Research at St. Francis Hospital
The Spirit of Research at St. Francis
Jane Cao, M.D., MPH, FACC
Director of Research and Education
Dr. Alan Guerci founded The Department of Research and Education more than 20 years ago. His historical perspective of research at St. Francis reminds us how far we have traveled in this exciting journey. To date, we have more than 100 active research protocols including diverse clinical trials and investigator initiated research projects in all disciplines of cardiology and in surgery and oncology. Many of our researchers are nationally and internationally renowned and their publications are widely cited. This section of the St. Francis website acknowledges that accomplishment and shares the ongoing exciting development of research at St. Francis.
At St. Francis, most of our research is clinically based, both in the areas of advanced diagnostic imaging and cutting edge therapeutics. Because of such research we are able to keep our community at the frontier of today’s medicine. In the spirit of research, we have extensive collaboration across subspecialties, which I believe is the most valuable asset of our research community at St. Francis. The collective expertise in diverse disciplines enables us to gain unique perspective and to expedite discoveries. To date, our research network is beyond the St Francis community as we have extended our collaborations nationally and internationally.
Moving forward, we will continue to expand our research network, to enhance infrastructure for greater efficiency and productivity, to add more research dimensions by recruiting new talents, and to train next generation researchers by mentoring young investigators. With the strong support from St. Francis Hospital Foundation, administration and medical community, I am optimistic that research at St. Francis will continue to grow and to succeed.
The History of St. Francis Research, a Founder’s Perspective
Alan Guerci, M.D., CEO
St. Francis Hospital began in the 1930s as a sanitarium for children with rheumatic fever. With the advent of penicillin and the near-total eradication of rheumatic fever in the late 1940s and early 1950s, St. Francis had to reinvent itself. It became a heart center, complete with an open heart surgery program, a dog laboratory for surgical research, and its own journal.
St. Francis Hospital became a designated heart center in the late 1970s and conducted regional and national recruiting efforts to attract elite cardiologists and cardiac surgeons. In 1988, Dr. Joseph Levine was recruited from Johns Hopkins to begin an electrophysiology program. Dr. Levine brought with him the first wholly intracardiac lead system for implantable defibrillators and leadership of randomized clinical trials that defined the indications for defibrillator implantation. This included MADIT 1 and DEFINITE, which demonstrated that implantable defibrillators reduce mortality in high risk asymptomatic patients with and without ischemic cardiomyopathy.
Simultaneously, the hospital raised money to endow a clinical research program. This program began with the St. Francis Heart Study, a combination natural history study and randomized clinical trial of electron beam CT scanning to identify and treat patients with high levels of coronary calcification and coronary disease risk. The study demonstrated that the coronary calcium score predicted coronary disease risk more accurately than conventional risk factors and that the combination of coronary calcium score plus risk factors predicted atherosclerotic cardiovascular disease events more accurately than either one alone.
Around the time that enrollment in the St. Francis Heart Study was completed, the hospital developed clinical and research programs in non-invasive cardiac imaging. These programs have complemented research in the cardiac catheterization laboratory and clinical work generally. To date, clinical research has expanded to include all subspecialties of cardiovascular disease and beyond.
Commitment of St. Francis IRB
Mitchell Chorost, M.D.
Chairman, SFH IRB
The St. Francis Hospital’s Institutional Review Board (IRB) is a designated group responsible for reviewing and monitoring research involving human subjects. Created in 1985,the St. Francis IRB consists of members who are well versed in the elements of informed consent, institutional processes of research, compliance with relevant regulations and ethical guidelines. The purpose of the IRB is to protect the rights, welfare and well-being of human research participants, recruited to participate in research conducted or supported by the staff at St. Francis Hospital. This occurs by ensuring compliance with relevant local, state and federal laws and regulations as well as ensuring compliance with CHS, FDA and NIH policies and regulations.
Federal law requires that an IRB review and approve any research involving human subjects before a subject is enrolled into a research study, study procedures begin or data collected. For ongoing projects, an annual review is necessary as is a mid-course review if protocol changes occur or unanticipated participant risks are identified. A legally effective informed consent must be obtained from study participants, or the IRB must approve a request to waive or alter the requirements of informed consent. Additionally, the IRB will provide guidance to investigators to ensure sound research design, scientific integrity, and determining if the research contributes to generalizable know-ledge and is worth exposing subjects to risk.
We are available to answer any relevant research questions and assist in the safe collection of data.