Information for Physicians
The goal of St. John’s Mercy Research Institute is to provide the research community at St. John’s Mercy Medical Center with outstanding administrative, informational, systems and logistical support.
If you are planning a research project, please review the Steps for Initiating a Research Project procedural document. If you have questions regarding the process or require assistance, please contact the Office of Research Administration at 314-251-6841.
St. John’s Mercy Research Institute works closely with the following entities to facilitate research at St. John’s Mercy Medical Center:
Office of Research Administration
The Office of Research Administration (ORA) consists of research professionals who serve as liaisons with physicians, clinical investigators, regulatory agencies, external sponsors and Medical Center administration to facilitate successful research projects.
ORA staff members provide:
A partial listing of Research Institute services is outlined below:
- Research coordinator support services/data collection
- Investigational study design, protocol development and analysis, feasibility study
- Statistical analysis (before, interim, after investigational study)
- Clinical trial agreement analysis and sponsor contracting services
- Financial analysis/budget review
- Legal review
- Grant preparation support
- Financial management of research funds
- Informed consent document preparation
- Investigator training in human subjects research and OHRP/FDA requirements
- Investigator training in contract pricing for protocol specific testing (lab, radiology, pathology, other services)
- IRB review and oversight services
- IRBNet training
- Logistical analysis/study completion plan
- Interim investigational study analysis
- Data analysis upon investigation completion
- Manuscript preparation
- Abstract/poster preparation
Institutional Review Board
Under U.S. Food and Drug Administration (FDA) regulations, an Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
Donald York, Ph.D., is chairman of the IRB at St. John’s Mercy Medical Center and director of St. John’s Mercy Research Institute. Dr. York may be reached at 314-251-6453 or donald.york@mercy.net. The St. John’s Mercy IRB performs a critical oversight function by providing:
- IRB review of all research studies involving human subjects
- Approval/disapproval of (or requests for modifications to) research projects
- Reviews of compliance with the Code of Federal Regulations
- Education of principal investigators and research coordinators.
St. John’s Mercy Research Committee
The St. John’s Mercy Research Committee functions as an advisory committee to the IRB in reviewing applications for research projects. The Research Committee is responsible for:
- Research policy development for St. John’s Mercy Medical Center
- Reviews of research project applications
- Recommendations to the St. John’s Mercy IRB of research projects to be supported
- Reviews of the effectiveness of present policies and recommendations for policy changes.
Committee Members:
| Robert W. Taylor - Committee Chair |
| Paul Hintze - VP Medical Affairs |
| Donald York - IRB |
| Denise Scoffic - Finance |
| Jeanne Cantalin - Legal |
| Keith Starke - Internal Medicine |
| Tim Smith - Internal Medicine |
| Elizabeth Jung - Neonatology |
| Gilbert Webb - Ob/Gyn |
| Terri Halloran - Nursing |
| Dotti James - Nursing |
| Kathleen Simpson - Nursing |
| Jacklyn O'Brien - Research Coordinator |
| Vito Mantese - Vascular Surgery |
| John Ponzillo - Pharmacy |
| Bethany Sleckman - Hem/Onc |
| William Logan - Neurosciences |
| Michael Petersen - Pediatrics |
| Robin Hansen - Pediatrics |
| Bruce Czarnik - Cardiology |
| Farrin Manian - Infectious Diseases |
| Christine Janney - Laboratory Medicine |
