The KUMC Human Research Protection Program (HRPP) supports the requirement for single IRB review by collaborating with multiple external IRBs. The process to use an external IRB has 8 basic steps:

1. Confirm that KUMC has a reliance arrangement with the proposed IRB
2. Gather the sponsor's or lead investigator's approved documents
3. Request KUMC ancillary approvals as applicable
4. Customize the external IRB approved study wide consent template with KUMC-specific details
5. Work with the KUMC HRPP to complete SMART IRB or other paperwork required by the IRB at an external institution
6. Obtain permission from KUMC to apply to the external IRB
7. Update the KUMC HRPP once the external IRB approves our site
8. Update the KUMC HRPP during the study with local reportable events

Step 1: Confirm that KUMC has a reliance arrangement with the proposed IRB

KUMC has the following IRB reliance arrangements currently in place:

• SMART IRB (This is not an IRB, but instead, a network of IRBs from multiple academic institutions, hospitals, and institutes across the United States.)
• National Cancer Institute Adult IRBs
• National Marrow Donation Program
• Advarra IRB
• WCG IRB
• Frontiers Regional Partners (Children's Mercy Hospital, St. Luke's, UMKC, KCUMB)
• Great Plains Cooperative (12 medical centers, funded by PCORNET)
• StrokeNet network
• KU Lawrence campus
• KU School of Medicine-Wichita Collaborations
• Individual research consortiums

In addition to the listed groups above, the KUMC IRB can negotiate reliance on a study-by-study basis. Please contact IRBreliance@kumc.edu if your collaborator is not represented above.

Step 2: Gather the sponsor's or lead investigator's approved documents

In preparation for your request to use an external IRB, please gather the following documents:

• Study protocol, approved by the external IRB
• Template consent form, approved by the external IRB
• Initial External IRB Approval letter for the study as a whole
• Any patient-facing materials that will be customized (beyond just adding contact information) for use at KUMC

In addition, refer to the checklist at the end of the Request to Use an External IRB application. Complete submissions must include this application and all relevant documents in that list.

Step 3: Request KUMC ancillary approvals as applicable

While the review related to federal IRB regulations can be outsourced, other state and institutional requirements are not covered by the external IRB; these must be managed locally. Starting the ancillary reviews early will streamline study start-up. Frequent ancillary reviews include the following areas:

• All studies involving health system resources require a (UKHSRR ID#) Clinical Research Start Up number
• Cancer Center protocols require a PRMC approval letter
• Research involving radiation requires approval from the Radiation Safety Committee through their standard application process
• Research involving recombinant DNA or gene therapy will require approval from the Institutional Biosafety Committee
• Investigators should contact the KUMC Conflict of Interest Program if anyone on the study team has a reportable financial interest related to the study

Please contact KUMC HRPP with questions about which ancillary reviews apply to your study.

Step 4: Customize the consent template with KUMC-specific details

Create a KUMC-specific consent form, starting with the external IRB's approved study wide consent template and adding information from the boilerplate guidance provided below. The customized language is typically limited to the medical records bar code on the first page; local PI contact information and 24-hour phone number; KUMC-specific language about costs, payments and treatment for injuries; and local HIPAA entities. KUMC language for conflict of interests, certificates of confidentiality, and parental or surrogate decision-maker signature blocks should be added when applicable.

• Boilerplate Consent Language for External IRBs
• IRB Training Videos

Step 5: Work with the KUMC HRPP to complete SMART IRB or other paperwork

When the collaboration involves academic or institutional IRBs, KUMC study teams may be asked to complete a ‘local context questionnaire' that asks about state laws, KUMC policies, study team credentials and our local study population. Some IRBs also require an institutional profile to be signed off by the KUMC HRPP. Please provide these documents to the KUMC IRB reliance contacts so we can answer questions and assist you with this documentation:

• Kathy Jurius, IRB Reliance Manager:     kjurius@kumc.edu
• Emily Swanger, IRB Reliance Manager: eswanger@kumc.edu
• Kyle Stephens, HRPP Director:              kstephens3@kumc.edu

Step 6: Obtain permission to apply to the external IRB

The study team should do the following:

• Complete a Request to Use an External IRB form.
• Assemble all the documents listed in the checklist on the last page of the form.
• Refer to the Submitting a Request for External IRB Study in myIRB guidance document.
• The KUMC HRPP may request other documents or consent changes needed to fulfill local requirements. Once those are addressed, you will receive a letter confirming your permission to apply to the external IRB. Ths letter must be included within the site documentation gathered for the initial submission to the external IRB.

