Report on Research Compliance

  1. 'Speak-Up' Culture Provides Opportunities to Keep Problems From Becoming Violations

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    The complaint came in anonymously, recalled Joshua Toas, vice president of compliance at the State University of New York (SUNY) Research Foundation. “My manager harasses me, doesn’t let me do X, Y, and Z. It’s a violation of policy,” the person alleged. “Well, we have 17,000 employees, [and] that’s the extent of the complaint. I don’t know what campus you’re at, what location you’re at, what program you’re in,” said Toas. In this case, the person didn’t respond to follow-up questions, even though they were posed through a channel that would have allowed the employee to remain unidentified...

  2. False Claims, Overcharging Allegations Prove Costly: $16M Paid Just This Year

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    Perhaps nothing can drive home the need to deal effectively with suspected infractions of policies and procedures related to federal research grants more than learning that a fellow university has had to pay millions to settle alleged False Claims Act (FCA) violations or questions of overcharging on grants...

  3. Engaging the Community, Looking Inward: Meeting the Imperative of Diversity in Trials

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    As the pandemic continues to grip the United States, bringing more illness and death to minorities in particular, and the nation reflects on a summer of unrest over racial injustice, the linked issues of lack of diversity among clinical trial participants and growing health disparities have come to the fore perhaps like no period in recent history...

  4. Diverse Participant Engagement Strategies

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    A checklist for sponsors, clinical research organizations and investigators on the four stages of clinical research...

  5. Multitude of OCR Settlements Serve As Warning on Hacks, Record Requests

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Jane Anderson  | October 22, 2020 

    Academic medical centers and research institutions that treat patients don’t just have to worry about policies imposed by NIH or regulations by funding agencies. They also must watch the enforcement actions by the HHS Office for Civil Rights related to their standing as HIPAA covered entities (CEs). And in recent weeks, OCR has been very busy...

  6. In This Month's E-News: November 2020

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 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.”...

  7. RRC E-Alerts: October 1, 2020

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    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...

  8. RRC E-Alerts: October 8, 2020

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 2020 

    “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...

  9. RRC E-Alerts: October 15, 2020

    Report on Research Compliance Volume 17, Number 11. October 22, 2020  | Author: Theresa Defino  | October 22, 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.”...

  10. Scripps Pays $10M for Alleged FCA Violations; Whistleblower Warned of 'Soft Money Policy'

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    What the federal government—and a whistleblower—allege were False Claims Act (FCA) violations actually resulted from an “accounting discrepancy,” according to the Scripps Research Institute. Regardless of the language used, Scripps officials agreed to pay the Department of Justice (DOJ) $10 million,[1] of which $5 million is restitution, according to the settlement obtained by RRC...

  11. Research Admins Report Few Issues With Telework; Adopt Strategies to Ensure 'Balance'

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    When Kris Wolff, director of the Office of Sponsored Programs at Fordham University, came down with COVID-19, she didn’t hide it from her staff. “I was really open when I got sick and let them know things to look out for” should they also become ill, Wolff said...

  12. When Telework Ends, 'I Don't Want to Go Back'

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    In the spring, colleges, universities and research institutions ordered all nonessential staff to work from home.[1] A few strategies, such as regular communication, can make the experience better, but administrators from the University of Florida, Indiana University, and New York told RRC their experiences have been generally positive.[2]...

  13. Recent FDA Guidance, OIG Audit Plan Demand Focus on ClinicalTrials.gov

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    Prior to considering the imposition of fines for failures to comply with ClinicalTrials.gov reporting, the Food and Drug Administration will give “responsible parties” 30 days to come into compliance, according to new FDA guidance that finalized a 2018 document.[1] This notice of noncompliance will be posted on the agency’s website and sent to NIH, which will then post the notification on ClinicalTrials.gov itself...

  14. OLAW: New Guidelines for Euthanasia in Effect Oct. 1

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    On July 13, the NIH Office of Laboratory Animal Welfare (OLAW) announced that grant applications and contract proposals submitted as of Oct. 1 must comply with updated guidelines for the euthanasia of animals.[1]...

  15. In This Month's E-News: October 2020

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    ◆ Although full implementation is several years away, leaders of research institutions and organizations representing them are asking the Department of Defense to exempt fundamental research from requirements in DoD’s Cybersecurity Maturity Model Certification (CMMC) program. Contractors and possibly subcontractors would be required to obtain third-party CMMC depending on the type of information they hold and the level of security required. In a recent letter, the Council on Governmental Relations, the Association of American Universities, and others expressed concern that “without additional clarification, [there is] too much room for the inappropriate application of certification requirements that are not relevant to...

