In 2003 Springfield Neurological and Spine Institute (SNSI) first became involved in research through clinical trials. Since that time SNSI has participated in several clinical trials. SNSI works with our local Institutional Review Board at CoxHealth to approve these clinical trials as well as track devices that fall into the category of human device exemption. Below is a brief synopsis about clinical trials.
What is a Clinical Trial?
Clinical trials are research studies in which patients help doctors and researchers find ways to improve health care. Each study tries to answer a scientific question to find a better way to prevent, diagnose or treat diseases/conditions. The design of a clinical trial is to compare a new treatment options with the standard of care or a placebo if no standard treatment exists. New treatment options are studied in different stages, to receive Food and Drug Administration (FDA) approval a treatment must go through three phases of study.
What to Expect?
Your doctor will help determine if you are eligible to participate in a clinical trial. All clinical trials have very strict criteria for enrollment. Once it is determined that you are able to enroll in a clinical trial the clinical research coordinator or physician will review the Informed Consent Form with you. This form will list the rules and responsibilities of your involvement in the clinical trial. If you are confused please call your doctor or the research coordinator. There are no additional costs associated with participation in a clinical trial.
What is Informed Consent?
Informed consent is a process that gives a research volunteer all the information available about a clinical trial. This process of information exchange may include subject recruitment materials, verbal instructions, question and answer sessions, and measures of subject understanding.
Your physician or the clinical research coordinator should explain the clinical trial to you, including any risks. Prior to participating in the study, you will be given an informed consent form. If something in the form is not clear to you, ask your physician or the clinical research coordinator to explain it to you.
It’s up to you to decide whether or not you want to take part in a clinical trial. If you decide to take part in the study, you will sign the consent form and be given a copy for your records. Please note that the informed consent contains important information you may refer to during the trial. If you choose not to participate in the trial your care will not be affected in any way.
What is an IRB?
An Institutional Review Board (IRB) is a committee charged with protecting the rights and welfare of people participating in research activities. The IRB reviews research applications involving human subjects, provides ongoing oversight to ensure regulatory compliance, and assures that the risks to research subjects are minimized and participation by these subjects is done so on a voluntary, informed basis. All clinical trials at Springfield Neurological and Spine Institute have been reviewed and approved by the Western International Review Board (WIRB)
Questions for your Physician
When you’re considering participating in a clinical trial, you need to know as much information about the study and its components as possible. We’ve included a few of the questions you might ask before becoming a research volunteer:
- What is the purpose of the study?
- How long will the trial last?
- What other options or choices do I have if I decide not to participate?
- What tests and treatments does the study involve?
- What are the short- and long-term side effects; or risks and benefits of this trial?
- How do these compare to my current treatments? What is this referring to? Side effects, treatments, risks and benefits?
- What type of long-term follow up care is part of the study?
- Who will pay for the treatment and all other expenses related to the study?
- How can I end my participation in the study if I change my mind?
- Whom do I contact for questions and information about the study?
- For additional information regarding clinical trials at SNSI, please contact the Clinical Research Coordinator Jessica Ratcliff at 417-885-3888
Links for Clinical Trial Information
- Clinicaltrials.gov is a database of information on federally and privately supported clinical trials.
- The Food and Drug Administration (FDA) assures the safety of foods and cosmetics and the safety and efficacy of pharmaceuticals, biological products and new medical devices.
- The Health Insurance Portability and Accountability Act (HIPAA) is a US law designed to provide privacy standards to protect patients’ medical records and other health information provided to health plans, physicians, hospitals and other health care providers.
- National Institutes of Health’s (NIH) mission is to uncover new knowledge that will lead to better health for everyone.