Medical knowledge never stands still. We are constantly evolving our medical insights, techniques, technology and prescribed medications as part of our effort to provide the most advanced and effective treatments currently available to our patients. And because we are a hospital system, each new medical advance can be shared across the entire St. Vincent family of hospitals and facilities, giving you access to the latest in world-class medical care.
Research is a big part of how we make this happen. At St. Vincent we have an extensive network of physician researchers who partner with the National Institutes of Health, the Food and Drug Administration (FDA), medical device manufacturers, pharmaceutical companies, private foundations, and other researchers from around the world to pioneer new medical procedures, find innovative uses for existing technologies, and participate in clinical trials.
St. Vincent physicians, nurses, pharmacists and other healthcare providers are currently conducting research in these areas of pediatric and adult treatment and care:
Participating in a clinical trial allows patients to receive potentially ground-breaking treatment or therapies that are currently in development, advancing the frontiers of scientific knowledge and treatment of disease. Clinical trials are important to develop new therapies and treatments. Most of the standard treatments accepted and used by doctors today are based on the results of previous clinical trials.
Clinical trials are strictly controlled research studies conducted on people. Each study is carefully designed to answer specific questions about a new treatment like a drug or a medical device to make sure it is safe and effective to use in people.
The details of the clinical trial, including all the tests and procedures used in the study, are outlined in a research plan, also called a protocol. The doctors, nurses and scientists who run the clinical trial must follow the protocol and run the tests according to the strict rules set by the Food and Drug Administration (FDA) and other government agencies. The rules ensure that people who participate in the clinical trial are treated as safely as possible.
The St. Vincent Research and Regulatory Affairs Department is the core of a robust infrastructure that serves researchers throughout the St. Vincent System. This centralized office:
The St. Vincent Institutional Review Boards (IRB) review all study protocols to ensure the protection and ethical treatment of human subject research participants as well as the scientific integrity of the research. Our IRB's operate under a domestic Federal Wide Assurance for the Protection of Human Subjects (FWA #00001631) granted by the U.S. Department of Health and Human Services.
St. Vincent has established a Human Research Protection Program, and has designated an Organizational Official to oversee this Program. The St. Vincent Human Research Protection Program covers all research involving human subjects performed at or under the auspices of any St. Vincent system hospital or subsidiary ministry (Ministry). The term "research involving human subjects" includes any research-related procedure conducted at the Ministry or any Ministry-controlled facility.
Under the terms of the St. Vincent Human Research Protection Program, the Organizational Official is authorized to determine the Institutional Review Boards (IRBs) that shall be relied upon by the Ministry. The St. Vincent IRBs are currently the sole boards that have received this reliance designation. The Ministry may rely upon IRBs of another organization subsequent to review and approval by the Organizational Official, who must ensure that appropriate steps have been taken to ensure local review of compliance with St. Vincent Ministry policies.