Report on Research Compliance

  1. To Combat Racism, NIH Advised to Require Annual Data, Issue Institutional ‘Report Card’

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    Following social injustice protests over police brutality against Black people and the health disparities accelerated by the COVID-19 pandemic, an advisory committee assisting NIH with diversity efforts has recommended[1] that the agency require institutions to report acts of racial discrimination, details of their programs to promote faculty members who are Black and other related metrics. NIH should then annually issue “report cards for institutions and principal investigators that receive NIH funding.”...

  2. Slipup With Licenses for Animal Pathogens Brings $54K Fine, Audits in Rare Export Case

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    Generally speaking, compliance-related training programs help prevent lapses by educating employees on how to handle a situation, including what not to do under given circumstances. But on occasion, they may also prompt an individual to realize—and, ideally, to acknowledge—that a mistake has already been made...

  3. OIG Turns Sights to ‘Flexibilities,’ Keeps Focus on Foreign Influences

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    Early results from two audits of institutions funded by the National Science Foundation (NSF) show they have been meeting guidelines on spending “flexibilities” offered by the Office of Management and Budget (OMB) during the COVID-19 pandemic. The NSF Office of Inspector General (OIG) is planning a total of 10 such audits...

  4. Agencies Preview Cures Act Guidance Documents, Rules for Animal Research

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    Four years after the Cures Act[1] was signed into law, three agencies with oversight of animal care and use programs and research involving animals report making progress complying with a requirement to reduce administrative burdens. Updated policy guidance, regulations and other resources are in the works, according to agency officials, although they offered few specifics as to timing...

  5. In This Month’s E-News: April 2021

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 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,...

  6. RRC E-Alerts: February 25, 2021

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    More than three dozen times during a five-year period, Princeton University researchers sent animal pathogens to foreign investigators without obtaining the export control licenses, a potential violation of regulations that resulted in a penalty of $54,000 and requirements to conduct audits. In an announcement, the Bureau of Industry and Security, part of the Department of Commerce, said Princeton “voluntarily self-disclosed potential violations of the Export Administration Regulations (EAR) to BIS, and cooperated with the investigation that was conducted by the New York Field Office of BIS’s Office of Export Enforcement.” In addition to the payment, Princeton “agreed to complete one...

  7. RRC E-Alerts: March 4, 2021

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    As part of a new initiative called UNITE created to “identify and address structural racism within the NIH-supported and the greater scientific community,” NIH has formed five internal committees, made a statement, launched a new website and issued a request for information (RFI). UNITE was first announced during a special meeting of NIH Director Francis Collins’ Advisory Committee to the Director (ACD) held Feb. 26. “To those individuals in the biomedical research enterprise who have endured disadvantages due to structural racism, I am truly sorry. NIH is committed to instituting new ways to support diversity, equity, and inclusion, and identifying...

  8. RRC E-Alerts: March 11, 2021

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 2021 

    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,”...

  9. RRC E-Alerts: March 18, 2021

    Report on Research Compliance Volume 18, Number 4. March 23, 2021  | Author: Theresa Defino  | March 23, 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,...

  10. Former SACHRP Chair Has Pride Over Efforts, But Sees 'Reckoning,' Need to Restore Trust

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    When the highest-ranking federal committee on human subject protections meets later this month for its first gathering of 2021, it will be led by a new chair who reflects a return to academia. In January, Stephen Rosenfeld, MD, formerly executive review board chair of a commercial institutional review board (IRB) concluded four-and-a-half years as head of the HHS Secretary’s Advisory Committee on Human Research Protections, which followed his three years of service as a SACHRP member...

  11. OIG Details Missteps by Universities Handling Suspected Misconduct in NSF-Funded Research

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    A principal investigator (PI) who was initially accused of one instance of plagiarism noted that he had similarly copied text into two other National Science Foundation (NSF) proposals as a way of explaining how he did citations in applications versus in publications. But, as the NSF Office of Inspector General described it, “the PI’s response to our inquiry did not dispel the allegation,” and OIG ultimately determined he had “knowingly committed plagiarism” in three proposals by inserting text from three sources.[1]...

  12. NSF Misconduct Findings Carry Training, Other Requirements

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    During the second half of the previous fiscal year (FY), the National Science Foundation (NSF) disagreed with its Office of Inspector General’s (OIG) recommendation to debar two investigators who committed research misconduct, defined as fabrication, falsification or plagiarism.[1]...

  13. HIPAA NPRM Alters Notices, Quickens Records Access, Revises 'Harm' Warning

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    Research universities, academic medical centers and institutions with components that comply with HIPAA may wish to comment on a new notice of proposed rulemaking (NPRM)[1] that was published just a day after President Biden was inaugurated...

  14. To Build Trust, HRPPS Should 'Look In The Mirror, Not Out The Window'

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    Members of institutional review boards (IRBs) and others who oversee human research protection programs (HRPPs) have a variety of training options available to them. But has there ever been a course or conference offering titled, “How to deal with a difficult HRPP?”...

