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Participant safety is the number one priortiy of any study. The ethical and legal codes that govern medical practice also apply to clinical trials. Most clinical research is also federally regulated with built in safeguards to protect the participants. The trials follow a carefully controlled protocol or plan which all investigators and research staff must follow. Every clinical trial in the U.S. must be approved by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefit. An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures that the trial is ethical and protects the rights of the participants. |
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