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I would like to add non-KUMC personnel to my study

I would like to add non-KUMC personnel to my study

When the KUMC IRB is responsible for overseeing the activities of non-KUMC personnel, legal arrangements must be made with their employing organization or with them directly, as individual collaborators.  The following are the most common scenarios:

 

  • External collaborators who conduct research-specific activities are employed by another academic or professional organization
    • Collaborators are directly interacting with research participants or analyzing identifiable data
    • KUMC will negotiate a reliance agreement (global or study-specific) with their organization
    • The collaborators need human subjects training and a current conflict of interest disclosure. Most frequently, this is accomplished by their home institution confirming that these requirements have already been met.  Otherwise, KUMC resources can be made available upon request. 
    • If not approved with the initial IRB submission, KUMC investigators should create a modification in eIRB. Instructions about submitting modifications are posted on the main IRB website.

 

  • The KUMC study team will include students from regional institutions
    • The students are directly interacting with research participants or analyzing identifiable data
    • Unless the students are being paid by KUMC or otherwise acting on behalf of KUMC, this arrangement requires a reliance agreement (global or study-specific) between KUMC and the regional institution.
    • KUMC has global reliance arrangements with KU-Lawrence, Children’s Mercy, St. Luke’s Hospital, University of Missouri-Kansas City and Kansas City University of Medicine and Biosciences
    • The students need training in human subjects’ protection and a current conflict of interest disclosure. Most frequently, this is accomplished by the regional institution confirming these requirements have already been met.  Otherwise, KUMC resources can be made available upon request. 
    • If not approved with the initial IRB submission, KUMC investigators should create a modification in eIRB. Included in the modification documents should be an acknowledgement from the student’s home institution.   

 

  • Members of the community, such as consumer or patient advocates, are helping implement the research
    • Community members are directly interacting with research participants or handling identifiable data
    • These individuals need training in human subjects’ protection and a current conflict of interest disclosure. CITI training or NIH training are accepted.  Alternatively, the HRPP can consult with the study team about incorporating basic training in human subjects’ protection into other research-specific training these individuals will be completing.   A current conflict of interest disclosure is required.  Paper forms are provided to study teams so that accounts in eCompliance are not needed.  Paper forms will be required annually as long as the study is active. 
    • These individuals sign an unaffiliated investigator agreement (UIA) through which they agree to adhere to research regulations, follow the study protocol and protect confidentiality.
    • If not approved with the initial IRB submission, KUMC investigators should create a modification in eIRB. IRB staff members will coordinate with the individual about signing the UIA. 
    • NOTE: These requirements apply to community members contributing to specific research protocols. The requirements may not apply to members of the community who consult with KUMC investigators to suggest topics for future research or give general feedback about the most effective means of accomplishing research goals. Investigators may contact the IRB office to discuss individual situations.   

 

  • Licensed, independent healthcare professionals are conducting research-specific activities
    • These professionals are specifically trained to do the research-specific activities (genetic tests, interviews, focus groups, clinical assessments, therapy sessions, etc.)
    • The professionals are directly interacting with research participants or handling identifiable data
    • The individuals need training in human subjects’ protection. CITI training or NIH training are accepted.  A current conflict of interest disclosure is required.  Paper forms are provided to study teams so that accounts in eCompliance are not needed.  Paper forms will be required annually as long as the study is active.
    • These individuals sign an unaffiliated investigator agreement (UIA) through which they agree to adhere to research regulations, follow the study protocol and protect confidentiality.
    • If not approved with the initial IRB submission, KUMC investigators should create a modification in eIRB. IRB staff members will coordinate with the individual about signing the UIA. 

 

  • Licensed healthcare professionals are performing standard medical tests or procedures, and the results are part of the study data
    • These professionals are performing the standard clinical tests or procedures in the same way, and with the same frequency, as would be provided for standard health care
    • The individuals, or their employer is being paid the standard rate for their professional services, either with study funds or by participants’ health insurance.
    • The activity of these individuals is described in the protocol.
    • If these individuals directly interact with research participants or handle identifiable data, the disclosure of health information is covered in the HIPAA section of the consent form.

In this scenario, the individuals are not considered part of the study team.  No additional compliance requirements apply.


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Last modified: Aug 25, 2018
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