Report on Research Compliance 19, no. 4 (April, 2022)
◆ A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the services, according to a Feb. 28 compliance determination letter posted by the HHS Office for Human Research Protections (OHRP). In the letter, the first such enforcement and oversight document OHRP has issued since Sept. 28, 2020, OHRP officials described finding via a not-for-cause evaluation in September 2016 that NJH “did not have adequately trained HRPP [human research protection program] staff or sufficient IRB written procedures per regulatory requirement[s] and as described in OHRP’s guidance,” OHRP said. A follow-up visit two years later found that NJH “had made significant changes to address deficits in their HRPP” but that “additional concerns related to their compliance with HHS regulations persisted. OHRP acknowledges that NJH was still in the process of hiring qualified staff to better manage their HRPP, in the beginning stages of implementing an electronic protocol management system, had updated their IRB written procedures, and implemented new IRB forms and checklists.”
OHRP had also “observed little evidence of the HRPP’s preparation for the January 2019 implementation of the revised Common Rule. Further, interviews with the IRB members, staff and researchers revealed minimal knowledge of the revised Common Rule or plans to implement changes that would assure that the institution would be able to comply with the new requirements in the revised Common Rule,” according to the letter. “Additionally, through OHRP’s review of IRB records and observations made during an NJH IRB meeting, it appeared that significant IRB member training would be needed for the IRB to properly comply with HHS regulations. OHRP provided NJH with specific studies which appeared to illustrate compliance issues with the IRB’s review.” According to the new letter, as of May 2020, NJH transferred its IRB functions to an external organization. “NJH still recognizes its continuing institutional responsibility to maintain appropriate oversight over the human subjects research in which NJH is engaged. OHRP has determined that concerns identified during the two site evaluations have been adequately addressed,” the letter said. OHRP’s letter gives no indication whether the agency ever took any action against NJH for the apparent “compliance issues” before the transfer was made, nor did the agency post any of the correspondence it referenced. NJH’s website indicates IRB functions are handled by Biomedical Research Alliance of New York, founded and led by “a consortium of academic medical centers including NYU School of Medicine, Montefiore Medical Center, and Icahn School of Medicine at Mount Sinai.” (3/17/22)
◆ In its second case so far this month after a six-month break with no findings, the HHS Office of Research Integrity (ORI) announced a former postdoctoral researcher in the Department of Physics at the University of California, Berkeley (UCB) “intentionally, knowingly, and/or recklessly falsified two-photon microscopy and in vivo electrophysiological activity images, figure legends, and text descriptions of hippocampal neurons from a mouse running on a treadmill in a head-fixed virtual reality (VR) set up.” According to a March 11 post on ORI’s website, Shuo Chen inserted these elements and other items into an application for funding from the National Institute of Neurological Disorders and Stroke that he submitted on June 25, 2019.
Chen did not admit or deny the misconduct, but he agreed to a settlement that provides for a one-year period of supervision, beginning Feb. 28. Any application for funding submitted to the Public Health Service will have to be accompanied by a plan involving a committee of two to three senior faculty members who “will provide oversight and guidance,” and “review primary data from [Chen’s] laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates and [Chen’s] compliance with appropriate research standards and confirming the integrity of Respondent’s research.” This committee will also certify to ORI that “the data presented in the proposed application, report, manuscript, or abstract is supported by the research record.” Chen also agreed not to serve as an adviser to a PHS “advisory committee, board, and/or peer review committee.” This is ORI’s second finding this month and second of the year. (3/17/22)
◆ Applications submitted to NIH for conferences and scientific meetings, called R13/U13 awards, that are due April 12 will need to be accompanied by a Plan to Promote Safe Environments if they are approved for funding, Michael Lauer, NIH deputy director for extramural research, said in a March 2 post on his Open Mike blog. “Conferences, unfortunately, may present increased risks for harassment compared to campus environments. Increased harassment risks at off-campus events have been linked to a lack of awareness regarding codes of conduct, unavailability of reporting mechanisms, and power imbalances among attendees,” Lauer wrote. NIH first announced the requirement in a Feb. 11 notice.
