In early 2018 Ochsner Health System’s HRPP and the Ochsner Cancer Institute embarked on a journey to discover the best way to use a preferred external IRB. This was to address our anticipation of FDA harmonization with the revised Common Rule’s single IRB mandate (sIRB) and to ensure our researchers would have a well tested process in place when the time arrived. What ensued was a host of challenging situations and revelations about our processes and the single IRB idea in general. We ended the pilot program early and want to share our experience to help any institution especially non-traditional academic medical centers, CRCs or study teams faced with regularly using a sIRB, or other IRBs trying to tackle the sIRB issue understand the challenges and complexity of formalizing external IRB use.
Upon completion of this Webinar, attendees should be able to:
Address the regulatory reasons for use of an external IRB.
Highlight the process and challenges that come with formalizing the sIRB program and what that means for the CRC workforce.
Address considerations for IRB reliance.
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