Conducting Research at University Health

Requirements, Processes and Tips

University Health (UH) Research Application form

To determine if an activity meets the federal definition of human subjects research and requires institutional review board (IRB) review/approval, submit a Research Determination to the UMKC IRB. The UMKC IRB is the primary IRB for most research conducted at UH (see UMKC IRB panel below).

If the project is determined as not human subjects research (NHSR) by the UMKC IRB, then no UH Research Application form is needed.

  • Complete UH research application and obtain department and administrative approvals.
  • Attach the appropriate items (study protocol, consent form, etc., listed on page 3) with the application form and submit to somresearch@umkc.edu.
  • Make sure to add any new project staff to the UH research application by forwarding the individual’s name, along with project the title (must match IRB submission title), principal investigator name and IRB number.

Online research training education

Human Subjects training

  • All researchers and study personnel must complete the CITI education course for the protection of human research subjects (Group 1-Biomedical) and renew every three years. See Group 1: Biomedical Investigator Human Subjects Research on our CITI Training page.
  • If sponsored/funded project, complete Conflict of Interest (COI) and renew every four years. See Conflict of Intrest Training on our CITI Training page.

UMKC Institutional Review Board (IRB)

Per formal agreement and in compliance with Department of Health and Human Services regulations, the UMKC IRB is the primary IRB that reviews research conducted at UH. There are situations where IRBs enter into collaborative review agreements and some federally funded multicenter, clinical trials that require a different IRB to review. Please discuss with Research Administration and the UMKC Office of Research Services compliance for those situations. Submit the project (or amendment to add additional project staff) to the UMKC Institutional Review Board (IRB).

Visit the Office of Research Services compliance page to learn more.

Informed Consent form

The UMKC IRB informed consent form templates meet the new federal Common Rule requirements and also include required institutional language. For research conducted at UH, a bar-code label is included on the consent form to help ensure the consent form is added to subjects’ medical records to maintain compliance with accreditation requirements. Most research conducted at UH will require consent forms to have the UH bar-code label or a sticker of the bar-code label affixed to the consent.

The UH bar-code (UH consent template) consent form may not be needed if the following conditions are met:

  1. No invasive study protocol procedures (labs, radiology imaging, dispensing of study drug, etc.) will be performed on subjects at UH, and
  2. UH is not engaged (or could be perceived as not engaged) in human subjects research because the investigator recruiting subjects is not a UH employee or is not a UH Medical Staff member with full clinical privileges.

Research Support

Students and residents may contact the Research Support team of study coordinators for guidance on the UH research application and the appropriate IRB forms for the IRB submission. 

Residents may use Research Project Protocol template (PDF) as a guide for a protocol.

Additional requirements for non-UH medical staff or non-UH employees

  1. UH Compliance Training
    • Register and complete annual training required by UH Compliance.
  2. Complete and submit the UH Office of General Counsel’s Confidentiality Agreement form (PDF) to somresearch@umkc.edu.
  3. Onboarding Process
    • Non-UH medical staff or non-UH employees must go through UH’s onboarding process. Please contact the UH Onboarding Specialistat 816-404-2566 in UH Human Resources for required HR background check, UH Occupational Health assessment — includes TB skin test and vaccine review — and attend UH HR orientation.

Statistical evaluation and data capture

Submit the project to the School of Medicine's Research and Statistical Consult Service for statistical evaluation, if statistical expertise is not provided by the mentor.

How much lead time should be provided?

Faculty, staff, residents and students must 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 two 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 a 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 worksheets. REDCap accelerates research by limiting repeated effort and centralizing processes. REDCap helps ensure data confidentiality and is much preferred over using Excel worksheets. Department of Biomedical and Health Informatics staff are available to train researchers on using REDCap. Email the department for more information.