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- What are Clinical Studies?
- Why should I participate?
- Will I be compensated?
- Are there safeguards to protect study volunteers?
- I'm interested in participating. How do I get started?
Clinical trials are research studies in which real people participate as volunteers. The purpose of clinical trials is to find new and improved methods of treating, preventing, screening for, and diagnosing different diseases.
During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are hoped to be at least as effective as -- or possibly more effective than -- current treatments.
There are strict rules for clinical trials, which are monitored by Institutional Review Boards and the U.S. Food and Drug Administration more broadly.Clinical trials make it possible to apply the latest scientific and technological advances to patient care.
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, medical technology and advancement ceases to exist.
You may receive a new treatment before it is widely available to the public.
You can provide researchers with the information they need to continue developing new procedures and introducing new treatment methods.
Your treatment costs may be decreased or free, because many of the tests and doctor visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. Your insurance is not billed for any study-related procedure(s).
In addition to top notch medical care and free study-related protocol procedures, qualified study participants are often compensated for their time and effort in participating in a clinical research study. An Institutional Review Board approves the stipend amount which can be found in the Informed Consent form.
Protocol review: All protocols must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
Informed consent. Your participation in any clinical research protocol is voluntary. For every study in which you intend to participate, you will receive a document called "Consent to Participate in a Clinical Research Study" that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you.
If you are interested in participating in one of our clinical research studies, you should complete the Confidential Contact Form. We will contact you within one business day.
In the message section, identify the study in which you are interested and put the best time of day for us to call. Your message goes right to our clinical research coordinators who will contact you to review some preliminary information about the study and ask you a few screening questions.
After the initial phone screening, our staff will schedule a more in depth screening visit appointment at our medical office. At this appointment, you will be given the Informed Consent form which is written in easy to read language and provides information about the research study. You will have the opportunity to ask any questions of the research team, including the study doctors. You may bring family members with you and include them in the question/answer session. You may also take the Informed Consent form home with you to discuss the research with whomever you please. When all of your questions have been answered and you indicate you wish to proceed, you will sign the Informed Consent form and the Screening visit will begin.
Often the screening visit takes a couple of hours because it includes plenty of time to answer your questions. The screening visit will include reviewing inclusion criteria, taking a complete medical and surgical history, and reviewing current medications. Additionally study related medical exams, which may include vitals, physical exam, blood draw, ECG, mammogram, etc. may be performed or scheduled according to the specific protocol.
It is important to note that you can withdraw from a study at any time for any reason.