Report on Research Compliance 21, no. 11 (November, 2024)
◆ On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a blog post reminding the awards community that a “key cybersecurity best practice to remember here is to not share one’s…credentials and passwords with others” to access eRA Commons, the federal government’s grants management system. Lauer did not mention Cleveland Clinic, but RRC has previously reported that the Department of Justice (DOJ) cited shared credentials in its May FCA settlement with Cleveland Clinic, which hinged mostly on allegations that it failed to report foreign support for an investigator. According to DOJ, NIH imposed a one-year corrective action plan on Cleveland Clinic and required it to “create a mandatory training program addressing requirements for disclosing other grant support, research security, and cyber security,” among other tasks.
In his Oct. 15 post, Lauer said it is “critical that all users exercise what we call ‘cyber-honesty’ when engaging with NIH grant systems and be fully transparent with the information provided.” NIH officials “trust that the vast majority of users interacting with eRA are doing so appropriately and honestly,” he wrote, but added that they “are aware of instances” of inappropriate password sharing. When there is a “legitimate need” to assist someone with completing tasks within the eRA system, the appropriate steps should be followed to delegate those responsibilities, Lauer said. Delegable tasks include updating personal profiles; submitting financial conflict of interest information, progress reports and inclusion data; and “viewing application status information, aside from summary statement or priority scores,” Lauer wrote. When there are “concerns” with submitted information, such as when an applicant or awardee makes a false statement, accesses confidential reviews or “knowingly skirts eRA rules,” NIH may require “return of awarded grant funds,” impose terms and conditions on awards and require other corrective actions, according to the blog. (10/17/24)
◆ In an unusual case involving inappropriate enrollment in clinical trials, the HHS Office of Research Integrity (ORI) took a rare enforcement action against an investigator whose research was previously suspended by the Office for Human Research Protections (OHRP) and in the absence of any known final action by OHRP. ORI announced Oct. 8 that Bret Rutherford, M.D., formerly a research scientist at New York State Psychiatric Institute, “engaged in research misconduct by recklessly falsely reporting that all human research subjects met the inclusion/exclusion criteria for late-life depression studies in five (5) published papers, thus affecting the reported clinical research methods and results including demographics, gait speed, Positron Emission Tomography (PET) scan brain activities, depression scores, Magnetic Resonance Imaging (MRI) brain volumes, neuromelanin MRI contrast values, cognition tests, diffusion brain imaging data. and other neurocognitive assessments and conclusions in five (5) published papers,” which appeared from 2019 to 2021; three papers were retracted, and two have been corrected. Rutherford was studying the use of levodopa for depression and reduced mobility in older people; it is currently approved for Parkinson’s disease.
More specifically, Rutherford “falsely reported that all subjects met the studies’ inclusion/exclusion criteria by not having taken exclusionary medications at time of study enrollment for as many as forty-five (45) subjects, by reporting eligibility of subjects who had taken exclusionary medications during a 28-day washout period prior to enrollment for as many as fifteen (15) subjects and by reporting full medication washout periods for as many as eight (8) subjects who received shorter washout periods than 28-days.” Rutherford entered a voluntary, three-year exclusion agreement, also called a governmentwide debarment, effective Sept. 27. According to The New York Times (NYT) coverage from 2023, OHRP at some point in June of that year began investigating Rutherford and the institute, and “restricted its ability to conduct H.H.S.-supported human subject research.” The institute itself “voluntarily paused all studies that included ongoing interactions with human subjects,” it reported. The actions were taken following the suicide of a research participant. NYT said this pause “affected 417 studies, of which 198 have continuing participation. Of those, 124 receive federal funding.” RRC previously reported that the Food and Drug Administration (FDA) in March issued warning letters to Rutherford and the institute. (10/17/24)
◆ Louisiana State University (LSU) Health Center’s institutional review board (IRB) failed to inform FDA that it had administratively closed eight protocols during 2021 and 2022, and, moreover, lacked written policies and procedures for notifying FDA of terminations and suspensions. According to a Sept. 27 warning letter FDA posted on its website, the IRB “did not adhere to applicable statutory requirements…governing the protection of human subjects” specified in FDA regulations and enabling legislation. LSU told FDA in a 2023 response letter that “the IRB failed to recognize administrative closures as instances of termination of IRB approval, and therefore did not take reporting actions as dictated by IRB policies and FDA regulations,” and that it had taken a number of corrective actions to become compliant.
