Report on Research Compliance 19, no. 2 (January 27, 2022)
◆ While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as president and the appointment of Mary Sue Coleman as interim president. Schlissel “may have been involved in an inappropriate relationship with a University employee,” the board said in a statement posted on its website. “After an investigation, we learned that Dr. Schlissel, over a period of years, used his University email account to communicate with that subordinate in a manner inconsistent with the dignity and reputation of the University.” The regents’ actions were swift: U-M officials said they received an anonymous tip about the relationship on Dec. 8.
In their Jan. 15 termination letter to Schlissel, board members called his behavior “particularly egregious considering [his] … involvement in addressing incidents of harassment” by U-M employees and his “declared commitment to work to ‘free’ the University community of sexual harassment.” The board posted 188 pages of detailed text messages, emails and other correspondence between Schlissel and the unidentified subordinate, which date from September 2019 to December 2021. They show the two planning to meet and coordinating travel, as well their takeout orders for Indian food and pizza. Coleman, who retired as U-M president in 2014 after serving 12 years, said in a post to the U-M community that she “accepted the interim appointment because of my love and respect for this institution.” Coleman also offered her “deep appreciation to all of you during a difficult time for U-M. I know some will feel a sense of loss. What we can do now is to renew our commitment to learning together, as well as to doing research and public service as a collectivity.” A search for a new president is underway. (1/20/22)
◆ Dr. Robert Califf’s bid to be commissioner of the Food and Drug Administration (FDA) for the second time has advanced to the floor of the Senate, but a vote has not yet been scheduled. On Jan. 13, Sen. Patty Murray, D-Wash., announced that the Health, Education, Labor and Pensions (HELP) Committee, which she chairs, had voted 13 to eight to forward the nomination to the full Senate. The subject of a HELP Committee hearing on Dec. 14, Califf was nominated by President Biden in November. Califf previously served as commissioner for 10 months in 2016, the final full year of the Obama administration.
“As our nation continues to fight the COVID-19 pandemic, the scientists and experts at the Food and Drug Administration who are working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,” Sen. Murray said after the committee vote. “As a former FDA Commissioner, Dr. Califf is an experienced pick to lead this important agency, and today the Committee advanced his nomination in a bipartisan manner.” (1/20/22)
◆ More than 20 universities or research institutions, including Vanderbilt University Medical Center, Johns Hopkins University (JHU) and the University of Texas (UT) Austin, received a warning from the Animal and Plant Health Inspection Service (APHIS) last year for alleged violations of the Animal Welfare Act (AWA). A warning “is not to be construed as a final agency action, or as an adjudicated finding of a violation,” but indicates that formal action could occur in the future if an alleged violation is repeated, the website states. There was one such case in the last two years. In a change from the past, violation notices, posted online, contain almost no details. For example, on June 4, Vanderbuilt was accused of an AWA “handling” violation occurring on April 27. Animals are to be handled “expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort,” the warning letter states.
APHIS informed JHU on July 29 that on June 17 it had allegedly violated general requirements related to primary enclosures, which APHIS said “must be constructed and maintained so that they…Protected the nonhuman primate from injury.” There is no mention of type of animals involved. The agency told UT on June 22 that it had failed to ensure “all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties,” an alleged violation that occurred on May 20. APHIS’s online database of enforcement actions, which seems to only go back to 2020, includes one citation and penalty for a research institution—a notice that provides more details. On April 5, 2020, APHIS imposed a penalty of $74,000 on the Univerisity of Wisconsin-Madison, stemming from 23 violations from 2015 to 2019 related mostly to nonhuman primates. Specifically, it was cited for problems with handling, watering, structures, grouping, feeding and facilities; some incidents involved mice and squirrels. According to APHIS, one incident involved a “younger” nonhuman primate who died in December 2015, four days after being severely attacked by a “cagemate.” The nonhuman primate was returned to the same enclosure following medical treatment. (1/13/22)
◆ The University of Rochester Medical Center reviewed 15 papers by its cancer researchers, one of whom has left the institution, but did not find that problems reached the legal definition of misconduct, according to Retraction Watch. Dirk Bohmann, the medical center’s senior associate dean for basic research, told Retraction Watch that the inquiry into papers whose coauthors included Soo Ok Lee “determined that incorrect images appeared in 13 of the 15 articles investigated, which were published in 10 different journals between September 2015 and September 2019.” The investigation reportedly ended in the summer of 2020. Lee “acknowledged” the errors, “saying they resulted from a faulty data management system and multiple experiments being conducted in the same time frame,” Bohmann said.
