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What Protection Do You Have as a Patient in a Clinical Trial?
   
 

Clinical trials are governed by the same legal and ethical codes that oversee medical practice. Safeguards for patient protection are ensured in clinical trials that are federally funded and/or regulated. Constant checks are made on research protocols and passages from one phase to the next.

Each study site has an Institutional Review Board (IRB) with members (scientists, clergy, physicians, and local citizens) having the job of reviewing the study protocol, noting the presence of safeguards, and identifying what the benefits and potential risks would be. The IRB exists to protect the study volunteers.

Government agencies are always overseeing the progress of clinical trials and will only permit studies that have been fully planned, researched, described, and documented. Aside from the precautions taken to ensure the patient's security with the scientific aspect of the trial, medical ethics and personal needs are always taken into account.

Informed consent is a key component that helps to protect patients. Scientists and government agencies require the ability to review the information gathered as the trial progresses. This guarantees adequate inspection and continuous checks. Any deviations from the protocol must be recorded and reported, and any changes in the study protocol have to be approved by the IRB.

Patients are constantly encouraged to ask questions. Not only is this a beneficial step for the participants, but the doctors and researchers gain from the queries as well.



 


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