  16. RRC E-Alerts: August 27, 2020

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    In its third misconduct finding this month, the HHS Office of Research Integrity (ORI) concluded that Anil K. Jaiswal, a former professor of pharmacology at the University of Maryland School of Medicine, “intentionally, knowingly, or recklessly: (a) used random blank background sections of film or empty boxes to falsely represent or fabricate western blot analyses; (b)used manipulated images to generate and report falsified data in figures; and (c) used mislabeled images to falsely report data in figures.”...

  17. RRC E-Alerts: September 3, 2020

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    Texas A&M University (TAMU) professor Zhengdong Cheng was arrested Aug. 23 and charged with conspiracy, making false statements and wire fraud in connection with payments the Department of Justice (DOJ) said were provided by a Chinese university while he was also the recipient of awards from NASA. As described in an Aug. 24 DOJ press release, “Cheng and TAMU [allegedly] received funds based on Cheng knowingly providing false information to TAMU and consequently to NASA. In addition to the funds, Cheng personally benefited from his affiliation with TAMU and NASA with increased access to unique NASA resources, such as the...

  18. RRC E-Alerts: September 17, 2020

    Report on Research Compliance Volume 17, Number 10. September 24, 2020  | Author: Theresa Defino  | September 24, 2020 

    Although full implementation is several years away, leaders of research institutions and organizations representing them are asking the Department of Defense to exempt fundamental research from requirements in DoD’s Cybersecurity Maturity Model Certification (CMMC) program. Contractors and possibly subcontractors would be required to obtain third-party CMMC depending on the type of information they hold and the level of security required. In a recent letter, the Council on Governmental Relations, the Association of American Universities, and others expressed concern that “without additional clarification, [there is] too much room for the inappropriate application of certification requirements that are not relevant to the...

  19. Deception by Professor Costs Lehigh $200K As Yet Another University Settles an FCA Case

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    The investigator’s assessment was stark and unsparing. “ArkLight is not a corporation,” wrote Erik Saracino, a special agent in NASA’s Office of Inspector General. The only “office” of ArkLight was in the home of then-Lehigh University professor Yujie Ding and his wife Yuliya Zotova, and a 2013 search revealed “no laboratory or equipment.” Other than Ding and Zotova, “ArkLight has no known employees, contractors or affiliates.”...

  20. 'Bad Science Moves Quickly': Rushed Papers, Expanded Access Requests Threaten Research

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    The COVID-19 pandemic is leaving its mark on the design and conduct of studies, including in ways that benefit subjects and patients, particularly through telemedicine. But two ethicists warn that developments such as the increasing use of unproven medications outside of clinical trials and the rise of publishing platforms less rigorous than peer-reviewed journals are shaking the research enterprise in profound, lingering and negative ways...

  21. SACHRP: Secretarial Waiver Needed to Transplant Organs Subjected to Research

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    Federal officials should begin the process of creating a national board to review studies involving organs subject to research interventions that will be transplanted into living recipients, and of establishing a waiver of some informed consent requirements, according to HHS’s highest ranking panel on human subjects research...

  22. Lehigh U. Compliance Plan Provides Blueprint for Oversight, Audit Schedule

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    As part of its recent settlement with the Department of Justice regarding allegations of False Claims Act (FCA) violations, Lehigh University of Pennsylvania is implementing an oversight and training structure that could serve as a template for others with federal research dollars, according to the compliance plan obtained by RRC...

  23. Could 'Challenge' Trials Speed Development of a COVID-19 Vaccine?

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    While many, if not most, research compliance officials are at least partially familiar with how vaccines (and drugs and devices) are approved by the Food and Drug Administration (FDA), they may be less acquainted with some of the more uncommon types of trials gaining prominence today, such as so-called “challenge” trials...

  24. In This Month's E-News: September 2020

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    ◆ The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February by adding new sections and revisions to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards that OMB said “clarify areas of misinterpretation” and are “intended to reduce recipient burden by improving consistent interpretation.” Scheduled for publication in the Aug. 13 Federal Register, the guidance was posted on the Register’s Public Inspection website on Aug. 11. But OMB also said the final guidance reflects a “foundational shift” and a “focus on improved...

  25. RRC E-Alerts: July 30, 2020

    Report on Research Compliance Volume 17, Number 9. August 20, 2020  | Author: Theresa Defino  | August 20, 2020 

    In its fourth misconduct finding this year, the HHS Office of Research Integrity (ORI) announced that Prasadarao Nemani, a former research professor of pediatrics in the Division of Infectious Disease at Children’s Hospital Los Angeles, “recklessly includ[ed] falsified and/or fabricated data” in eight figures in a published paper and four NIH grant applications. The 2009 paper was retracted nine years later in May 2018. Nemani “falsified and/or fabricated image data for enterobacterial infection-induced intestinal epithelial cell injury in a neonatal murine model to falsely represent results using images from unrelated experiments,” ORI reported in the July 24 Federal Register. According...