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Consent and the Autonomy of Human Subjects

 

 

 

 

 

The False Claims Act provides that any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval is liable for civil penalty.

 

Recent Findings of False Claims

 

 Department of Justice:

 

         August 2013

       Case Summary - Emory University Pays $1.5 Million to Settle False Claims Act Investigation

        October 2014

    Case Summary - Former Northwestern Physician to Pay $475,000 to settle Fraud Claims       

 

 

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, according to 42 CFR Part 93.

 

Recent Findings of Research Misconduct

 

Office of Research Integrity:

 

August 2014

ORI Case Summary - Falsified survival times of mice

 

July 2014

ORI Case Summary - Falsified data in publications

 

July 2014

AP Report - Criminal charges filed for research misconduct

 

June 2014

ORI Case Summary - Falsified data submitted to NIH

 

April 2014

FDA Warning Letter - Failure to ensure proper monitoring of investigation

 

 

February 2014

ORI Case Summary - Falsified data for increased subject enrollment

December 2013

ORI Case Summary - Fabricated data in publications

 

November 2013

FDA Warning Letter - Failure to ensure adherence to regulations and subject safety

February 2013

ORI Case Summary - Falsified data in publications and abstracts

 

January 2013

FDA Warning Letter - Failure to ensure informed consent, honor sponsor agreement, and maintain records

 

November 2012

ORI Case Summary - Falsified data that was included in published papers, a manuscript, grant applications, and progress reports

 

July 2012

ORI Case Summary - Falsified results for research support

 

June 2012

ORI Case Summary - Falsified data submitted for publication

 

June 2012

ORI Case Summary - Falsified cell count data to report effects of   pesticides

 

February 2012

ORI Case Summary - Falsified/fabricated grant application data

 

February 2012

ORI Case Summary - Falsified subject enrollment numbers