/index.html

If you are going to any of the EU countries, you should review the EU's Protection of Personal Data legislation.  See also GDPR Data Protection.

Legal is not always adequate and research that is exempt in the United States may not be exempt in other countries. An investigator should go the extra mile and seek approval for their research from the local IRB, ethics committee or other local resource acting on behalf of the local constituency the PI wishes to study. Be sure that you know details such as what the local legal age to consent is, that your method of collecting data will not be disturbing or insulting to your subjects, that your method of getting and documenting consent is reasonable for the population to be studied.

The political or social climate in a foreign country may be such that normal methods for protecting data and the confidentiality and identity of research subjects in the U.S. are not adequate. Researchers should address these problems in their IRB application. Projects dealing with advocacy, history, minorities, politics, religion, refugees, roots or sexuality may not be welcome in the host country. Try to make a local contact who knows the indigenous culture.

The Kenyon IRB will ask for information on the Country's regulations and requirements and, especially in the case of student PIs, may request that a formal connection to an educational, research, or government institution be made. (This could be a college/university department or faculty member willing to act as the adviser to the Kenyon student.)

Some international study programs have a research requirement and some run their own IRBs. Even if the program's IRB approved your project, if you intend to use your research for Kenyon course or graduation requirements after you return, your research protocol must be reviewed by the Kenyon IRB. You will be asked to supply a copy of the international study program's IRB approval. Be sure to keep all documentation including IRB application, approval, protocol documents including recruitment, consent, and questionnaires or other measurement or interview tools or schedules. Additionally, you must have completed Kenyon's required Human Subjects in Research training course.

Faculty PIs may find that a collaboration with an academic in the country of interest will increase the likelihood of permission to do research in that country.

Applying the basic principles of the Belmont Report, "Respect for Persons, Beneficence, and Justice," provides a framework for conducting ethical human subjects research. Interpreting and applying those principles in another cultural setting may be challenging. Researchers need a clear understanding of both the ethical guidelines and government regulations pertaining to any proposed research, from both the U.S. and host country governments.

Investigators who will be conducting research internationally will want to provide the IRB with at least the following information:

• Information about where the research will be conducted (both the geographic location and the performance site, where applicable).
• A copy of local IRB or equivalent ethics committee approval, when required.
• Information about the investigator's knowledge of the local research context, including the current social, economic, and political conditions.
• Information about whether there are any additional risks subjects might face as a result of the population being studied and/or the local research context.
• The language(s) in which consent will be sought from subjects and the research will be conducted, as well as whether the investigator is fluent in this language, or whether an interpreter will be used. If an interpreter will be used, it should be clear what risks, if any, this might pose for subjects, as well as how the risks will be minimized.
• Copies of the translated informed consent documents and instruments, including verification of the accuracy of the translation(s).
• Information on how the investigator will communicate with the IRB while in the field.