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July 2015 | IRB and Human Subjects Research Updates
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Office for the Protection
of Research Subjects
Human Subjects Research
Newsletter

USC Flex Policy Audit: Great Results

Since launching the flex policy in 2010, Office for the Protection of Research Subjects annually audits studies reviewed by the IRB under the USC Flex PolicyThis year, findings show the policy is being implemented correctly. 
Auditing assures appropriate application of the policy which allows the IRB to grant exempt or 3-year approval to some minimal-risk, non-federally funded studies that would not otherwise qualify. 

HSIRB Audit Results
UPIRB Audit Results

New CTO Interim Director

Mr. Ben Holstein is the new Interim Director of the Clinical Trials Office during a recruitment period which is expected to last till September 30th.
Ben will manage day-to-day CTO operations, supervise and train staff, manage customer service relations with Keck School of Medicine, and address customer issues.    

CTO Resource Page

USC Signs Expansive IRB Reliance Agreement 

USC has joined an IRB Reliance Agreement with Cedars-Sinai, UCLA, Charles-Drew, and LA Biomed. The agreement facilitates efficient review of multicenter human studies. Investigators may request that IRBs rely on the review of any one of the IRBs in their multi-site project. 
USC Reliance Agreements

Congress Passes Bill to Streamline Clinical Research

The 21st Century Cures Act address key research issues like requirements for single Institutional Review Board approval for multiple trial sites, challenges in patient recruitment for clinical trials, and inefficient data collection and monitoring. One provision of the bill mandates a system for gathering and analyzing clinical trial data and standardization of data collected with funding from an HHS department. 
More about 21st Century Cures Act
Letter of opposition from Patient Advocacy Group 

USC Personal Protective Equipment Standard Expanded

The Research Safety Oversight Committee (RSOC) and the Office of Environmental Health & Safety (EH&S) have issued an expanded standard on the use of Personal Protective Equipment (PPE) to be worn in research and teaching laboratories, shops, studios and other areas of the campus where hazardous materials or hazardous conditions are present.   

USC Personal Protective Equipment Standards
Lab Coat Fact Sheet

Articles Worth Reading

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