Clinical Research Information
What is Clinical Research?
Clinical research helps answer questions regarding best treatments for diseases. Clinical trials provide patients with opportunities to receive cutting-edge treatments not yet available. By participating in an IRB-approved clinical trial, patients and families can be assured care is delivered under the highest quality standards with special attention to each patient’s symptoms, quality of life and response to treatment.
Who Pays for Clinical Research and Trials?
The National Cancer Institute (NCI) and Heartland Cancer Research National Community Oncology Research Program (NCORP) provides funding that benefits cancer patients in five states, including patients in the Decatur area. The Heartland Cancer Research NCORP is a cooperative of three community cancer research programs that includes the Heartland Cancer Research NCORP administered by Decatur Memorial Hospital (DMH) and Cancer Care Specialists of Illinois (CCSI).
Formed in 2013, the Heartland Cancer Research NCORP is a committed network of cancer doctors, nurses and administrators from Missouri Baptist Heartland CCOP (St. Louis, MO), Illinois Cancer Care CCOP (Peoria, IL) and the Central Illinois CCOP (Decatur and Springfield, IL). Physicians, nurses and research staff serve patients and families throughout Illinois outside of the Chicago area, Missouri and portions of Kentucky, Tennessee and Arkansas.
Formed in 2013, the Heartland Cancer Research NCORP is a committed network of cancer doctors, nurses and administrators from Missouri Baptist Heartland CCOP (St. Louis, MO), Illinois Cancer Care CCOP (Peoria, IL) and the Central Illinois CCOP (Decatur and Springfield, IL). Physicians, nurses and research staff serve patients and families throughout Illinois outside of the Chicago area, Missouri and portions of Kentucky, Tennessee and Arkansas.
Funding for clinical trials is also provided by various pharmaceutical companies (industry) in addition to the NCI-funded clinical trials. These clinical trials are only available at Cancer Care Specialists of Illinois (CCSI) and its satellite locations, including Crossroads Cancer Center (Effingham), Centralia Oncology Clinic, and Cancer Care Center of O’Fallon.
The DMH Clinical Research Department provides access to more than 150 clinical trials to patients in Decatur and surrounding communities, utilizing clinical research coordinators, nurses, regulatory compliance workers and support staff. The Heartland Cancer Research NCORP, one of the largest U.S. programs of its type, is projected to move more than 500 patients into cancer clinical trials annually. The institutions within the Heartland Cancer Research NCORP, including Cancer Care Specialists of Illinois and Decatur Memorial Hospital, recognize we must all do our part to help move science forward and ultimately defeat cancer.
Awards and Achievements
The National Cancer Institute has presented the Heartland Cancer Research NCORP with numerous certificates for overall achievement while also recognizing many physicians for their contributions to cancer research. Our success is due to the collaboration between the CCOP groups, in addition to the collaboration between the radiation oncologists at DMH and the medical oncologists at CCSI - and all research staff - who work diligently to provide individual care to each and every patient.
As a result of our funding, patients in Central Illinois and beyond receive state-of-the-art therapies not previously available at smaller cancer centers and community hospitals. Patients and family members can search the clinical trials we offer at: https://createcancercare.com
Institutional Review Board
The Decatur Memorial Hospital Institutional Review Board (IRB) is charged with protecting the rights, welfare and safety of individuals recruited for, or participating in, human subjects research. The IRB accomplishes this feat by ensuring that all studies comply with institutional policies, as well as state, local and federal laws.
Education and Training Requirements
Federal regulations and guidelines require documented evidence that all individuals involved in the design and conduct of human subjects research have received (and continue to receive) training and education in the protection of human subjects. Pursuant to this requirement, Decatur Memorial Hospital IRB policy requires that all individuals involved in human subjects research receive and maintain ‘certification’ in the protection of human subjects prior to their involvement in such research.
For Human Subjects Protection training, the DMH IRB will accept training from either CITI Program or from ACRP. All other training courses will be considered on a case-by-case basis. The ACRP training is free. Create an account or sign in below.
Access ACRP Training
Once an account is created, select “all courses” and then search “Ethics and Human Subjects Protection”. Select “pricing without contact hours”, and then add it to your cart. Continue to “my cart” to obtain this free training. When you have finished, there is a survey that will need to be completed in order to obtain the completion certificate.
For Good Clinical Practice training, the DMH IRB will accept training from either CITI Program or from NIDA Clinical Trials Network. Again, all other training courses will be considered on a case-by-case basis.
Please forward all training certificates by email to the DMH IRB Administrator. Questions? Please call at 217-876-4756.
Policies and Procedures
Federalwide Assurance
Federal policy requires that each institution “engaged” in federally-funded human subjects research file an Assurance with the Office for Human Research Protections (OHRP). This Assurance is a testament to our commitment in protecting the rights and welfare of participants in research conducted at or sponsored by Decatur Memorial Hospital. The FWA number for Decatur Memorial Hospital is FWA00012630.
IRB Registration
Decatur Memorial Hospital has an Institutional Review Board (IRB) that reviews research involving human subjects conducted or supported by the Department of Health and Human Services (DHHS), or other federal departments or agencies that apply the Federal policy for the protection of human subjects to said research. The DMH IRB is also regulated by the Food and Drug Administration (FDA). The DMH IRB is registered under Memorial Health System as Decatur Mem Hosp IRB #1 with a registration number of IRB00001766.
The IRB is comprised of at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted. The IRB is sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including considerations of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The names and qualifications of the IRB members are on file with OHRP.
To access roster information, click here.
To access the IRB’s Statement of Compliance, click here.
Student Research
If you have a research project that requires submission to the DMH IRB, have no fear. It is a relatively easy and simple process.
- Contact the DMH IRB Administrator through email. Email the DMH IRB Administrator.
- Identify who you are and the nature of your research project. Most students will be performing Quality Improvement Initiatives.
- Attach your documentation to include your school's IRB application, your human subjects and/or GCP training certificate(s), any pre- and post-tests, training modules, PowerPoint presentation, and letter of invitation or consent form. This list is not all-inclusive, and not every document listed will be required.
- If your research project involves medical records, a Data Use Agreement is required. This document can be obtained by Memorial's Legal Department. Be aware this process takes time.
- All research projects require students to sign a Student Assurance. The assurance also requires the signature of Dr. Dana Flatley. You can download the Student Assurance form here.
- Decatur Memorial Hospital utilizes iRIS by iMEDRIS, an electronic system for IRB.
- Once the study application is completed, the student will be provided with instructions for submitting.
- Almost all student research can be IRB approved by the DMH IRB Chair within days.
- Your approval documents and IRB approval letter will be forwarded to you via email. You will need this documentation prior to submitting your formal application to your school's IRB.
Participants
Participant or research participant is the term used to describe an individual who has agreed to take part in a clinical trial (also referred to as a “study”).
For information on becoming a research participant or if you have questions about a study that you are currently participating in at Decatur Memorial Hospital, contact the IRB Administrator at (217) 876-4756.
Research participants are volunteers who come from all walks of life. Every participant has their reason for doing so. Reasons include helping others, wanting to learn more about a particular disease, obtaining investigational treatments, or just wanting to help advance science. Whatever the reason, Decatur Memorial Hospital is grateful to the many individuals who participate in our clinical trials.
2024 Meeting Dates