Research Compliance Report, Volume 18, Number 7. In this month’s e-newsletter: July 2021 | Healthcare Compliance Association (HCCA)


Research Compliance Report 18, no. 7 (July 2021)

In a review of more than 500 NIH awards, the Office of the Inspector General (OIG) of HHS found that about one-fifth were funded “off-rating,” and for more than one-third of those, ” no reasoning was documented ”- a violation of HHS policy. “This means that the NIH does not know whether the integrated circuits [institutes and centers] are funding in order of priority to advance the NIH mission or because of issues that merit NIH attention, ”OIG said in the June 15 report. favorably by the first level of peer review compared to an application which was ranked more favorably. Priority funding allows CIs to fund grants that match their research priorities or address emerging threats to public health, for example. The OIG reviewed fiscal year 2018 data for awards from the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Drug Abuse and several others.

In total, “CIs funded 109 of the 540 grants in our sample in order of ranking”, but this varied widely. For example, NIDDK “funded 67 of its 130 out-of-rank sample grants”, while NINDS “funded 8 of its 184 out-of-rank sample grants”. The NIH supported the OIG’s recommendations for changes to increase transparency. “The NIH has said it will develop structured data to identify, track, and monitor the compliance of non-ranked grants awarded, with implementation slated for fiscal year 2021,” OIG said. “The NIH also said it would conduct a full review in the same year and implement additional internal controls, guidelines, and compliance testing as necessary based on the results of the review.” In addition, the NIH will revise “its internal policy and staff guidelines to reflect the requirement in the HHS Grants Policy Administration Manual to link funding justifications to the factors documented in the funding opportunity announcement. “. (06/17/21)

A friendly caveat to the research community: With the rise of biobanks / big data sets in the 21st century, researchers should pay close attention to restrictions on data rights and carefully check the ‘use any data source before using it for scientific purposes’. This advice came from a research team at the University of West Virginia to Retraction watch after being forced to ask a newspaper to delete an article published just three months ago on alopecia. According to comments that first author Ahmed Yousaf made to Retraction watch, the research team requested, and believed they had obtained, permission to use the UK Biobank data that was the basis for the article in JAMA Dermatology.

The biobank’s ambulatory data set was limited to studies involving COVID-19 research, and the group published one such article. The team had “requested primary care data without COVID restrictions,” he said, and were “shocked” by the biobank’s notification that the use for the alopecia study was not had not been granted. Yousaf said Retraction watch he was not sure whether the team would submit a new authorization request after the retraction. “It was unfortunate to pull an otherwise ethically sound article with a solid premise, we agree with UK Biobank that the proper use of data and the protection of participants outweighs the value of any publication,” Yousaf said. (06/17/21)

Although randomized clinical trials are considered the gold standard, “their test designs may be inappropriate and underpowered due to small sample sizes,” according to David M. Murray, associate director for prevention of the NIH and director of its office of disease prevention. “To have a solid and rigorous study, researchers must provide enough information about the selected methodology, statistical analysis and sample size when proposing a trial,” he continued in an article. invited on June 9 on the Open Mike Blog. (06/17/21)

The watchdog organization Public Citizen urges the Office for Human Research Protections, the Food and Drug Administration and NIH Director Francis Collins to investigate an NIH-funded trial of epilepsy treatments that has recruited more of 400 subjects in 58 American hospitals. In June 8 letters to the agencies, Michael Carome, MD, director of the Public Citizen’s Health Research Group, said the goal of the established status epilepticus treatment trial was to assess whether one of the three anticonvulsant drugs “would result in better seizure resolution and responsiveness within 60 minutes after initiation of the assigned drug, without additional anticonvulsant drugs”, in patients who had previously been treated with benzodiazepines following treatment. a crisis. (6/10/21)

