Author: Zack Machuga

Categories
Export Control

Settlement Reached in Princeton Biological Material Export Control Violation

Tysons Corner construction overlooking the new Metro Silver line in the background. Photo by Evan Cantwell/Creative Services/George Mason University

Princeton University paid a penalty of $54,000 after voluntarily disclosing to the Federal Government’s Bureau of Industry and Security (BIS) 37 occasions where it exported various genetic elements of animal pathogens without required export licenses.

Princeton’s unauthorized shipments occurred between November 2013 and March 2018, and involved the export of strains and recombinant materials to research institutions in Australia, Canada, China, India, Singapore, South Korea, and the U.K.  These items were controlled for Chemical and Biological Weapons reasons, and had a total value of approximately $27,000.

In addition to the financial penalty, Princeton is also required both to complete an internal export compliance audit and to hire an independent consultant at the University’s expense to conduct an external audit.  The university must report the results of these audits (including any actual or potential violations of the Export Administration Regulations) to BIS.

Princeton reportedly discovered these potential violations, voluntarily disclosed the information to BIS, and cooperated with all matters of the investigation to resolve the violation.  A press statement by BIS noted that self disclosure helps mitigate the penalties imposed when violations have occurred.

Additional Information:

https://www.bis.doc.gov/index.php/documents/about-bis/newsroom/press-releases/2716-princeton-university-press-release-final-updated-2021-02-02/file 

https://efoia.bis.doc.gov/index.php/documents/export-violations/export-violations-2021/1287-e2642/file 

Categories
Conflict of Interest

Reminder: Annual Mason Conflict of Interest (COI) Disclosure

All Mason employees who receive benefits (benefited employees) are required to access the site https://coi.gmu.edu/ and disclose whether or not they have any COI.

  1. First, click the “Submit Your Disclosure” button and sign in with your Mason ID.
  2. From the drop-down menu, choose the VP, Dean, or other senior leader to whom your position reports.
  3. You will read through a one-page Training document describing what needs to be disclosed.
  4. You will then click Yes or No when asked if you have any COI to disclose.
  5. If you have an immediate family member (defined as a spouse or someone who lives in your house and is your dependent) who also works at Mason, you will also be required to disclose the name of your immediate family member.
  6. If you do not have any COI to disclose, then the declaration process is complete. If you do have COI to disclose, you will be asked to further describe the COI.

Personal Interest in a Contract: Virginia law (§ 2.2-3106 of the Virginia Code) prohibits employees of Mason from having a personal interest in any contract or transaction with Mason unless there is a COI waiver in place. The law defines a personal interest as more than $5,000 in annual income or 3% ownership interest. If any employee has such a personal interest, they must disclose it and Mason’s COI Committee will determine whether a waiver can be granted. All disclosures made through the COI website will be reviewed by the COI Committee to determine whether a waiver is required.

**If you do not know whether an entity has a business relationship with Mason, you can sign in here to Search for vendor’s G number or contact ewoodley@gmu.edu.**

Significant Financial Interests (SFIs) and Research Proposals: Significant financial interests related to institutional responsibilities must be disclosed prior to proposal submission. Significant financial interests include more than $5,000 in equity for publicly traded firms, or annual income or any ownership interest in a privately held firm.

All benefited employees must complete this disclosure at least once annually. Keep in mind that if your disclosure changes at any time, you must update it throughout the year. On 10/26/2019, I will forward a list of employees who have not yet completed their disclosures to Mason’s Deans and Vice Presidents, who will follow up with their employees who have not yet completed the disclosure.

If you have questions about COI or SFI disclosures, you may contact Elizabeth Woodley, University Ethics Officer and Policy Manager, or Chris DiTeresi, Associate Director, Research Integrity.

Note to Statement of Economic Interest (SOEI) filers, you know who you are!: This disclosure is in addition to your SOEI, is made to Mason directly rather than the Commonwealth, and is much simpler.

 

Categories
Conflict of Interest Foreign Support

NSF Updates to the Research Performance Progress Report

Sunflower with Research Hall in the background. Photo by Evan Cantwell/Creative Services/George Mason University

On September 28, the National Science Foundation announced the additional of new questions, effective October 5, to their Project Reporting System which is where awardees prepare and submit performance progress reports for their federally funded research projects and research-related activities. The edits include the following questions: (1) Has there been a change in the active other support of the PI/PD(s) since the last reporting period?; (2) What was the impact on teaching and educational experiences?; (3) What percentage of the award’s budget was spent in a foreign country?; and (4) Has there been a change in primary performance site location from that originally proposed?

Depending on these answers, PIs could also upload follow-up supporting documents. Finally, the changes also include the addition of further guiding text to clarify instructions where needed.

