What is a clinical trial?    Who can participate?    Are clinical trials safe?    What happens and why should I participate?    What are my rights?    What are the costs?    Will my medical information be kept private?

A clinical trial is a research study that involves human volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. Cancer clinical trials often compare the most accepted cancer treatment (standard treatment) with a new treatment that doctors’ hope will be both safe and effective. Clinical trials are carefully designed and monitored to ensure the safety of patient volunteers. Clinical trials are required by the Food and Drug Administration (FDA) before any medication can be used by the general public. Learn more at:  www.nhlbi.nih.gov​

Many treatments used today are the results of past clinical trials.

Any participant who gives consent to participate in a clinical trial or who is asked to give consent on behalf of another has the following rights:

• To be told the purpose of the clinical trial
• To be told about all the risks, side effects, or discomforts that might be reasonably expected
• To be told of any benefits that can be reasonably expected
• To be told what will happen during the trial and whether any procedures, drugs, or devices are different from those that are used as standard medical treatment
• To be told about available options and how such options may be better or worse than what is being studied in the clinical trial
• To be allowed to ask any questions about the trial before giving consent and at any time during the course of the trial
• To be allowed ample time, without pressure, to decide whether to consent to participate
• To refuse to participate, for any reason, before and after the trial has started
• To receive a signed and dated copy of the Informed Consent form
• To be told of any medical treatments available if complications occure during the trial

Adapted from The Center for Information and Study on Clinical Research Participation. Learn more at: www.ciscrp.org

Participants have rights.​

Research studies have costs, and health insurance does not always pay for all your costs in a study. When you take part in a trial, you may visit the clinic more frequently during a trial than you would under routine care. Your doctor keeps a close eye out for any adverse effects and makes sure you’re safe during the study. It’s important to discuss these expenses with your medical team or social worker. Some health plans will not reimburse such expenses. For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute’s Web site. You can print a copy of the “Clinical Trials and Insurance Coverage” information from this website as well.

There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. They include:

• Doctor visits
• Hospital stays
• Standard cancer treatments
• Treatments to reduce or eliminate symptoms of cancer of side effects from treatment
• Lab tests
• X-rays and other imaging tests

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

• The study drug
• Lab tests performed purely for research purposes
• Additional x-rays and imaging tests performed solely for the trial

Understand patient care and research costs.​

Efforts will be made to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from the study is published or presented at scientific meetings, your name and other personal information will not be used.

A record of your progress will be kept in a confidential form at your hospital or doctor’s office where you receive treatment. Organizations may inspect and/or copy your research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for quality assurance, research, and data analysis. If your record is used or given out for government purposes, it will be done under conditions that will protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of information and law-enforcement responsibilities of the agency. These agencies may review the research to see that it is being done safely and correctly. You authorize the use of clinical information contained in your records, but any publication which includes such information or data shall not review your name, show your picture or contain any other personally identifying information, except as otherwise required by law. Learn more at: privacyruleandresearch.nih.gov

Respect the privacy of every research patient.​