fter you find a clinical trial and pass the screening process, there is another step before joining a trial. The research team must give you some important information about the trial before you decide to participate. This is called the informed consent process. During this time you will have the chance to ask questions until you have all the information you need.
Before you can enroll in a clinical trial, the research team must tell you what to expect during a trial and what might happen unexpectedly. The informed consent document outlines all this information.
If you agree to take part in a trial after you learn about the potential risks, benefits, and your rights and responsibilities, you sign the informed consent document. However, this document is not a contract. You can leave the trial at any time for any reason.
Informed consent is a continuing process that helps you decide whether to enroll in a trial. During the first meeting and in follow-up meetings the research team will tell you about
- tests or treatments that you may get if you are assigned to the treatment group
- possible risks and benefits of these tests or treatments
- standard tests and treatments available now
- what you need to do, such as take medications at a certain time.
Scientific studies can be complicated, and the research team needs to know if you understand all the information they give you. They may test how well you understand by having you fill out a questionnaire, asking you questions, or having you explain certain parts of the trial in your own words.
Sometimes, a potential participant may not be able to give informed consent because of memory problems or mental confusion. Someone else, usually a family member with a durable power of attorney, can give consent for that participant. That caregiver must be confident there is small risk to the participant, and the participant would have agreed to consent if he or she were able to do so.
So what questions should you ask the research team to help you decide whether or not to enroll in the trial? You have the right to ask them anything about their clinical trial. If you do not like the answers they give you, ask more questions. If you are still not satisfied, do not agree to take part in the trial.
You should ask the research team the following questions.
- Why are you doing the study?
- What treatment, procedure, or test will I have? Will it hurt?
- What will I have to do?
- What are my chances of getting the experimental treatment?
- How will the study affect my daily life?
Ask the research team the following questions.
- What are my possible benefits?
- What are my risks, such as side effects?
- How will I be protected?
- Can I take my regular medicines while in the trial?
- Will I be able to see my own doctor?
- Where will the study take place?
- Will transportation be provided if I need it?
- How long will the study take?
- Will being in the study cost me anything?
- Will my insurance cover the costs?
One question the research team can't answer is whether you will be assigned to the experimental treatment group. Your placement in the treatment or control group is done randomly, usually by a computer.
After getting the facts about the trial, and you agree to participate, the research team will give you the informed consent document. It describes the trial and explains your rights and responsibilities as a participant. If there is anything you don't understand in the consent document, ask for a better explanation before signing it.
During the trial, the research team may discover new information that could affect your health or change your mind about staying in the study. They will give you this information and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information makes you uneasy about continuing.
From the National Institute on Aging
03 January 2008
http://nihseniorhealth.gov/participatinginclinicaltrials/informedconsent/01.html
