SCHOOL OF MEDICINE

Department of Medicine

Infectious Diseases Clinical Research Program

FAQ

What is clinical research?

Clinical research (also called a clinical study or clinical trial) uses human volunteers under close observation to answer questions concerning disease issues. Clinical studies are the fastest and safest way to find answers and treatments that work in humans to improve health. Studies are carefully conducted and must follow a strict set of rules and regulations, called a protocol. The protocol is designed to protect the safety of the volunteer to the highest degree. Clinical trials must also be approved by an independent committee(IRB) that examines the risks and benefits of the study and determines if risks are reasonable.

There are different types of clinical trials. Some need volunteers with specific illnesses and some need healthy volunteers. Some examine the effects of a new drug, vaccine, or treatment and others examine large populations in natural settings.

Why volunteer?

There are many benefits in volunteering for a research study. Some people believe that those who participate in research studies are the "guinea pigs." This belief is false. Research volunteers receive the same quality of care as other patients. Moreover, research volunteers may gain access to new research treatments before they are widely available to the general public. All volunteers are required to receive information about the specific risks and benefits of the study through informed consent. They must provide their consent to participate before any research procedures are performed. Furthermore, participation in research studies helps others by contributing to the general fund of medical knowledge. For example, some studies measure how effective a medicine is in treating a certain illness or disease. Through the help of study volunteers it can be determined if the medicine had any effect on the illness or disease. Did the new medicine improve the symptoms or did it have no effect at all? There are many questions in research and with the help of research volunteers many of them can be answered.

Is research confidential?

The same ethical and legal codes that apply to medical practice also apply to research. Clinical research is federally regulated and this protects all volunteers and their personal information. All personal and medical information will remain confidential, only to be seen by those authorized to do so.

Can a participant leave a clinical study?

Yes. The participant may leave a study at any time. The participant is willingly volunteering to participate in the research study and may choose to leave at any point in time. If withdrawing from a study, the participant should contact the research team and inform them and the reasons for leaving the study. The participant many be asked to return for a safety evaluation before withdrawing from the study.

If you have any other questions or are interested in one of our current studies, feel free to contact us at (317) 278-2945.