Human Subjects Research

Harvard University Area IRB  
Email: cuhs@harvard.edu 
 

Federal regulations and Harvard University policy require that research involving human subjects be reviewed and approved by an Institutional Review Board (IRB) before the research begins. This requirement applies to all studies that meet the definition of human research, whether conducted by faculty, staff, or students; whether on or off campus; and regardless of funding status or source. The IRB for researchers on the Allston/Cambridge campus, including those in the Faculty of Arts and Sciences, is the Harvard University Area (HUA) IRB, historically known as the Committee on the Use of Human Subjects (CUHS). 

The mission of the HUA IRB is to protect the rights and welfare of subjects in studies conducted by Harvard researchers. It achieves this by partnering with researchers to understand the risks and benefits of their studies, and by evaluating the informed consent process for subjects. The IRB’s guiding ethical principles—respect for persons, beneficence, and justice—are outlined in The Belmont Report. 

Researchers should review the University’s policies on human research prior to submitting to the IRB. This includes the IRB Lifecycle Guide, which provides introductory information about all stages of the IRB review process. The HUA Investigator Manual provides a more comprehensive explanation of these policies and includes guidance for research protocol preparation and consenting subjects. The most current version of the Investigator Manual can be found in the IRB’s library of documents in the Electronic Submission, Tracking and Reporting system (ESTR), where IRB applications must be submitted. 

Please consult the HUA IRB website or contact the HUA IRB office at 617-496-2847 or cuhs@harvard.edu to find out more information about: 

  • The types of research that require IRB review,
  • The process for submitting applications,
  • The training required for investigators and Faculty Sponsors,
  • Appropriate forms, templates, and guidance documents, and
  • The submission process and training program for undergraduate research, the Undergraduate Research Training Program. 

Additionally, the HUA IRB assigns dedicated reviewers to departments. Reviewers offer office hours and can be contacted directly for consultation, including on the need for submitting to the IRB.