To protect the rights and welfare of clinical research volunteers, U.S. Federal Agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the medical research in the United States. Institutional Review Boards (IRBs) oversee the cancer centers, such as Rutgers Cancer Institute of New Jersey, where clinical trials are conducted. IRBs review and approve the clinical trial plan (also called a protocol) to ensure that a clinical trial is ethical and that volunteers’ rights are protected. A participant in a clinical trial has access to the IRB that is overseeing the research, to a volunteer advocate, and to the physicians conducting the study.
When conducting clinical trials, Rutgers Cancer Institute of New Jersey’s most important responsibility is to protect patients through well-designed protocols, a dedicated Institutional Review Board (IRB), a careful informed consent process and rigorous monitoring of the safety of the clinical trial. A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. As part of Rutgers University, researchers must follow the protocol approved by the University's Institutional Review Board.