Current  Archive  
Cancer IRB Transition
Friday, January 20, 2012 (45 reads)

The IRB review responsibilities of Case Comprehensive Cancer Center Institutional Review Board (Cancer IRB) were transitioned to the IRB offices and committees of the University Hospitals Case Medical Center (UHCMC) on December 12, 2011 and to the Cleveland Clinic (CC) beginning on October 24, 2011.



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Informed Consent Update: New FDA language required regarding Clinicaltrials.gov: March 7, 2011
Thursday, March 10, 2011 (498 reads)

The Food and Drug Administration (FDA) has amended the federal regulations pertaining to the basic elements of informed consent (21 CFR 50.25a), adding a new requirement to discuss the availability of basic trial information and results on Clinicaltrials.gov in the informed consent form and as part of the informed consent process. The effective date for this revised regulation is March 7, 2011. The language that will be required by the FDA is as follows:

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iRIS Rollout for Currently Approved Paper-Based Studies
Thursday, July 15, 2010 (791 reads)

Over the next several months, the University Hospitals Case Medical Center IRB will begin transitioning all currently approved, paper-based human subject research studies into the iRIS system. This process will involve a “study registration” process that will require research staff to “register” a currently approved study within the iRIS system.



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Revised “Research Subject Rights” Phone Line in Consent Form
Thursday, July 15, 2010 (754 reads)

The consent template language has been revised to change the “Research Subject Rights” phone number that has been established through the University Hospitals Case Medical Center Chief Medical Officer.



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New Version of the Consent Template and Consent Tutorial Available
Tuesday, March 30, 2010 (995 reads)

A new version of the UH Research Consent Template and the UH Research Consent Tutorial are now available on-line and in the iRIS electronic IRB system.

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