Despite the lack of a finding, three retractions by the researchers to date “stemmed from the misconduct inquiry,” Retraction Watch reported. Bohmann also said Lee is no longer with the medical center. “Although the investigation did not prove misconduct, these revelations were disappointing and concerning to us. Whether the cause was intentional misconduct or poor laboratory practice, the fact that flawed information was entered into the scientific record by members of our University is incongruent with our standards as a research institution,” Bohmann was quoted as saying. It is not clear whether more retractions will be forthcoming, but all the journals were alerted of the image errors problems, Bohmann told Retraction Watch. The research at issue did not involve federal funds but was “supported entirely by the University,” Bohmann said. (1/13/22)
◆It will be sometime in spring before Charles Lieber, former chairman of the Chemistry and Chemical Biology Department at Harvard University, is sentenced after a jury found him guilty last month on six felony charges he faced in connection with income and other support he received from Chinese organizations but did not disclose. After a six-day trial, a jury on Dec. 21 found Lieber guilty of two counts each of making false statements, failing to report foreign income and other financial information, and filing false tax returns. Lieber was “a contractual participant in China’s Thousand Talents Plan from at least 2012 through 2015,” and as a result, he was paid a “salary of up to $50,000 per month, living expenses of up to $150,000” and given $1.5 million to establish a research lab at Wuhan University of Technology, the Department of Justice said. He also received “more than $15 million in federal research grants between 2008 and 2019.”
Lieber faces up to 26 years in prison and a fine of $1.2 million; a sentencing date has not yet been scheduled. In court documents filed Dec. 28, his attorneys and the government established a schedule for post-trial motions that would occur before sentencing. Lieber’s filings are due Feb. 1, and government “opposition” briefs are due March 1; Lieber must reply to these by March 14. His is the first trial in the government’s “China Initiative” to result in a guilty verdict. In September, a federal judge acquitted Anming Hu, a NASA-funded, former tenured professor of engineering at the University of Tennessee Knoxville, on charges of failing to disclose ties to a Chinese university. (1/6/22)
◆ Applications are due in March to the HHS Office of Research Integrity (ORI) for a chance to win an award for up to $150,000, ORI announced Jan. 3. ORI is offering two types of awards: funding for research and for conferences. Between now and the end of fiscal year 2022 (Sept. 30,) ORI “anticipates funding three to six awards of between $75,000 and $150,000 in total costs (direct plus indirect) per year, for a project period not to exceed two years (two 12-month budget periods)” as part of ORI’s Ensuring Research Integrity - Research, Development, and Demonstration Grant Program. This initiative “supports projects that undertake the development and implementation of innovative practical approaches, tools, and/or resources that improve practices related to research integrity and compliance with 42 C.F.R. Part 93.” ORI will consider projects for funding to “1) conduct research on one of the four FY 2022 focus areas identified below; 2) develop innovative approaches/tools/resources based on the results of this research; and 3) demonstrate the impact and/or effectiveness of these approaches/tools/resources.” ORI said the focus areas are “1) transparency in the conduct or reporting of research; 2) effective communication between authors and/or collaborators for the purpose of avoiding, mitigating, and resolving authorship/collaborator disputes and/or issues related to the integrity of the research; 3) handling allegations of research misconduct under 42 C.F.R. Part 93; or 4) interventions to address issues related to research culture and climate that can negatively impact the integrity, conduct, quality, and reliability of research.” ORI will hold a technical assistance webinar on this funding opportunity on Jan. 18. The deadline for applications is March 15.
The agency’s Ensuring Research Integrity Conference Grant Program “supports conferences and workshops that provide a mechanism for those concerned with research integrity to meet to discuss topics related to promoting the responsible conduct of research, preventing research misconduct, and/or addressing issues that arise after an allegation of research misconduct is brought forward at an institution,” ORI said. The new funding opportunity “solicits applications for projects to plan and implement conferences or workshops on research integrity and compliance with 42 C.F.R. Part 93. In-person and virtual conferences and workshops, or a combination of both, will be eligible for funding” and should be “designed to provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: 1) fostering an environment that promotes research integrity and the responsible conduct of research; 2) prevention of research misconduct; 3) effective handling of research misconduct allegations; 4) training in the responsible conduct of research; or 5) other topics linked to research integrity and compliance with 42 C.F.R. Part 93.” Up to two one-year grants totaling $50,000 are available. The deadline to apply is March 23; a technical assistance webinar is also scheduled for Jan. 18 following the one for the research award. (1/6/22)
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