When medical or behavioral research is performed using human subjects, approval of all experimental and research protocols must be obtained from an IRB, or institutional review board. In some organizations, the IRB is called an ethical review board or an independent ethics committee.
A researcher seeking to obtain IRB approval for a project must submit his research protocols to the IRB for review. These protocols typically include appropriate training for everyone involved with the project who will interact with any human subjects. Some institutions require continued IRB approval of projects on a yearly or other regular basis. Different types of projects may go before different types of IRBs and may require different levels or complexities of review before approval. No pilot studies involving human subjects are allowed without IRB approval of protocols.
IRB approval is required for research using human subjects to protect the subjects from any harm and to maximize their safety. Protocol review by an IRB examines the purpose of the research, benefits to be derived from the research, risks involved in the research, the research's proposed methods and the procedure by which human subjects are fully informed of any risks. In the United States, IRBs are regulated by the Office for Human Research Protections of the Department of Health and Human Services and by the Food and Drug Administration.