What is an informed consent?
After you have been fully informed of the nature of the clinical study, you will be given a written agreement, known as an informed consent. It is required by the FDA for all people enrolling in a clinical trial to provide written consent indicating that they comprehend and agree to the potential risks that are involved. It’s important to take your time and understand all of the provided information before signing the consent form.
The informed consent will tell you the following information:
- The purpose of the clinical trial – what it is set up to find out
- What is expected of you and how long the trial will be
- The potential benefits
- What’s known and unknown about the new drug or procedure
- Any possible risks
- Whom you should contact if you have any questions or problems with the study
- Other possible treatment options
- Your patient rights
- How your personal information will be protected
What is the informed consent process?
The informed consent is not just a document that gets signed, it’s a process. The process provides you with ongoing information and explanations that will help you make educated decisions about whether or not you want to begin or continue participating in a clinical trial. Before enrolling in a clinical trial, you will be given information about your rights and the study. If you decide to participate in the study, you will be continuously updated and informed on any new information that may affect you. You will always have the opportunity to ask any questions or bring up any concerns you may have before, during and after the trial.
During your initial meeting at Advanced Clinical Care, you will meet with a member of our research team who will explain the information outlined in the informed consent. The information will be given to you in a way you can understand, and you will be given enough time for you to think it over and ask questions.
Time to understand the information.
It’s difficult to absorb this much new information in one sitting. You will be given a copy of the consent information for you to review at home. Many patients like to take the consent form home and review with their family and loved ones for support. Our research team will make sure we make every effort to be sure that you fully understand the information we have given you. We will ask you questions and have you explain to us about the clinical trial in your own words.
Chances to ask questions.
If at any time you are unsure about the information given to you, our research team is available to answer questions. You may not have questions until you have had time to absorb the information after the initial meeting. We encourage you to keep asking questions until you know enough to make your decision.
During your participation in a study, you will be informed of any new discoveries that the research team makes that may affect your health, well-being, or willingness to continue participating in the study.
What is the purpose of an informed consent?
Before a person makes the decision to participate in a clinical trial, they are provided with the study information that will help them make their decision. The informed consent process is intended to protect participants by providing enough information for a person to fully understand all of the risks and potential benefits of participating in a clinical trial.
Is an informed consent a contract?
No, an informed consent is not a contract. Participants in a clinical trial may withdraw from a trial at any time, even if the trial is not over.