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 TMC (see UMKC IRB panel below).
If the project is determined as not human subjects research (NHSR) by the UMKC IRB, then no TMC Research Application Form is needed.
- Complete TMC research application and obtain department and administrative approvals.
- Attach the appropriate items (study protocol, consent form, etc., listed on pg. #3) with the application form and submit to email@example.com.
- Make sure to add any new project staff to TMC research application by forwarding the individual’s name, along with project title (must match IRB submission title), principal investigator name, and IRB #.
- 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 3 years. See #1 at http://med.umkc.edu/ora/human_subjects/
- If sponsored/funded project, complete Conflict of Interest (COI) and renew every 4 years. See #3 at http://med.umkc.edu/ora/human_subjects/
To avoid bias and assure objectivity in research, researchers and staff submit a signed disclosure form for all sponsored projects to firstname.lastname@example.org. See: http://ors.umkc.edu/docs/default-document-library/2012-financial-disclosure-form.pdf?sfvrsn=18.
Per formal agreement and in compliance with Department of Health & Human Services regulations, the UMKC IRB is the primary IRB that reviews research conducted at TMC. 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). See: http://ors.umkc.edu/research-compliance/irb/
The UMKC IRB informed consent form templates meet the new federal Common Rule requirements and also include required institutional language. For research conducted at TMC, 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 TMC will require consent forms to have the TMC bar-code label or a sticker of the bar-code label affixed to the consent.
The TMC bar-code (TMC consent template) consent form may not be needed if #1 and #2 below are met:
- No invasive study protocol procedures (labs, radiology imaging, dispensing of study drug, etc.) will be performed on subjects at TMC, and
- TMC is not engaged (or could be perceived as not engaged) in human subjects research because the investigator recruiting subjects is:
- not a TMC employee or is not a TMC Medical Staff member with full clinical privileges.
- Health Information Privacy and Security training – HIPS
- TMC Compliance Training
- Register/complete training (annual) required by TMC Compliance-http://www.webinservice.com/truman
- After registering, TMC Compliance assigns the appropriate training lesson(s) to your registration.
- Complete and submit the TMC Office of General Counsel’s Confidentiality Agreement Form to email@example.com
- Onboarding Process
- Non-TMC medical staff or non-TMC employees must go through TMC’s onboarding process. Please contact the TMC Onboarding Specialist: Elizabeth.Shee@tmcmed.org or (816) 404-2523 in TMC Human Resources for required HR background check, TMC Occupational Health assessment – includes TB skin test and vaccine review, and attend TMC HR orientation.
- After completion of the above – the TMC authorized requester (e.g., appropriate TMC dept. manager) may request user access and TMC sign-on by submitting a request to KC One (TMC Information Services/Cerner).
- 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/
The Research Support team created a detailed and comprehensive Research Information Guide for residents, students and faculty that plan to conduct research activities at UMKC and the clinical affiliates – Truman Medical Centers, Children’s Mercy Hospitals, St. Luke’s, and the Center for Behavioral Medicine. The Research Information Guide is posted at: http://med.umkc.edu/docs/research/Research-Info-Guide.pdf