|Year : 2019 | Volume
| Issue : 1 | Page : 5-10
United States federal government regulation of international research collaborations: What every physician-scientist should know
Andrew C Miller1, Amna Ziad-Miller2
1 Department of Emergency Medicine, Division of Research, East Carolina University Brody School of Medicine, Greenville, NC;The MORZAK Collaborative, Columbia, MD, USA
2 The MORZAK Collaborative, Columbia, MD, USA
|Date of Web Publication||8-Mar-2019|
Dr. Andrew C Miller
Department of Emergency Medicine, Division of Research, East Carolina University Brody School of Medicine, 600 Moye Blvd., Mailstop 625, Greenville, NC 27834
Source of Support: None, Conflict of Interest: None
| 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
|How to cite this article:|
Miller AC, Ziad-Miller A. United States federal government regulation of international research collaborations: What every physician-scientist should know. Int J Crit Illn Inj Sci 2019;9:5-10
|How to cite this URL:|
Miller AC, Ziad-Miller A. United States federal government regulation of international research collaborations: What every physician-scientist should know. Int J Crit Illn Inj Sci [serial online] 2019 [cited 2020 Jul 7];9:5-10. Available from: http://www.ijciis.org/text.asp?2019/9/1/5/253765
| Introduction|| |
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. Ignorance of these laws offers no protection. Presumed knowledge of the law is the jurisprudence principle that one is bound by a law even if one does not know of it: Ignorantia juris nonexcusat (Latin for “ignorance of the law is no excuse”). This is the price paid to assure that willful blindness may not justify exoneration.
As globalization interconnects the health of disparate populations, international research collaborations (IRC) allow participants to share knowledge and resources to address relevant scientific and health questions. Such partnerships enhance one's ability to approach complex problems from varied perspectives, promoting the development of a wider range of research skills and techniques, and improved publication and citation rates.,, According to Web of Science records, IRC rates have grown rapidly from 1990 (10%) to 2011 (25%). Reasons may range from equipment sharing to accessing unique population-specific data. Historically, collaborative ties have shown a proximity effect,, but that appears to be diminishing. Whereas some investigators may seek to improve research capacity through collaboration, others may seek partners with a specialized focus or patient population not available in their geographic proximity. Of course, these relationships may be facilitated or discouraged by factors including language, culture, and political climate, however websites such as ResearchGate (ResearchGate Gmbh, Berlin, Germany), Academia.edu (Academia Inc., San Francisco, US), Publons (Clarivate Analytics, Philadelphia, US), and Mendeley (Mendeley Ltd, London, UK) are increasingly uniting researchers across specialty, geographical, political, cultural, and religious boundaries. Moreover, social media sites including Facebook (Facebook Inc., Menlo Park, CA, US) and Twitter (Twitter Inc., San Francisco, CA, US) are increasingly being utilized to facilitate collaborative projects, as are general medical and specialty-specific websites, listservs, and discussion forums.
For national security and foreign policy reasons, US export control laws restrict the shipment, transmission, and transfer of certain knowledge, items, software, technology, and services from the US to foreign countries and individuals, including some foreign nationals within the US. They additionally restrict foreign travel and business with certain countries, entities, and individuals. Of importance, medical research falls within this broad stroke.
Although many academic medical activities may qualify for an exception to export control laws, others may be restricted. Examples of activities that may be subject to export control laws include, but are not limited to: research, teaching, collaboration, regulated technology, and equipment use, hiring employees, travel, mailing and shipping, purchasing, money transfers, and contracting. Noncompliance with federal laws exposes individuals (and their employer) to criminal and civil penalties (fines and imprisonment) as well as administrative sanctions (loss of research funding and export privileges).
| Regulation of International Collaboration|| |
The regulation of international collaboration is performed by the US departments of state, commerce, and treasury. The department of state's international traffic in arms regulations (ITAR) regulates the production of defense articles and the provision of defense services, whereas the Department of Commerce's Export Administration Regulations (EAR) regulates dual-use items, or those having both commercial and military or proliferation applications.
