Human Research Protection Program

HITECH Act

Human Research Protections in International Research

Human research conducted outside the United States must conform to the same ethical and regulatory standards to which research conducted in the United States is held, and must conform to applicable local laws and norms of the host country. When Yale researchers are involved, international human research must be conducted in accordance with Yale policies for the conduct and review of human research, including those concerning informed consent and participation of vulnerable populations. All Yale research involving human subjects conducted outside the United States must receive approval from the Yale IRB and, where available, from the IRB or Independent Ethics Committee (IEC) used by the international site.

Yale University and its researchers recognize that research is enhanced through collaborations with individuals external to the University. Yale researchers therefore, frequently engage others from throughout the world in their research projects. For US Federally-funded research, Yale must enter into formal research collaborations or partnerships when professionals representing these external organizations or independent investigators join the Yale research team or are otherwise “engaged” in human research as defined by the U.S. Department of Health & Human Services (DHHS), Office for Human Research Protections (OHRP).

Review and approval by the external organization’s Institutional Review Board (IRB) is required prior to any agent, employee or other representative from these external entities taking part in the research.

Who should read this section?

This section describes the requirements for Yale researchers wishing to engage in international human research, and also provides insights for those international collaborators seeking to bolster human subjects protection in their local environment.

For Yale Researchers

For International Researchers

The international researchers’ webportal was supported by Award Number S07TW008848 from the Fogarty International Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Fogarty International Center or the National Institutes of Health.

 

 

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