Additional Information

https://www.nsf.gov/bfa/dias/policy/

 

Categories
Export Control

OFAC Issues Cuba Travel Restrictions

Cody Lucas is a rising senior, Information Systems Operations Management major, who has developed an app called TavelWeb in which people can map trips they are taking in real time and share with friends. Photo by: Ron Aira/Creative Services/George Mason University

The US government has revoked several broad authorizations and imposed additional conditions related to travel to Cuba by US persons:

  • US persons must now apply for and receive specific permission (a license) to organize or attend professional meetings or conferences in Cuba.
  • OFAC has eliminated the general authorization that formerly permitted US persons to organize or participate in public performances, clinics, workshops, and many types of athletic and non-athletic competitions and exhibitions in Cuba.
  • Persons permitted to travel to Cuba under the various authorizations that remain in the regulation are prohibited from lodging, paying for lodging, or making any reservation for or on behalf of a third party to lodge at any property the US government identifies on its new “Cuba Prohibited Accommodations List (the CPA).” This prohibition includes travel in connection with permissible educational activities. It does not make illegal any transactions that were formerly authorized and that were initiated prior to the date a property is officially added to the CPA.

Note: The general license permitting full time professional research in Cuba is still valid, but complying with the terms of that authorization is challenging.  If you plan to conduct research in Cuba, please consult with us well in advance of your intended travel date.

The new restrictions became effective on September 24, 2020.

More information can be found at the following links:
https://home.treasury.gov/news/press-releases/sm1134
https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-21084.pdf.

Please contact us at export@gmu.edu if you would like to discuss these changes.

Categories
Authorship

NIH publishes case study on research integrity

On September 2, the NIH published a redacted version of a case study showing an example of the misuse of funds. In the example, a distinguished medical professor reportedly shared NIH grant applications with members of his laboratory, including junior non-tenured faculty, and requested them to complete his written critiques as if they were an NIH peer reviewer. These individuals had also been instructed not to disclose this request to anyone else, in addition to directly violating NIH’s confidentiality statement preventing disclosure to anyone who is not officially designated to participate in the peer review process. The resulting complaint was reported to the Dean of Research at the university, and action was taken to remove the professor from their current position, impose sanctions on future grant applications, and review past peer reviews that may have been similarly compromised.

Noting that NIH reports they were so impressed by the careful handling of the situation, this story is meant to raise awareness, encourage dialogue, and inspire creative problem solving for challenges in maintaining integrity in peer review.

Additional Information

https://nexus.od.nih.gov/all/2020/09/02/case-study-in-review-integrity-abuse-of-power/

Categories
Export Control

BIS considers export controls on foundational technologies

Prince William Campus aerial photos with student pilot Sean Graham. Photo by Craig Bisacre/Creative Services/George Mason University

On August 27, BIS published an advance notice which announced the start of their review of foundational technologies pursuant to section 1758 of the Export Control Reform Act of 2018. More specifically, BIS is considering potential export controls on “foundational technologies” as well as commodities (i.e., hardware, production equipment and materials) and software. Currently the notice only requests industry comments, which can be made through October 2020, as the Bureau seeks to define the term “foundational technologies” and understand what types of controls might be appropriate.

Then, with input on the technologies within scope, BIS could increase controls on items already subject to anti-terrorism controls on the Commerce Control List, place new controls on previously uncontrolled items classified for export as EAR99, and also establish a framework for future identification of fundamental technologies. As for a timeline, the previous implementation of restrictions concerning emerging technologies suggests that BIS could begin implementing specific new controls, or expand existing controls, on foundational technologies as soon as early 2021.

Additional Information

https://www.jdsupra.com/legalnews/potential-expansion-of-u-s-export-89592/

Categories
Animal Subjects

PETA calls for audit of animal subject research across the University of California system

On August 31, PETA authored a letter claiming that the use of animals in nonessential experiments at five universities across the UC system was in violation of various federal research standards, including those from the U.S. Public Health Service. The reason for PETA’s alarm is twofold: first is the belief that hundreds of animals were euthanized in order to reduce laboratory populations when nonessential experiments were postponed or cancelled because of the pandemic, and second is an inquiry into the taxpayer dollars used in nonessential experiments. It is their hope that an audit would determine if any of the reported $428 million in public research funding allocated to UC campuses in fiscal year 2019 was used for experiments on animals found to be extraneous during the pandemic, and also to take corrective action if this is found to be the case.

Although official university representatives have denied these beliefs to be the case, PETA’s perspective is an important consideration for other universities to be reminded of the high sensitivity involved with animal subjects research, and in the possibility of similar probes being requested elsewhere.

