What is an informed consent?
Informed consent is a process of questions and answers that begins with our initial contact and continues through out the study. It is also a document that you sign stating that you have been informed about the trial and that you freely consent to participate. The consent contains the following information: The purpose of the trial. Which procedures will be performed. The number of visits. The risks associated with the study drug. Who to contact with questions. Your rights as a study participant.
How long will my participation last?
Your participation will vary depending on the trial you are interested in. Some studies are completed in one day, but typically they will last a couple of months.
Is there always a benefit to participating in a clinical trial?
No, often the only benefit is to future Cystic Fibrosis patients.
What happens if I think the study drug is making me sick?
Your health and well being is our primary concern. If the research team agrees that your health is being compromised we will withdraw you from the study, but we would ask that you to return for one final study visit.
In general what procedures can I anticipate while participating in a study?
Most often you will have your vital signs taken (heart rate, respiratory rate, height, weight, temperature and pulse oximetry check), a physical exam, blood work and usually spirometry.
While participating in a study what is my responsibility?
You need to show up for all study visits on time, comply with study procedures, and notify study staff of changes in your health and medications as soon as possible.
When I come to a study visit who will see me?
Usually you will be seen during your visit by the study coordinators.
Do I need to tell my primary physician that I am participating in a clinical trial?
Yes, if you like we will contact your doctor at the beginning of the study to discuss your participation.
What happens if I get sick while I'm enrolled in a clinical trial?
Contact your study coordinator immediately. The coordinators are on call 24 hours a day and we will direct your care through the research team.
If I participate in a study will I receive study drug for sure?
No, study subjects are most often randomly assigned to groups (study drug vs. inactive agent). The exact sequence for assignment to study drug is specified in the informed consent. Usually the study subject, the coordinators and the rest of the research team does not know which participants are getting study drug.
Is it OK for me to drop out of a study after I enroll?
Yes, you can always drop out of a study but the team will ask why you want to leave. Remember, you have made a commitment to participate.
Do I get paid to participate in a clinical trial?
Most often you are reimbursed for your time and inconvenience. Each study is a bit different. This information is clearly stated in the informed consent.
Who do I contact if I am interested in future clinical trial participation?
You should call one of the study coordinators:
- Zoe Davies (650) 498-5315
- Colleen Dunn (650) 736-0388
In order to reach our goals of better treatments and ultimately a cure for Cystic Fibrosis, we need your help. You ask: "why me?" we reply: "why not you?" Together we can work to attain our goals.
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