The short version
- An IRB reviews a study for ethics and checks in periodically.
- A data and safety monitoring board can review results while the study is running.
- Regulators and sponsors can also inspect and require changes.
The review board
An institutional review board reviews the plan, the consent form and any changes, and continues to review the study at set intervals.
Monitoring committees
Many larger studies have an independent data and safety monitoring board. It looks at accumulating information and can recommend stopping, changing or continuing the study.
Sponsors and regulators
Sponsors monitor sites for accuracy. Regulators, such as the FDA, can inspect records and require action if rules are not followed.
Why it matters
These layers exist so someone other than the people running a study can look at the data. We explain how oversight is generally arranged; each study differs.
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