Charles River Campus IRB
Policies and Procedures
Title: International Research
Date: May 31, 2016
The purpose of this policy is to describe the process for reviewing research that is conducted outside of the United States.
The Charles River Campus (Charles River Campus) Institutional Review Board (IRB) requires that human subjects research that is conducted outside of the United States (US) complies with US regulations and guidelines and any applicable regulations and laws of the country in which the research is performed.
Principal Investigator Responsibilities
When conducting international research, the Investigator is required to:
- Provide the same or equivalent protections to human subjects in research conducted in other countries
- Be aware of local laws, regulations, political and socio-economic factors, and cultural content
- Comply with local laws and adhere to cultural norms
- When applicable, provide documentation that the Investigator has permission to conduct research in the country. This documentation should be obtained from the appropriate local ethics committee, local experts, or community leaders. A list of regulations, laws, and guidelines pertaining to international human subjects research can be found at: International Compilation of Human Research Protections created by OHRP
- Submit Appendix A “International Research Form” along with the IRB Application. This form can be located on the IRB website
The IRB will review the research protocol to ensure that it includes the following information:
- The Investigators experience/qualifications for conducting research in this location with this community. If the research will be conducted in a language other than English, the Investigator must either state that he/she speaks the language or, if he/she does not speak the language, describe the process for communicating with subjects
- The Investigators knowledge of local customs and culture; if appropriate, a local collaborator may be used/involved
- The payment method and schedule and how it relates to the local economy and subject income
- The consent process
- Plan for protecting the privacy of subjects and the confidentiality of the data
- Plan for communicating with the IRB for requesting amendments or reporting unanticipated problems, non-compliance, and subject complaints
- Plans for post-approval monitoring. If applicable, the IRB may require review by the QI Specialist.
- Communication plan with local IRB’s/ethics committees if appropriate
When evaluating risk, different considerations may apply to research conducted outside of the US. Research that may be considered to be minimal risk in the US may be greater than minimal risk when conducted in other countries. The following will also be considered by the IRB:
- Questions that may be innocuous in the US may be offensive in other countries
- Assuring and maintaining confidentiality may be difficult in other countries
- Breach of confidentiality could have more dangerous consequences than in the US
The IRB will request consultation with individuals who are knowledgeable about the location and study population as necessary. The consultant may either be identified by the IRB or the IRB may request that the Investigator provide the name of an individual who is knowledgeable and can serve as a consultant. This individual does not need to be from Boston University.
The informed consent process should be conducted in the language most familiar to the subject and must take into account local customs, literacy levels, and confidentiality concerns. The Investigator must be familiar with the cultural attitude regarding consent. This may differ from what is expected in the US.
If the Investigator and/or study staff are not fluent in the local language, interpreters/translators who are fluent should be used for the study. Any documents that are translated into another language must be submitted to the IRB for review and approval prior to use. The Investigator must also submit an Attestation Form with the translated documents. The Attestation Form can be located on the IRB website.
The Investigator should request a waiver of documentation of consent if documentation of consent is not consistent with local customs. In some locations, documentation of consent may not be appropriate because:
- Subjects may be illiterate
- It may be inappropriate to ask for a signature
- There may be legal implications when signing documents
- Subjects may become suspicious or fearful when asked to sign a document
The IRB will consider the following when research involves children:
- In the location of the research, at what age is an individual considered to be an adult
- The relationship between parents and their children in that county
- Acceptable and effective parental permission processes
- If child assent it acceptable/permissible in that country
Title: International Research
Author: Cynthia Monahan
Effective Date: December 10, 2014
Last Review/Update Date: May 31, 2016
Revision #: 1
Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance