What is a clinical research study?
A clinical study tests the safety, effectiveness and side effects of an investigational
medicine or an investigational device on a group of volunteers. These studies
are sponsored by private organizations and government agencies to find better
ways to treat diseases.
Why are these studies important?
The research we conduct today will lead to tomorrow’s medical standards
of care. Clinical research help scientists develop improved treatments and
sometimes lead to cures.
What can I expect as a volunteer?
First and foremost you can expect the utmost in care and privacy. Our medical
team will review your medical history and determine if you are eligible for
the study. If you are eligible you will be given instructions for participating
and we will monitor your health throughout the process. Some studies require
more tests and doctor visits than you would normally have for an illness
or condition.
What is informed consent?
Informed consent is the process that takes place before you join a study. A
doctor, nurse or another person on the team will explain why the study is
being done, and what you can expect. You are encouraged to ask any questions
you have about the study. You will be given a consent form to read and will
be told about the strict confidentiality of your personal medical information.
If you decide to take part in the study, you will be asked to sign the consent
form. Even if you sign the consent form, you can still change your mind and
stop at any time.
Are clinical studies safe?
There are risks and side effects associated with almost any treatment whether
it is standard of care or a clinical study. However, there are safeguards
in place to make clinical studies as safe as possible and protect patient
rights. Before a treatment is tried with patients, it is studied in the laboratory
to determine the best new treatment methods with people safely and effectively.
What is the Institutional Review Board (IRB)?
Any research involving people at Veritas Clinical Specialties must be approved
by an Institutional Review Board (IRB). The IRB is made up of doctors of
different specialties, ethicists (often a chaplain), administrators as well
as members of the public. The members of the IRB are authorized to review,
require changes to, approve or disapprove studies. The U.S. Food and Drug
Administration (FDA) requires IRB’s to ensure protection of the rights
and welfare of patients who are enrolled in clinical studies.
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