FDA also cited the IRB’s failure to conduct appropriately timed continuing review of at least two protocols that both were twice reviewed later than required, which is “at intervals appropriate to the degree of risk, but not less than once per year.” For one study, continuing review was 12 days late in 2020 and 78 days late in 2021. “We note that during the second lapse in IRB approval, between August 19, 2021, and September 29, 2021, study activity was ongoing, including enrollment of two subjects at clinical sites, and clinical site protocol deviations occurred,” the letter said. FDA acknowledged that its report to LSU following the inspection conducted from July 17 to July 26, 2023, did not include continuing review issues. However, LSU itself said in its response to the inspection report that its IRB notification system had failures in 2021 and 2022 that were addressed at the time. FDA asked for details as to LSU’s planned corrective actions within 15 days of receipt of the letter, saying FDA could not ascertain whether the responses to date were “adequate to prevent similar violations in the future.” (10/10/24)
◆ The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will not hold a two-day, in-person meeting later this month. Instead, what would have been its only in-person gathering this year will now be held as a webcast on Oct. 22 only. OHRP announced the change in its October newsletter. A single-day meeting was scheduled in light of just two items for SACHRP’s consideration. The committee, which meets three times a year, will continue reviewing and presumably approve recommendations for assessing uninformative research and begin a new topic—equivalent protection determination considerations for HHS-regulated research, according to the agenda posted on OHRP’s website. The meeting will mark the first with new OHRP Director Molly Klote, M.D., formerly deputy chief research officer for the Veterans Health Administration, at the helm. Klote’s appointment, announced Sept. 23, fills a position that has been vacant since the December 2022 retirement of Jerry Menikoff. The newsletter also noted that OHRP is accepting applications for education director, a position currently held by Yvonne Lau. (10/10/24)
◆ Eliezer Masliah, M.D., director of the Division of Neuroscience (DN) in the National Institute on Aging (NIA) beginning in 2016, committed research misconduct by falsifying and/or fabricating figures in two publications, NIH announced Sept. 26. Masliah’s actions involved the “re-use and relabel[ing] of figure panels representing different experimental results.” NIH said it “will notify the two journals of its findings so that appropriate action can be taken.” NIH—which did not identify the publications at issue—said it received allegations from ORI in May 2023, after which it began its “research misconduct review process”; in December, it began an investigation, which ended Sept. 15. “Currently, Dr. Masliah is not serving in the capacity of director of the NIA DN. Amy Kelley, M.D., NIA Deputy Director, is also serving as the Acting NIA DN Director. Beyond this information, NIH does not discuss personnel matters. Any allegations involving Dr. Masliah’s NIH-supported extramural research prior to joining NIH would be referred to HHS ORI, consistent with NIH policies and procedures,” the agency said, without disclosing his prior appointments. (10/3/24)
◆ A lack of standards for the National Science Foundation’s (NSF) sexual harassment investigations “may have led to inconsistency” and “contributed to a lack of trust” in U.S. Antarctic Program (USAP) employers’ “ability to properly investigate sexual harassment allegations and prevent retaliation,” NSF’s Office of Inspector General (OIG) found during an 18-month review. “During our McMurdo site visit in February 2023, we interviewed 51 individuals including the Special Deputy US Marshal, HR [human resources] staff, firefighters, and USAP personnel. We held open office hours for staff wanting to discuss sexual harassment and assault concerns,” OIG said. At McMurdo, USAP participants “said there were inconsistent consequences for harassment incidents, offenders were not held accountable, and individuals who reported harassment faced retaliation,” it reported. (10/3/24)
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