Report on Research Compliance Volume 19, Number 9 (September, 2022)

◆ According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los Angeles (UCLA), Department of Pathology & Laboratory Medicine, agreed to a three-year supervisory plan for committing research misconduct in three funded and eight unfunded NIH awards. Jiang “knowingly and recklessly falsif[ied] and/or fabricate[d] flow cytometry data” in the awards, ORI said. The announcement does not mention any publications resulting from the research that need to be retracted. Retraction Watch reported the three awards totaled $58.7 million, with the “vast majority” used to fund the UCLA Clinical and Translational Science Institute. “The extent of Jiang’s part in that application and the extent to which they led to the success of the grant is unclear, but it seems likely they were a minor contribution,” Retraction Watch reported.

For three years, beginning July 22, Jiang must follow a plan for supervision prior to submitting any funding application to Public Health Service (PHS) agencies; the plan “must be designed to ensure the integrity” of her research, and include a “committee of two senior faculty members at the institution who are familiar with [Jiang’s] field of research.” Additionally, her primary data must be submitted to ORI on a quarterly basis, and, at six-month intervals, she must submit information about “committee meeting dates and [Jiang’s] compliance with appropriate research standards and confirming the integrity of [her] research.” The committee also must review any funding application before submission and submit a certification to ORI that any data she provides “are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported and not plagiarized in the application, report, manuscript, or abstract.” During the three years, she also will not serve as an advisor or consultant to any PHS agency. (8/18/2022)

◆ An audit of 45 transactions totaling $1,197,627 in costs claimed by North Carolina Central University (NCCU) for nine National Science Foundation (NSF) awards as of Sept. 2, 2021, found $60,320 of unallowable expenditures. “Specifically, the auditors found $24,029 in unallowable expenses, $22,748 of inappropriately allocated expenses, and $13,543 of inadequately supported expenses,” according to the Aug. 12 report from the NSF Office of Inspector General (OIG). The transactions were chosen from a universe of $14.8 million in claimed costs for 45 awards.

Among the unallowable expenses were $13,909 in participant support costs, including $888 for baseball tickets, $3,736 for unbudgeted compensation paid to a graduate student, and $4,847 for an unbudgeted software license renewal. The $22,748 included “insurance, airfare, consultant, and materials and supplies expenses to three NSF awards,” auditors said. They “also identified three compliance-related findings for which there were no questioned costs: non-compliance with NCCU policies, non-compliance with federal requirements for pass-through entities, and insufficient controls related to the application of indirect cost rates.” The unsupported costs included 50 gift cards for students that auditors said lacked documentation for who received them and when. “The auditors included six findings in the report with associated recommendations for NCCU to provide supporting documentation that it has repaid the questioned costs and to ensure NCCU strengthens administrative and management controls.” NCCU agreed to repayment and implement auditors’ recommendations. Regarding the baseball tickets, NCCU said they “had a programmatic purpose and it had authority to transfer funds from one budget category to another; however, it did not receive prior written approval for this type of expense,” auditors said. (8/18/2022)

◆ ORI debarred a former University of Kentucky (UK) cancer investigator for four years and imposed supervisory requirements on another who hails from Southwest National Primate Center. ORI announced Aug. 8 that Stuart Jarrett, described as a “former research-track assistant professor” at UK’s Markey Cancer Center and its Department of Toxicology and Cancer Biology, “intentionally, knowingly, or recklessly falsified and/or fabricated Western blot and histological image data related to mechanisms of melanoma protection by reusing, relabeling, and manipulating images or using blank panels to falsely report data in twenty-eight (28) figures included in four (4) [Public Health Service] PHS-supported published papers, one (1) funded PHS grant application, and two (2) unfunded PHS grant applications.” He is prohibited from participating in government-supported programs and serving as an advisor to any PHS agency for a four-year period that began July 18. Of the four papers, which appeared from 2014 to 2018, only the oldest publication has not yet been retracted. The ORI notice said HHS would “notify” the publisher “of the need for retraction” of this one, as well.

Deepak Kaushal, professor and director of the Host Pathogen Interactions Program at Southwest National Primate Research Center, part of Texas Biomedical Research Institute, “intentionally, knowingly, and/or recklessly falsifying and fabricating the experimental methodology to demonstrate results obtained under different experimental conditions that were included in a published paper” since retracted, and two NIH funding applications, ORI announced Aug. 3. His work is supported by eight NIH grants, according to the agency. Kaushal signed a voluntary settlement agreement that calls for him to be supervised for one year, which began July 22. A committee of experts in his field that does not include his supervisor “will provide oversight and guidance;” review primary data from his lab “on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates and Respondent’s compliance with appropriate research standards and confirming the integrity of Respondent’s research,” among other related requirements. The fact that he apparently faced no sanctions from Texas Biomed outraged some, Science reported. (8/11/2022)

◆ NSF intends to issue guidance and strengthen policies and procedures to help Established Program to Stimulate Competitive Research (EPSCoR) award recipients address areas of concern identified by the Office of Inspector General (OIG). As OIG explained in “Capstone Report: EPSCoR Recipients Need Stronger Oversight and Controls,” the award program “supports projects in states, commonwealths, and territories (jurisdictions) that have historically received a small share of NSF grant dollars and is NSF’s largest program for broadening participation and expanding support for institutions to ensure geographic diversity. The program’s mission is to enhance research competitiveness in targeted jurisdictions by strengthening science, technology, engineering, and math (STEM) capability and capacity.”

