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I want to rely on an external institution’s IRB for my collaboration

I want to rely on an external IRB

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 consent template with KUMC-specific details
  5. Work with the KUMC HRPP to submit SMART IRB or other paperwork
  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 (a network of 600+ academic institutions, hospitals, and institutes)
  • National Cancer Institute Adult IRBs
  • National Marrow Donation Program
  • Advarra IRB
  • Western 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

In addition to these groups, 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
  • Any patient-facing materials that will be customized for use at KUMC

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 to time to study start-up. Frequent ancillary reviews include the following areas:

  • All studies involving health system resources require a UKHS Research Review number
  • Cancer Center protocols require a PRMC approval
  • 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 feel free to contact with 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 consent template and adding information from the boilerplates 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.

Step 5: Work with the KUMC HRPP to submit 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
  • Karen Blackwell, HRPP Director:            kblackwe@kumc.edu

Step 6: Obtain permission to apply to the external IRB

The study team should do the following:

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

While you are waiting for approval from the external IRB, your project will be in "Clarification Requested" status in the eIRB system. Once the external IRB approves, it is important to return the eIRB submission, uploading the external IRB's approval of our site and the consent form that is approved for use 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 eIRB system. This internal letter is required before a contract can be signed. 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.

  • 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 consent form changes.

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

  • Changes to study personnel
  • Updates on conflict of interest disclosures
  • Changes that impact any of the KUMC ancillary reviews (such as changes to the amount of radiation used in the study)
  • Continuing Review Approvals or Study Closures
  • Local serious adverse events and reportable non-compliance (outlined below)

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 eIRB system using our internal SAE form at: http://www.kumc.edu/human-research-protection-program/institutional-review-board/forms-and-templates.html. Additional information about adverse events is available on the KUMC IRB's website.
  • Unless the event requires urgent local action or a change to local study processes, 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.
  • During this time, the HRPP will confirm that applicable institutional responsibilities and contractual obligations have been met.
  • The KUMC HRPP will work collaboratively with the external IRB to address the problem. 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 eIRB system. The form is posted at: http://www.kumc.edu/human-research-protection-program/institutional-review-board/forms-and-templates.html
  • The KUMC Quality Assurance Program may be asked to evaluate the proposed corrective action plans and assist with any implementation questions. The HRPP and Quality Assurance Program will confirm that applicable institutional responsibilities and contractual obligations have been met.
  • 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 KUMC HRPP will work collaboratively with the external IRB to address the problem. If a report to federal agencies is required, the KUMC HRPP will provide information and input as outlined in the reliance agreement.

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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Last modified: Aug 20, 2020
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