Faculty SPiRe Application

The School of Medicine is pleased to solicit applications for a new Research Funding Program supported by the Sarah Morrison Endowment Trust. The fund, the Sarah Morrison Pilot Research Fund (SPiRe) is intended to provide funds for scientists to develop preliminary data or to pursue high risk innovative research that will enable submission of highly competitive applications to national funding sources.
The deadline for receipt of applications for SPiRe funding is December 2, at noon. Applications will be rigorously reviewed.
Eligibility:

  • SPiRe Application
  • SPiRe Guidelines
  • The research must be performed at the School of Medical (SOM) or in collaboration with faculty at the SOM where at least 50% of the research is performed.
  • Tenure track, Tenured, Research Faculty, and clinical Faculty are eligible to apply.
  • Department chairs must sign the application and guarantee salary support of the faculty member for the duration of the research project.
  • Standard awards are $15,000 total that can be spent over 2 years. If a compelling case for need can be made, up to $20,000 may be requested.

Questions may be directed to Dr. Monaghan-Nichols prior to preparing and submitting applications – (816) 235-6663.

Applications may be directed to the Office of Research Administration (Mark Hecker)  – (816) 235-6015.

Grant Management

At UMKC and the hospital affiliates located within the UMKC Health Sciences District the management of research projects, grant awards, grant subcontracts, clinical trials contracts and research gifts administered by the institutions is dependent on the sponsor and intent of the funds.

To protect human subjects that participate in research, all research activity at UMKC must be reviewed by the UMKC Institutional Review Board (IRB) of the UMKC Research Compliance office.

Virtually all human subjects research projects conducted at Truman Medical Centers (TMC) is reviewed/approved by the UMKC IRB unless the institution has entered into an IRB reliance agreement with an external IRB that allows the other IRB to review and approve the project. UMKC does have an IRB reciprocity agreement with other entities in Kansas City.

  • Federally funded grants – including subcontracts from other universities and institutions as well as foundation supported research grants – e.g., American Lung Association, are processed through UMKC. This includes federally supported research projects that involve the consent and enrollment of study participants at TMC. The School of Medicine (SOM) Office of Research Administration (ORA) works closely with the campus Office of Research Services (ORS) to process the grant proposal process (Pre-Award) and spending/allocation of resources on grants (Post-Award) for SOM faculty. More info about SOM faculty and grant awards – see #1 below.
  • Philanthropic support to the University to support a program or University faculty member’ projects are considered gifts and are managed by the UMKC Foundation.
  • Clinical trials sponsored by pharmaceutical and device industry manufacturers are coordinated and contracted via Truman Medical Centers and the physicians’ employer – e.g., University Health Physicians. TMC and University Health Physicians are the collectively listed as the party in clinical trial agreements with industry research sponsors. The ORA negotiates the terms and requirements of the clinical trial agreements with study sponsors. The research process for TMC is listed at: https://med.umkc.edu/ora/conducting-research-at-tmc/
  • Gifts and monies to support TMC’s mission and its requests related to patients are managed by the TMC Charitable Foundation: https://www.tmcgiving.org/
  • Government grants and awards related to patient care at TMC are requested and managed through the TMC Government Relations Office. Contact Linda Sharp at (816) 404-2350.
1. University employed faculty salary effort on University grant awards

The federal government and other grant sponsors require that the effort (or amount of time) devoted to a sponsored project be appropriately documented. Principal Investigators, University grant project staff, and ORA work with University Fiscal Officers to allocate salaries to grant awards in the University system. The University requires semiannual certification of grant salary called effort verification reporting.

2. Salary cap monitoring of University employed personnel on grant awards

NIH and other grant funders such as PCORI may limit the amount of annual salary paid from a grant award. The University refers to any grant effort allocated to a grant award, but paid from institutional resources (non-grant) as cost-sharing. The University creates cost-sharing accounts to track and monitor mandatory and voluntary salary cost-share to meet sponsor requirements.

Current NIH salary cap limits: https://grants.nih.gov/grants/policy/salcap_summary.htm

3. SOM faculty clinicians employed by University Health Physicians

The University has a formal agreement with University Health Physicians (formerly UPA) to allow invoicing of salaries, fringe benefits and other approved expenses approved in the grant proposal on University grant awards. This agreement precludes the necessity of a per project subcontract. The University and TMC also have a similar agreement for invoicing/allocating appropriate TMC expenses such as study coordinator salary expenses on University awards.

Federal guidance indicates that Clinical Practice Plan compensation is the appropriate salary expense to use for University Health Physicians’ faculty when incorporating institutional base salary on a grant award.

Salary allocation for SOM faculty primarily employed by University Health Physicians is accomplished when principal investigators’ certify and approve their grant effort on invoices and submitted to ORA for payment and allocation to the grant.

4. SOM faculty clinicians employed by University Health Physicians and salary cap monitoring

Similar to the requirements for University employees, other entities such as University Health Physicians may have to cost-share when required by the funding agency or when proposed by the principal investigator. Invoices for University Health Physicians clinicians shall include cost-share details and the principal investigator shall certify the cost-share when approving the invoice for payment by the University for allocation to a grant award.

