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Part 1: Foreign Influence in Clinical Research - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

July 7, 2020 @ 12:00 pm 3:00 pm

Virtual Event

The first part of the 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 NIH and DoD investigations have focused on scientists in the United States who have received and not properly disclosed foreign appointments and remuneration. The NIH has named 180 scientists at 71 institutions as targets of investigation and asked their respective institutions to investigate them. 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. While the investigations have to date primarily affected academic organizations, their impact may well spread to industry as academic investigators who conduct research for industry sponsors come under investigation and the scope of the government’s investigation widens.

Attendees learned about the NIH and DoD investigations into foreign influence in clinical research and discussed how research activities within academia and industry may have to adapt to accommodate the government’s concerns.


Meeting Summary

Released on: July 7, 2020

Topics: I) Legal and Regulatory Issues Related to COVID-19 in Human Subjects Research, II) Foreign Influence in Clinical Research, and III) Impact of Fraud and Abuse Laws on Clinical Research