How participants are protected in the US
Institutional Review Boards
Pharmacologists, doctors and other interested parties serve on local IRBs to review and monitor research conducted on humans in hospitals or research institutions in their catchment area. IRBs ensure that the selection of participants is fair and that they are fully informed about the trials before they consent to take part.
Data Monitoring Committees
These bodies become involved when one treatment is being compared with another, and are also actively engaged in trials of treatments for serious or life-threatening diseases.
FDA inspections
The Food and Drug Administration inspects the records of the personnel, clinics and other research sites involved in studies. The FDA ensures that trials are conducted correctly and the volunteers are protected. It's also involved in the procedure to resolve complaints made by test participants.
- Yang Wanli
Source: US Food and Drug Administration
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