Report on Research Compliance

  1. Community Representation, Better Study Design, Subject Payments Can Foster Justice in Research

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    “Injustice has no place in human subjects research and undermines public trust in science.”...

  2. First Jail Term for Undisclosed Foreign Support Appealed; NIH’s Lauer Laments ‘Tragic’ OSU Case

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    To his supporters and colleagues, Song Guo Zheng, MD, PhD, was the most productive worker they’ve seen in 50 years, publishing nearly 300 papers, a man who lived modestly and was “at the forefront” of research into autoimmune disorders to which he “devoted his professional life.” Yes, he made mistakes when he failed to report all of the support and positions he held in China, but he did not benefit personally...

  3. NIH Logs 500+ Foreign Influence Cases

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    In the three years since NIH Director Francis Collins first warned institutions to be alert to the possibility that investigators had inappropriate, and undisclosed, ties to foreign governments, the number of agency-supported “scientists of concern” has grown to more than 500...

  4. ‘Dr. Zheng Did Not Disclose Any of This’

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    As requested by NIH in April 2020, Ohio State University dug into the affiliations of Song Guo Zheng, MD, PhD, hired barely a year earlier as chair of OSU’s Division of Rheumatology and Immunology in the Department of Internal Medicine...

  5. OCR Vacancy Lingers; Former Director Predicts Records Access Cases Continue

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    In November, the University of Cincinnati Medical Center agreed to pay the HHS Office for Civil Rights (OCR) $65,000 and follow a two-year corrective action plan to settle allegations that it had violated the privacy rule by taking too long to send a woman her medical records.[1]...

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

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    ◆ A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and allegedly fabricated data in the award application has agreed to pay the government $215,000. The payment resolves potential violations of the False Claims Act that resulted from Sam W. Lee’s alleged research misconduct, the Department of Justice announced Aug. 6. MGH conducted an “internal review,” according to the settlement, and then “stopped drawing federal funds for [Lee’s award] and voluntarily disclosed to the United States that Dr. Lee allegedly submitted grant applications to NIH containing...

  7. RRC E-Alerts: July 29, 2021

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    National Science Foundation Office of Inspector General (OIG) auditors questioned approximately half of the costs of sampled expenditures claimed by Tennessee State University on NSF awards, but TSU believes most are appropriate. According to the July 20 report, OIG tested 80 transactions totaling $305,526 among approximately $5.9 million in costs TSU claimed on 11 awards from June 1, 2014, to July 25, 2019. Overall, OIG questioned $155,432 of the tested expenditures; TSU agreed to make repayment of only $28,859. OIG also found issues with TSU’s effort certification process. The largest portion of the questioned costs, $121,797, was related to four...

  8. RRC E-Alerts: August 5, 2021

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    The National Science Foundation Office of Inspector General (OIG) has completed its 10th audit of a university’s use of administrative flexibilities in spending NSF awards as offered by the Office of Management and Budget and again found no problems or “exceptions.” However, like some of the others, auditors questioned costs unrelated to flexibilities granted during the pandemic. In conducting an audit of the University of Michigan (UM), dated Aug. 2, OIG tested 39 transactions totaling $1,006,989, “and identified four examples in which UM used the COVID-19 flexibilities,” which affected just $36,896...

  9. RRC E-Alerts: August 12, 2021

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    With the completion of its 10 reviews of universities’ implementation of COVID-19 administrative flexibilities granted by the Office of Management and Budget last year, the National Science Foundation (NSF) Office of Inspector General (OIG) has issued a “capstone” report on its findings. The picture it paints is of the flexibilities providing some level of assistance but also of award recipients not making full opportunity of them, sometimes out of fear born of less-than-ideal implementation across the federal government. “Because OMB required federal agencies to issue their own guidance regarding whether and how recipients should implement the COVID-19 flexibilities, recipients did...

  10. RRC E-Alerts: August 19, 2021

    Report on Research Compliance Volume 18, Number 9. August 26, 2021  | Author: Theresa Defino  | August 26, 2021 

    A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and allegedly fabricated data in the award application has agreed to pay the government $215,000. The payment resolves potential violations of the False Claims Act (FCA) that resulted from Sam W. Lee’s alleged research misconduct, the Department of Justice (DOJ) announced Aug. 6. MGH conducted an “internal review,” according to the settlement, and then “stopped drawing federal funds for [Lee’s award] and voluntarily disclosed to the United States that Dr. Lee allegedly submitted grant applications to NIH...

  11. OIG Seeks Debarment of Two NSF-Supported PIs, Reveals Machinations Behind Misconduct

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Theresa Defino  | July 22, 2021 

    “The graduate student claimed that his student was responsible for the plagiarism, although he had no students.”...

  12. As NIH Strives to Reduce Sexual Harassment, Many Details Remain Hidden, Institutions Balk

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Theresa Defino  | July 22, 2021 

    NIH is continuing to face pushback and questionable actions by institutions grappling with agency-funded “superstar” principal investigators (PIs) who sexually harass their colleagues or students. In “quite a number of cases,” institutions have imposed a variety of sanctions without removing the PI from an award, something to which NIH objects, according to Michael Lauer, NIH’s deputy director for extramural research...

  13. NIH Extramural Harassment Statistics*, **

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | July 22, 2021 

    Characteristic/CY...