5. Expenses for individuals employed by St. Luke’s Hospital (SLH) and Children’s Mercy Hospital (CMH) that collaborate on University grant awards

The University must enter into a per project subcontract with SLH or CMH so that the other entity (SLH or CMH) may comply with federal regulations and hospital affiliate requirements regarding invoicing, effort reporting, managing conflicts of interest and other federal requirements that the University must adhere.

6. CITI research training and annual financial disclosure
7. Cost-share

Cost Share flowchartClick the image to view full size

Submitting an Annual University Financial Disclosure

As part of the University of Missouri System policy on conflicts of interest located in the Collected Rules & Regulations Chapter 330.015, the University requires that members of the UMKC research community complete an annual disclosure to disclose any financial or personal interest that is an actual or possible conflict of interest.

UMKC uses the Osprey system to track and submit annual disclosures for grant investigators.

First, request the campus Office of Research Services (ORS) set-up an Osprey account for you.
Contact Linda Daugherty, UMKC ORS Pre-Award Manager: Daughertyl@umkc.edu (816) 235-5634

After your Osprey account is set-up, then complete your annual disclosure:

1. For Osprey accounts set-up with UMKC email.
Go to: https://umkc.coiriskmanager.com and complete your annual University financial disclosure.
Use your University sign-on and password. The screen = like the below.

SSO login screen

 

2. For Osprey accounts set-up using other email extensions (non-UMKC):
Use the following link and log-in: https://umkcexternal.coiriskmanager.com/
Login with the user name provided when your account was set up.

For questions on how to answer the form or Osprey access issues, please contact UMKC ORS Pre-Award:

Chelsea Dahlstrom at 816.235.1315, or
Andrea Uhl at  816.235.5168.

For additional info please see: www.ors.umkc.edu/office-of-research-services/financial-conflict-of-interest

General Instructions for Resident Research

A number of research support services are offered by UMKC School of Medicine to residents and fellows.

The Associate Dean for research, Dr. Paula Monaghan Nichols (Nicholsap@umkc.edu), can help with general research questions, project design, finding a mentor and identifying research resources and collaborators.

The Office of Research Administration (ORA) facilitates approvals of research at Truman Medical Center (TMC) including connecting researchers with TMC department managers, dept. Chairs, Lab, and Pharmacy departments as needed for review/approval of projects listed on the TMC Research Application Form. ORA may provide required research education course certificates for the Collaborative Institutional Training Initiative (CITI) system. ORA is the point of contact for any research contracts such as clinical trial agreements, data use agreements, and material transfer agreements. Research projects that require registration on the NIH research database www.clinicaltrials.gov should also start with ORA. Contact: SOMResearch@umkc.edu or (816) 235-6247.

The grantsmanship officer, Dr. Mark Nichols (nicholsmark@umkc.edu) can assist with project designing, writing and reviewing grant proposals and identifying grant funding mechanisms.

A team of study coordinators called Research Support are available for guidance on how to submit research protocols and consent forms to the applicable review committees such as the UMKC Institutional Review Board (IRB), Children’s Mercy IRB, St. Luke’s Hospital IRB and preparation of the TMC Research Application Form for department approval at TMC. Contact: ResearchSupport@tmcmed.org

Conducting Research at TMC

TMC 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 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 somresearch@umkc.edu.
  • 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 #.
Online Research training education
UMKC Institutional Review Board (IRB)

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/

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 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:

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

Students and residents may contact Research Support team of study coordinators for guidance on the TMC research application and the appropriate IRB forms for the IRB submission. ResearchSupport@tmcmed.org

Residents may use this template as a guide for a protocol

Additional requirements for non-TMC medical staff or non-TMC employees
  • 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 somresearch@umkc.edu
  • 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).
Statistical Evaluation and Data Capture
  1. 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).

  2. Optimizing Data CollectionREDCap (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/

Research Information Guide

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: https://med.umkc.edu/docs/research/Research-Info-Guide.pdf

 

UMKC School of Med student – process to conduct research at the Children’s Mercy Hospital and Clinics (CMH)

1. Communication

Students should use their UMKC email account for all communication.

2. Contact CMH Graduate Medical Education (GME)

Student to contact CMH GME for required CMH documents (e.g., student access application, health form, etc.,) for access at CMH.

Ms. Leslie Ranney
Medical Student Coordinator
Children’s Mercy Hospital and Clinics
Medical Student Research Program

3. Submit CMH GME paperwork to School of Medicine (SOM) Student Affairs

Student takes the CMH GME application to the SOM Student Affairs (SA) office or a designated Education Team Coordinator – to complete the info regarding student’s health form and vaccine record.

For course credit = student shall obtain approval from SA or SOM Curriculum.

4. Complete the SOM Student Research Information Form

Student completes the Student Research Information Form (list the CMH mentor) and submit to the SOM Office of Research Administration (ORA) with a copy of student’s resume/CV.

