Report on Research Compliance 20, no. 12 (December 2023)
◆ Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California Institute of Technology (Caltech) ended up paying NSF more than OIG flagged—due to other costs Caltech itself identified later. The audit covered costs from March 1 to Sept. 30, 2020. Auditors tested approximately $170,000 of the more than $54.9 million of costs claimed to NSF during that period. According to the audit resolution report recently posted online, NSF allowed $31,856 in subaward charges auditors said were “unapproved” because Caltech did not request prior approval from NSF. The agency found the costs were incurred under an agreement that was “more closely aligned with a contract,” versus a subaward agreement, and thus no prior approval was required. This is the argument Caltech made in response to draft audit findings. However, NSF agreed with the auditors—and disagreed with Caltech—that $16,351 in salary expenses were not allowed. These were charged roughly one month after the expiration of the Office of Management and Budget’s (OMB) memorandum that allowed certain flexibilities during the pandemic. In response to the draft audit findings, Caltech maintained the salaries were permissible because “it was unreasonable for OMB to have discontinued the flexibilities…without a retirement period” and that OMB should have defined the phrase "exhaust other available funding sources.”
Auditors had also flagged $1,515 in inaccurately applied indirect costs—an amount that grew. According to the audit resolution report, “Caltech reviewed the ledgers for the two awards in question and returned additional funds considered unallowable in the amount of $38,302 which was refunded to NSF. Based on CalTech’s concurrence, NSF’s management decision is to disallow total questioned costs of $39,817.” Overall, NSF required Caltech to repay $57,167. Caltech’s audit was one of 10 OIG auditors conducted to assess institutions’ compliance with OMB’s flexibilities during COVID-19. (11/16/23)
◆ Recognizing that the growing use of digital technologies in research may be accompanied by challenges in obtaining informed consent, NIH is seeking comment on “sample language and accompanying considerations developed for use in informed consent documents for digital health technologies utilized in research” that it recently issued. NIH defined digital health technologies as “wearable devices, sensor technologies, and mobile software applications (‘apps’) most often used with tablets, watches, or phones,” and noted that the resource it issued “does not address considerations for implantable devices, artificial intelligence, or other types of digital health technologies.”
Digital technologies “are increasingly being deployed in biomedical and behavioral research, leading to enhanced scientific discovery and improved health outcomes,” NIH said. However, integrating them “into traditional research frameworks may pose new considerations when developing and reviewing informed consent documents for research studies.” The agency added that “institutions, funders, and researchers have a shared responsibility to ensure that the unique potential benefits and risks from use of digital health technologies in research are effectively communicated in a clear and concise manner, to aide participants in making an informed choice regarding whether to take part in a research study.” NIH is “interested in input on the specific language proposed in the informed consent sample language and any gaps or additional concepts that should be included or clarified, including within the points to consider.” The agency is also seeking “input on the utility and usability of this resource, any hurdles or barriers to the voluntary use by the community, and other feedback relevant to this resource.” The deadline for feedback is Dec. 12. (11/16/23)
◆ NSF OIG auditors are recommending the agency require that the University of Vermont and State Agricultural College (UVM) repay $30,717 in costs UVM charged to four NSF awards from Oct. 1, 2019, to Sept. 20, 2022. Overall, UVM claimed $27.7 million in expenses on 101 awards during the audit period, according to the Oct. 24 audit. Specifically, the auditors found “$19,422 of inadequately supported internal service expenses, $7,596 of inappropriately allocated equipment expenses, and $3,699 of unallowable participant support costs.” The questioned service expenses consisted primarily of “$18,720 for internal microscope services. The UVM lab managing the microscope charged the award using estimated and unsupported rates,” auditors wrote. “Additionally, UVM did not maintain a log or other documentation to support the number of days and hours the microscope was in use, and UVM noted the costs represented a reasonable usage fee, rather than the actual hours and number of days the microscope was used. Further, the microscope was not a shared instrument at the time of use and did not have a standard usage fee; therefore, UVM calculated the expense using a daily rate that was established for a different microscope in a different lab, rather than an established rate specific to the microscope used for the services.”
