◆ The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and all types” imposed by NIH, the National Science Foundation (NSF) and other federal agencies to address inappropriate foreign influence on research. COGR surveyed 22 institutions with annual federal research and development expenditures of $100 million or greater and four with less than that amount about their expenditures during fiscal year 2022 to 2023. This is the first fiscal year after NIH, NSF and the Office of Science and Technology Policy “took steps toward harmonizing and clarifying” the requirements, according to COGR.
Disclosure-associated costs ranged “from an average of over $100,000 for smaller institutions to over $400,000 for mid-size and large institutions. Although some of these expenses are one-time costs, a sizeable portion will be annual recurring compliance costs,” the report states. “Overall, the cost impact to research institutions in year one is expected to exceed $50 million. Further, all research institutions will experience significant cost burden and administrative stress, and smaller research institutions with less developed compliance infrastructure may be disproportionately affected.” COGR said it hopes the report “will both encourage and facilitate discussions of equitable cost allocation, as well as how the costs of research security compliance “should be considered and measured.” (11/17/22)
◆ Romina Mizrahi, currently associate chair of research in the Department of Psychiatry at McGill University in Montreal, committed research misconduct in a funding application submitted to the National Institute of Mental Health in 2018, according to the HHS Office of Research Integrity (ORI). Mizrahi selectively included and excluded the PET scan data of research participants to show a greater response in the patient group versus the healthy volunteers in the application, “Imaging nociceptin receptors in clinical high risk and first episode psychosis,” ORI said in a Nov. 14 notice on its website.
At the time of the application, Mizrahi was a clinician scientist at the Centre for Addiction and Mental Health and an associate professor in the Department of Psychology at the University of Toronto, ORI said. Mizrahi agreed to have her research supervised for one year beginning Nov. 3. Under the terms of the settlement, Mizrahi is required to submit a plan for supervision “to ensure the integrity” of her research that consists of two-to-three senior faculty members who will “conduct an advance review of each application for [Public Health Service] PHS funds, or report, manuscript, or abstract involving PHS-supported research” in which she is involved. She agreed to other related requirements and will not serve as a PHS advisor during the supervisory period. (11/17/22)
◆ Sen. Cory Booker, D-N.J., has asked HHS Secretary Xavier Becerra to investigate the oversight and approval of an award to the University of Washington (UW) for its Washington National Primate Research Center in Seattle and a breeding center for macaques in a desert area north of Mesa, Arizona. “This grant was renewed despite documentation of multiple unresolved, serious issues, including failure to maintain biosecurity—which threatens not only public safety but has also compromised the health of the monkeys and data from studies using them—repeated animal welfare violations, financial issues with taxpayer funds, and failure to comply with both state and federal laws,” Sen. Booker wrote in the recent letter.
The Arizona Republic “exposed” five significant issues, Sen. Booker said. These include the prevalence of diseases among the monkeys; violations of state importation laws related to failure to report such diseases; violations of the Animal Welfare Act regarding “adequate veterinary care, unsafe caging resulting in multiple escapes, veterinary error leading to deaths”; and financial and personnel “disarray.” According to the Republic, UW receives approximately $13 million in annual NIH funding. Booker asked Becerra to answer eight questions relevant to oversight of the program, including how it coordinates with the state officials and the U.S. Department of Agriculture and how the award was made, including whether “grant officers” were aware of the concerns. (11/10/22)
◆ For the first time, the Bureau of Industry and Science (BIS), part of the Department of Commerce, is offering a two-day, online interactive conference addressing “the same topics typically covered in the two day, in-person programs,” the agency announced. These include the scope of the Export Administration Regulations Act, “how to classify your items for export, how to apply for an export license, understanding and using license exceptions, deemed exports, de minimis and direct product rules, export clearances, export enforcement, and developing an export management and compliance program.”
This live event will offer “an opportunity to see and hear BIS specialists present, have your questions answered, and participate in interactive exercises to expand your regulatory and compliance knowledge,” the agency said. Training will be offered in four three-hour sessions. Cosponsored by the World Trade Center (WTC) Denver, the cost is $350 for WTC Denver members and $400 for nonmembers. (11/10/22)
◆ The University of Arkansas at Little Rock (UALR) still hasn’t changed its institutional review board (IRB) policies and procedures to comply with the 2018 revised Common Rule, according to the HHS Office for Human Research Protections (OHRP). “Instead, UALR indicated that their researchers and IRB members would need to visit the OHRP website, contact the IRB, or visit UALR’s Blackboard site for further information about complying with the 2018 regulatory requirements,” OHRP said in an Oct. 7 determination letter to UALR. The letter posted on the agency’s website summarizes OHRP’s previous correspondence with UALR, which occurred twice this year. UALR has a policy to “continually, and at least annually, assess the adequacy of existent policies and the need for new policies as the field of research ethics and human participant protection evolves,” OHRP said, quoting UALR. “At least once every four years, in the fall semester, the IRB will implement a process to review all of its policies and procedures” and “will adopt and implement the revisions” at the end of the four-year cycle.
UALR should have been following the revised Common Rule as of January 2019 but OHRP “determined that UALR does not have IRB written procedures that the IRB can follow to ensure adequate review and compliance with the 2018 regulatory requirements,” the agency wrote. “For example, UALR’s existing IRB written procedures do not include the 2018 additional requirements for informed consent.” OHRP asked UALR to provide the agency with “IRB written procedures that reflect the 2018 regulatory requirements. These procedures should include sufficient detail to ensure that the IRB is reviewing human subjects research in a way that is compliant with the 2018 regulatory requirements, for research subject to those regulations.” OHRP asked UALR to send the new policies by Nov. 10. (11/3/22)
◆ The White House Office of Science and Technology Policy (OSTP) has issued a request for information (RFI), in tandem with the National Security Council, to “ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.” According to a notice in the Oct. 26 Federal Register, the government is considering creating a federal “governance structure and outreach to a wide range of institutions, clinical trial networks, and other potential trial sites that can participate in emergency research, both domestically and internationally.”
OSTP is also seeking to “support the expansion of clinical research into underserved communities, and increase diversity among both trial participants and clinical trial investigators” and would “appreciate receiving comments on how the domestic emergency clinical trials effort overall can be designed to coordinate with international research and preparedness initiatives.” The RFI also discusses the potential of creating a “warm base” of research sites. Warm base studies “not only gather data under a particular clinical research protocol but also serve the function of keeping trial sites in a state of readiness to undertake additional or future research,” according to the Federal Register. Carrie Wolinetz, OSTP deputy director for health and life sciences and Grail Sipes, assistant director for biomedical regulatory policy, discussed the RFI in a blog post. Michael Lauer, NIH deputy director of extramural research, also addressed the RFI on his Open Mike blog, noting, “it is a good time to look back on our clinical trial efforts as the public health emergency moves into a new phase. What worked? What did not? How can we apply lessons learned moving forward?” The RFI comment period ends Dec. 27. (11/3/22)
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