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I am conducting my study at non-KUMC locations

I am conducting my study at non-KUMC locations

When KUMC investigators conduct research at non-KUMC locations, the legal arrangements will depend on the type of activities being proposed.  The following are the most common scenarios:

  • The non-KUMC location provides space for the KUMC study team to conduct the research.
    • Personnel at the research location might post or distribute materials that explain the research, but they do not actively recruit and do not obtain informed consent.
    • If the non-KUMC location was not approved with the initial submission, KUMC investigators should create a modification in eIRB. Upload information about the location, the activities that will occur there, and a letter from leadership at the location confirming permission for the study team’s activities. 
  • The non-KUMC location provides access to patient/client information for KUMC’s recruitment efforts.
    • Non-KUMC personnel allow access or provide individually-identifiable records to the KUMC study team, but they are not otherwise involved in study activities.
    • If the non-KUMC location was not approved with the initial submission, KUMC investigators should create a modification in eIRB. Upload information about information being provided by the location.
    • If the information being provided is covered by HIPAA, then an official of the non-KUMC location must confirm permission for the study team’s access. A sample letter is available from the KUMC IRB office. 
    • When the study involves informed consent, the consent form discusses access to the location’s records and the research-specific use of the information.
  • Employees of the non-KUMC location are members of the study team.

Please refer to instructions in the section entitled “I would like to add non-KUMC personnel to my study”


I would like to...

Last modified: Aug 25, 2018
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