The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other healthcare professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
The Informed Consent Process Protects Participants
Informed consent is the process in which researchers communicate with potential and enrolled participants about a clinical study. It provides the potential benefits as well as the risks to the patient. It informs the patients that participation in the trial is voluntary, and they may discontinue participation at any time.
The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues until the study ends.
Before you begin the screening process to determine eligibility for the clinical trial, the research team will provide you with details about the study and answer any questions so that you are thoroughly informed about the trial, its procedures and potential risks/benefits, use and potential disclosure of personal health information, and alternatives to trial participation, among other details. At this point, if you decide to participate, you will sign an Informed Consent Form showing that you have been given this information and understand it.
The Informed Consent Form will include information that tells you:
- the fact that the study involves research of an unproven drug or device
- the purpose of the research
- how long the study will take
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that the FDA may look at study records, but the records will be kept secret
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study or your rights, or if you get hurt
- that you can quit at any time
Volunteers can leave the study at any time, for any reason, even after they’ve signed the Informed Consent Form.