eCompliance Updates

The Reliance Agreement forms for CTSA and non-CTSA institution collaborations have been combined into the Initiating a Reliance Agreement (Non-Exempt Research with CTSA & Non-CTSA Institutions) form.  

Request to Rely

Human subjects research that engages an institution must either obtain local IRB review (UMKC IRB review) or the UMKC IRB may rely on the review of another IRB. In general, an institution is considered engaged in human subjects research when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

IRB Authorization Agreement (IAA) 
There are situations that arise when UMKC researchers are involved in multi-site research or collaborative projects with investigators at other institutions. Such research requires IRB review by each site engaged in the research unless an IRB Authorization Agreement (IAA) is in place. An IAA is a joint review arrangement where one IRB relies upon the review of another qualified IRB to avoid duplication of effort. 

See the IAA Guidance Document (PDF) for more information regarding IAA's. 

UMKC will not agree to be the reviewing IRB in situations in which there are no reasonable means to monitor the research. Potential risks of harm to research subjects and the research site where the risks are incurred are factors in making the decision. Generally, UMKC will not agree to be the reviewing IRB for research taking place abroad.

The agreement consists of a short form that must be signed by institutional officials from both institutions. (UMKC's institutional official is the Vice-Chancellor for Research.)  It may take several weeks to obtain the necessary signatures and send the agreements back and forth.

IRB Authorization Agreements are not intended for use when collaborators are engaged in exempt research. 

There are two processes that may be used when UMKC researchers collaborate on a project with researchers from other institutions:

1. Collaboration with one of the CTSA Partner Institutions (St. Luke's Hospital (SLH), Children's Mercy Hospital (CMH), Kansas City University (KCUMB), the University of Kansas Medical Center (KUMC).
2. Collaboration with a non-CTSA Partner Institution.

1. Complete a Request to Rely on a CTSA Partner IRB in eCompliance
   1. Once you have logged in to eCompliance:
      1. Click on Institutional Review Board
      2. Click on IRB forms
      3. Click on Reliance Agreement (Non-Exempt Research with CTSA & Non-CTSA Institutions)
   2. The RTR must be completed by the UMKC/UH researcher intending to collaborate with one of the CTSA partner institutions.
2. Be current on CITI Training
   1. Human Subjects (within 3 years)
      1. Group 1 Biomedical Investigator or Group 2 Social and Behavioral Investigator
   2. Conflict of Interest (COI) (within 4 years)
      1. Completed through eCompliance or
      2. Attestation within the application
         1. The Research Compliance Office will confirm your COI disclosure status if completed in eCompliance.