Treasury is one of 50 titles comprising the US Code of federal regulations (CFR Title 31 is the principal set of rules and regulations governing money, finance, and the treasury, with 31 CFR Parts 500–599 describing foreign assets control regulations. The Department of Treasury's Office of Foreign Assets Control (OFAC) administers the bulk of their programs under the International Emergency Economic Powers Act (IEEPA; 50 USC §§1701–1707), signed into law by President Jimmy Carter on December 28, 1977. OFAC prohibits working with any person, government or entity for which an active US sanction or embargo exists, or for any individual or entity designated on various restricted party lists unless there is an authorizing OFAC license.
The export administration act (EAA) of 1979 (Public Law [Pub. L] 96-72) provided legal authority to the President to control US exports for reasons of national security, foreign policy, and/or short supply. The act was in force from 1979 to 1994. The EAA was reauthorized by Pub. L. No. 106–508, and it remained in effect through August 20, 2001. Since August 21, 2001, the EAA has been in lapse and the President, through Executive Order (3 CFR 2001 Comp. p. 783 (2002)), has continued the EAR under the IEEPA (50 U. S. C. §§1701–1707). The IEEPA falls under the provisions of the National Emergencies Act; Pub. L. 94–412, 90 Stat. 1255, codified at 50 U. S. C. § 1601–1651, meaning that an emergency declared under the act must be renewed annually to remain in effect.
In October 2001, Congress passed the USA PATRIOT Act which, in part, enhanced the IEEPA asset blocking provisions under 50 U. S. C. §1702 (a)(1)(B) to permit blocking assets during a pending investigation. This statutory change gave the Treasury's OFAC the power to block a subjects assets without the need to provide evidence of the subject's wrong doing, and without allowing the subject a chance to respond to the allegations in court. Further amendment on October 16, 2007 (Pub. L. 110–96, amending IEEPA § 206) clarified stiff penalties for acts deemed unlawful.
On an institutional level, many universities have an empowered official, as defined in ITAR (22 CFR § 120.25), that is empowered to sign export license applications or other approval requests on behalf of the institution. The empowered official's duty is to understand the provisions and requirements of the various export control statutes and regulations, and the criminal liability, civil liability, and administrative penalties for violations.
Beyond the aforementioned regulations, the US. Federal Bureau of investigation (FBI) has weighed in over recent years from the perspective of reducing intellectual property theft and espionage. Concerns have been voiced on Capitol Hill about US universities being particularly vulnerable to theft of valuable intellectual property, including research data, by hostile foreign governments.
| Which Regions Require Office of Foreign Assets Controls Approval for Collaboration?|| |
OFAC maintains a list of specially designated nationals (SDN) and blocked persons on the US Department of treasury web page. Cuba, Iran, North Korea, and Syria are currently the four comprehensively sanctioned countries. Sudan was the fifth until October 2017. Sanctions related to other countries are more often targeted to specific industries, institutions, companies, or specific groups or individuals. For example, Venezuela sanctions only prohibit the exchange of certain services and goods with the government and select individuals/entities. Ukraine/Russia-related sanctions target specific entities for supporting Russia's invasion/annexation of Crimea, impacting the Russian Industry Sector (translating into their energy sector), but not medical research per SE The Lebanon sanctions program targets entities that supported Lebanon's interference with Syria. As such, medical research would likely be permitted. Other regions with partial sanctions necessitating OFAC review include the Balkans, Belarus, Central African Republic, Democratic Republic of Congo, Iraq, Libya, Somalia, Yemen, and Zimbabwe. It is important to note, however, that both sanctions and regions to which they apply are subject to change according to political relationships and motivations.
The takeaway is that collaboration with North Korean and Syrian entities generally are prohibited with a policy of denial. Collaborations with Cuban and Iranian entities require an OFAC license. For all other countries, one must review the restricted party lists (US departments of treasury [i.e., OFAC], commerce, and state) to ensure that collaborating entities are not designated entities. If so, the submission of an application for an OFAC license is necessary.
| What Type of Collaboration Needs Approval?|| |
Various types of research collaboration require approval. Original investigations (prospective and retrospective), meta-analyses, reviews, and case series/reports with designated entities require OFAC approval as it is considered providing an individualized service to these countries. Other types of academic output are more case specific. Opinion pieces are likely exempted in the regulations as personal communication, but OFAC review is still required. Both professional conversations and translation services are dependent on the specifics and require OFAC review.
