To conduct research at Saint Luke’s Hospital (SLH), UMKC School of Medicine (SOM) residents/fellows/students must initiate the research approval process at least 2 months prior to research project start date. Residents/fellows/students must complete applicable items to initiate a research project and obtain Institutional Review Board (IRB) approval.
- Residents must identify a faculty research mentor at SLH and discuss the research background, design, methods of data collection and analysis with the mentor. The primary research mentor must complete the Mentor Agreement Form.
- 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. See sample project protocol. To avoid duplicate work, you can use your SLH Institutional Review Board protocol as your brief project summary.
The proposal should include:
- Brief Background;
- Research Question;
- Abbreviated Study Design including methods of analysis and statistical approach.
- 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/
Send the brief summary of the research proposal and the signed Mentor Agreement Form to the SOM Associate Dean of Research to review the research proposal.
- Email Dr. Paula Nichols: firstname.lastname@example.org
- In email Subject Line – type Research at SLH.
Dr. Nichols will either –
- approve the proposal;
- schedule a brief phone interview; or
- schedule a brief one-on-one interview meeting to discuss the project proposal.
The SLH Institutional Review Board (IRB) will require a signed approval document provided by Dr. Nichols.
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); and
- Principal Investigator’s Department Director.
The SLH IRB also requires a copy of the Mentor Agreement Form (see step 1).