New treatments must be studied in the laboratory first to determine safety, before they can be administered to people. Treatments which have acceptable safety profiles and show the most promise are then moved into clinical trials. For safety purposes, clinical trials start with a small group of volunteers or patients to find out whether a new drug causes any harm. In later phases of clinical trials, larger populations are involved, and researchers learn more about the benefits and possible risks of the new treatment when it is administered over longer periods of time. These studies follow a written plan called a protocol that specifies the procedures to be carried out and includes set instructions and standards to protect all participants. The protocol also ensures all information collected about the participants remains private and confidential. Before a clinical trial can begin, the protocol has to be approved by an independent group of doctors, nurses and lay people to make sure the protocol conforms to a globally set of ethics and procedures designed to ensure the participant’s safety.Clinical trials are designed to obtain consent at every step, so nothing will be done to a participant without their permission. In addition, protocols require that the health of participants are closely monitored and any safety concerns are promptly addressed. If the drug is found to cause harm or the participant cannot tolerate it for any reason, the trial team may discontinue treatment to that patient, and at any time, participants may leave the trial for any reason without it impacting their future medical care.