This video explains the process of informed consent, the different sections of the informed consent form, and your rights if you choose to take part in a clinical trial.
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This video explains the process of informed consent, the different sections of the informed consent form, and your rights if you choose to take part in a clinical trial, also known as a research study.
Informed consent is a process during which a member of the research study team explains to you information about the study. This information includes the possible risks and benefits to you.
This study team member will talk with you about the study, answer your questions, and give you information in writing.
This allows you to learn enough about the study to decide whether or not you would like to take part in it. The choice to take part is entirely up to you.
Now, we’re going to review the different sections of the informed consent form.
The study team member will review the form with you and provide you with time to review it on your own. You will also be given time to ask questions.
The first section explains the usual approach to your particular condition or disease. If you decide that you don’t want to take part in the study, there will also be a list of other choices.
The purpose of the study is described next. This includes information about why the study is being done and what the researchers hope to accomplish.
After you learn about the purpose of the study, a description of the study groups is explained, followed by information about how long you can expect to be in the study.
The next several sections outline any extra tests and procedures you will need to have if you choose to take part in the study. These procedures are called screening. They are needed in order to find out if you can be in the study.
Most of the screening you will have for the study are part of the usual care you would receive for your condition or disease. However, as part of the study, you may need some additional tests or exams.
Next, you will learn about what happens during the study if you choose to take part. This includes specific information about any tests, procedures, or doctor’s visits that you may need during the study. It will also describe any medications or other important instructions. There may be a study calendar to help outline the schedule more clearly.
Being part of the study may bring side effects or risks. These will be described in detail within the informed consent form and discussion. Please take time to review this information carefully and talk with a member of the study team about any questions or concerns you may have.
The informed consent also describes any benefits to taking part in the study, along with other choices that you have if you decide you don’t want to take part.
If there are any potential conflicts of interest with the investigator or MSK, they will be written in the informed consent form. The contact information for a patient representative is also included. He or she is available to speak with you about the steps MSK has taken to protect your best interests.
If you decide to take part in the study, it is your right to stop at any time. The informed consent form explains this and explains what steps you need to take to stop being in the study. The study doctor may also decide to take you off the study. The consent form explains this, as well.
Taking part in a clinical trial is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. It will not have any impact on your care here at MSK or elsewhere. If you have any questions about your rights, the informed consent form has the contact information for people who can answer your questions.
The costs of taking part in the study are on the informed consent form and are separated into costs which may be billed to you or your insurance company, and the costs which you will not be billed for.
If you’re injured as a result of the study, you will receive medical treatment. It is important to review the injury section of your informed consent form.
Your study records will be kept private. If information from the study is used for reports or publications, your name and any other information that could be used to identify you will not be used. Only the staff involved in your care and those listed in the Research Authorization are allowed to see your medical information. We will discuss research authorization in just a little bit.
If you have any questions or concerns regarding the study, talk with the study doctor. Their contact information will be listed in the form.
There may be additional studies for you to consider in the next section. If you see this section, the research team is asking for your permission to do some additional research that is not part of the main study. This additional research will be described for your consideration. It is your choice. You may still take part in the main study, even if you do not agree to take part in the optional research study.
Toward the end of the informed consent form, you will see the Research Authorization. The Research Authorization tells you who will have access to your health information and what information about you will be used or shared as part of the study. Your privacy rights are also described. Your approval is required before we can use information that can be used to identify you for research purposes.
If you agree to take part in the study, both you and a member of the study team have to sign the informed consent form. Signing the informed consent means the study team has explained the study to you, answered your questions, received your consent that you agree to the terms of the study. You will be given a signed copy of the consent form to keep.
For more information about clinical trials, also known as research studies, visit the National Cancer Institute website. A description of the clinical trial will be available on www.Clinicaltrials.gov.