Step 7: Update the KUMC HRPP once the external IRB approves our site

No changes should be made to the submission in this step until you are adding the initial external IRB approval documentation to complete the initial submission process. While you are waiting for approval from the external IRB, your project will be in "Clarification Requested" status in the myIRB system. Once the external IRB approves, it is important to return to the myIRB submission, upload the external IRB's approval of our site and the consent forms approved for use specifically at KUMC.

When the documents from the external IRB are uploaded, IRB staff will issue a final KUMC letter of release (Acknowledgment of Oversight) in the myIRB system. You can start your study after the contract is signed and the site activation process is complete.

Step 8: Update the KUMC HRPP during the study with local reportable events

You are now under the authority of the External IRB and must follow their rules.

• Quick Tips for External Updates
• Familiarize yourself with the standard operating procedures and submission processes of the external IRB.
• Respond promptly to requests from the commercial IRB, or from the lead investigator if the study is an institutional collaboration.
• Most IRB submissions and communication will be routed only to the external IRB. The KUMC HRPP will not review routine protocol amendments, revised investigator's brochures or study wide consent form changes that do not involve changes to site-specific information.

Report to the KUMC HRPP by submitting an Update in myIRB when the following changes occur:

If there are local changes to the study:

1. Local study personnel updates
2. Changes to the Principal Investigator
3. Approved Continuing Review (study continuation) or Study Closures by the External IRB
4. Updates on conflict-of-interest disclosures
5. Changes that impact any of the KUMC ancillary reviews (such as changes to the amount of radiation used in the study)
6. Contractual changes related to payment for study-related injury
7. Changes impacting HIPAA privacy or data security
8. Changes impacting costs to participants
9. Addition of payments to participants, if payments were not included in the original submission or the removal of payments to participants if payments were included in the original submission but will no longer be issued
10. A consent is being newly added to the study (that was not part of the initial review of the study). This should be reviewed by the KUMC HRPP team prior to submission to the external IRB
11. Any KUMC specific recruitment materials

For additional information please see the Updating a Study Relying on an External IRB guidance document or refer to the video instructions on how to update a study under external IRB review.

During the study, you must update the KUMC HRPP with certain reportable events:

If an adverse event occurs to a subject at our site:

• Implement actions to eliminate any immediate threat of harm to subjects
• Notify the sponsor as required by the protocol
• Notify the external IRB, as required by their standard operating procedures, using the process required by that IRB.
• If the event meets KUMC reporting criteria, then file a Report of New Information in the KUMC myIRB system using our internal SAE form. Additional information about adverse events is available here. 
• The KUMC HRPP will await guidance from the external IRB as to whether the event constitutes an unanticipated problem and whether the event must be reported to federal agencies. The HRPP may require local corrective or preventive steps in the interim.
• If a report to federal agencies is required, the KUMC HRPP will provide information and input as outlined in the reliance agreement.

If there is a serious protocol deviation at our site:

• Implement actions to eliminate any immediate threat of harm to subjects
• Notify the sponsor as required by the protocol
• Notify the external IRB as required by their standard operating procedures
• If it meets KUMC reporting criteria, then submit a Non-Compliance Reporting Form in the KUMC myIRB system.
• The KUMC HRPP will await guidance from the external IRB as to whether the event constitutes serious or continuing non-compliance and whether the event must be reported to federal agencies.
• The HRPP or Quality Assurance Program may require local corrective or preventive steps in the interim.
• If a report to federal agencies is required, the KUMC HRPP will provide information and input as outlined in the reliance agreement.

For complete instructions about events and problems that should be reported, consult our Reportable Events Guidance.

Whom should I contact with questions about using external IRBs?

The KUMC HRPP has a dedicated IRB reliance manager. For questions, please contact IRBreliance@kumc.edu 

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