Safety plans “will be requested as Just-In-Time materials,” Lauer wrote. Award applicants “should consider resources that may be needed to maintain a safe and respectful environment as they are preparing an application,” he added. “Conference organizers are required to describe strategies that communicate ‘safety plans’ to attendees, to describe how they will document allegations and resulting actions, and to describe information on steps to ensure a safe and respectful environment.” NIH officials, Lauer said, “hope that attendees will feel welcomed at NIH-supported conferences to share their scientific ideas, perspectives, and points of view without concerns about harassment and discrimination.” (3/10/22)
◆ For at least four years, Yue Liu, also known as Troy Liu, while a University of Wisconsin-Milwaukee (UWM) engineering professor, “fraudulently obtained more than $1.1 million from foreign students and visiting professors” after promising to pay their tuition and other expenses. U.S. Attorney Richard G. Frohling with the Eastern District of Wisconsin announced that “the essence of the scheme was to obtain money, through materially false promises and representations, from foreign students who were accepted into graduate programs at UWM.” From 2016 to 2020, Liu actually “used a portion of the money he received for personal purposes, including to fund investment accounts and to pay credit card expenses. Liu also attempted to conceal the scheme by creating a fraudulent research agreement between UWM and a fictious entity purportedly based in China and using a portion of the money to fund this agreement,” Frohling’s office said.
UWM had “waived the students’ tuition because they were research assistants. Liu emailed letters to students in which he made false representations about the program, and he wrote those letters using a fictitious name he invented and using what appeared to be a UWM logo,” the office said. Liu signed a plea agreement last month admitting to wire fraud, which “carries a maximum penalty of 20 years in prison, a maximum fine of $250,000, and up to five years of supervised release following any prison term,” and to one count of unlawful monetary transaction, which “carries a maximum penalty of 10 years in prison, a maximum fine of $250,000, and up to three years of supervised release,” the government said. The court file does not indicate a sentencing date. (3/10/22)
◆ Based on an audit of the Massachusetts Institute of Technology (MIT) by the National Science Foundation (NSF) Office of Inspector General (OIG), NSF intends to update its policy on the cost of education (COE) allowance for recipients of its Graduate Research Fellowship Program (GRFP). According to OIG’s Feb. 24 memorandum to NSF about MIT, which includes NSF’s response, MIT is not complying “with current GRFP award terms and conditions requiring institutions to exempt fellows from paying required tuition and fees.” Instead, MIT “holds fellows responsible for tuition in excess of the COE allowance provided by NSF.” OIG quoted MIT’s materials for GRFP participants that state they are responsible to pay the “substantial tuition shortfall remaining” after the COE allowance is applied. MIT’s interpretation is based on guidance that is no longer in effect, and NSF “expects GRFP fellows to be compensated for their work to the same extent that other graduate students at the institution are compensated for similar work,” OIG said. NSF should require MIT “to update its policies and practices to ensure it complies with Graduate Research Fellowship Program award terms and conditions related to waiving tuition and fees,” OIG said.
In its response, NSF officials “confirmed with the GRFP Program that it has never been the intent that GRFP recipients would be required to fund any shortfall in tuition, be it through funds or teaching. Program further confirms that any teaching requirements must be decoupled from tuition, and consistent with institution policies and career development concerns.” The agency added that it “is concerned that MIT’s interpretation of the NSF policy on this issue may be held by other institutions.” As NSF put it, to address the “potentially systemic nature of this issue,” NSF intends to update its GRFP guidance and “communicate the updated policy to all awardee institutions to remind them of their obligations under GRFP awards, and direct that they update their policies as needed.” (3/3/22)
◆ On March 1, the Food and Drug Administration (FDA) finalized three guidance documents related to trials for cancer research. “Inclusion of Older Adults in Cancer Clinical Trials” addresses ways to enroll “older adults in early phase studies of cancer clinical trials,” design of trials, “recruitment strategies, information collection, and developing and reporting more discrete age groups to encourage enrollment of this historically excluded population.” A draft version of this guidance was published in 2020. As of RRC’s deadline, FDA had not yet posted the final guidance, but officials said it would be online shortly.
“Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics” finalizes 2018 guidance. The document addresses “designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs.” Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses “master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.” This guidance also was issued in draft form in 2018. The documents “parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care,” FDA said. (3/3/22)
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