Report on Research Compliance 18, no. 4 (April 2021)
◆ A new report by the National Academies of Sciences, Engineering, and Medicine examining the impact of the COVID-19 pandemic found “intensified complications related to work-life boundaries that largely affect women,” NASEM officials said in an announcement. These effects, among others, “may roll back some of the achievement gains made by women to date,” said Eve Higginbotham, chair of the committee authoring the report. Higginbotham is vice dean for inclusion, diversity, and equity and a professor of ophthalmology at Penn Medicine. The committee commissioned five research papers; one included a survey conducted in October of 933 women in science, technology, engineering, math and medicine (STEMM). “Preliminary evidence suggests women in academic STEMM are experiencing increased workload, decreased productivity, changes in interactions, and difficulties from remote work caused by the COVID 19 pandemic and associated disruptions,” NASEM said.
For example, “budget cuts made by many colleges and universities in response to the economic constraints that arose during 2020 greatly affected contingent and non-tenured faculty members—positions disproportionately occupied by women and People of Color,” according to highlights of the report, which also noted that “nearly 70 percent of faculty are not on the tenure track.” Committee members were asked “to inform, without making recommendations,” but they did suggest nearly three dozen questions related to the pandemic and women in STEMM positions that warrant further study. The report “may help inform the decisions that academic leaders, funders, other interested stakeholders, and both current and aspiring academics will continue to have to make over the course of the COVID-19 pandemic,” according to highlights. (3/18/21)
◆ Following a self-disclosure to the HHS Office of Inspector General, the Board of Regents of the Nevada System of Higher Education paid the government $1,450,947.81 million to settle possible violations related to unallowable subaward and misspending of funds from NIH and Health Resources and Services Administration (HRSA) awards, OIG announced. A former principal investigator at the University of Nevada, Las Vegas, caused UNLV to make unallowable subawards to “organizations without sufficient documentation of whether the activities were for the performance of the awards, or because they were made to entities with which the PI had an undisclosed conflict of interest,” the agency said.
Additionally, salary and fringe benefits for the PI lacked “adequate documentation,” and awards were improperly spent on “travel and associated costs of at least two trips to Nigeria that were unallowable because there was no evidence that the trip was in furtherance of the NIH-funded research.” Related to the HRSA award, OIG said UNLV improperly charged a portion of the salary of a nurse practitioner working in UNLV’s HIV clinic, “when UNLV lacked sufficient documentation to support such salary costs charged to the award.” OIG’s announcement said UNLV had potentially violated the Civil Monetary Penalties Law. It did not say when the self-disclosure or the alleged improper expenditures occurred or what the payment amount is based on. (3/11/21)
◆ Stating that “many research institutions have begun evaluating their policies and processes concerning conflict of commitment” (COC) in response to “federal research funding agencies’ focus on disclosure of international research activities and support,” the Council on Governmental Relations (COGR) has released a framework to help such evaluations. The framework includes “major principles that institutions might consider,” as well as “illustrative case studies.”
Among the key points in the framework are that institutions should consider both the risks and benefits of faculty involvement in external activities; establish clear expectations for what is allowable and what is not, while ensuring that duties to the employing institution take precedence; and coordinate COC policies with those governing financial conflicts of interest. Policies should also address “who and what the COC policy covers and what level of review (chair, dean, provost) is required for categories of activities” and establish sanctions for noncompliance, among other issues. Institutions should seek to “minimize faculty burden and maximize transparency.” Challenges to establishing such policies include how to handle faculty with nine-month appointments, overlap with effort reporting and certification, and the evolving nature of disclosure and other requirements from federal agencies. Ten examples of possible COC scenarios are included, as is a chart comparing disclosure requirements. (3/11/21)
◆ As part of its efforts to help educate individuals and family members who may be interested in joining a research trial, the HHS Office for Human Research Protections (OHRP) has developed a new video on children. Posted on YouTube on Feb. 18, the seven-minute video “provides basic information about research with children, why it is important, and what parents should expect if considering enrolling their child in a study,” OHRP said in its monthly newsletter that was emailed March 2.
The video, “Research with Children: What Parents Need to Know,” joins others addressing protecting human research volunteers, including about informed consent. Other categories of videos concern types of research and basics of clinical research. All are posted to “help potential research volunteers understand how research works, what questions they should ask, and things to think about when deciding whether to participate in a study,” according to OHRP’s informational videos website. (3/4/21)
◆ A group of associations is seeking the opportunity to offer input before the government implements any recommendations on combating foreign influence in research that were completed while Trump was in office. In a Feb. 10 letter to Kei Koizumi, acting director of the Office of Science and Technology Policy, a group including the Association of American Medical Colleges, the Association of American Universities, and the Council on Governmental Relations expressed concerns about two documents: the “Presidential Memorandum on United States Government-Supported Research and Development National Security Policy (NSPM-33)” and the Joint Committee on the Research Environment’s (JCORE) “Recommended Practices for Strengthening the Security and Integrity of America’s Science and Technology Research Enterprise.”
The group said members “actively engaged with federal officials as the JCORE process permitted and awaited the release of its proposals. The documents, though, were released as the Trump Administration was departing, providing no opportunity for stakeholders to evaluate or discuss them.” At least initially, the groups “believe some items in the two documents are clear, targeted, feasible and well-grounded,” and cited JCORE’s recommendation for the adoption of a risk-based approach that addresses both benefits and risks of “open, international collaboration.” But “differing definitions of some terms between the various documents and the scope of some requirements and recommendations” are of concern, they said. “We urge you to consult with the academic research community—preferably through a public comment period—before deciding whether and how to move ahead with NSPM-33. We also request that additional clarification be provided on the Administration’s expectations concerning the Recommended Practices document, including guidance regarding the risk-based application of the recommendations, as advocated in the document.” The letter was also sent to Eric Lander, science adviser to President Biden. (2/25/21)
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