FAQ

Questions and Answers

Should I participate in a research study?
What is a research study?
What can I expect?
What happens after the study?

Q: Should I participate in a research study?

A: As a volunteer in a research study, you help in the possible development of therapies that may offer better treatments and even cures for life-threatening and chronic back pain. People volunteer to participate in research studies for a number of reasons, including the advancement of science, hope for treatment that does not exist or improved medical care, or improved medical care. Whatever the reason, the following information answers some frequently asked questions. Be sure to make an informed choice about volunteering for a research study.

Q: What is a research study?

A: A research study is a carefully designed trial that is done with volunteers who receive investigational treatments under supervision by a physician and other research professionals to try to determine how well the treatment works and how safe it is. The clinical testing of a new treatment alternative is a step-by-step process that ensures volunteers receive medical attention. Sometimes volunteers in one study group will receive an investigational treatment, while other volunteers receive a placebo or a treatment already available. It looks like the study treatment, but has no medical effect. Whether you receive the placebo or the investigational treatment, the level of care you receive is the same.

Q: What can I expect?

A: Once you are enrolled in a study, you may receive a study-related physical examination and your medical history will be reviewed. A detailed description of your specific research study and what is expected of you will be outlined in your consent form. Risks and benefits of participating in the study will also be discussed with any research staff. Feel free to discuss your medical treatment with the investigator or any research staff member at any time during the course of the medical research study. It is important that you receive all the treatments as prescribed and keep all the scheduled visits. It is also important for you to answer questions regarding how you feel. Your study physician needs to record any adverse reactions you may experience, no matter how minor they may seem. If you miss a treatment schedule, tell your physician or research staff. As a volunteer, you have the right to leave the study at any time.

Q: What happens after the study?

A: After a study is complete, all of the information is collected and analyzed to help determine how well the study treatment works, how safe it is, and what side effects may have occurred. Food and Drug Administration medical advisors and specialists closely review this data before considering any new investigational treatment or apparatus for approval.