IRB or Institutional Review Board is designated by the FDA under its regulations, to monitor and review any biomedical research that involves human subjects. IRB is also known as an ethical review board, or an independent ethics committee.

The main purpose of the IRB is to assure that appropriate measures are taken to protect the rights and welfare of people participating in research as a test subject. The IRB employs a group process in reviewing research protocols and other related materials such as informed consent documents. They are most commonly used in the fields of social sciences such as anthropology, psychology, sociology and in the fields of health like when performing clinical trials of drugs and devices.

All institutions that are conducting research which involves human subjects must have their own Institutional Review Board. This will ensure that the research being performed follows correct research protocol. Although, FDA regulations allows institutions without their own IRB to have an third-party or an outside review board to oversee the research they are engaged in.

Regulatory guidelines in clinical trials are mainly about safeguarding the rights, well-being and safety of all human subjects. Those who have special conditions such as pregnant women, the elderly and children should be rendered with special attention. The proposed trial should also be reviewed thoroughly and within a reasonable amount of time. Documents about the trial, recorded dates of approvals and all other necessary documents should also be reviewed regularly.

Some researches that involve human subjects have exemptions from IRB approval. These are the researches that are conducted in established or accepted educational settings. Educational tests such as cognitive, aptitude, achievement, diagnostic, and survey and interview procedures are exempted. Moreover, research that involve collection of existing data, documents, records and even taste and food quality evaluations are also exempted from IRB approval.