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How are Trial Participants Protected?

Clinical trials have several built-in safeguards to help protect the people who participate. One or more review groups must approve the protocol for every study prior to enrolling patients. All clinical trials must be approved by the FDA. On a local level, the hospital or clinic has a committee, the Institutional Review Board (IRB), which oversees all clinical trials in the health care facility.

The IRB, which includes doctors, nurses and members of the community, review every clinical trial conducted at Mercy Medical Center and/or Mercy Clinics. The IRB members do not have any personal interest in the results of the study. They serve as neutral reviewers with a primary concern of protecting the rights and welfare of people who participate in clinical trials. This is the main focus of the IRB.

Most of all, participation in a clinical trial is voluntary. A person who agrees to participate can choose to stop participation at any time.

 

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