People who participate in clinical research make it possible to develop knowledge that improves human health. The path to finding out if a new drug is safe or effective is to test it on patient volunteers.
Informed consent is one of many safeguards in place to ensure patient protection. Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.
If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.
Clinical trials are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimized and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. The Food and Drug Administration (FDA) must also approve most clinical trials that involve stem cells in the U.S.