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Human Subjects in Research

Research involving collecting or using data from or about living individuals may require approval of Harvard's Committee on the Use of Human Subjects in Research (CUHS), the University’s Institutional Review Board or IRB. For University area Schools, the IRB is located at FAS. In some cases research may be exempt from review. All HKS research projects led by faculty or doctoral student investigators (and selected research fellows) requiring human subjects approval are reviewed by the IRB. To determine if a project requires review or can be considered exempt from these requirements, please complete the FAS application form and return (as a Word document) to: cuhs@fas.harvard.edu.

Federal agencies use the "just-in-time" principle for approval of the use of human subjects in research. Institutional Review Board (IRB) approval does not need to be received at the time of a proposal submission, but must be in place before funds are disbursed if an award is made. Harvard University has a federal wide assurance (FWA) of compliance with the US Department of Health and Human Services regulations for the protection of human subjects. If research proposes the use of human subjects that is not deemed to be exempt from review by the Harvard IRB, and approval has not yet been received, the FWA number certifies that Harvard has procedures in place to comply with human subjects protection regulations.

Federal Wide Assurance number:  00004837

Institutional Review Board Registration Number:   00000109

Also please read:

Human Subjects Payment Policy (pdf)

NIH Requirements FAQ: Human Subjects (pdf)

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