Arthritis Studies: A Guide for Patients
Informed Consent continued...
You are free to decide whether you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your arthritis care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments for arthritis.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
Who Can Participate In a Clinical Trial?
Every clinical trial is designed to meet a specific set of research criteria. Each study enrolls patients with certain conditions and symptoms. If you fit the guidelines for a trial, you may be able to participate. In some instances, you may be required to undergo certain tests to confirm your acceptability as a candidate.
I'm Nervous About Participating In a Clinical Trial. Should I Be?
Even though there are always going to be fears of the unknown, understanding what is involved in a clinical trial before agreeing to participate can relieve some of your anxieties.
This may help ease your concerns:
- The personal information gathered about you during the clinical trial will remain confidential and will not be reported with your name attached.
- If at any time throughout the trial you and your doctor feel it is in your best interest to exit the trial and use other known arthritis treatments, you will be free to do so. This will not in any way affect your future treatment.
- Clinical trial participants typically receive their care in the same places that the standard arthritis treatments are given -- in clinics or doctor's offices.
- Clinical trial participants are watched closely, and information about you will be carefully recorded and reviewed.
Important Questions to Ask About a Clinical Trial
If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to participate. Here are some important questions to ask:
- What is the purpose of the clinical trial?
- What kinds of tests and treatments does the clinical trial involve, and how are these tests given?
- What is likely to happen in my case with, or without, this new research treatment? (Are there standard arthritis treatment options for my situation, and how does the study compare with them?)
- How could the clinical trial affect my daily life?
- What side effects can I expect from the experimental treatment?
- How long will the clinical trial last?
- Will the clinical trial require extra time on my part?
- Will I have to be hospitalized? If so, how often and for how long?
- If I withdraw from the clinical trial, will my arthritis care be affected? Will I need to change doctors?