Global Medical Institutes, LLC

Introduction to Clinical Trials I Glossary I General Information on Clinical Trials

Participation In Clinical Trials
For those considering participation in a clinical trial, the following frequently asked questions are important in understanding the role of the participant and the unique process of clinical trials.
»  Who can participate in a clinical trial?
»  What happens during a clinical trial?
»  What is informed consent?
»  What kind of preparation should a potential participant make for
    the meeting with the research coordinator or doctor?
»  What should people consider before participating in a trial?
»  Does a participant continue to work with a primary health care
    provider while in a trial?
»  What are side effects and adverse reactions?
»  What are the benefits and risks of participating in a clinical trial?
»  How is the safety of the participant protected?
»  Can a participant leave a clinical trial after it has begun?

What is informed consent?

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.