Report on Research Compliance 19, no. 5 (May, 2022)

◆ Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS Office for Human Research Protections (OHRP) has closed its books on its investigation related to Alexander Neumeister, M.D., formerly a psychiatry and radiology professor at New York University (NYU) Grossman School of Medicine. The lengthy March 21 closeout determination letter from OHRP to Imad Alsayed, NYU vice president of clinical research operations and regulatory affairs, doesn’t identify Neumeister but notes that the Office of Research Integrity (ORI) made a “determination” in the case on Jan. 7, 2020. On that date, ORI published an announcement that Neumeister agreed to exclude himself from government-funded programs for two years effective Dec. 13, 2019, for “intentionally, knowingly, and/or recklessly falsifying and/or fabricating data in the clinical records of research supported by six (6) NIMH [National Institute of Mental Health] grants, resulting in the inclusion of falsified and/or fabricated research methods and results in four (4) published papers.” Neumeister agreed to the sanction but did not admit to the misconduct.

The letter appears to be the first public acknowledgement that OHRP was aware and deeply involved in issues related to Neumeister, particularly long before he was the subject of a scathing story in The New York Times in 2016. OHRP’s letter describes a process that started with a not-for-cause evaluation begun in May 2014 but which expanded to a site visit after NIMH “informed” OHRP of concerns related to six NIMH-funded studies and that the principal investigator had been placed on leave “due to significant irregularities in his management of certain research projects.” The New York Times later revealed that NYU had “quietly shut down eight studies at its prominent psychiatric research center and parted ways with a top researcher after discovering a series of violations in a study of an experimental, mind-altering drug.” The letter notes that the investigator had reported “deviations” that had occurred with a study in June and July 2013. During the ensuing years, NYU conducted various audits and investigations of Neumeister and corresponded with OHRP numerous times, most recently in September 2020; it is not clear whether OHRP ever imposed sanctions on NYU for noncompliance. OHRP said that NYU had updated its policies and procedures, “strengthened its general human subjects training requirements,” and taken a number of other actions, including expanding its “internal audit capacity by creating a central administrative office known as Human Research Regulatory Affairs.” Prior to Neumeister’s misconduct finding, he pleaded guilty to “theft of government funds” and “admitted stealing $87,000 from New York University and various grant programs from 2012 to 2014.” Neumeister was “required to repay $76,000 after stealing money while he was at Yale from 2004 through 2010, though that was not part of the criminal case resulting in his plea,” the Associated Press reported in October 2018. Although he faced jail time, Neumeister was sentenced to play piano at various indigent care centers at least twice weekly for three years in Connecticut. (4/14/22)

◆ The Animal and Plant Health Inspection Service (APHIS) has recently issued notices of alleged violations of the Animal Welfare Act (AWA) to Old Dominion University in Norfolk, Virginia, and to a teaching zoo in Gainesville, Florida. The letters are in keeping with APHIS’ current practice of leaving out most details of alleged violations, such as the species of animals involved and the nature of the possible wrongdoing. A letter issued to Old Dominion on March 25 indicates that APHIS officials, part of the U.S. Department of Agriculture, have “evidence” that two alleged violations occurred on Sept. 15, 2021. One refers to the operation of its institutional animal care and use committee, which is required to “review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities.” The second relates to requirements for an attending veterinarian and adequate veterinary care. “Each research facility shall establish and maintain programs of adequate veterinary care that include: The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care,” the letter states.

The letter to Santa Fe College Teaching Zoo, dated Feb. 25, refers to an alleged violation that occurred on Jan. 20 of this year. “Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort,” the letter states. Identical language in both letters notifies the organizations that the warning “is not to be construed as a final agency action, or as an adjudicated finding of a violation. If APHIS obtains evidence of any future violation of these federal regulations, APHIS may pursue civil penalties, criminal prosecution, or other sanctions for this alleged violation(s) and for any future violation(s).” (4/14/22)

◆ A woman who earned her Ph.D. from the University of Wisconsin-Madison in 2014 and now teaches seventh and eighth grade science at a private school in Mill Valley, California, included fabricated or falsified data in her dissertation, a grant application submitted to the National Cancer Institute in 2017, and in seven papers that were published from 2013 to 2018, ORI announced April 5. According to information on the website of Mount Tamalpais School where Brand is employed, she earned a bachelor’s of science in molecular, cellular, and developmental biology from the University of California, Santa Barbara, “then worked as a brain cancer researcher at the University of California, Los Angeles,” after which she applied to graduate school. Her Ph.D. is in cellular and molecular pathology. At some point later, Brand joined the University of California San Francisco (UCSF) as a post-doctoral researcher; it is not clear when she left there. Some of the misconduct occurred during her time at Wisconsin (in particular, in her dissertation) but also at UCSF.

