What is an IRB?

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An Institutional Review Board (IRB) is a committee established at institutions or organizations where human subjects research is conducted or supported.

The IRB is charged with reviewing, approving and monitoring research projects involving human subjects for compliance with institutional policies and state, local, and federal laws. The IRB will also assess whether the risks posed to subjects are proportional to the benefits.

The IRB is comprised of at least five members from relevant academic disciplines including at least one non-affiliated member. The members include faculty, staff, students, and members from the local community. The IRB functions as a surrogate “human subject advocate” whose role is to protect subjects participating in research by reviewing research projects before research is allowed to begin.

IRB members must have the necessary experience and expertise to evaluate proposed research projects. IRBs must be diverse in terms of race, gender, and cultural backgrounds.

The IRB is part of a comprehensive system, the Human Subjects Protection Program (HSPP), responsible for the protection of research subjects. The HSPP at USC includes the Office for the Protection of Research Subjects, the Office of Compliance, the IRBs, and the Institutional Official.

IRB functions and duties are described in the 1991 Federal Policy for the Protection of Human Subjects (Common Rule – Title 45 CFR 46).

What does the IRB do?

The IRB is responsible for reviewing and approving proposed or continuing human subjects research. The IRB review process is designed to protect the rights and welfare of human subjects by ensuring equitable subject selection, obtaining fully informed consent, minimizing risks, maximizing possible benefits and assuring the maintenance of privacy and confidentiality of persons and data. Human subjects research projects cannot be conducted without the approval of the IRB.

The committee has the authority to approve, require changes to study procedures, or disapprove proposed research projects. Institutional officials can disapprove an IRB approved project but cannot approve a project that has been disapproved, suspended, or terminated by the IRB.