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FAQ: ClinicalTrials.gov - What Protections Are There?


Question: What protections are there for participating in a clinical trial?
Answer:

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

An IRB is a committee of physicians, statisticians, patient advocates, and other members of the community that reviews the protocol, or study plan, to ensure that the study is ethical and that participants are not likely to be harmed.

An IRB can stop a study if it appears to be causing unexpected harm to participants, or if there is evidence that the risks outweigh the benefits.

An IRB can also stop a study if there is clear evidence that the new treatment is effective, to make it more widely available.

Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources
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