  14. IRB Role Seen as Critical in Promoting Diversity and Equity in Research

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Jane Anderson  | July 22, 2021 

    The specific value of institutional review boards and research ethics committees in promoting diversity in research has been underrecognized and their authority has been underutilized, even as the disproportionate impact of COVID-19 on certain populations in the United States has focused attention on inequalities in health, IRB officials and leaders in research ethics wrote in Science.[1]...

  15. Institutions Craft Different Solutions to Potential Issues Involving Service Animals

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Jane Anderson  | July 22, 2021 

    Research institutions are required under the Americans with Disabilities Act (ADA) to allow service animals access to all campus locations where staff or students can go. But there may be instances in laboratory facilities where service animals nonetheless should be excluded—either for their own safety or for the safety of laboratory animals, experts said during a prerecorded webinar posted online by the HHS Office of Laboratory Animal Welfare (OLAW).[1]...

  16. In This Month’s E-News: August 2021

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Theresa Defino  | July 22, 2021 

    ◆ “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and securely, and with respect for the privacy, autonomy, and well-being of research participants and the communities to which they belong,” the agency said in a recent notice. “As part of this commitment, NIH is working with stakeholders to identify best practices for developing and implementing effective consent practices to inform prospective research participants about potential risks and benefits of data and biospecimen sharing for future research.”...

  17. RRC E-Alerts: July 1, 2021

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Theresa Defino  | July 22, 2021 

    Following publication in December of a draft version, the National Science Foundation (NSF) on June 22 published a final Proposal & Award Policies & Procedures Guide (PAPPG), which is applicable for proposals “submitted or due on or after” Oct. 4. As described on the NSF Policy Office website, new sections address “requests for reasonable and accessibility accommodations regarding the proposal process or requests for accessibility accommodations to access NSF’s electronic systems, websites and other digital content,” and the necessity of assuring that meetings for which support is requested have a “written policy or code-of-conduct addressing harassment.”...

  18. RRC E-Alerts: July 15, 2021

    Report on Research Compliance Volume 18, Number 8. July 22, 2021  | Author: Theresa Defino  | July 22, 2021 

    “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and securely, and with respect for the privacy, autonomy, and well-being of research participants and the communities to which they belong,” the agency said in a recent notice. “As part of this commitment, NIH is working with stakeholders to identify best practices for developing and implementing effective consent practices to inform prospective research participants about potential risks and benefits of data and biospecimen sharing for future research.”...

  19. Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    Elisabeth Bik will not be silenced...

  20. NIH: Harassment Proposed Rules Could Mandate Training, Misconduct Disclosures

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    Although the item does not yet appear on a federal compendium of regulatory actions underway or planned for the future, NIH is drafting a regulation to beef up requirements for awardee institutions and principal investigators (PIs) related to sexual and other harassment and misconduct. New regulations could include mandatory harassment training and PI disclosures of investigations and past findings...

  21. Now Hiring (Again): ORI Leader Joins Secretary’s Office; Findings Plummet

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    In 2014, David E. Wright, then-director of the HHS Office of Research Integrity (ORI), was so fed up with various problems and what he called dysfunction at the HHS Office of the Assistant Secretary for Health (OASH) that he quit his job. Wright had been at the agency that investigates allegations of research misconduct in studies funded by Public Health Service agencies, including NIH, for just two years...

  22. NIH Embraces Recommendations to Enhance Rigor in Studies Using Animals

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    “Investigators need NIH’s support and active participation to increase the rigor and transparency of their research. NIH must obtain and commit sufficient financial resources toward improvements and also effectively use incentives and oversight in the grant application, review, and funding process.”...

  23. In This Month’s E-News: July 2021

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    ◆ In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a third of those, “no reasoning was documented”—a violation of HHS policy. “That means that NIH lacks insight into whether the ICs [institutes and centers] are funding out of rank order to further NIH’s mission or because of problems that warrant NIH’s attention,” OIG said in the report released June 15. The agency explained that “NIH’s grantmaking process provides ICs with discretion to fund a grant application that was...

  24. RRC E-Alerts: May 27, 2021

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    Following a guilty plea in November on one count of making false statements on NIH applications, a former Ohio State University (OSU) rheumatology professor will serve a prison term of 37 months and repay OSU $413,000 and NIH “more than” $3.4 million, the Department of Justice (DOJ) recently announced. Song Guo Zheng was arrested a year ago in Alaska “as he prepared to board another charter flight in order to flee to China. He was carrying three large bags, one small suitcase and a briefcase containing two laptops, three cell phones, several USB drives, several silver bars, expired Chinese passports...

  25. RRC E-Alerts: June 10, 2021

    Report on Research Compliance Volume 18, Number 7. June 24, 2021  | Author: Theresa Defino  | June 24, 2021 

    Watchdog organization Public Citizen is urging the Office for Human Research Protections, the Food and Drug Administration (FDA) and NIH Director Francis Collins to investigate an NIH-funded trial of epilepsy treatments that enrolled more than 400 subjects at 58 U.S. hospitals. In June 8 letters to the agencies, Michael Carome, M.D., director of Public Citizen’s Health Research Group, said the goal of the Established Status Epilepticus Treatment Trial (ESETT) was to assess whether one of three anticonvulsant drugs would “result in better seizure resolution and responsiveness within 60 minutes after initiation of the assigned drug, without additional anticonvulsant medications,” in...