Information for International Studies

Whether domestic or international, the CHS is required to have knowledge of the local research context in order to provide a thorough review, to understand particular risks and benefits of the study population, and the relevance, customs and cultural significance of study procedures to the community in which the research is taking place. All sites are required to have a local IRB or Independent Ethics Committee approval (IEC) or an FWA when use of federal funds have been awarded for the research.

Regardless of funding, IRB or IEC approval is always required, unless there is no such board where the research is taking place. While some less populated communities may not have such a board, most communities have a structure (council or local leader) in place that approves the activities of that community. In addition to the approval of this committee or person, a letter of support from the local site (such as a school principal or superintendent, or a clinic director) where the research activities will be taking place should be obtained by the Investigator and provided to the CHS. The letter should include information pertaining to the appropriateness of the study to the local community, any required changes to the study, and a review and approval of the consent document, whenever possible.

Depending on the research, the risks to participants, and the support from the local community; the CHS may also request that someone (other than the Investigator) with special knowledge of the setting either review a particular protocol, or attend an IRB meeting to provide the CHS with recommendations based on his or her expertise. This person must be familiar with the customs, practices, or standards of care where the research will be taking place.

Information regarding special research data security concerns for international research can be found on the Research Data Security Policy website; Advisory for Travelers.

Updated: 21-Dec-2010