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Health Care law Section
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assistant study coordinator ) were accused of falsifying data to make it appear as though subjects were participating in clinical research trials when they were not .
In October , a former Miami man who worked as a study coordinator and project manager at the same company pleaded guilty before U . S . District Judge Robert N . Scola Jr . to conspiracy to commit mail and wire fraud . As part of his plea agreement , the defendant admitted to falsifying medical records in connection with clinical trials . Sentencing is scheduled for January .
OIG Guidance
Though one could argue that falsifying clinical research data and medical records is clearly impermissible , the Office of the Inspector General ( OIG ) recently opined on nuances in the research space that should be considered by clients .
In OIG Advisory Opinion No . 21-13 , the OIG concluded that it would not impose administrative sanctions on parties entering into a proposed arrangement in which the requestors ( a professional medical society representing radiologists and a charity supporting research related to Alzheimer ’ s disease ) would pay the coinsurance amounts that Medicare beneficiaries participating in the study would otherwise owe for Medicare-reimbursable PET scans used during the study . The requestors stated that without the coinsurance assistance , study enrollment from minorities would be jeopardized , insinuating that the overall research data would be less valuable without diverse participation . The OIG ultimately concluded the arrangement would not be subject to administrative sanctions due to safeguards outlined in the Advisory Opinion .
Future Enforcement
Unsurprisingly , in a country where 425 million Americans placed their trust in clinical trial data when receiving a COVID-19 vaccine , clinical trials now face enhanced scrutiny . Consequently , the US Attorney ’ s Office along with the Food and Drug Administration ( FDA ) are making it a priority to crack down on falsified clinical trial data . Acting U . S . Attorney Juan Antonio Gonzalez for the Southern District of Florida stated , “ compromised clinical data jeopardizes the researchers ’ ability to evaluate the safety and efficacy of new drugs . Prosecuting these cases will continue to be a top priority for our office .”
Assistant Commissioner for Criminal Investigations , Catherine Hermsen of the FDA stated , “ the agency will aggressively pursue violations that threaten the integrity of clinical trial data in order to protect the public ’ s access to safe and effective products .”
We anticipate enhanced enforcement in the area of clinical research compliance and the need for Sponsors , Sites , and Principal Investigators engaging in research to obtain specialized counsel in the area . n
Author : Jenna Horowitz - Epstein Becker & Green , P . C . j a n - f e b 2 0 2 2 | H C b a L a W Y e R
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