What are clinical trials?
Clinical trials are research studies in which people participate as volunteers. Clinical trials are a means of developing new treatments and medications for diseases and conditions. There are strict rules for conducting clinical trials, which are followed by Medical Associates of North Georgia and monitored by the U.S. Food and Drug Administration. Some of the research studies conducted at Medical Associates of North Georgia involve promising new treatments that may directly benefit patients.
Why should I participate?
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you who take part in clinical research. The role of the volunteer in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at Medical Associates cannot be accomplished.
Are there risks involved in participating in clinical research?
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.
What Is Informed Consent?
Your participation in any clinical trial 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.
What are the benefits of volunteering to take part in clinical research?
Healthy volunteers who take part in clinical research studies at Medical Associates of North Georgia may receive Physical Exam(s), Lab evaluations, ECG(s), Medication, Compensation and additional medical knowledge. In addition, you may experience the satisfaction of helping someone suffering from a chronic, serious, or life-threatening illness as well as provide important scientific information for developing new disease treatments.
Will I be compensated?
Yes. We compensate volunteers for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the volunteer’s time; the study’s principal investigator determines inconvenience rates. Medical Associates of North Georgia reports compensation of $600 or more to the Internal Revenue Service and sends a “Form 1099-Other Income” to the volunteer at the end of the year.
If you have any questions regarding our Clinical Research Trials, please contact Christopher Davis – firstname.lastname@example.org