Informed Consent: A Process Designed For You
Imagine for a moment you are a patient considering clinical trial participation. Or perhaps you have a family member or friends that are considering clinical trial participation. Either way, let's say you want to understand more about clinical trials and whether or not you (or your loved one) should participate.
First, take a minute and ask yourself two questions:
- Where would I go to get more information to learn about clinical trials?
- What information would be most important for me to find out about the trial?
A recent patient survey tells us that most patients get information about a clinical trial from their health care provider and, generally speaking, most patients want to know more about the specifics of the trial such as: "What will be involved if I participate? Are there risks? What are the benefits?" These are probably some of the same questions you have asked yourself. The good news is that there is a specific process designed just for you to learn about clinical trials and your role as a study participant.
This process, called informed consent, allows YOU to learn about the trial, openly ask questions and get answers. The purpose of informed consent is to make sure potential research participants are aware of the important details about the clinical trial so that each person can make an informed choice about participating.
Before enrolling in a clinical trial, before any procedures are conducted, potential participants must understand ALL the important details about the trial so that each person can make an informed choice about participating. Once people agree that they understand and choose to participate, they will be asked to sign an informed consent form (ICF).
The informed consent form (ICF) is a part of an information sharing process that provides details of the trial in writing, so participants have something to refer to both during the discussions and once they have gone home.
Research participants will receive the ICF from study site staff members who will explain the clinical trial in detail and answer any questions they may have. Participants will have plenty of time to go home, discuss with their family, friends and regular health care provider before making a decision to enroll.
The ICF includes details about the trial's purpose, length, procedures, risks, benefits and other information that all participants should know. Trial participants are asked to read the ICF, discuss it with the research team, and have their questions answered. After learning all of this information—and if they decide moving forward is the right decision—they sign the ICF and their clinical trial journey begins.
Each time new information about the trial becomes available, study participants will go through this process again. This repeating process is important since new information could affect someone’s decision to either stay in the trial or stop participation, even if the trial itself has not ended.
Remember participation is voluntary (just because you signed ICF does not mean you are unable to stop participation—it is not a contract).
Now that you have learned a little bit more about informed consent we hope that you use what you have learned to talk to your health care provider about participating in a clinical research trial.
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