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In Law360, Attorneys Analyze Expanded U.S. Government Scrutiny of Research Compliance

Practices: Health Care, Life Sciences, Clinical Research, Health Privacy & Security, Regulatory Enforcement & Civil Litigation, Incident Response and Preparedness

Capital Insights.

The U.S. Department of Justice, lawmakers and federal funding agencies are pushing forward with efforts to raise attention to researchers with undisclosed research and academic affiliations and funding, largely through the People’s Republic of China (PRC) and academic and hospital entities in PRC. A series of recent criminal actions and legislative efforts reinforce the changing landscape for research compliance. For universities, academic medical centers, hospitals and other research institutions, demands to expand oversight and install new or more extensive compliance measures will likely continue.

In a Law360 article, health care and life sciences counsel Valerie Bonham (Washington, D.C.), health care and life sciences partner Mark Barnes (Boston), health care associates Daniel Weeks (New York) and Christina Ravelo (Washington, D.C.) examine the expanded U.S. government scrutiny of research compliance.

The authors note that on the federal legislative front the “Safeguarding American Innovation Act,” includes a series of significant and potentially controversial actions designed to protect U.S. research and intellectual property from foreign threats. The legislation offers the prospect of harmonizing grant reporting, a welcome change for many, but it will push federal research awardees and investigators to be more transparent, raise the costs for reporting failures and reduce access for some foreign collaborators who seek to come to the United States.

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