Report on Research Compliance

  1. After Paying HHS $1.45M, UNLV Enhances Award Oversight; OIG Touts Self-Disclosure

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    Nearly four years after noticing spending “irregularities” by a principal investigator (PI), the University of Nevada Las Vegas (UNLV) entered into a settlement agreement[1] with the HHS Office of Inspector General (OIG), refunding $1.07 million and paying a penalty of almost $400,000.[2] The four awards at issue—three from NIH and one from the Health Resources and Services Administration (HRSA)—totaled $5.7 million...

  2. Bills Boosting NSF Funding Spark Concern As Congress Takes Aim at Foreign Threats

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    Members of Congress from both parties are rallying around bills that would boost funding for the National Science Foundation (NSF), but they also contain provisions designed to shore up federally funded research from foreign interference that some say go too far. Advocates hope these provisions can be revised before coming to a full vote...

  3. SACHRP: Thorny Sponsor Interactions With Subjects Require Approval, Oversight

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    Under the leadership of new chair Douglas Diekema, M.D., the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has forwarded its first recommendations of 2021 to new HHS Secretary Xavier Becerra. These address the need for institutional review boards (IRBs) and institutions to play a greater role in overseeing—and perhaps halting—certain activities by study sponsors that involve research subjects.[1]...

  4. SACHRP-Recommended Limits on Sponsor-Subject Interactions

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    At its first meeting of the year, the HHS Secretary’s Advisory Committee on Human Research Protections forwarded two sets of recommendations to the agency.[1] One addresses the increasingly nettlesome interactions between study sponsors and research subjects and the rise of third-party vendors, outlining a role for institutional review boards (IRBs) in establishing a framework for such interactions and for vendor activities.[2]...

  5. ACD Okays AI/ML Research Program, Expects ‘UNITE’ Update This Month

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    During a quick meeting[1] —its second special session so far this year—the NIH Advisory Committee to the Director (ACD) gave unanimous approval to a “bold” $50 million program to fund a consortium to conduct research involving electronic health records (EHRs) using artificial intelligence (AI) and machine learning (ML). The goal is to seek ways to reduce health disparities. ACD members also got a preview of the agenda for the regularly scheduled meeting to be held this month...

  6. In This Month’s E-News: June 2021

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    ◆ Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440, agreeing only to refund NSF $133,736 of $61 million in costs claimed on awards from March 1, 2017, to February 2020. According to the April 30 report, auditors questioned “$83,248 of inappropriately applied indirect costs; $57,318 of inappropriately allocated expenses; $58,000 of unreasonable and unallocable computer cluster node access expenses; $45,620 of inadequately supported expenses; $23,689 of unallowable expenses; and $8,565 of indirect costs over-applied to supplemental funding.” They also “identified four compliance related findings for...

  7. RRC E-Alerts: April 29, 2021

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    HHS has reversed a 2019 requirement that “all research applications for NIH grants and contracts proposing the use of human fetal tissue from elective abortions will be reviewed by an Ethics Advisory Board,” NIH recently announced. As a result, the Human Fetal Tissue Research Ethics Advisory Board will not meet, NIH said April 16. However, other requirements for funding of extramural fetal tissue research “remain unchanged.” The reversal reflects the Biden administration’s policies toward the use of tissue from elective abortions, which the Trump White House had opposed. NIH established the board in 2019, and it only met once, recommending...

  8. RRC E-Alerts: May 6, 2021

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    Following a confirmation hearing on April 30, the Senate Commerce, Science, and Transportation Committee expects to vote sometime later this month on the nomination of Eric Lander, director of the Broad Institute, to be the new director of the Office of Science and Technology Policy (OSTP). The committee will hold the record open until May 13 to accept additional comments and questions for Lander, after which time a vote will be scheduled. The nomination will then move to the full Senate for approval. This marks the first time an OSTP leader faces confirmation, as President Biden elevated the job to...

  9. RRC E-Alerts: May 13, 2021

    Report on Research Compliance Volume 18, Number 6. May 20, 2021  | Author: Theresa Defino  | May 20, 2021 

    Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440, agreeing only to refund NSF $133,736 of $61 million in costs claimed on awards from March 1, 2017, to February 2020. According to the April 30 report, auditors questioned “$83,248 of inappropriately applied indirect costs; $57,318 of inappropriately allocated expenses; $58,000 of unreasonable and unallocable computer cluster node access expenses; $45,620 of inadequately supported expenses; $23,689 of unallowable expenses; and $8,565 of indirect costs over-applied to supplemental funding.” They also “identified four compliance related findings for which...

