Multi-site or collaborative research occurs when researchers on KU's Lawrence campus and researchers from another institution both will be engaged in research procedures.
Any KU-Lawrence personnel engaged in non-exempt* human subjects research must have IRB oversight, which can be accomplished in either of the following two ways:
- Receive HRPP approval for the human subjects research activities, through a new study submission in eCompliance
- Request KU IRB rely on another institution's IRB review by signing an IRB Authorization Agreement
- HRPP must be contacted in order to initiate an IRB authorization agreement. A researcher cannot sign an agreement on behalf of KU.
- Another institution’s IRB approval does not provide IRB oversight for KU personnel unless an IRB authorization agreement is signed. Contact KU HRPP to discuss signing an IRB authorization agreement.
*Please note that non-exempt determinations should be made by the HRPP office.
An individual is engaged in human subjects research if they are involved in any of the research procedures outlined on the IRB review page, as defined by OHRP guidance.
SMART IRB process
KU is participating in SMART IRB, a platform used to streamline the review and reliance process for multi-site studies. Email IRB if you need access to other forms, documents or checklists when using SMART IRB.
Submit a request for reliance using the Online Reliance System:
- Create an account in the SMART IRB Online Reliance System by clicking "Request Investigator Access." Once created, you will receive email notification that your account is activated.
- Refer to the SMART IRB Reliance Checklist (see reliance checklist below) for full instructions
- Email HRPP for any additional required forms
- Submit a request for reliance via SMART IRB:
- Click on "New Request"
- Provide basic information about your study
- Upload supporting documents, including:
- Consent form
- List of sites and study teams engaged and their activities
- Submit the request
- Once the agreement has been finalized, you will receive notification of the determination via email.
- Submit a modification in eCompliance to upload the SMART IRB determination letter and add external investigators to the study team.
- Make sure to submit a modification that is both “Other parts of the study” and “Study team member information”
- Log in to the Online Reliance System and click “New Request."
- Provide information about your study:
- Basic information about the research (title of study, a brief description)
- Name of the Principal Investigator
- Select the institution that you would like to serve as the Reviewing IRB
- Funding sources (optional)
- List the sites that will be engaged in human subjects research for the study;
additional sites may be added later, via the amendment process
- For each site:
- The site investigator’s name and contact information
- Research personnel names and contact information (optional)
- Research participants and activities
- Upload supporting documents:
- Research protocol
- Consent templates (optional)
- Other documentation (optional)
- Review the request for accuracy.
- Submit the request. You can log back in to the Online Reliance System to track the progress of your request. You will be notified by email once a reliance decision has been reached.