Additional Information

https://www.peta.org/call-for-state-audit-of-uc-campuses-after-covid-19-related-non-essential-experiments/

Categories
Responsible Conduct of Research

U.S. Office of Research Integrity explores ideas for future growth

Graduate students in Shane Gallagher's Instructional Technology classroom. Photo by Evan Cantwell/George Mason University

An article published by the American Chemical Society this week offers insight regarding the possible future direction of the U.S. Office of Research Integrity under the DHHS. Based on an interview with Interim Director, Elisabeth Handley, one of the major ideas is to add new technologies to their wheelhouse. Officially, the ORI provides oversight to misconduct investigations within U.S. research institutions, but a major challenge is that the tools available to researchers have drastically changed since many of the agency’s regulations were established – some of which date back to 2005. At the moment, ORI is particularly concerned about data stored in cloud computing databases, personal electronic equipment, and storage devices. Furthermore, the need for technological improvements is currently exacerbated by the COVID-19 crisis which not only moved research remotely, but has led to many rushed publications before the chance for credibility-adding peer reviews.

Operationally, the office receives around 200 allegations of research misconduct each year, and each of its investigators take on roughly 35–40 cases. Many of these can be dismissed if they fall outside ORI’s scope, but approximately 40-70 cases are closed – meaning that there was a determination of insufficient evidence, actual misconduct, or probable misconduct but the responsibility of which is unable to be pinpointed to a specific person. Most importantly, any delays to these findings are undesirable because it allows fraudulent studies to continue or even follow-up studies to be conducted on top of faulty studies. Therefore, many in the academic community appreciate the intention to accelerate the timeline of misconduct investigations and bring the technological understanding of ORI up to the level that is already being used by researchers.

Additional Information

https://cen.acs.org/research-integrity/misconduct/New-Office-Research-Integrity-leaders/98/web/2020/08

 

Categories
Human Subjects

FDA ramps up enforcement of clinical trials

On August 14, the FDA released new guidance detailing increased penalties for identified cases of noncompliance with the requirement to register their studies and post results on ClinicalTrials.gov. This motion arises out of recent findings that compliance with these requirements remains low, and more so within academia than industry. Further, it is believed that poor compliance is likely reflective of a lack of enforcement by regulators, and stepping up enforcement efforts would be a useful remedy for the issue.

Currently, federal requirements mandate the use of this service in order to monitor clinical trial information for potential concerns as specified in 42 CFR 11.10(a). Specifically, researchers must register within 21 days of the first study subject enrollment, and the results must be posted within one year of completion. This applies to any studies that fall under FDA’s regulatory thumb, or studies receiving funding from the NIH. Failure to comply with this policy could result in penalties up to $10 thousand for each day until the violation is corrected, as well as civil or criminal proceedings.

To identify such violations, evidence is typically collected either during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO) or based on the evaluation of complaints received at the agency. Once discovered, the FDA said it’s continuing to send what it calls “pre-send notice letters,” which alert a company of potential violations and gives it 30 days to fix it. During a pilot enforcement project before the issuance of the rule, the FDA said it sent 15 such letters out and all the companies subsequently complied – further evidence that a more active stance would be beneficial for bolstered compliance.

Additional Information:

https://www.fda.gov/media/113361/download

 

Categories
Government

American Institute of Physics provides preview of 2021 National Defense Authorization Act

At the end of July, the House and Senate approved separate versions of this year’s NDAA, expected to be finalized during the Fall. These provisions included in this year’s annual legislation touch on all aspects of national security, with many aiming to strengthen the defense R&D enterprise, promote specific military technologies, and bolster U.S. nuclear security. To address the topic covered, AIP published a new bulletin this week, with highlighted changes below:

National security innovation base

  • The establishment of a new position of assistant secretary of defense for industrial base policy
  • The provision of a directive to recommend executive, regulatory, and legislative steps needed to implement a 2017 executive order on strengthening the defense industrial base
  • The creation of an advisory board for National Security Innovation Capital or National Security Innovation Network to promote collaboration between the department, universities, and technology startups
  • The bolstering of National Nuclear Security Administration monitoring efforts
  • The initiation of a study of China’s defense industrial base, focusing on manufacturing capacity, capability gaps, workforce skills and education, and supply chain integrity

Research security and talent recruitment

  • The initiation of a National Academies study to compare U.S. and Chinese efforts to “recruit and retain domestic and foreign researchers”
  • The uniform requirement that prospective recipients of grants or cooperative agreements disclose all current and pending support and the sources of such support at the time of the application for funds
  • The removal of a provision to exempt “basic research” from streamlined vetting procedures
  • The designation of an official responsible for liaising with the academic and research communities
  • The additional of employment restrictions for current and former employee to work for companies controlled by the Chinese government
  • The publication of a list of foreign talent programs that pose a threat to U.S. national security interests
  • The assessment of exchanges of scientists, engineers, and academics between China and Russia
  • The initial exploration regarding the creation of a talent recruitment program for the national security innovation base
  • The creation of a new immigration category for scientific or technical experts who are specially endorsed by the secretary of defense

Additional Information

https://www.aip.org/fyi/2020/innovation-base-and-research-security-proposals-fy21-national-defense-authorization-act

 

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