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Informed Consent
 
Informed Consent

Every potential subject is given a copy of the Informed Consent Form that can be read at the subject's own pace.  We encourage every potential subject to take the informed consent home and discuss the information contained in the consent with family and friends.  A member of the study staff will go over the Informed Consent and answer any questions that may be asked or need to be clarified. The Investigator will be available for any additional questions or concerns.  Our goal is for the subject to understand all aspects of the study, subject rights, and subject responsibilities.  All subjects will be given a copy of the signed Informed Consent for their personal records.  The subject will be given contact names and telephone numbers should any questions arise at a later time.

 

Questions Answered in the Informed Consent (on same page as the below)

What is the purpose of the clinical trial?

What treatments will be done and how?

How is patient safety going to be evaluated?

What are the possible side effects and risks of treatment?

How could this treatment benefit me?

Other than the one being tested, what treatments are available for the same condition?

Where is the trial being done and how long will it last?

Who is sponsoring the trial? Will I have to pay for anything?

What should I do if I have new symptoms or concerns develop? While I am in a treatment under study?

What if I need to withdraw from the study?