Report on Research Compliance Volume 19, Number 3. In this month’s eNews: March 2022 | Healthcare Compliance Association (HCCA)

Research Compliance Report 19, no. 3 (March 2022)

Since the beginning of the year, the Animal and Plant Health Inspection Service (APHIS) has issued notices of alleged violations of the Animal Welfare Act (AWA) to a university and a health system in Oregon.. Both were published late. In a Notice of Alleged Violation Warning dated Jan. 14, APHIS said it “has evidence” that the University of Louisiana at Lafyette violated the AWA on Aug. 26, 2021, regarding standards for housing facilities, in particular water and electricity. “The accommodation shall have a reliable and adequate power supply for heating, air conditioning, ventilation and lighting, and to meet other husbandry requirements in accordance with the regulations of this subpart. The housing facility must provide running potable water for the watering needs of non-human primates. It must be sufficient for cleaning and for the fulfillment of other husbandry requirements,” the notice states.

Also dated Jan. 14, a Notice of Alleged Violation was issued to Legacy Health of Portland regarding standards for veterinarian attendance and adequate veterinary care. APHIS cited provisions of the AWA that require research facilities “to establish and maintain adequate veterinary care programs that include: (b)(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, restraint, anesthesia, analgesia, tranquilization and euthanasia.APHIS said evidence shows this provision was violated on September 23, 2021. Unlike in previous years , APHIS now withholds details of warning notices that would indicate the specific type of animal involved – such as the type of non-human primate – and any details about the alleged infractions. Both notices state that if “APHIS obtains evidence of a future violation of these federal regulations, APHIS may pursue civil penalties, criminal prosecution, or other penalties for such alleged violation(s). ed and for any future violations”. (02/17/22)

The Office of Science and Technology Policy (OSTP) is expected to make a number of revisions to its January 4 report Guidance for Implementing the Presidential National Security Memorandum-33the Council on Government Relations (COGR) said in a February 15 letter to the agency. Areas of general concern include the lack of attention to adopting a risk-based approach, the lack of uniformity within the guidelines themselves and between granting agencies, inappropriate standards for basic research and the need to reduce the “unreimbursed institutional costs” of compliance, among others. others.

COGR also provided specific comments, proposing alternate language for the “exceptionally broad” definition of foreign government-sponsored talent recruitment programs, noting that some of the violations’ enforcement mechanisms exceed those allowed, offering suggestions training programs and materials; and emphasizing that institutions already have cybersecurity programs in place, so any “mandatory research-specific cybersecurity standard should enable institutions to benefit from their compliance with these other federal standards.” The research safety program should also enable them to determine applicability to institutional components based on risk assessment,” COGR said. (02/17/22)

Jason Edmonds, who the government says was a research biologist for the US Army Combat Capability Development Command’s Chemical Biology Center, was charged with conspiracy and corruption. for allegedly accepting $40,000 in cash and awarding a central award to John Conigliaro, owner and CEO of EISCO Inc., the U.S. Attorney’s Office for the District of Maryland announced Feb. 8. Conigliaro “was separately charged with conspiracy in an information” earlier in the month. The center is “the Department of Defense’s primary technical organization for non-medical chemical and biological defense,” according to its website.

From 2012 to 2019, “Edmonds accepted cash and other financial benefits…in return for favorable action on CB Center contracts. For example, the indictment alleges that in July 2013, Edmonds led a $300,000 CB center project at EISCO,” officials said. Conigliaro then “gave Edmonds $40,000 in cash so Edmonds could purchase two rental properties. Once Edmonds purchased the rental properties, the indictment alleges that Conigliaro paid thousands of dollars for renovations to the rental properties.The indictment alleges that Edmonds executed a “promissory note”, in which Edmonds wrote that he repaid Conigliaro some of the funds Conigliaro gave him with the CB Center projects.” The government added that “from 2016 to 2018, Edmonds led four CB Center projects at EISCO. same period, Conigliaro reportedly paid more than $30,000 in renovations to the a personal residence of Edmonds. A conviction for conspiracy carries a sentence of up to five years, while bribery can carry a sentence of up to 15 years. (02/10/22)

A new version of HR 4521, the COMPETES (America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength) Act of 2022, introduced Jan. 25, garners praise from the Association of American Universities (AAU). In a Jan. 26 statement, AAU President Barbara Snyder “welcomed” the bill, calling it “an important step toward reauthorizing the National Science Foundation (NSF), the Department of Energy’s Office of Science and other research and STEM”. [science, technology, engineering and math] education programs essential to maintaining our country’s leadership role in science and innovation.

According to Snyder, “The House bill helps strengthen global science and technology leadership and the economic competitiveness of the United States by balancing the need to secure critical, federally funded academic research with the need to grow and develop.” ‘attract national and international STEM talent’. Snyder noted that the Senate has already passed its version of the bill and the two will need to be reconciled. “As the House considers this bill, we hope it will gain strong bipartisan support and move quickly through prosecution approval” and reconciliation, she added. Snyder noted that in addition to this legislation, Congress must pass appropriations “for programs it authorizes to maintain United States preeminence in science, health, national security, and economic competitiveness”. However, the AAU also reported in its Jan. 28 weekly bulletin that Rep. Frank Lucas, R-Okla., said the bill “undoes more than a year of bipartisan work by the House Science Committee to craft and pass comprehensive legislation to double investment in Basic Search.” Lucas is the senior member of the House Science, Space and Technology Committee. (02/03/22)

Awardees with funds from NIH’s Small Business Innovation Research and Small Business Technology Transfer Programs will be able to “retain applicable data for 20 years after the date of award,” according to the new policy FAQ. NIH Data Management and Sharing (DMS).. In a Jan. 25 blog post, Lyric Jorgenson, acting director of the NIH Office of Science Policy, said the first set of nine FAQs will be followed by additional resources in the future. Other FAQs dealt with non-compliance with the policy, which comes into effect one year after the blog post (January 25, 2023). The NIH may terminate an award or add special conditions, which it has not specified. According to an FAQ on the application, recipients who have not complied with their DMS plan may find themselves against them when applying for funding in the future.

Jorgenson explained that the NIH’s goal is to make “sharing the norm” and noted that while some organizations may already have policies in place, “forward planning of how to share data (i.e. i.e. developing plans, applying for NIH funds) may be new to some.” During the year, the NIH plans to release “guidance for developing budgets in plans outlining data management and sharing,” “updated information on privacy principles and anonymization of research participants to help guide sharing of research participant data”, “educational resources, including webinars and potentially sample plans”, and “plans to further harmonize the management NIH data and share expectations, especially reducing duplicate plan submissions,” Jorgenson wrote. (02/03/22)

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Amanda J. Marsh