Clinical Trials: Your Rights and Informed Consent

Since World War II, government organizations worldwide have declared that you have specific rights if you agree to participate in a clinical trial. No one can take these from you.

• You have the right to join a research study only if you wish to do so. You should never be pressured or coerced to join a study.
• You have the right to leave a research study whenever you want. You should never be pressured or coerced to stay in a study. You cannot lose access to your regular medical care if you leave a study.
• You have the right to full and complete information about what the study means for you personally. This is the process of informed consent.
• You have the right to ask questions about the study, both before it begins and as it continues.
• You have the right to know about alternative options. When you evaluate a clinical trial of a new medication, you should receive information about other treatments (if any) that exist.
• You have a right to join a clinical trial if you meet the eligibility criteria. You should not be excluded on the basis of age, sex, race, or any other characteristic unless this is explicitly stated in the approved protocol.

Informed Consent -- What It's All About

Informed consent is a crucial aspect of clinical trials. Informed consent is the process of giving you all of the information that you need to make an informed decision about a research experiment. Informed consent has several parts:

• Researchers clearly and accurately describe what the clinical trial involves.
• Researchers provide all of the information in writing in the informed consent document.
• You review the information and ask as many questions as needed.
• You decide whether to join and sign the informed consent document.
• You receive a copy of the signed informed consent document.

The informed consent document is a written description of what will happen in the study. In some clinical trials, the informed consent document may be several pages, but you should read it carefully. Only when you understand it fully should you join a clinical trial. If parts are complicated or unclear, ask for clarification until you are satisfied. Keep a copy of the document because you may have questions later.

The Informed Consent Document

Informed consent documents generally include the following sections:

• Introduction -- A general reminder about your rights as a study participant.
• Purpose of the Study -- A brief statement about why researchers plan to do the clinical trial. It should mention whether you will take any experimental medications not yet approved by the federal government.
• Subject Selection -- A description of how many people will enroll in the study and what the selection criteria are.
• Procedure -- An explanation of all of the tests and procedures that you will undergo, such as hospitalizations, clinic visits, questionnaires, and laboratory tests.
• Risks and Discomforts -- A list of all the risks the clinical trial may contain, such as side effects or complications from medications or medical procedures. Researchers should also explain how common these risks are.
• Benefits -- A description of the direct benefits you can expect. In clinical trials that test new medications, benefit from those medications is not included, since researchers do not yet know what the benefits will be.
• Alternatives -- An explanation of your options if you do not participate. These include using standard therapies for specific medical conditions.
• Participation and Withdrawal -- A reminder about your right to leave the clinical trial at any time, and an explanation of reasons that a researcher may remove you from a trial.
• Cost or Payment -- A list of expenses that you can expect and any compensation you will receive.
• Injuries -- A statement about who will pay for your medical care to treat research-related injuries. Federal guidelines require that this section be included in all informed consent documents, even for clinical trials that pose minor risk.
• Confidentiality -- A description of how researchers will ensure that information from the clinical trial remains private and confidential.

Clinical trials differ in what they involve, so some informed consent documents may not include all of these sections.