A peer review performed as part of routine journal editing or as part of a journal peer review panel is acceptable if the work is not export-controlled otherwise. Editing an individual's work outside of the scope of the aforementioned mechanisms always requires OFAC approval.
| Approval Process|| |
Applications for collaboration approval are submitted through an institution's designated official, or directly with OFAC. They will assess whether any collaborating parties or institutions are on the banned or sanctioned parties list. In addition, they will determine whether any preexisting licenses exist to support the work. Should no license exist, then a new license should be applied for. Individuals may self-report or apply for an OFAC license through the US department of treasury web page. Correspondence should contain (for each collaborator) the individual's name, affiliation, and country, and a brief description of the proposed collaboration.
| Consequences of Noncompliance|| |
Penalties for noncompliance range from institutional administrative action to criminal penalties. Institutional disciplinary action may include the imposition of sanctions or dismissal from employment. When the EAA (Pub. L. 96–72) is in effect, administrative monetary penalties can reach $11,000 (per violation), and $120,000 (per violation) in cases involving items controlled for national security reasons. Criminal penalties under the EAA can reach $1,000,000 USD, 20 years in prison, or both (per violation). When the EAA is in lapse (as it is now), the penalties are set forth by the IEEPA. Civil penalties (under IEEPA) are up to (1) $250,000 USD or (2) an amount that is twice the amount of the transaction that is the basis of the violation. Criminal penalties (under IEEPA) include a fine up to $1,000,000 USD, 20 years in prison, or both (Pub. L. 95-223, title II, § 206, Dec. 28, 1977, 91 Stat. 1628; Pub. L. 102-393, title VI, § 629, Oct. 6, 1992, 106 Stat. 1773; Pub. L. 102–396, title IX, § 9155, Oct. 6, 1992, 106 Stat. 1943; Pub. L. 104–201, div. A, title XIV, § 1422, Sept. 23, 1996, 110 Stat. 2725; Pub. L. 109–177, title IV, § 402, Mar. 9, 2006, 120 Stat. 243; Pub. L. 110–96, § 2 (a), Oct. 16, 2007, 121 Stat. 1011.).
Moreover, violators may also be subject to denial of their export privileges, which for a physician or scientist may include their knowledge. EAA § 11 (h) provides that, at the discretion of the Secretary of Commerce, no person convicted of a violation of the EAA, IEEPA, arms export control act § 38, or one of the several espionage-related statutes will be eligible to use or apply for any export license issued under the EAA for up to 10 years from the date of the conviction. In addition, EAA § 11 (h) provides that the Secretary of Commerce may revoke any export license which the party had at the time of the conviction. A denial of export privileges prohibits a person from participating in any way in any transaction subject to the EAR, including teaching and research. Furthermore, it is unlawful for other businesses and individuals to participate in any way in an export transaction subject to the EAR with a denied person.
The US government has also used a variety of indirect legal remedies that impact international collaboration. For instance, the FBI and the Department of Justice (DoJ) have increased attention on violations of intellectual property transfer and espionage. In one example, the US DoJ brought charges against three Chinese researchers in 2013 working at New York University on a project sponsored by the National Institutes of Health (NIH). The agency accused the defendants of colluding with representatives from a Chinese-sponsored research institute and attempting to steal patented technology and license it to a Chinese medical imaging company. Charges ranged from commercial bribery conspiracy (max sentence 5 years in prison) to falsifying records associated with an NIH grant (max sentence 20 years in prison). In another case, a research assistant at the Medical College of Wisconsin was arrested for allegedly stealing three vials of a cancer-fighting compound from a colleague's desk, and attempting to use the material to apply for Chinese government funding. They were charged with economic espionage benefiting a foreign government, foreign instrumentality, or foreign agent, in violation of Title 18 U. S. C. § 1831 (a) (1, 2, 3) That researcher eventually plead guilty to illegally downloading research data and was sentenced to time already served plus 2 years of probation.
