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Int J Crit Illn Inj Sci. 2019 Jan-Mar;9(1):5-10. doi: 10.4103/IJCIIS.IJCIIS_63_18.

United States federal government regulation of international research collaborations: What every physician-scientist should know.

Author information

1
Department of Emergency Medicine, Division of Research, East Carolina University Brody School of Medicine, Greenville, NC, USA.
2
The MORZAK Collaborative, Columbia, MD, USA.

Abstract

In the United States (US), the degree to which federal law has encroached on international research and academic communications is not widely known or understood. Despite this, a web of legal code, statutes, executive orders, and intersecting agency jurisdictions apply to all US researchers, with stiff civil and criminal penalties for those who transgress. As the transfer of knowledge is considered an export by the US government, and Title 31 code of federal regulations 500-599 applies to research collaboration, teaching, presenting, publishing, and other activities. Collaboration with persons or institutions in sanctioned entities (e.g., Cuba, North Korea, Iran, Syria, and others) requires approval by the Office of Foreign Assets Control (OFAC). Original investigations, meta-analyses, reviews, and case reports/series performed with designated entities also requires OFAC approval. Other types of academic output are more case specific. Opinion pieces may be exempted, but still require OFAC review, as do professional conversations and translation services. Peer review performed as part of routine journal editing or peer review panel is acceptable if the work is not otherwise export controlled. Editing an individual's work outside of these avenues always requires approval. Noncompliance with federal regulations may yield criminal penalties up to $1,000,000 USD and/or 20 years in prison (per violation). The US investigators must be informed of these regulations to prevent inadvertent legal transgressions and repercussions.

KEYWORDS:

Health law jurisprudence; international medicine; medical research

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