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June 29, 2017  

Sponsored Projects News and Updates
CWRU IRB to Begin Accepting Biomedical Protocols Next Week

Beginning next Monday, July 3, 2017, the Case Western Reserve University Institutional Review Board (CWRU IRB) will expand its scope to accept protocols that are biomedical in nature in addition to social, behavioral and educational research protocols. Studies that take place at CWRU affiliate hospitals and/or involve patients, equipment or data at those sites will continue to be reviewed by the respective hospitals’ IRBs.

It is anticipated that this change will primarily affect CWRU researchers whose studies are not performed in hospital settings but involve some biomedical procedures, such as:

  • prospective collection of blood, teeth, saliva and other biospecimens;
  • FDA-regulated drugs, devices and biologics (but only if administration in a hospital setting is not required);
  • collection of biomedical data through noninvasive procedures such as electrocardiography, ultrasound, doppler blood flow, and echocardiography.
Researchers wishing to submit biomedically-oriented studies to the CWRU IRB will use the current CWRU iRIS system (https://cwru-iris.case.edu/) to enter protocols. A revision to the current iRIS system will be published on July 3. Social and Behavioral researchers will not experience any changes when submitting protocol applications to the CWRU IRB.

Those wishing to submit a biomedical protocol will fill out an additional form, called a “Protocol Template Document”. This form will be available on the CWRU IRB website beginning Friday at http://case.edu/research/faculty-staff/compliance/irb/.

Questions regarding the expansion of the CWRU IRB’s scope can be directed to Kim Volarcik at kav6@case.edu.

 
Organizations Jointly Request Delay in Common Rule Compliance Dates

The Association of American Medical Colleges (AAMC) and three other organizations representing research universities have requested that the Department of Health and Human Services (HHS) delay the compliance date of the revised Common Rule by one year, to January 19, 2019, for most provisions and to January 19, 2021, for the mandate to use a single institutional review board (IRB). The rule is among those being reviewed by the new administration because of its publication date, which was just days before President Trump took office.

Ready the joint letter at: http://tinyurl.com/y7bp2adr.

 

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