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I would like to use a commercial IRB

I would like to use a commercial IRB

Which commercial IRBs are available to KUMC investigators? 

KUMC currently has reliance agreements with Western IRB and Advarra (formerly Schulman IRB). 

 

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

Yes.  An abbreviated application process is required at KUMC even when a commercial IRB will provide the federally-mandated oversight. The 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.

 

How do I obtain a KUMC-specific consent form from a commercial IRB?

The KUMC HRPP has negotiated boilerplate consent language with each commercial IRB. The boilerplate language is inserted into the consent form that has already been approved for the study as a whole. The boilerplate language for each commercial IRB is posted on our website, as noted below.

Regulatory staff or study team members at KUMC will create a draft consent as part of the submission process when the initial request is made in eIRB. The commercial IRB will confirm the appropriate language as part of their review.  Once all required elements have been addressed, the commercial IRB will issue the consent document that is used to recruit KUMC subjects. 

 

When can I start my study?

If you are using a commercial IRB, you may start your study when:

  • The KUMC HRPP confirms that the correct boilerplate language is in the proposed KUMC version of the consent form.
  • Conditions of any ancillary committees (such as the Conflict of Interest Committee or Radiation Safety Committee) have been addressed
  • The KUMC HRPP has approved submission to the commercial IRB
  • The commercial IRB has approved the involvement of KUMC and has issued the KUMC-specific consent form
  • The study contract is signed
  • The sponsor has activated our site

 

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

Investigators using a commercial 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 deviations that could impact safety or data integrity

 

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

  • Implement actions to eliminate any immediate threat of harm to the subject
  • Notify the sponsor as required by the protocol
  • Notify the commercial IRB as required by their standard operating procedures
  • 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 a commercial IRB and there is a serious protocol deviation at our site? 

  • Implement actions to eliminate any immediate threat of harm to the subject
  • Notify the sponsor as required by the protocol
  • Notify the commercial IRB as required by their standard operating procedures
  • Inform the HRPP so the KUMC Quality Assurance Program can evaluate the proposed corrective action plans and assist with any implementation questions.

 

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

 

Instructions for submission and review of studies under Western IRB.

Instructions for submission and review of studies under Advarra IRB.

 

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


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Last modified: Jul 31, 2018
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