ORI officials told RRC that both the University of Wisconsin and UCSF separately conducted investigations, leading to some delay in the finding. The retraction notice for one of the papers, published in Science Signaling on Jan. 3, 2017, said the University of Wisconsin committee “found…issues were due to carelessness and lack of attention to detail rather than through any intent to deceive, and thus concluded that no research misconduct was committed.” However, ORI considered this paper among the seven containing evidence of misconduct. ORI said Brand’s misconduct consisted of “fabricating western blot data, by reusing and relabeling data to represent expression of proteins in control experiments measuring the purity of cytoplasmic and nuclear cell fractionation, measurements of proteins of interest, and measurements of the same protein under different experimental conditions or loading controls, included in twenty-four (24) figures” used in the publications and her dissertation. Brand did not admit to the misconduct as part of the settlement, which calls for a four-year supervisory plan should she apply for Public Health Service funding beginning March 23. Brand also agreed to retract or correct three papers. She did not respond to RRC’s request for comment. (4/7/22)

◆ The National Science Foundation (NSF) Office of Inspector General (OIG) has requested that NSF develop a “written corrective action plan…that detail[s] specific actions and associated milestone dates” following a report that the agency did not ensure all of its Antarctic support contract (ASC) personnel “were onboarded and vetted in accordance with NSF requirements; instead, NSF relied on the contractor’s internal vetting processes, which are less rigorous than the minimum level of investigation NSF requires.” OIG auditors “initiated a performance audit of NSF’s Information Security Program for fiscal year 2021 as required by the Federal Information Security Modernization Act of 2014,” according to a March 18 memorandum OIG posted online.

Since 2016, Leidos Innovations Corporation has been NSF’s ASC. The practice of using the contractor’s internal vetting process apparently carried over from the contractor that preceded Leidos. “NSF did not always complete required contractor vetting before onboarding and authorizing ‘privileged’ USAP [United States Antarctic Program] network access for users responsible for the maintenance, operation, monitoring or management of IT systems and USAP information,” OIG said. It was not clear from the memorandum how many of NSF’s 859 contractors had not been vetted as required because that number is redacted. NSF accepted OIG’s recommendations to “review and update NSF contractor vetting procedures as appropriate to develop a risk-based approach consistent with applicable laws and regulations,” and to “ensure current and future ASC contractors are submitted…for vetting as required per those procedures” to NSF’s Personnel Security and Suitability team. (4/7/22)

◆ Two former researchers with Albert Einstein College of Medicine agreed to a 12-year supervision program and a four-year exclusion, respectively, according to a March 21 announcement by ORI. The agency said Hui (Herb) Bin Sun, formerly a professor of orthopedic surgery and radiation oncology, and Daniel Leong, a research technician, “engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/or fabricating data included in sixteen (16) grant applications” that were submitted to the National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Heart, Lung, and Blood Institute. ORI said the misconduct occurred from 2013 to 2019; neither Sun nor Leong admitted to misconduct but nonetheless agreed to settlement terms. More specifically, ORI said that Sun reported and Leong created “Western blot and histological image data for chronic deep tissue conditions including osteoarthritis (OA) and tendinopathy in murine models.” ORI said the data at issue “were falsely reused and relabeled as data representing different experiments.”

Under the terms of Sun’s agreement, which began March 1, he must submit a supervision plan should he apply for funding from any Public Health Service (PHS) agencies or participate “in any capacity in PHS-supported research.” A committee of two to three senior faculty members at Sun’s institution would “provide oversight and guidance” and, on a quarterly basis, review primary data from his laboratory. They also would report to ORI every six months regarding Sun’s “compliance with appropriate research standards and confirming the integrity of [Sun’s] research.” Sun is also required to “ensure that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research” in which Sun is involved, “a certification to ORI that the data provided by [Sun] are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract.” After Leong’s governmentwide exclusion concludes, he agreed to be subject to a four-year supervision period with requirements that echo those imposed on Sun. An Albert Einstein spokesperson told Retraction Watch that “Leong left Einstein voluntarily in 2016, prior to our investigation. Dr. Sun was terminated in 2019 at the conclusion of our investigation that found evidence of research misconduct.” (3/31/22)

◆ Five years after conducting an on-site evaluation of the University of Texas Southwestern Medical Center (UTSMC), OHRP has closed its review after resolving concerns about its noncompliance reporting system. In a March 8 determination letter posted online, OHRP said that, at the time of the May 31-June 2, 2017, site visit, UTSMC’s human research protections program (HRPP) “portfolio consisted of approximately 3,500 active human research studies, of which approximately 300 were HHS-supported. During our visit, we reviewed over 35 active HHS-supported studies, IRB [institutional review board] written procedures, IRB meeting minutes and various IRB forms and checklists,” OHRP said. The agency praised UTSMC’s “well-organized” program, and said staff conveyed a “sincere commitment to and concern for the protection of human research subjects.”

However, OHRP informed UTSMC in a June 6, 2018, letter of its concern that “IRB members, staff, and researchers…appeared to lack understanding of which incidents needed to be reported to OHRP.” Subsequently, UTSMC “revised and issued a 335-page HRPP Policy and Procedure. Based on our review of the revised policies and procedures, we acknowledge that these written procedures define which events must be reported promptly and describe the requirements for timely submission of reportable events to the HRPP Office,” OHRP said. UTSMC also conducted “numerous training sessions of IRB members and researchers,” and its “corrective actions…adequately addresse[d] OHRP’s concerns,” the agency said. This is OHRP’s second determination of the year. It released no letters in 2021 and just four in 2020. In previous years it issued dozens of compliance actions. (3/31/22)

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