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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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