OIG recently completed seven audit reports, questioned more than $2.7 million among five institutions with EPSCoR funding and “reviewed external audits that included EPSCoR findings from the past 22 years to identify systemic issues.” The three key areas where awardees should strengthen oversight, with NSF’s help, are assessing and monitoring subrecipient risk, charging unallowable entertainment or promotional costs for summer research programs and making errors and claiming otherwise unallowable costs as a result of accounting system updates. NSF officials thanked OIG for the findings and said they “also recognized the significant need to build sustainable research support and services at under-resourced institutions, including emerging research institutions and minority-serving institutions. To this end, we have proposed a new funding program in FY23, Growing Research Access for Nationally Transformative Equity and Diversity (GRANTED) to provide resources to enable institutions to build stronger research administrative infrastructure.” (8/11/2022)

◆ A Phase II study of a “new endometrial sampling device” approved by the institutional review board (IRB) of Biomedical Research Alliance of New York (BRANY) violated federal criteria that “requires an IRB to ensure, when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects,” the HHS Office for Human Research Protections (OHRP) told BRANY, according to a 4,000-word determination letter OHRP recently posted on its website. The July 13 letter identified numerous other issues associated with specific studies and with BRANY operations that were uncovered during OHRP’s site visit in April 2021—all of which OHRP said were later resolved to its satisfaction. OHRP said a “description of the criteria the [endometrial] study would use to evaluate the safety of the experimental sampling device was not found in the study documents. No data and safety monitoring plans were evident; however, the protocol stated that an analysis of the data will be conducted once 50% of study subjects have been enrolled.” Further, the IRB did not have sufficient information to know “whether the device was safe and effective and, thus, the IRB did not have sufficient information to evaluate the risk-benefit ratio of the study as required.” OHRP also found multiple problems with the consent forms used in this study. OHRP recounted changes BRANY made in its overall review processes but did not address this particular study except to say it “closed in October 2021.” The number of subjects who had been enrolled was not disclosed.

In addition, a study of “patients” with dermatitis was inappropriately approved under expedited review when it did not qualify because it “involve[d] a skin punch biopsy which appears to be invasive,” OHRP said. The agency also reported that “during the record reviews, OHRP noted that the files in the IRB records seemed inconsistently named and the location of the files varied among study records, which made it a challenge to reconstruct a complete history of some IRB actions related to a protocol review.” Moreover, OHRP made several findings related to the functioning of IRB meetings, noting, for example, that it was not clear whether members “had access to documents that included revisions to the protocol or consent form that were proposed by the primary or secondary IRB reviewers. Other IRB members seemed to rely on the primary and secondary reviewers’ oral description of their proposed changes to the protocol and consent form. The IRB did not appear to summarize the conditions for approval prior to taking a vote on whether to approve the research.” For another study of an online system for addressing teen depression in primary care, OHRP said, “the protocol describes two phases of the research, and it was unclear to the OHRP site visit team how the waiver of consent or waiver of documentation of consent were applied and to which phase.” The corrective actions OHRP said BRANY took in response to these concerns included retraining and the implementation of new policies and procedures. This marks only the third determination letter OHRP has posted this year. In 2021 it posted zero, and in 2020, just four. In the past, OHRP posted dozens per year. (8/4/2022)

◆ A Senate committee has approved Arati Prabhakar, formerly director of the National Institute of Standards and Technology (NIST) and the Defense Advanced Research Projects Agency (DARPA), to be the new director of the White House Office of Science and Technology Policy (OSTP), despite an attempt to derail the nomination based on what one senator called “right-to-life issues.” The nomination now moves to the full Senate, although a vote has not been scheduled; after this week, the Senate is on recess until after Labor Day. At a hearing of the Science, Commerce, and Transportation Committee on July 27, 2022, Sen. Roger Wicker, R-Mississippi, said he didn’t want to vote on Prabhakar’s nomination that day and hoped the nomination would be delayed based on his concerns over certain “right-to-life issues” he did not detail.

However, Sen. Maria Cantwell (D-Washington), committee chair, noted the historic nature of the nomination, which she called “of monumental importance, putting a woman of color at the helm of the OSTP for the first time in the agency’s history. Dr. Prabhakar is supremely qualified, having previously served as NIST and DARPA, two federal Research and Development agencies at the forefront of scientific innovation and technology advancement. Her proven leadership and accomplishments at these agencies will be of great service to the OSTP,” Cantwell said. “At DARPA, she led the program that prototyped a system for detecting nuclear and radiological materials before a terrorist can build a bomb, and developed tools to find human trafficking networks on the internet, and enabled complex military systems to work together even when they were not originally designed to do so.” Cantwell said she was “happy to see another accomplished woman at the forefront of the federal government’s scientific community, I am just as heartened by her commitment to put people at OSTP first, and I am pleased to support her nomination. If confirmed, she will be tasked with elevating OSTP’s role to ensure the U.S. remain a global leader in [Science, Technology, Education and Math], increasing investments in [research & development], promote greater diversity in the sciences, improve our weather forecasting capabilities, and protecting our scientific research.” OSTP has been without a director since Eric Lander resigned in disgrace six months ago following a staff bullying scandal. (8/4/2022)

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