Patient Education

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

• A research study involving human volunteers to answer specific health questions.
• A clinical research study is conducted according to a plan called a protocol.
• A protocol describes what types of patients may enter the study; schedules of tests and procedures, drugs, dosages, and length of study, as well as outcomes that will be measured.
• Each person participating in the study must agree to follow the protocol.
• A clinical research study explores new ways of using known treatments.

• The clinical research study protocol outlines what types of individuals are eligible for participation in a particular study.
• The study can specify that people of a specific age, medical history, disease type or current diagnosis are eligible to be in a study.

• Participants may gain access to new medications and interventions prior to general availability.
• The ability to take a more active role in personal health care decisions
• The potential to improve health status if the study therapy proves to be effective.
• Unique opportunity to help others by contributing to clinical research.

• The treatment may not be effective.
• Participating in the trial may be demanding and time consuming.
• Health status may not improve or there may be unpleasant or serious side effects resulting from the treatment.

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.

• The federal government has strict guidelines and safety standards to protect clinical research participants.
• An Institutional Review Board (IRB) (an independent committee of physicians, health care professionals, and community members) is responsible for ensuring that clinical research is both scientifically and ethically sound.

• The decision to participate in a clinical research study is up to you.
• If you decide to participate you do so as a volunteer.
• As a volunteer, you can decide to stop the study treatment at any time

• As a research volunteer, you can end your participation in the study at any time.
• For safety reasons, a follow-up visit may be required.

• You do not have to participate in a research study.
• Your decision to not participate in a research study will not affect your heath care.

• Who is conducting the research study?
• Who is sponsoring the research study?
• Who will be responsible for my care?
• What is the purpose of the research study?
• What are the potentials benefits/risks of participating in the research study?
• What are the clinical research study-related costs?
• What is the overall time commitment that is expected of me?
• What are my other treatment options?
• How does the research study therapy compare to other treatment options?
• How often are clinical research study-related visits conducted?
• How long will the clinical research study last?
• How do I end my clinical research study participation if I change my mind?
• How many people will be in this study?