Report on Research Compliance Volume 17, Number 11. In This Month's E-News: November 2020

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 11 (November 2020)

In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board policy—provided that the government sponsor agrees and “where reliance” on an sIRB would not be practical, OHRP announced Oct. 8. The exception applies to cooperative research “that is ongoing or initially reviewed by the IRB” during the pandemic and that would be in effect “for the duration of the research.”

“The COVID-19 public health emergency has created unprecedented burdens and disruption to the research enterprise, while at the same time requiring urgent research responses that necessitate flexible approaches to oversight in order to provide vital information and to allow other research to continue where possible,” OHRP said. “This exception represents an effort to prioritize the health and safety of both research subjects and investigators, and provides flexibility to institutions in seeking IRB review due to the unique challenges created by the COVID-19 outbreak.” OHRP also provided six examples where an sIRB might not be practical, which is part of the criteria for using the exception, applicable when “the HHS division supporting or conducting the research approves of the use of this exception.” The exception is effective for research that is “ongoing or initially reviewed by the IRB” during the COVID-19 public health emergency. First declared in January, HHS Secretary Alex Azar renewed the emergency on Oct. 2. Declarations are valid for 90 days. (10/15/20)

Geoffrey Girnun was sentenced to a year and a day in prison, and he resigned his position as associate professor of pathology at Stony Brook University related to his theft of government funds stemming from his creation of two “sham” corporations that billed more than $200,000 for purported materials for his cancer research. U.S. District Judge Denis Hurley also sentenced Girnun to forfeit $225,000 and pay $225,000 in restitution to NIH and Stoney Brook, which he had previously agreed to as part of a plea arrangement.

According to Department of Justice (DOJ), Girnun founded Atlas Metabolomics LLC and Empyrean Biosciences LLC in 2013 and 2017, respectively. “From approximately December 2013 to approximately September 2019, Girnun submitted fraudulent electronic invoices to Stony Brook University for payment to the sham companies for equipment, goods and services that were never received or provided,” DOJ said Oct. 6. Instead, Girnun used the funds “for personal expenses, including payments toward the mortgage on his residence and tuition for his children.” Seth DuCharme, acting U.S. attorney for the Eastern District of New York, said Girnun’s actions “undermined the important mission of his fellow researchers, who are dedicated to curing this deadly illness,” and the mission of NIH and Stony Brook. (10/15/20)

“Cybersecurity risks in biomedical research are continually evolving, threatening the integrity of our science and the public’s trust in our findings. It’s up to each one of us to mitigate these risks by staying vigilant, working together, and following the policies that are in place to protect our people and our science.” That’s the word from Michael Lauer, deputy director for extramural research, at the start of National Cybersecurity Awareness Month. In a post on his Open Mike blog, Lauer explained that NIH’s grants policy statement obligates awardees to safeguard “sensitive and confidential data as part of proper stewardship of federally funded research.”

This includes not keeping “sensitive and confidential information about NIH-supported work on portable electronic devices”; ensuring data are encrypted; implementing “proper controls to limit access to personally identifiable information”; transmitting data only “when the security of the systems on the other side is known”; and taking “all reasonable efforts to prevent sensitive personal information, such as that held within online systems at your home institution, from being inadvertently lost, released, or disclosed.” Organizations must comply with the Federal Information Security Act, which includes the perhaps “annoying” requirement to change passwords on NIH’s electronic Research Administration system every 120 days. “If you or your institution experiences an incident or breach, immediately report it to the NIH grants management specialist identified on your award and provide a copy of the report to your program official,” Lauer added. (10/8/20)

◆ Universities and other institutions can create “a more open research ecosystem” by providing researchers with data management tools that “accommodate the scholarly workflow,” better integrating “library and scientific communities,” supporting an open persistent identifier infrastructure, and “unbundling” data management platforms, among other ideas. The recommendations are part of “Implementing Effective Data Practices: Stakeholder Recommendations for Collaborative Research Support,” issued by the Association of Research Libraries, the Association of American Universities and similar stakeholders that participated in a December 2019 conference funded by the National Science Foundation (NSF).

“Based on the information and insights shared during the conference, the project team developed a set of recommendations for the broad adoption and implementation of NSF’s recommended data practices. The report focuses on recommendations for research institutions and also provides guidance for publishers, tool builders, and professional associations,” the organizations said Sept. 25. (10/8/20)

Saying that all leaders in academic medicine—including within his own organization—“must step up and transform rhetoric into action,” David Skorton, president and CEO of the Association of American Medical Colleges, released the “AAMC Framework for Addressing and Eliminating Racism at the AAMC, in Academic Medicine, and Beyond.” Issued Oct. 6, the framework contains “four pillars of work that will guide the AAMC’s efforts ‘to create a shared vision of the AAMC and academic medicine institutions as diverse, equitable, inclusive, and anti-racist organizations.’” These address “individual self-reflection on systemic racism and its manifestations in the workplace and beyond” and anti-racism efforts within the AAMC, the academic medical community and the broader community. The framework, AAMC said, “is designed to guide and inspire the academic medicine community to begin addressing decades of structural racism within medicine.” (10/8/20)

Effective Oct. 5, the National Science Foundation (NSF) will add several new questions to its online project reporting system to reflect changes in annual and final research progress performance reports. A new question applicable to projects reporting “active other support” will ask if the principal investigators or project directors have experienced a change in active other support since the previous report. If so, “they will be required to upload their most up-to-date Current and Pending Support document in an NSF-approved format,” NSF announced Sept. 29. (10/1/20)

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