Institutional Review Board (IRB)

Members include scientists, non-scientists and people unconnected with the institution, so that no single viewpoint dominates. The board examines the study plan, the risk and benefit balance, how participants are chosen and the consent materials. It can approve, ask for changes or reject, and it reviews progress, safety reports and amendments, often at least once a year. In many countries a trial cannot lawfully start without such approval. The body goes by different names: ethics committee is common in Europe and India. In the United States, IRB is the official term. Bodies can sit inside a hospital or university or be commercial, and commercial ones often serve multi-site studies. Research approved by one is respected by regulators, journals and funders. Researchers who start enrolling before the approval letter arrives can have their data refused by journals and regulators.

A university researcher plans a study that asks patients with chronic pain to try a new exercise programme and share health records. The board asks her to simplify the consent form, to explain how records will be anonymised and to set stopping rules if pain worsens. She revises the plan, the board approves it for one year, and she reports any adverse events to the board as they occur.