What is an institutional review board (IRB)?

In the U.S., an institutional review board (“IRB”) is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin without IRB approval. The IRB members generally include health care personnel such as doctors, nurses, and pharmacists. The IRB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members.

The IRB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the IRB believes that these conditions have been met, it may approve the study and allow it to begin.

Once the clinical research study begins, the IRB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the IRB if the participant has a question or concern about how the study is being conducted.