The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB. IRBs are governed by federal regulations under both the FDA and the Department of Health and Human Services.

The first two questions the IRB faces are whether the activity involves research, and second, whether it involves human subjects. Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" Human subjects are defined by the regulations as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" The FDA defines research as: Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration.

There are a number of different levels of review, each dependent upon the level of risk involved in a study. For definitions and guidance, including contact information, please see the Partners IRB website: http://healthcare.partners.org/phsirb/