How are participants protected?
The government has a system designed to protect human research subjects. Before a government-funded clinical study can begin, the trial plan (also called a protocol) must be approved. During the trial, review committees make sure that the plan is being followed and participants are being protected.
Regulations require the researchers performing studies to thoroughly inform patients about a study’s treatments and tests and their possible benefits and risks before a patient decides whether or not to participate in any study. This process is called informed consent.
What is informed consent?
Informed consent is a process in which you learn the key facts about a clinical study before you decide whether or not to participate. Your doctor or nurse will discuss the facts with you, and you will receive a written consent form that you can take home to read and discuss. The consent form will include details about:
- the study approach
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have
Don’t hesitate to ask questions until you have all the information you need. Informed consent continues as long as you are in the study. You can change your mind and leave the study at any time.
Could I receive a placebo?
A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested in a clinical study. In treatment studies involving people who have cancer, placebos are very rarely used.
Many treatment studies are designed to compare a new treatment with a standard treatment. In these studies, patients are randomly assigned to one group or another. When no standard treatment exists for a cancer, a study may compare a new treatment with a placebo. However, you will be told about this possibility during informed consent, before you decide whether or not to take part in the study.
What happens during a clinical study?
If you decide to participate in a clinical study, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians and other health care professionals. They will provide your care, monitor your health carefully and give you specific instructions about the study.
Participating in a trial may mean that you might have more tests and doctor visits than you normally would. Team members also may continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, it is important for participants to follow the research team’s instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.