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What protection do you have 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 or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of the protocol (the study plans) and the progress of each study by researchers at other places.

For example, federally funded and federally regulated clinical trials must first be approved by the Institutional Review Board (IRB) at Baptist Health Louisville. The IRB is designed to protect patients and is made up of doctors, clergy and other people from the Louisville area. The 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 supported or regulated studies also go through reviews by a government agency, such as the National Cancer Institute, which sponsors and monitors many trials around the country.

Any well-run clinical trial, whether federally supported or not, is carefully reviewed for medical ethics, patient safety and scientific merit by Baptist Health Louisville. Every study should provide for monitoring the data and the safety of patients on an ongoing basis.

As discussed earlier, informed consent is also an important process that helps to protect patients.

After patients join a clinical trial and it progresses, the doctors report the results of the trial to scientific meetings, to medical journals whose articles are approved by experts and to various government agencies.

The above information is taken from "What Are Clinical Trials All About?" published by the National Institutes of Health, National Cancer Institute