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.

What rights does a clinical trial participant have?

Deciding whether or not to participate

If you are eligible for a clinical study, you will be given information that will help you decide whether or not to take part. As a patient, you have the right to:

• Be told about important risks and benefits.
  
• Require confidentiality, or having maintained as private all personal medical information and personal identity.
• Know how the researchers plan to carry out the research, how long your participation will take, and where the study will take place.
• Know what is expected of you.
• Know any costs you or your insurers will be responsible for.
• Know if you will receive any financial compensation or reimbursement for expenses.
• Be informed about any medical or personal information that may be shared with other researchers directly involved in the clinical research.
• Talk openly with doctors and ask any questions.

Once you have decided to participate

After you join a clinical research study, you have the right to:

• Leave the study at any time. Participation is strictly voluntary. You can choose not to participate in any part of the research. However, you should not enroll if you do not plan to complete the study.
• Receive any new information that might affect your decision to be in the study.
• Continue to ask questions and get answers.
• Maintain your privacy. Neither your name nor any other identifying information will appear in any reports based on the study.
• Ask about your treatment assignment once the study is completed, if you participated in a study that randomly assigned you to a treatment group.

What are the possible financial costs to joining a clinical trial?

In some clinical research studies, the medical facility conducting the research pays for your treatment and other expenses. In other trials, you may be responsible for costs. Be sure to ask about possible expenses.

• You or your health insurer may have to pay for some costs of your treatment that are considered part of standard care. This may include hospital stays, laboratory and other tests, and medical procedures.
• If you have health insurance, find out exactly what it will cover. If you don’t have health insurance, or if your insurance company will not cover your costs, talk to the researchers or their staff about other options for covering the cost of your care.
• You also may need to pay for travel between your home and the clinic.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.