Why the IRB Conducts a Review
HMS and HSDM receive federal funds to support human studies research. As a requirement of receiving these funds, the Institution must hold a FederalWide Assurance (FWA) certifying adherence to the federal regulations governing human studies research and appointing an IRB to review and approve research projects in accordance with these regulations.
The President and Fellows of Harvard College (the legal name of Harvard University) have delegated the authority to develop, implement and monitor all human research protection programs to the Divisions of the University. In turn, the Faculty of Medicine established the Committee on Human Studies to review research projects and activities that involve human participants, and which oversees the implementation of all policies and procedures for human studies research for the medical and dental schools.
Requirements for IRB review of human studies was formally established in 1974 with the National Research Act. This Act was a direct result of the Code at Nuremberg that defined the necessity of informed consent after the trials at Nuremburg revealed abuses of prisoners who were subject to extreme medical experiments by Nazi doctors. Over the years, evidence of further abuse (such as the Tuskeegee Study) highlighted the need to impart ethical standards, such as the Belmont Report and the Declaration of Helsinki.
Updated: 22-Oct-2009