What is a clinical research study?
A clinical research study is a study in human volunteers to answer specific health questions. Research studies determine whether investigational treatments or new ways of using known therapies are safe and effective under controlled environments. Research studies may also address health issues in large groups of people or populations in natural settings.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical research study 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 study explain the details of the study. The narcolepsy research team, in particular, 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 study at any time.