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 Clinical Research Program supports the Ministry's Core Values of Creativity and Wisdom through the courageous innovation of new approaches to serve and care for our patients, and the translation and integration of the best of those approaches into our healing ministry. Research directly improves the quality, safety and evidence-based care provided to our patients and community, opens channels to provide care for those who otherwise may not have access, and raises the academic level and reputation of our institution.
The Mission of the St.Vincent Research and Regulatory Affairs Department is to provide infrastructure support both for the St.Vincent Clinical Research Program as a whole, and specifically for the St.Vincent Institutional Review Boards ("IRBs"), which oversee human research subject protection across St.Vincent. IRBs are formally designated to approve, monitor, and review research involving humans with the aim to protect the rights and welfare of the research subjects and minimize risk. We are committed to the protection of research subjects and excellence in research performance.
Central to the St.Vincent mission of fostering excellence in research is a commitment to ensuring that all individuals conducting a research study involving human subjects receive adequate education in the protection of those human subjects.
The St. Vincent Investigator Manual defines the educational requirements for the conduct of human subject research as follows:
The St. Vincent IRB will not approve a request for a new or continuing research study until all members of the Research Team have met the education requirements.
All Research Team members (individuals who conduct research involving human subjects, or who assist in the performance of such research activities) where that research will be performed at or under the auspices of any St.Vincent system hospital or subsidiary ministry (Ministry) must complete this training. The term "research involving human subjects" includes any research-related procedure conducted at the Ministry or any Ministry-controlled facility.
For the purposes of the educational requirement, a human subject means a living individual about whom a person conducting research obtains 1) data through intervention or interaction with that individual; or, 2) information that is both private and identifiable.
CITI is a web-based human research protections training program created by the Collaborative Institutional Training Initiative. Individuals affiliated with St.Vincent can access the CITI program at www.citiprogram.org
Existing CITI Users: Use your CITI username and password to access the system.
NOTE: If you have already registered with CITI, even if that registration was with an organization other than St.Vincent, you do not need to re-register. Just use the username and password you had from your prior registration to access the system. Once you have logged onto the CITI system, you will have the option of changing your institutional affiliation. To do so, click the option for "Affiliate with another institution", and choose Ascension as your Participating Institution.
New CITI Users: At the main CITI login page, click the New Users "Register Here," and choose Ascension as your Participating Institution. Complete the remainder of the registration steps as instructed on the CITI page, and click the "Submit" button. NOTE: CME/CEU credits can be obtained for your CITI coursework, but St.Vincent does not currently provide the funding for obtaining these credits
Yes. All students, residents, and fellows who are investigators, co-investigators, or members of a Research Team must complete the mandatory education.
The St.Vincent Research and Regulatory Affairs Department serves as a centralized resource for researchers (physician, nurses, residents and others) throughout the St.Vincent System. Specific areas of consultation/assistance are:
Protocol design often is the first step in investigator initiated research and we assist investigators with an idea for a research project by helping develop a research hypothesis, a reliable study design, and an appropriate research protocol
Expert statistical consultation is available through our office, including protocol development, statistical methodology, and data management and analysis.
We assist with study budget development and coverage analysis/billing grid preparation.
After investigators design their projects, they will need to complete an IRB application to ensure compliance with federal, state, and organizational human subject protection regulations and policies. In addition to the initial application, investigators may need to complete amendments, continuing reviews, and final reports. Our staff is available to provide expert advice prior to IRB submission to ensure the smooth and timely processing through the IRB system.
All legally binding contractual documents for clinical research, including, but not limited to, Confidential Disclosure Agreements (CDA) and Clinical Trial Agreements (CTA) must be reviewed and negotiated through an attorney designated by the St.Vincent Contract Management Office. The purpose of such negotiations is to ensure that study subjects, investigators, and St.Vincent are legally protected. All CDAs and CTAs received from sponsors should be submitted through the Research and Regulatory Affairs Department using the Clinical Study Intake Form, and our staff will facilitate the processing of these agreements through the St.Vincent Contract Management system.
Once the study has begun, our clinical research compliance program is available to help ensure clinical research performance excellence, as well as regulatory compliance. The services offered by the clinical research compliance program include:
Contact us at firstname.lastname@example.org or 317-338-2194 to access any of the services described above.
In addition to the services available within the Research and Regulatory Affairs Department, our staff can facilitate access to resources in other areas of St. Vincent.
Investigational pharmacy service is available to help ensure patient safety through adherence to protocol-specific drug treatment and monitoring parameters. Compliance with regulatory requirements for clinical drug trials is maintained through appropriate data collection and monitoring. An experienced investigational pharmacist provides expertise on drug study set-up and procedures from start-up to completion of the clinical trial.
St.Vincent is committed to compliance in clinical research financial management and research patient care billing. It is the responsibility of investigators and their staff to ensure that billing for all clinical research studies occurs only as appropriate and in compliance with relevant laws, regulations and St.Vincent policies. All investigators and research staff involved with studies that involve clinical services for research participants at St.Vincent need to be familiar with and abide by all research billing processes and policies.
There are several Standard Operating Procedures and other related documents at St.Vincent that provide guidance for research billing compliance. See the links below to access these documents.For additional details and assistance with any aspect of research billing compliance or other research financial management issues, contact our Research Finance Compliance Analyst at 317-338-6741, or e-mail our office at email@example.com
|Tina Noonan, MBA, CHRC, CIP||Director, Research and Regulatory Affairsfirstname.lastname@example.org||317-338-6705|
|PT Hodgin, MD, MPH||Co-Medical Director/ IRB Chairemail@example.com||317-338-2359|
|Eric Prystowsky, MD||Co-Medical Director/ IRB Chairfirstname.lastname@example.org||317-338-6024|
|Patti Noblet, RN, CCRP||Clinical Research Operations Manageremail@example.com||317-338-2535|
|Sandy Love, RN, CCRP||Clinical Research Auditorfirstname.lastname@example.org||317-338-2576|
|Jeanne Lewis, CIM||Clinical Research Billing Manageremail@example.com||317-338-6741|
|Jennifer Kessinger, CIM||IRB Coordinatorfirstname.lastname@example.org||317-338-3420|
|Marissa Swanson, CIM||IRB Coordinatoremail@example.com||317-338-2140|
|Adrian Katschke, MS||Biostatistician||Adrian.firstname.lastname@example.org||317-338-8069|
|Todd Foster, Ph.D||Research Scientistemail@example.com||317-338-8068|
|Isaac Janson, Ph.D.||Research Scientist (Neurosciences)||Isaac.firstname.lastname@example.org||317-338-9930|
|Thom Parks||Research Data Analystemail@example.com||317-338-9514|
Below is a partial list of potential sources for grants and other funding.
There are many resources that provide valuable information and education about clinical research and ongoing clinical research trials. Below are some links that will connect you with more information.