ORA will verify SA approval of student to participate in research activities and compliance with hospitals’ requirements.

5. Online Research Training

To comply with CMH IRB and UMKC IRB requirements, student completes:
UMKC CITI  training courses:  https://med.umkc.edu/ora/human_subjects/

  • Human subjects of research training – Group 1-Biomedical (#1)
  • Conflicts of Interest training (#3)
6. Institutional Review Board (IRB)

For clinical research projects at CMH – mentor will complete CMH IRB submission/add a student to current CMH IRB approval.

7. For Students Participating in Research That Is Part of University Course/Class or Required UMKC Student Activity at CMH
Only SOM students enrolled in a University course or class that requires research activity at CMH need to complete section 7 because these students are acting as an agent of the University and are engaged in human subjects research.
To comply with CMH and UMKC IRB requirements, student completes:

  1. The UMKC IRB Request-to-Rely (R-t-R) form – for UMKC to rely on the CMH IRB review: UMKC Request to Rely on a CTSA Partner
  2. Complete the UMKC Compliance Office Financial Disclosure Form:  General Financial Disclosure

Student submits the R-t-R and Disclosure Forms with CITI certificates to the UMKC IRB – umkcirb@umkc.edu

*For guidance on how to complete the UMKC IRB forms – students may contact the Research Support team of study coordinators at: ResearchSupport@tmcmed.org

8. Research Information Guide

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: https://med.umkc.edu/docs/research/Research-Info-Guide.pdf

 

Resident/Student Research Process at Saint Luke’s

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.

1. Identify a Research Mentor
  1. Residents and students 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.
2. Complete online required human subjects training
  1. Complete the required Collaborative Institutional Training Initiative (CITI) training before beginning the research.
  2. The required CITI trainings are:
    UMKC Group 1-Biomedical Investigator and
    Conflict of Interest courses,
    which are listed athttps://med.umkc.edu/ora/human_subjects/.  You may contact the UMKC School of Medicine Research Administration office – SOMResearch@umkc.edu to obtain a copy of their CITI training certificates.
3. Write a brief project summary
  1. 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:

    1. Brief Background;
    2. Hypothesis;
    3. Research Question;
    4. Abbreviated Study Design including methods of analysis and statistical approach.
4. Statistical Evaluation and Data Capture
  1. 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).
  2. Optimizing Data CollectionREDCap (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/
5. Research Evaluation

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.

  1. Email Dr. Paula Nichols: nicholsap@umkc.edu
  2. In email Subject Line – type Research at SLH.

Dr. Nichols will either –

  1. approve the proposal;
  2. schedule a brief phone interview; or
  3. 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.

6. Contact the SLH IRB to Initiate the IRB Submission Process
Contact the SLH IRB at IRB@saint-lukes.org or call (816) 932-2589.

The completed SLH IRB submission requires the following signatures at SLH:

  1. Director of Medical Education (Diana Dark, MD);
  2. project Principal Investigator (SLH Medical Staff member); and
  3. Principal Investigator’s Department Director.

The SLH IRB also requires a copy of the Mentor Agreement Form (see step 1).

7. Research Support team
  1. Contact the Research Support team of study coordinators for guidance on completing the appropriate IRB forms for the IRB submission. ResearchSupport@tmcmed.org

 

 

Clinical Trials Registration

What is ClinicalTrials.gov?

It is a government operated website and database that contains the information on both federally and privately funded clinical trials. The website is maintained by the National Library of Medicine. Study sponsors and / or principal investigators provide and update all study information.

Why do I need to register a clinical trial?

The U.S. Food and Drug Administration Amendments Act 801 (FDAA801) requires by law the registration of clinical trials on ClinicalTrials.gov to ensure transparency and full public access to all study-related research and results. Our affiliated teaching hospital, Truman Medical Center, requires registration as part of their contract process for clinical trials. For simplification purposes, UMKC makes these same recommendations.

How do I register a study on ClinicalTrials.gov?

Visit https://clinicaltrials.gov/ct2/manage-recs/how-register for detailed information. Contact the School of Medicine Research Administration office for access to the SOM registration group.

 

What information do I put in the ClinicalTrials.gov record and results database?

What benefits does ClinicalTrials.gov offer?

Clinicaltrials.gov also satisfies all publication requirements set forth by the International Committee of Medical Journal Editors (ICMJE), which includes ICMJE journals such as the Journal of the American Medical Association, New England Journal of Medicine, and The Lancet.

Helpful Links:

Research Support

UMKC School of Medicine residents and students may contact a team of study coordinators called Research Support for guidance on how to submit research protocols to the applicable review committees such as the UMKC Institutional Review Board (IRB), Children’s Mercy IRB, St. Luke’s Hospital IRB and preparation of the TMC Research Application Form for department approval. See the Research Submission Guidance for more details.

Kemble, Laurie
Kemble, Laurie
McKinney, Hollie
McKinney, Hollie