Patients’ Rights & Protections
Institutional rules at the University of Rochester and federal regulations are in place to protect patients who take part in clinical trials. For example, any research involving patients at Wilmot first must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the community. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials. The IRB is authorized to review, require changes to, approve, or disapprove research studies.
Through a process called” informed consent,” a patient is given ample time and opportunity to ask about details of the trial before deciding to participate.
Before enrolling, patients should clearly understand the objectives of a trial and should realistically plan for all possible outcomes, including a disappointing result or even death. No one is ever placed in a study without his or her knowledge.