Established by Congress in the 1974 National Research Act, institutional review boards (IRBs) are decentralized committees that review and monitor nearly all federally funded research projects involving human subjects in the United States. In most other nations these groups are called research ethics committees (RECs). The purpose of IRBs is to ensure that research conforms to ethical standards and protects the rights and welfare of the people who participate as research subjects. This is accomplished through the IRB Review of Research process, which involves the review of protocols, informed consent documents, and related materials for proposed research. Although flawed and contentious, the IRB regulatory framework is improving in its ability to assure the upholding of ethical standards in a rapidly evolving research context.

Background

The unethical practices of Nazi doctors at concentration camps spurred several attempts to formulate ethical principles for the conduct of research...