IRB Management & Function

Institutional Review Boards are committees at research institutions that monitor and approve studies that involve human participants. IRBs exist to protect human participants in experiments, and ensure that research is conducted in an ethical manner. The FDA sets requirements about the composition and functioning of an IRB committee if an IRB will be reviewing studies of FDA-regulated products.
  1. Necessity

    • Prompted by the atrocities of human experimentation in Nazi Germany and other experiments such as the Tuskegee Syphilis Study in the early twentieth century, the U.S. adopted the National Research Act of 1974 that established IRBs. IRBs are committees that oversee research studies involving human participants to ensure that participants are treated ethically.

    Function

    • Most research institutions have their own IRBs that review research that involves human participants. IRBs are usually used to review health, psychology, sociology and anthropology studies. They review research proposed by investigators from their institution, weighing the benefits of conducting new research on human participants against the costs of the harm that might come to those participants.

    Composition

    • The IRB must have at least five members and the members must have diverse backgrounds to ensure that all points of view are represented when deciding whether the research is ethical and necessary. The IRB should include both men and women and they must not all be from the same field. At least one member must be an outsider and at least one member must be a non-scientist.

    Management

    • IRBs have a chair, someone who is selected by the governing body and who has stature and respect in the community. IRBs are run by the chair and the committee and they set out procedures for researchers to follow who want to propose new studies. When a researcher submits a study for review, the IRB reviews the study for ethical concerns. IRBs must review each study at least once a year to ensure that the study continues to meet ethical guidelines and provide benefits.

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