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What Are Your Rights as a Patient in a Clinical Trial?

The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect patients. These safeguards include regular reviews of the protocol (the study plans) and the progress of each study by researchers at other places. For example, federally regulated clinical trials must first be approved by an Institutional Review Board (IRB) usually located at the institution where the study is to take place. IRBs, designed to protect patients, are made up of scientists, doctors, clergy as well as other various individuals within the community. An IRB reviews a study to see that it is well designed with safeguards for patients and that the risks are reasonable in relation to the potential benefits. Federally regulated studies also go through reviews by a government agency, such as the Food and Drug Administration (FDA) which monitors trials throughout the country. Any well-run clinical trial is carefully reviewed for medical ethics, patient safety, and scientific merit by the research institution. Every study should provide for monitoring data and the safety of patients on an ongoing basis.