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Mar 09, 2020

Meeting of the Research, Development, and Regulatory Roundtable (R3) – Postponed

10:00 AM to 3:00 PM

Location: San Francisco, CA

This meeting has been postponed.  

Discussion topics: (1) Foreign Influence in Clinical Research, and (2) Impact of Fraud and Abuse Laws on Clinical Research. 

Topic Summary:

  1. Foreign Influence in Clinical Research

The first part of the March 9th meeting will address the ongoing National Institutes of Health (NIH) and U.S. Department of Defense (DoD) investigations into foreign influence in American research. The government appears concerned that researchers who receive federal funding have failed to disclose foreign financial interests and time commitments, thus misleading the U.S. government when it evaluates research awards, thus harming the federal fisc and the American research enterprise. In addition, the U.S. government fears that foreign influence on scientific research is allowing the transfer of intellectual property to foreign countries without being subject to export regulations set forth by the U.S. Department of Commerce.

  1. Impact of Fraud and Abuse Laws on Clinical Research
The second part of the meeting will address the effect on clinical research of fraud and abuse laws, including the Anti-Kickback Statute and the Beneficiary Inducement provisions of the Civil Monetary Penalty Law, as well as their state law counterparts. These laws have major implications for clinical research conducted in the United States, affecting practices ranging from research sponsors paying for copayments or deductibles associated with standard of care services required under a clinical trial protocol, to payments from life sciences companies to physicians to collect data for registry studies, to the provision of “smart devices” to patients as part of a research study.
If you have questions, please contact mrct@bwh.harvard.edu.