The IRB Policy

Institutional review board (IRB) policy guides the approval or denial of research involving human subjects to ensure this research is ethical and safe. Principles of human subject protections that define IRB policy and regulatory oversight of IRBs have their origins in the Nuremberg Code used to judge Nazi atrocities in human experiments.

Identification

• An IRB is a committee within a research institution--such as a university or hospital--that reviews, approves and monitors research that uses human subjects. Researchers at institutions with an IRB must submit a detailed description of their research plan, known as a research protocol, to their IRB. The IRB then evaluates and approves or denies the plan based on the rules and guidelines in the IRB policy. Some institutions also use the terms "independent ethics committee" or "ethical review board" for the IRB.

History

• The Nuremberg Code used to judge Nazi atrocities in human experiments established the basic principles of modern human subject protections that guide institutional review boards. These include requirements that research must minimize risk relative to benefits and that human subjects must consent voluntarily, free from coercion with an understanding of the risks and benefits. In 1964, the World Medical Association signed the Declaration of Helsinki, which defined rules for medical doctors conducting research and included the establishment of an independent committee to review research protocols before starting research.

Significance

• In the United States, the National Research Act of 1974 established a commission to define human subject protections that became Department of Health and Human Services regulations in 1981. Seventeen other departments and agencies adopted the key regulations as the Federal Policy for the Protection of Human Subjects, also known as the "Common Rule," which includes requirements for how institutional review boards form, operate and keep records.