| the Impact on Academics|| |
Sanctions do not only affect the clinical care and research capabilities of target regions. There may be collateral damage for investigators in the country imposing sanctions, as well as others. It may suppress publication of important but unpublished clinical trial data from studies initiated before knowledge of the regulations. In addition, it may generate significant delays or frank obstruction to initiating new clinical trials. There are also unique impacts on physicians and scientists immigrating to the US from sanctioned countries. For example, Iranian citizens are among the top ten groups of international physicians who acquired US certification in 2009. Relationships and collaborations do not end with emigration from one's home country, and applying these laws to medical research has placed such immigrants in a precarious position. It impairs their ability to continue communicating and collaborating with mentors, colleagues, and possibly even family members back home, as well as with those residing in other sanctioned regions. Some academics may continue collaborating with or mentoring individuals in their country of origin after their migration. Others may introduce investigators in their new country with known investigators in their country of origin. These relationships (and others) may create an entanglement that places unwitting academics at risk of running afoul of federal regulations, thereby risking their career, fines, or freedom.
Sanctions may also bias journals against publishing quality articles arising from particular geographic regions. For instance, following US political sanctions on Iran, some journals and publishing companies banned manuscripts arising from, or with co-authors from Iran to avoid potential litigation associated with 31 CFR Parts 500–599., This may in part be associated with the publishing fees that some journals exact, but certainly this is not the case for all. However, such concern on the part of publishing companies is unfounded. In October 2015, OFAC reported that publishing activities conducted by sanction country authors in their personal professional capacity, even if they are working at a government institution, is not problematic. Even if the author was preparing the paper or contribution on behalf of their government institution, it is also permitted if that institution was primarily involved in education or research.
| Profiling or Protecting|| |
The US commission on civil rights raised red flags in November 2015, suggesting in a letter to attorney general Loretta Lynch that the US government had unjustly pursued Chinese–American scientists., The organization's letter referenced recent news reports that detailed embarrassing attempts by the US federal government to prosecute Chinese–Americans for spying and economic espionage, only to drop the charges following revelations of serious errors., Examples include Xiafen “Sherry” Chen, a hydrologist with the US. National Weather Service, and Dr. Xiaoxing Xi, the former chair of Temple University's physics department. These two naturalized US citizens were arrested in 2014 and 2015, respectively, for alleged economic espionage. The US government had claimed that Chen downloaded information about US dams and lied about meeting a Chinese official, but all charges were dropped before trial in 2015., However, she was fired from her government job in 2016, and despite winning an appeal that ordered The National Weather Service to restore her position and provide back pay and benefits,, her employer appealed this decision and her position remains not reinstated.
In a separate case, Dr. Xi was arrested for supposedly sharing confidential blueprints of laboratory equipment with researchers in China., However, it soon became clear that the shared schematics were not for the equipment in question, making Xi's case another embarrassing incident and the charges against him were also dropped.,
| Conclusion|| |
It is essential that researchers know and understand the federal regulations that govern international collaborations to stay in compliance and avoid employment or criminal repercussions. We call on OFAC to improve dissemination of this information and to standardize and facilitate reporting mechanisms. To broaden knowledge of these requirements, we recommend that investigators insert a statement of OFACS approval following their statement of IRB certification when there are collaborators from sanctioned entities. Moreover, to disseminate knowledge and ensure compliance with this requirement, we recommend that US-based journals include a hard-stop in the submission process like those already in place for IRB certification and clinical trial registration. Part (a) would ask if the manuscript was produced wholly or in part through collaboration with entities on the OFAC SDN list. An affirmative answer would necessitate answering part (b) Was OFACS license obtained in accordance with 31 CFR Parts 500–599? This would begin to ensure widespread knowledge and compliance with U. S. federal laws regulating medical and scientific research.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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