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

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

How does the KUMC HRPP decide whether to rely on an external IRB?

If a reliance agreement with the external IRB has already been negotiated, the KUMC HRPP will confirm that the proposal fits the criteria of the existing agreement. If there is no agreement in place, the HRPP will evaluate whether an arrangement can be made. The decision will be based on several factors, including the risk level of the study, the location of most participants and study procedures and requirements of the funding source.

Which IRB reliance agreements are currently in place?

Our current IRB reliance arrangements include:

  • SMART IRB (a network of 400+ academic institutions, hospitals and institutes)
  • National Cancer Institute Adult IRBs
  • Advarra (formerly Schulman IRB)
  • Western IRB
  • Frontiers Regional Partners (Children’s Mercy Hospital, St. Luke’s, UMKC, KCUMB)
  • Great Plains Cooperative IRB Consortium (PCORI Partners)
  • StrokeNet network
  • KU Lawrence campus
  • IRBs for Via Christi and Wesley hospitals in Wichita

If the study is overseen by an external IRB, do I still have to apply to the KUMC IRB?

Yes. An abbreviated application process is required at KUMC even when another IRB provides the federally-mandated oversight. Our abbreviated application process allows KUMC to fulfill other research-related responsibilities such as ensuring proper training for the study team, completion of ancillary reviews (such as radiation safety, conflict of interest, data security, etc.) and fulfillment of state laws and institutional policies. The request is made through an application in our electronic IRB system.

Investigators should be aware that a reliance agreement pertains only to IRB review. The graphic below shows the difference between IRB review (which can be outsourced) and other

‘local context’ requirements cannot be shifted to the external IRB:

what is the difference between IRB vs HRPP Review

Source: CTSA Trial Innovation Network

When I am the local PI for a study being overseen by an external IRB, which consent form will I use?

Consent forms used to enroll participants from our site will use a consent form that is customized specifically for our site. The majority of the consent language will be the same for all study sites. Our KUMC-specific consent form will include:

  • Name and contact information for the local investigator
  • The affiliation with KUMC
  • KUMC-specific HIPAA language
  • Cost language approved by the KU Health System (for clinical trials)
  • Site-specific language for any local ancillary review such as radiation safety or conflict of interest
  • Provision of payment for study-related injuries
  • Applicable language required by state law

Study teams should refer to the document Guidance on External IRB Consent Forms for details about customization. The KUMC investigator may not initiate the study until the external IRB and the KUMC HRPP have agreed on the customizations to our site-specific consent form.

What are my additional responsibilities if my study is overseen by an external IRB?

In additional to general responsibilities of serving as an investigator, the KUMC investigator has the following responsibilities:

  • Obtain institutional approval to use the external IRB
  • Ensure that your entire team knows and follows the policies of the external IRB.
  • Comply with all protocol requirements
  • Submit reportable events as required by the external IRB

When can I start my study?

If you are using another institution’s IRB, you may start your study when:

  • The external IRB approves the project;
  • Local implementation is approved: all ancillary reviews are complete and the KUMC-specific consent form has been approved by the KUMC HRPP; and
  • Contracts or other funding arrangements are finalized

Once the external IRB has approved the study, what updates does KUMC require?

Investigators using an external IRB remain responsible to update the HRPP when key events occur. The HRPP must be notified about:

  • Changes to study personnel
  • Updates on conflict of interest disclosures
  • Injury to a KUMC subject
  • Protocol deviation resulting in potential or actual harm to KUMC subjects

What should I do if I am overseen by an external IRB and an adverse event occurs to a subject at our site?

  • Implement actions to eliminate any immediate threat of harm to the subject
  • Follow the protocol-specific plans for reporting the event to the overall PI and the external IRB
  • Implement any steps required by the external IRB
  • File a Report of New Information in the KUMC eIRB system using our internal SAE form
  • If the adverse event involves hospitalization or non-standard medical treatment, the KUMC HRPP will evaluate contractual obligations related to research-related injury and will consider whether a consultation with risk management may be warranted.

What should I do if I am overseen by an external IRB and there is a serious protocol deviation at our site?

· Implement actions to eliminate any immediate threat of harm to the subject

· Follow the protocol-specific plans for reporting the event to the overall PI and the external IRB

· Inform the KUMC HRPP so that we can help you address any imminent concerns about safety and welfare of subjects. We can also advise about developing and implementing corrective action plans. The KUMC HRPP may also need to communicate with the external IRB about auditing and reporting to federal agencies.

How do I submit my request to use another institution’s IRB?

Requests are made in the electronic IRB system. Once the use of an external IRB is selected, the electronic application is truncated to collect information relevant to local administrative review. Please refer to our screenshot guide when starting your request in our electronic system.

Whom should I contact with questions about IRB reliance?

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


I would like to...

Last modified: Aug 25, 2018
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