Two employees of Tellus Clinical Research in Miami have pleaded guilty to falsifying data in two clinical trials for irritable bowel syndrome, the Department of Justice (DOJ) announced on June 8. Eduardo Navarro was sub-investigator and Nayade Varona was assistant study coordinator. “As part of their plea deals, Navarro and Varona have admitted to having agreed between themselves and with others to falsify medical record data in two clinical trials to evaluate treatment for irritable bowel syndrome. Among other things, Navarro and Varona falsified the data to make it look like the subjects were participating in the trials when in reality they were not, ”according to the DOJ. “Both face a maximum sentence of five years in prison and are expected to be sentenced on August 11,” the government said. (6/10/21)

National Science Foundation (NSF) OIG auditors examining the California Institute of Technology (Caltech) implementation of COVID-19 administrative flexibilities granted by the Office of Management and Budget (OMB) found only one exception or irregularity, apparently the first problem of nine such reports to be published by the OIG. Caltech’s audit was one of seven such audits released last month. According to the May 26 report, auditors “questioned $ 16,769 in ineligible salary billed” on several awards after the OMB’s flexibilities memorandum expired. However, Caltech officials disagreed with auditors regarding this conclusion. The funds were intended for “employees who could not perform their jobs until” July 19, 2020, and the OMB’s flexibility period ended on June 16, 2020, Caltech acknowledged. But officials argued that “it was unreasonable for the OMB to remove flexibilities… without a retirement period” and that the OMB should have defined “exhaust other available funding sources”. (6/10/21)

Following a guilty plea in November on one count of making false statements on NIH claims, a former rheumatology professor at Ohio State University will serve a 37-month prison sentence and will reimburse OSU and NIH $ 413,000 for “over” $ 3.4 million, the DOJ recently announced. Song Guo Zheng was arrested a year ago in Alaska “while preparing to board another charter flight to flee to China. He was carrying three large bags, a small suitcase and a briefcase containing two laptops, three cell phones, several USB drives, several silver bars, expired Chinese passports for his family, Chinese property deeds and other items. “, According to the DOJ.

Zheng did not reveal to the OSU or the NIH that he had participated since 2013 in the Chinese One Thousand Talents program, used “to recruit people with knowledge or access to intellectual property of foreign technologies.” It received $ 4.1 million from the NIH “to develop China’s expertise in the fields of rheumatology and immunology,” the government said. Zheng worked at the University of Southern California and Pennsylvania State University before joining OSU in 2019. “The failure of Zheng to disclose his foreign funding and support undermines confidence and undermines the credibility that the American people give to American research, while abusing the openness and transparency which is a fundamental value of American academia, ”said Chris Hoffman, special agent in charge of the FBI’s field office in Cincinnati . “This sentence should have a chilling effect and underscores the FBI’s commitment to work with our partners to investigate individuals whose actions cast a cloud over the cutting edge work being done at US universities.” (5/27/21)

In the third audit of how universities have handled COVID-19 attribution flexibilities granted by OMB, NSF OIG auditors said Florida International University (FIU) has complied with guidelines from the OMB. OMB, but found several unrelated issues that the OIG says require attention. According to the May 19 report, the auditors “adapted our data analysis sampling approach to allow us to select 31 transactions that the FIU has incurred in accordance with COVID-19 flexibilities, or that we have identified as high risk. for other related reasons ”which were processed from March 1 to September 30. “The audit covered approximately $ 208,000 of the more than $ 12.4 million claimed from NSF during the period,” they noted.

While not finding any “exceptions” or misuse of flexibilities, the auditors said the FIU could “improve its management of flexibility expenses charged to NSF grants related to travel credit tracking.” Auditors also identified concerns about the FIU’s compliance with certain federal and NSF regulations, NSF terms and conditions, and organizational policies unrelated to COVID-19 flexibilities, ”according to the report. “Specifically, the auditors identified $ 15,419 in inappropriate withdrawals from award cash management services and $ 6,725 in ineligible expenses. They also found that there was “incorrect application of unapproved benefit rates.” The FIU “agreed to correct the clerical error that caused it to inappropriately withdraw $ 14,167 from an NSF grant, but did not agree with the $ 1,252 in disputed costs related to the ‘credits expire,’ OIG said. (5/27/21)

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