To conduct research at Saint Luke’s Hospital (SLH), UMKC School of Medicine (SOM) residents/fellows must initiate the research approval process at least 2 months prior to research project start date. Residents/fellows must complete applicable items to initiate a research project and obtain Institutional Review Board (IRB) approval.
- Residents must complete the required Collaborative Institutional Training Initiative (CITI) training before beginning their research.
- The required CITI trainings are:
UMKC Group 1-Biomedical Investigator and
Conflict of Interest courses,
which are listed at: http://med.umkc.edu/ora/human_subjects/. Residents and fellows may contact the UMKC School of Medicine Research Administration office – SOMResearch@umkc.edu to obtain a copy of their CITI training certificates.
- Write a brief summary (2-3 page) of the proposed research project or protocol.
- Submit the project to the UMKC SOM Research and Statistical Consult Service for statistical evaluation, if statistical expertise is not provided by the mentor.
How much “lead time” should be provided ?
It is expected that the faculty, staff, residents and students will make a request at the beginning of the project (when designing) in order to obtain input from a statistician regarding study design, the research objective and measures, data collection/format, and the analysis plan. Lead time will depend on the complexity of the project, but at least 2 weeks will have best results.
Expectations — such as name on publications, presentations, etc., ?
Discuss this at the beginning. The biostatistician is able to provide and/or collaborate in creating written content, figures, and tables for papers and posters. We anticipate that the biostatistician who works on the project will be listed as one of the co-authors to the publication.
Researchers should incorporate other deadlines like IRB submission, factor in data collection, and meet with biostatistician.
Researchers are responsible for collecting data and making it available to the biostatistician in a de-identified, usable format (see REDCap info below).
Optimizing Data Collection – REDCap (research electronic data capture) is a recommended tool for research data collection and can be customized to the specific project. REDCap is designed to comply with HIPAA regulations and data can be exported in many formats such as SPSS and excel worksheet. REDCap accelerates research by limiting repeated effort and centralizing processes. REDCap helps ensure data confidentiality and is much preferred over using Excel data sheets.
The SOM Dept. of Biomedical and Health Informatics staff are available to train researchers to use REDCap, see –https://chi.umkc.edu/redcap/
- Residents must identify a primary mentor and discuss the research background, design, methods of data collection and analysis with mentor. Mentor Agreement Form.
- Send brief summary of the research proposal to Dr. Paula Nichols, SOM Associate Dean for Research, to review/approve proposal and/or schedule a brief phone interview and/or brief one on one interview
- Send your protocol to determine the reviewing IRB – either the SLH IRB or Schulman IRB (for clinical interventional projects). The Schulman IRB has been delegated review of certain research at SLH.
The previous items must be completed prior to submitting the project to the SLH IRB.
- Clinical interventional studies are reviewed by the Schulman IRB (SAIRB).
The submission forms are located under 1.0 at http://www.sairb.com/forms/
The Schulman IRB cover letter must be completed and sent to the SLH IRB. SAIRB Cover letterSend the SAIRB cover letter to the SLH IRB, along with the following items:
- CITI training certificates
- The signed UMKC mentor form
- Email all documents to IRB@saint-lukes.org
- Submit non-clinical interventional studies to the SLH IRB.
The project IRB submission forms – www.saintlukeshealthsystem.org/institutional-review-board
The completed SLH IRB submission requires the following signatures at SLH:
- Director of Medical Education (Diana Dark, MD)
- Project Principal Investigator (SLH Medical Staff member)
- Principal Investigator’s Department Director
And forward to the SLH IRB:
CITI training certificates
The signed UMKC mentor form
Email all documents to IRB@saint-lukes.org