  15. In This Month's E-News: March 2021

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    ◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct by “knowingly and intentionally falsifying, fabricating, and plagiarizing data and text” in six papers and eight manuscripts, according to the HHS Office of Research Integrity (ORI). In its Feb. 4 Federal Register notice, ORI said Yibin Lin “falsely created fictitious author names and affiliations without listing himself as an author to disguise himself from being the offender, and submitted them for publication in bioRxiv and medRxiv, open access preprint repositories, by falsely assembling random paragraphs...

  16. RRC E-Alerts: January 28, 2021

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    Stating that “racial funding disparity” by NIH “remains the most insidious barrier to success of Black faculty,” 16 women representing an informal network are urging NIH Director Francis Collins to publicly acknowledge that “racism persists in the US academic research enterprise and that it must be expelled” and to announce a plan to “immediately achieve racial funding equity.” Writing in a commentary in Cell that was posted online Jan. 26, the authors suggested NIH implement “diversity score-driving criteria, prioritize diverse teams for funding, and diversify review panels” and offer training to empower “NIH leadership, staff, and grant reviewers and recipients...

  17. RRC E-Alerts: February 4, 2021

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    Li Chen, a former researcher at a hospital in Akron, Ohio, was sentenced Feb. 1 to 30 months in prison after pleading guilty this summer to “conspiring to steal scientific trade secrets and conspiring to commit wire fraud concerning the research, identification and treatment of a range of pediatric medical conditions.” According to the Department of Justice (DOJ), “Chen admitted in her guilty plea in July 2020 to stealing scientific trade secrets related to exosomes and exosome isolation from Nationwide Children’s Hospital’s Research Institute for her own personal financial gain.” She and Yu Zhou, her husband and “co-conspirator,” both worked...

  18. RRC E-Alerts: February 11, 2021

    Report on Research Compliance Volume 18, Number 3. February 16, 2021  | Author: Theresa Defino  | February 16, 2021 

    A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct by “knowingly and intentionally falsifying, fabricating, and plagiarizing data and text” in six papers and eight manuscripts, according to the HHS Office of Research Integrity (ORI). In its Feb. 4 Federal Register notice, ORI said Yibin Lin “falsely created fictitious author names and affiliations without listing himself as an author to disguise himself from being the offender, and submitted them for publication in bioRxiv and medRxiv, open access preprint repositories, by falsely assembling random paragraphs of...

  19. MITRE: Risk Approach May Thwart Foreign Threats, Better Federal Info, Support Essential

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    “I don’t want to be on the front page of the paper with my best researcher being dragged off in handcuffs. It doesn’t look good for our university,” a senior university administrator said. “Funding has gotten harder to get in the U.S. and it became easier to get from foreign sources in some cases,” said a principal investigator (PI). “So what’s driving this is the challenges in the U.S. research environment.”...

  20. HIPAA News: MD Anderson Avoids $4.3M Fine, New Law Ties Penalties to Compliance Efforts

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    In a 15-page sternly worded ruling, an appeals court in New Orleans has thrown out the $4.348 million penalty the HHS Office for Civil Rights (OCR) imposed in 2017[1] against the University of Texas MD Anderson Cancer Center for three relatively small breaches of research patient data that occurred more than eight years ago...

  21. NSF Invites Feedback on Revised PAPPG, Plans October Start Date

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    In a change from the past, the National Science Foundation (NSF) issued a draft revised version of its awards bible just before the end of 2020,[1] and officials now say they don’t expect to put it into effect until October...

  22. OIG FY 20 Report Shows Drop in NSF Debarments for Misconduct

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    Instead of debarring a graduate research fellow who confessed to multiple instances of data fabrication that caused a “major setback” to his team and got him expelled from his university, the National Science Foundation (NSF) is requiring submission of a data management plan should he submit proposals to the agency within the next four years.[1]...

  23. NSF OIG Total Research Misconduct Findings FY 2011-2020

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    Fiscal Year...

  24. In This Month's E-News: February 2021

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    ◆ A National Science Foundation (NSF) Office of Inspector General (OIG) audit of five Established Program to Stimulate Competitive Research (EPSCoR) awards to the University of Kansas Center for Research (KUCR) questioned $1,550,054 in direct and indirect costs. The largest amount, $625,532, stemmed from what auditors called “inappropriately retained indirect costs.” KUCR’s charges to NSF “exceeded costs paid to its subrecipients,” auditors said in the Jan. 7 report. Subrecipients, under a 2016 agreement, “billed KUCR for indirect costs on EPSCoR awards at rates that were 8 percentage points lower than their formal negotiated indirect cost rates. KUCR paid subrecipients at...

  25. RRC E-Alerts: January 7, 2021

    Report on Research Compliance Volume 18, Number 2. January 20, 2021  | Author: Theresa Defino  | January 20, 2021 

    Auditors for the National Science Foundation Office of Inspector General (OIG) have recommended that NSF seek repayment from Texas A&M University (TAMU) of $137,558 for what they said were unallowable costs, including salaries, airfare, expenses incurred before an award start and indirect costs. Auditors reviewed costs incurred from Oct. 1, 2016, to Sept. 30, 2019, and tested 130 transactions totaling $1,485,454 in costs out of more than $63.6 million claimed during this period. “Specifically, the auditors found $50,439 of unallowable expenses, $50,409 of inadequately supported expenses, $20,739 of inappropriately allocated expenses, $15,312 of inappropriately applied indirect costs, and $659 of...