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Human Subjects in Research


Harvard Committee on the Use of 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.    

Electronic Submission, Tracking & Reporting (ESTR)

Harvard’s new system for electronic protocol submissions called Electronic Submission, Tracking & Reporting, or ESTR, is now implemented for CUHS. ESTR automates the IRB submission process, serves as a place to store and access study documents and makes it easy to create reports. All submissions to CUHS will be made through ESTR. You can find information about ESTR here, and log into ESTR at http://irb.harvard.edu.     

Federal Wide Assurance

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 #:

   FWA00004837

   FWA Expires:    February 16, 2018
   IRB Registration #:

   IORG00000109

   IRB Registration Expires:

    July 27, 2015

Exempt Research

Certain types of simple research with human subjects qualify for an exemption determination by CUHS, mainly research on normal educational practices and surveys or interviews that don’t collect information that is both identifiable and sensitive. Exempt research does not have to meet the Federal standards for approval, but Harvard policy requires that the research be reviewed. A formal determination that the research is exempt is required before the research can begin.  Read more

Guidance from the Committee on the Use of Human Subjects in Research:

HRP-215 Not Human Subjects Research Determination Request

CUHS Protocol Template

CUHS Template Guide (submission instructions/guidelines for determining exemption)

Human Subjects Payment Policy (pdf)

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