CWRU IRB to begin accepting biomedical protocols

Beginning July 3, 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. 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); and
• Collection of biomedical data through noninvasive procedures such electrocardiography, ultrasound, doppler blood flow and echocardiography.

Starting in July, researchers submitting biomedically oriented studies to the CWRU IRB will use the current CWRU iRIS system to enter protocols on a revised form. Training opportunities will be offered throughout June. Training sessions will provide step-by-step instructions to guide users through the new submission process. Social and behavioral researchers will not experience any changes when submitting protocol applications to the CWRU IRB. Future training sessions will be held:

• Tuesday, June 20, from 9 to 10 a.m.
• Friday, June 23, from 1 to 2 p.m.
• Thursday, June 29, from 3:30 to 4:30 p.m.
• Friday, June 30, from 1 to 2 p.m.

All training sessions will be held in Sears Building, Room 670. Registration is available online. To schedule a targeted training session for an individual department or school, contact Tracy Wilson-Holden at tjw18@case.edu. Questions regarding the expansion of the CWRU IRB’s scope can be directed to Kim Volarcik at kav6@case.edu.