Before the participation in a clinical research study, volunteers are required to be well informed of the consent process which thoroughly explains and describes the study as well as informing the volunteer of the potential risk and benefits. Future volunteers are also informed that they may cease their participation in the clinical research study at any time before or during the study period. Signing a consent form does not bind you to the study. You can still leave at any time.
The informed consent process includes learning the key facts about the clinical research study before deciding whether or not to participate. It is an on-going process throughout the study which is intended to keep the participant as well informed as possible. In order to educate potential or participating volunteers; doctors, nurses, staff or other clinical study coordinators are always on hand in order to help explain the details of the study or answer any potential questions.
If the participant's native language is not English, translation assistance can be provided. 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 study at any time.
