WHAT IS INFORMED CONSENT?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
DOES A PARTICIPANT CONTINUE TO WORK WITH A PRIMARY HEALTH CARE PROVIDER WHILE IN A TRIAL?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
· What is the purpose of the study?
· Who is going to be in the study?
· Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
· What kinds of tests and experimental treatments are involved?
· How do the possible risks, side effects, and benefits in the study compare with my current treatment?
· How might this trial affect my daily life?
· How long will the trial last?
· Will hospitalization be required?
· Who will pay for the experimental treatment?
· Will I be reimbursed for other expenses?
· What type of long-term follow up care is part of this study?
· How will I know that the experimental treatment is working? Will results of the trials be provided to me?
· Who will be in charge of my care?
CAN A PARTICIPANT LEAVE A CLINICAL TRIAL AFTER IT HAS BEGUN?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.