Research and Innovation Southeast Michigan
Since 1955, Trinity Health has been recognized as a major teaching hospital, providing clinical research and medical education in a patient care setting. From our early work to the numerous research initiatives underway today, we continue to search for new and improved treatments and preventions for our patient population.
Trinity Health has achieved numerous honors and is at the research forefront of many clinical specialty areas including:
- Cardiovascular Research
- The hospital's cardiovascular program is one of the top three cardiovascular programs in the state of Michigan based on volume. More than 40 leading cardiologists, cardiac surgeons, vascular surgeons, and interventional radiologists staff this comprehensive program. The Heart and Vascular Institute has a strong clinical trials research base and currently participates in more than 40 externally funded studies across the cardiology spectrum.
- The hospital's cardiovascular program is one of the top three cardiovascular programs in the state of Michigan based on volume. More than 40 leading cardiologists, cardiac surgeons, vascular surgeons, and interventional radiologists staff this comprehensive program. The Heart and Vascular Institute has a strong clinical trials research base and currently participates in more than 40 externally funded studies across the cardiology spectrum.
- Investigator-Initiated Research
- Investigator-initiated research studies are supported through a collaborative team composed of clinical research nurses and research coordinators, in addition to dedicated resources for biostatistical, accounting and regulatory support. Internal funding for Ann Arbor-based investigator-initiated studies is available through an internal Trinity Health endowment which is administered by the Research Committee. The Research Committee's review focuses on a scientific, peer-reviewed process, coupled with feasibility analysis.
- Investigator-initiated research studies are supported through a collaborative team composed of clinical research nurses and research coordinators, in addition to dedicated resources for biostatistical, accounting and regulatory support. Internal funding for Ann Arbor-based investigator-initiated studies is available through an internal Trinity Health endowment which is administered by the Research Committee. The Research Committee's review focuses on a scientific, peer-reviewed process, coupled with feasibility analysis.
- Oncology Research
- Trinity Health has been designated by the National Cancer Institute as a Clinical Community Oncology Program (CCOP) since 1994 and coordinates research studies with 14 additional component hospitals. The SJMHS CCOP is one of only 50 such programs in the United States and received an "Exceptional" rating in 2011 in its reapplication for federal funding. Trinity Health participates in more Phase III and IV cancer research studies than any other hospital in the area including over 140 cancer treatment, symptom management, and prevention studies.
Research Committee
The purpose of the Trinity Health Research Committee (RC) is to oversee, develop, and promote research activities at Trinity Health. It facilitates research throughout the hospital by requiring representatives from multiple departments to serve on the committee. It works concurrently with the Institutional Review Board (IRB) to ensure that all ethical principals regarding research are maintained. The RC is primarily focused on the scientific merits and financial aspects of research.
The RC sets Trinity Health policy and procedures for clinical research activities. The committee critically analyzes and evaluates the research programs and activities. Disbursement of research funds is conducted in accordance with policies associated with each fund. Criteria evaluated include study objectives, resources, costs, plans for study management and other relevant aspects. Quality improvement activity is monitored and reviewed as well.
Is your project research?
Sometimes individuals may not be sure if the project they plan to undertake is research, which does require Trinity Health IRB review and approval, OR, quality improvement, which does not require IRB review and approval.
A checklist has been developed to help researchers/ project leaders determine if the project will require IRB review or not:
The checklist is not used for those projects that are known to meet the definition of research, such as, Clinical Trials that test the use of a test article, device or biologic in human subjects.
Definitions
Quality Improvement is the combined and unceasing efforts of everyone – health care professionals, patients, and their families, researchers, administrators, payers, planners, educators – to make changes that will lead to better patient outcomes, better system performance, and better professional development.
Research is a systematic investigation in a clinical setting designed to develop or contribute to generalizable knowledge (the Common Rule definition of research).
When completing the checklist if any checkmarks (even just one checkmark) are placed in the "Clinical Research" column this indicates that there are components of clinical research in the proposed activity. If an activity such as public health practice, program evaluation, or quality improvement includes a research component, then IRB review should occur under current federal guidance and IRB policies. Go to the "Submissions" tab to see what will need to be submitted to the IRB for review.
If upon completion of the checklist it reveals that your project is a quality/process improvement project then you do not have to submit anything to the IRB. Retain the completed checklist within your project files for future reference. You may begin your project.
Contact Us
If you want to discuss the results of your completed checklist you may contact the IRB Office at:
- Research Compliance Office - 734-712-5470
For any questions on our research efforts, or to request additional information, please contact the Trinity Health research office at 734-712-5470.