Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 5 (May 2020)

Cybercriminals are “sending malicious phishing emails that appear to be from trusted federal agencies,” such as HHS, in order to “steal sensitive data,” warned Michael Lauer, NIH deputy director for extramural research. “Other phishing emails have contained a link to a malicious website that was designed to look like a live map of COVID-19 cases from Johns Hopkins University.” Writing April 8 in his Open Mike blog, Lauer urged everyone to “remain vigilant and be ready to report if we see anything suspicious, and continu[e] to keep our work, data, and professional and personal lives safer and more productive.” Lauer pointed out that threats are increasing now that more work is being done from home and access to NIH and research institutions is occurring with “internet tools more and more, challenging the safety and security of these electronic systems likely to a degree not seen before.” (4/16/20)

The HHS Office for Human Research Protections (OHRP) recently concluded a four-year investigation into research at Bloomsburg University of Pennsylvania, concluding that seven studies involving the same investigator were incorrectly designated as exempt, and thus conducted without the required approval of an institutional review board. But, according to a recently posted determination letter dated March 4, OHRP took no action against Bloomsburg, which acknowledged its error in handling the studies, one of which involved children. OHRP first exchanged correspondence with Bloomsburg beginning in August 2016, and continuing into 2019, about the seven studies to which Bloomsburg incorrectly applied exemption category 2, which pertains to the “use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.” (4/16/20)

About a month after HHS appointed Elisabeth “Lis” Handley director of the Office of Research Integrity, a Johns Hopkins University official has been named director of ORI’s Division of Education and Integrity, according to an April 2 blog post. ORI is responsible for making findings of research misconduct, defined as fabrication, falsification and plagiarism, in Public Health Service-funded research. Karen Wehner, who holds a doctorate in genetics from Yale University, previously was the associate director of the Division of Research Integrity at the Johns Hopkins University School of Medicine, where her duties included providing responsible conduct of research training. She also was the assistant research integrity official, offering “support for the institution’s response to allegations of research misconduct, and she handled other research integrity matters, such as authorship disputes and professional misconduct occurring in the research space.” (4/9/20)

NIH has terminated or restricted the service of nearly 90 peer reviewers due to confidentiality breaches, including 10 it permanently banned for also having “undisclosed foreign affiliations,” according to a new report by the HHS Office of Inspector General (OIG). Only one peer reviewer had been referred to other HHS authorities for possible suspension or debarment, but NIH “plans to refer additional individuals,” OIG said, citing data current as of November. In 2017 and 2018, NIH had to dissolve two study sections “because of evidence of systemic collusion among the reviewers in the section. At least one instance involved the disclosure of confidential information,” OIG reported. NIH has some 27,000 peer reviewers in total. (4/9/20)

In its second recent blog post since the COVID-19 pandemic, ORI is reminding institutions that they can—and probably should—collect evidence in cases of suspected misconduct before notifying accused individuals. Aware that the pandemic “is interrupting and delaying regular operations at institutions, including research misconduct proceedings,” ORI said it may be difficult to “access records on site.” In light of this, the agency advises institutions to “promptly begin sequestering electronic evidence remotely to the extent that it has the technological capability to do so (i.e., data and emails on network computers, servers, and cloud environments),” and that they “may postpone sequestering physical and other electronic evidence (i.e., laboratory notebooks, blots/films, other research records, and evidence on non-networked computers and devices) until it becomes reasonable and practical to sequester such evidence.” (4/2/20)

In a new audit, the National Science Foundation OIG has recommended NSF seek repayment of $75,139 from the University of Connecticut (UConn) for what it said were unallowable charges. Dated March 23, the audit covered the period from Feb. 1, 2016, to Jan. 31, 2019, during which time UConn claimed $63 million in costs among 401 NSF awards. Auditors tested 125 transactions, totaling $1,698,055 in costs claimed, concluding that approximately $75,000 were unallowable. Specifically, “auditors found $39,009 of expenses not appropriately allocated to NSF awards; $31,095 of expressly unallowable expenses charged to NSF awards; $3,184 of inappropriately used participant support funds; and $1,851 of fringe benefits not appropriately applied to payroll charged in different fiscal years,” the report said.

In addition, auditors made a total of nine findings, including “incorrect application of proposed indirect cost rates, travel comparisons not appropriately performed, cost transfer documentation not appropriately maintained, stipends not appropriately provided to [a specific type of scholar], and program income not appropriately used for which there were no questioned costs.” In its response to the draft audit, UConn officials disputed $13,476 of questioned costs, agreeing to repayment of the balance flagged by auditors. In most instances, UConn did not explain why it was agreeing to repayment; in opposing some questioned costs, it cited errors or what it believed to be allowable practices. Nevertheless, they plan to “evaluate and identify areas to improve policy, procedure, training and guidance,” the response said. Per procedure, NSF will work with UConn in determining whether to accept OIG’s recommendations or to allow the charges UConn did not agree to repay. UConn officials said the findings “relate almost exclusively to isolated incidents.” (4/2/20)

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