  10. Shift to Trials as Standard of Care, Chaos to ‘Normal’: Research Admin Life Amid COVID

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    In late February of last year, Kelly Cervellione was meeting with pulmonary medicine fellows when someone asked, “Did you hear about this COVID virus?” Another person said, “Oh, the clinical research department should look into remdesivir.” Cervellione, director of that department for Queens, New York-based MediSys Health Network, recalls responding, “OK, that’s some good information; let me look into it and see what’s going on.”...

  11. First ORI Annual Report in Years Emerges; Graphics-Laden Format Lacks Historical Data

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    For the first time since 2012, the HHS Office of Research Integrity (ORI) issued[1] an annual report, but for those used to previous updates or looking for useful details, it may prove to be a disappointment. Covering fiscal year (FY) 2020, the report consists mostly of graphics and presents essentially a snapshot of activities. Missing are trend data and any information from past years’ actions. ORI has a unique and crucial role in the research world: It investigates research misconduct, defined as fabrication, falsification or plagiarism, in the billions of dollars of studies supported by NIH and other Public Health...

  12. NIH’s Lauer: ‘This Is Not Just a Matter of Bad Apples’

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    In mid-April, members of NIH’s “integrity team” met to discuss active cases involving what Michael Lauer, deputy director for extramural research, terms “classic misconduct” (fabrication, falsification and plagiarism), but also foreign interference and harassment, which can include allegations of sexual harassment as well as racial discrimination. Members meet every several weeks, he said. Additionally, NIH is investigating cases of peer reviewers violating confidentiality...

  13. Bioethicists: Institutions Should Prioritize COVID-19 Clinical Trials to Optimize Impact

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Jane Anderson  | April 22, 2021 

    Limited resources for research into potential COVID-19 interventions make it critical to prioritize clinical trials, a group of research experts and bioethicists said. But because this important prioritization generally is not occurring upstream of individual institutions, the institutions themselves need to perform it, the experts wrote in Clinical Trials.[1]...

  14. Three Stages of COVID-19 Trial Consolidation and Prioritization

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | April 22, 2021 

    Source: Michelle N. Meyer et al., “An ethics framework for consolidating and prioritizing COVID-19 clinical trials,” Clinical Trials 18, no. 2 (February 2, 2021), http://bit.ly/38M7Ojh...

  15. In This Month’s E-News: May 2021

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    ◆ Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced Rep. Phil Roe, R-Tennessee. Roe retired in January. According to an undated letter posted April 13 by the Association of American Medical Colleges, the two have invited all members of Congress to join the caucus to “promote and recognize the important role that medical schools, teaching hospitals and faculty physicians play to improve the health of people everywhere.” In addition to pioneering medical treatments, academic medical centers serve as “vital economic engines at the local, state and...

  16. RRC E-Alerts: April 1, 2021

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    Gee-Kung Chang, a professor at Georgia Tech, has been indicted for wire fraud and conspiracy to commit wire and visa fraud, the Department of Justice (DOJ) announced. “Chang allegedly abused his position as a professor at Georgia Tech, an institution that was a designated exchange sponsor for the Department of State’s J-1 Visa program, to arrange for Chinese nationals to fraudulently obtain and maintain J-1 Visas,” according to the U.S. Attorney’s Office in the Northern District of Georgia. It is not clear how many visas or Chinese nationals were involved or when they were in the United States...

  17. RRC E-Alerts: April 8, 2021

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    Charles Lieber, on leave as chairman of Harvard’s Chemistry Department to battle charges of making false statements and failing to report income from China, has ruled out the possibility of a plea agreement and is seeking a trial expeditiously because he also “has a very advanced form of lymphoma” and “conventional treatments have failed.” According to an April 7 article in TheHarvard Crimson, Marc L. Mukasey, Lieber’s attorney, told Massachusetts District Court Magistrate Judge Marianne B. Bowler that Lieber “frankly does not have time for delay, procrastination, and stalling.”...

  18. RRC E-Alerts: April 15, 2021

    Report on Research Compliance Volume 18, Number 5. April 22, 2021  | Author: Theresa Defino  | April 22, 2021 

    Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced Rep. Phil Roe, R-Tennessee. Roe retired in January. According to an undated letter posted April 13 by the Association of American Medical Colleges (AAMC), the two have invited all members of Congress to join the caucus to “promote and recognize the important role that medical schools, teaching hospitals and faculty physicians play to improve the health of people everywhere.” In addition to pioneering medical treatments, academic medical centers serve as “vital economic engines at the local, state and...

  19. 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.”...

  20. 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...

  21. 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...

  22. 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...

  23. 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,...

  24. 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...

  25. 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...