Volunteer Frequently Asked Questions
WHAT IS A CLINICAL TRIAL OR A STUDY?
This is a research study with human volunteers to answer specific health questions. It is the best way to evaluate drug effectiveness and safety in a controlled environment. The FDA requires all medications be tested before they can be prescribed by a physician.
HOW DOES A DRUG GET APPROVED BY THE FDA?
Drug Companies must spend a considerable amount of time and money evaluating new drugs on at least 2,500 people. New drugs must be proven safe and more effective than a placebo (sugar pill).
IS MY INFORMATION CONFIDENTIAL?
Yes. Brevard Clinical Research Center assures its participants that all personal information is kept extremely confidential. Under Florida Medical Regulations, we will not sell or release your private information under any circumstance. Your information will not be shared without your permission or except as required by law.
WILL IT COST ME ANYTHING TO PARTICIPATE?
No. As a matter of fact, if you qualify for one our research studies, you may be compensated for your time and travel. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial which can vary per study. All visits, tests, and procedures related to the study are free of charge.
DO I NEED HEALTH INSURANCE?
No. Health insurance is not required when participating in clinical research studies.
WHAT IS INFORMED CONSENT?
This is the process designed to give volunteers the information they need before participating in a study. We discuss the requirements, risks, and potential benefits of the study and ask you to sign a document that records your willingness to participate in the study. We will answer all of your questions until you feel comfortable with your decision.
WHAT DO I NEED TO BRING TO MY FIRST APPOINTMENT?
Bring your pill bottles, your doctor’s contact info, and medical records, if available.
ONCE I HAVE ENTERED THE STUDY, WHAT CAN I EXPECT?
Once you have enrolled in a research study, you may receive a physical examination. Your study physician or a research staff member will review your medical history as well. A detailed description of your specific clinical trial and what’s expected of you will be outlined in the consent form.
HOW LONG DO THE APPOINTMENTS/VISITS LAST?
This will vary depending on the research study. Most visits for any study at our clinic are at least 30 minutes and some may be a few hours. The initial visit will be longer because it will be necessary to assess your medical history and discuss the consent process.
DO I HAVE TO STAY OVERNIGHT?
This depends on the research study you enroll in. Each study varies in the amount of time the patient needs to dedicate. Phase 1 studies are more likely to require overnight stays.
ARE CLINICAL STUDIES SAFE?
Volunteer safety is the number one priority for all clinical trials. Before a treatment is tested on people it is thoroughly tested using various laboratory techniques. The Food and Drug Administration has established rules to govern participant safety. An Institutional Review Board must approve study procedures before a clinical trial can begin.
WHAT IF I DECIDE I NO LONGER EANT TO PARTICIPATE IN THE STUDY?
Your participation is voluntary and you are always able to leave a study at any time. If you are having concerns about your participation we would like you to contact your coordinator or other staff member to discuss your concerns as soon as possible.