Research Study Participation - Frequently Asked Questions
Why participate in a clinical study?
Patients generally choose to participate in clinical studies because they are able to benefit from the new technologies and treatments being studied. It is also very meaningful to be able to say that you helped generations that will come after you. Someone had to be in your shoes to create the technologies and treatments we have available today. Some clinical studies also offer reduced pricing when compared to the standard treatment costs. The study sponsor and/or Vance Thompson Vision may pay for some of the costs associated with the clinical study. A member of our research will discuss all costs with you before you choose to participate in a clinical study.
Can I participate in a clinical study?
Every study we have defines the requirements for participants within that study. Eligibility differs for each study, based on characteristics such as age, medical history, and current medical conditions. If you call our office, we can give a preliminary estimate as to whether you might be a candidate, but the best way to find out is to come in for a free consultation. Then, we will be able to determine whether or not you qualify for a clinical study.
How do you protect research participants?
Each study is monitored by an Internal Review Board (IRB), whose responsibility it is to protect the patient’s rights and wellbeing. The IRB ensures that the study will not increase risk to patients and that ethical research is being conducted. The IRB discusses and releases content that informs patients and others about the study protocol, the benefits and risks, and what participants should expect during the study. Vance Thompson Vision is committed to evaluating risks vs. benefits of the studies we choose to participate in. All studies conducted at Vance Thompson Vision have to pass the test would we enroll ourselves or our family members. We are so confident in the studies we choose to participate in that several of our past participates have been family members and team members.
As a study participant, what are my rights?
If you decide to participate in a research study, it is important for you to understand what is expected of you and the importance of what you are doing. As you are considering participating in a clinical study, we want you to be assured of the rights that you have as the participant. We will provide more information when you are given the informed consent document for the study.
As a participant of a research study, you have the right to: Be informed of the study information and purpose, have an explanation of the details of the drugs or devices used in the study, have your responsibilities explained to you, know the benefits, risks, dangers, and discomforts of the study, be informed of your medical treatment options should you be injured while participating in the study, have the opportunity to ask questions regarding the research study, stop involvement within the research study at any time without affecting your treatment in the future, be given sufficient time to decide whether you would like to participate in the study without feeling pressured to participate, and be given a copy of the informed consent form which you have signed and dated.
As a research participant, what do I need to do?
When you consent to be in a clinical trial, you will be required to give us access to your accurate and complete medical history, listen to and follow the instructions and guidance of our research team, communicate with us about any questions or concerns you may have, keep us informed of any changes in your medical condition, and attend all the follow up visits required by the study protocol. All of these things are essential to obtaining the most accurate study outcomes.
What is the difference between preclinical and clinical studies?
Before humans are ever used to determine the safety of a technology, preclinical studies are conducted within a laboratory or animal treatment facility. Once a technology has been determined as promising, then clinical studies are conducted in a regulated manner and under the supervision of a select group of doctors. Clinical studies help determine the safety and efficacy of the technology, as well as whether the technology is superior to existing technologies. If a technology is determined to be safe and effective, then it may receive FDA-approval, at which point it is available to doctors and patients all across the nation.