The ethics board
Each study has an ethics committee, known as an institutional review board or IRB. It approves the plan first and then checks on progress for as long as the study lasts. It looks at the risks, the consent form and how volunteers are chosen, and it can require changes or suspend the study.
Its contact details are on your consent form, and you can call it yourself.
The data and safety monitoring board
Larger studies, and studies with higher risks, often have an independent panel of experts that looks at results while the study runs. Unlike the study team, it can see which volunteers are in which group. It can recommend that a study change course or stop early.
The FDA
For studies of medicines, vaccines and medical devices, the Food and Drug Administration reviews the plan before testing in people begins, receives reports of serious side effects and can inspect research sites. It can also put a study on hold.
The sponsor and the study team
The sponsor, often a drug company, a university or a government agency, designs and funds the study and has to monitor how it is run. The study team at each site follows the plan day to day and reports problems to the sponsor and the ethics board.
Treat this page as general background on how research protects volunteers. For your own situation, ask the study team or your doctor.