The $7,596 represented the partial cost of unspecified equipment that was inappropriately shared between several awards, according to OIG. The $3,699 was for “costs incurred to cover the cost of a participant’s computer that UVM noted was incorrectly charged as the computer was not used to benefit the award.” UVM officials said they would make repayment and mostly agreed with auditors’ recommendations, which included strengthening oversight. They did not address auditors’ nonfinancial finding that UVM lacks a policy for determining indirect cost rates, which OIG said could result in overcharging. However, data included in the audit showed UVM used rates that were lower than what OIG termed “appropriate.” (11/9/23)
◆ The Department of Veterans Affairs (VA) has permanently prohibited Hee-Jeong Im Sampen “from conducting VA research,” part of a series of sanctions imposed for research misconduct, according to a notice in the Nov. 3 Federal Register. Sampen, a research biologist at the Jesse Brown VA Medical Center in Chicago, is also a research professor at the University of Illinois-Chicago. The finding stems from falsified or fabricated data that appeared in three published and one unpublished paper, a poster presentation and a grant application. The papers published in 2015 and 2016 must be retracted.
Sampen apparently appealed the misconduct finding, but it was upheld on April 24, according to the notice. However, Sampen told Retraction Watch the “findings are unjustified.” She said the issues were due to unintentional errors by someone in her lab and that she was being punished because she was the supervisor. Sampen took issue with the investigative process, also telling Retraction Watch the “misconduct findings are made with respect to a tiny fraction of the huge volume of data generated by our lab.” Although she “regret[s] and is embarrassed by each and every error,” Sampen maintained that “the scientific validity of my lab’s research and findings have never been questioned.” (11/9/23)
◆ Under a new “simplified framework,” NIH peer reviewers will score funding applications based on “three broader factors” than the current five review criteria, Michael Lauer, NIH deputy director for extramural research, and Noni Byrnes, director of NIH’s Center for Scientific Review, wrote in a blog post on Oct. 19. Importance of the research, rigor and feasibility, and expertise and resources are the three new categories, replacing what the reviewers currently use: significance, innovation, approach, investigator, and environment. The change will be in effect for funding applications received as of Jan. 25, 2025.
The change will “help reviewers focus on crucial questions that determine scientific merit,” Lauer and Byrnes wrote. The changes address concerns about the “complexity of the peer review process,” the “increasing responsibilities of peer reviewers in policy compliance” and “the potential for reputational bias to affect peer review outcomes,” they wrote. “Another concern addressed in the new framework is the reliance on peer reviewers to assess policy compliance. Relying on peer reviewers for these tasks has the potential to distract them from their chief goal of assessing the scientific and technical merit of an application. To reduce reviewer burden, NIH staff will assume administrative responsibilities related to the Additional Review Considerations of Applications from Foreign Organizations, Select Agents, and Resource Sharing Plans.” The agency will hold a webinar on the new peer review process Nov. 3, and is “developing an integrated set of training events and resources to communicate the changes to applicants, reviewers, and NIH staff that will be rolled out over the next year.” (11/2/23)
◆ Lara S. Hwa, an assistant professor in the Department of Psychology and Neuroscience at Baylor University, agreed to have her work supervised for a four-year period that began Aug. 24, following a finding of research misconduct by the HHS Office of Research Integrity (ORI). According to a notice in the Oct. 24 Federal Register, Hwa was determined to have “knowingly or recklessly falsifying and/or fabricating data, methods, results, and conclusions in animal models of alcohol use disorders.” Hwa “falsified and/or fabricated experimental timelines, group conditions, sex of animal subjects, mouse strains, and behavioral response data” in a paper published in 2020 that has since been retracted, and another published a year earlier that she agreed to have retracted.
Additional fabrications or falsifications were found in two Public Health Service (PHS) applications, one of which was funded from 2019 to 2024, while the other was “administratively withdrawn” on Dec. 9. Under the settlement agreement, “prior to the submission of an application for PHS support for a research project on which [Hwa]’s participation is proposed and prior to [Hwa]’s participation in any capacity in PHS-supported research, [she] will submit a plan for supervision of [her] duties to ORI for approval.” The purpose of the plan is to “ensure the integrity” of her research and requires that a committee of several senior faculty familiar with Hwa’s work provide “oversight and guidance.” Their responsibilities also include reviewing primary data from Hwa’s lab on a quarterly basis and submitting a report to ORI regarding her compliance with research standards. She also will not serve “in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee” during the supervision period. (11/2/23)
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