Report on Research Compliance

  1. SACHRP Establishes 'Walls' for Public Health Surveillance Activities, Stresses Accountability

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    More than two years ago, as institutions were in the throes of readying to comply with the revised Common Rule, the HHS Office for Human Research Protections (OHRP) issued draft guidance on public health surveillance activities not considered to be research.[1] Fast forward two years, and the world has changed drastically as the globe grapples with the COVID-19 pandemic, which has put greater focus on the topic of the proposed guidance like never before...

  2. COVID-19 Woes: Safety, Money Worries Concern Institutions; Researchers Fear Career Disruptions

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    As the pandemic continues to not only drag on but intensify, the toll on institutions and staff is becoming more evident. To get a sense of what was happening, and how it could help, NIH conducted surveys this fall. The findings provide perhaps the first large-scale—albeit limited—look at the concerns organizations and researchers are wrestling with...

  3. U. of Cincinnati Pays OCR $65K to Settle Records Complaint

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    In its continuing quest to ensure that patients and family members or their representatives can access medical records, the HHS Office for Civil Rights (OCR) has imposed fines and corrective action plans (CAPs) on a dozen organizations—and now it has snagged a university hospital...

  4. Agreeing With OIG, NSF Disallows JHU's Late Equipment Costs, Travel Expenses

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    Post-award research compliance officials, particularly those in award-related finance and accounting roles, will want to review the trio of recent audit resolutions issued by the National Science Foundation for insights into the types of incurred costs NSF finds problematic...

  5. As Animal Research FOIA Requests Rise, OLAW Advises Careful Approach

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Jane Anderson  | December 24, 2020 

    Freedom of Information Act (FOIA) requests submitted to the NIH Office of Laboratory Animal Welfare (OLAW) have snowballed in recent years, and research institutions submitting reports and records to OLAW should assume those records will be released, top officials said...

  6. In This Month's E-News: January 2021

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    ◆ The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be finalized sometime next year. “To facilitate review, revised text has been highlighted in yellow throughout the document to identify significant changes. A brief comment explanation of the change also is provided,” the agency said in a Dec. 14 Federal Register notice. In an email to stakeholders, NSF Policy Head Jean Feldman said the draft incorporates “the revised [2 C.F.R. § 200]: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Award that...

  7. RRC E-Alerts: December 3, 2020

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    David Panka, M.D., who the HHS Office of Research Integrity (ORI) described as a former instructor of medicine at Harvard Medical School and a former associate professor of medicine at Beth Israel Deaconess Medical Center, engaged in misconduct in research supported by two NIH grants by “intentionally, knowingly, and/or recklessly falsifying and/or fabricating Western blot images by selectively cutting, flipping, reordering, and reusing the same source images or non-correlated images to represent different results” in three papers and one conference presentation. Overall, there were 12 figures at issue, ORI said in its Nov. 20 announcement, which had been published from...

  8. RRC E-Alerts: December 10, 2020

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    Charles A. Downs, who joined the University of Miami (UM) in August 2018 as an associate dean for research in the School of Nursing and Health Studies, submitted to NIH a half-dozen grant applications that contained 12 fabricated “figures and related text,” according to the HHS Office of Research Integrity (ORI). Downs’ misconduct consisted of “intentionally, knowingly, or recklessly falsifying and/or fabricating data” by “reusing and relabeling previously published figures to represent results from different experiments” when he submitted five applications to the National Institute of Nursing Research and one to the National Heart, Lung, and Blood Institute, ORI said...

  9. RRC E-Alerts: December 17, 2020

    Report on Research Compliance Volume 18, Number 1. December 24, 2020  | Author: Theresa Defino  | December 24, 2020 

    The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be finalized sometime next year. “To facilitate review, revised text has been highlighted in yellow throughout the document to identify significant changes. A brief comment explanation of the change also is provided,” the agency said in a Dec. 14 Federal Register notice. In an email to stakeholders, NSF Policy Head Jean Feldman said the draft incorporates “the revised [2 C.F.R. § 200]: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Award that was...

  10. NIH Data Policy Allows Time for Compliance; PIs Must Submit Plan With Funding Application

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    Under NIH’s new policy, data management and sharing plans (DMSPs) won’t be required until January 2023, giving both institutions and principal investigators (PIs) time to comply.[1] But, in a significant departure from the draft policy issued last year,[2] DMSPs must accompany funding applications, rather than be submitted following a positive funding decision during the just-in-time (JIT) process...

  11. With Data Plan Out, Compliance Prep Should Begin Now

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    In late October, NIH issued a final policy on data management and sharing plans (DMSPs), which has elicited a variety of reactions from stakeholders.[1] Although it will not apply to awards until submission dates after Jan. 25, 2023, there are activities that should be taking place now...

  12. Revised UG Ups Micro-Purchase Level, Eases Award Termination, Addresses Indirect Rates

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    The 120-day closeout that institutions fought for after the Office of Management and Budget (OMB) first released the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in December 2013 has now been codified in the five-year update to the Uniform Guidance (UG).[1] With a few notable provisions that were in force immediately upon publication in the Aug. 18 Federal Register, new UG requirements became effective in mid-November...

  13. Recent NSF Audit Resolutions Show Concerns Over Tuition, Speaker Fees

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    In three recently released resolutions of audits conducted by its Office of Inspector General (OIG), the National Science Foundation (NSF) has required three universities to pay back a total of $167,863, based in large measure on the concurrence of the awardees...

  14. ICYMI: Annual Reports Due to OLAW Dec. 1

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    With a little less than a month to go before the new Dec. 1 deadline, just 241 of nearly 900 institutions had filed their annual report of animal care and use program changes to the NIH Office of Laboratory Animal Welfare (OLAW), RRC has learned...

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

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    ◆ Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs,” which FDA said “offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit participation.” Additionally, the final guidance “provides recommendations on broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and recommendations on improving enrollment and retention of participants with rare diseases. The guidance notes that sponsors should consider early engagement with...

  16. RRC E-Alerts: October 29, 2020

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    Apparently responding to news reports and a letter from four U.S. senators, Patricia Brown, director of the NIH Office of Laboratory Animal Welfare (OLAW), said in a statement that she had determined that “transporting chimpanzees assessed by the facility veterinarian and the NIH Veterinary Panel to be significantly compromised by disease or exhibiting difficulty maintaining quality of life would be a violation” of the Animal Welfare Act and the Public Health Service policy. The Oct. 27 announcement on the OLAW website is headlined “Chimpanzees must remain in their current location and not be transported under certain conditions” and notes that...

  17. RRC E-Alerts: November 5, 2020

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    A year after releasing a draft version, NIH on Oct. 29 announced a final data management and sharing policy, but it will not be required of grant applications until January 2023. The policy calls for submission of a plan for data management “outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.” It also requires investigators to comply “with the awardee’s plan as approved” by NIH. In addition, NIH released three related notices that offer information on the elements of a plan, what costs are allowable, and recommendations “to...

  18. RRC E-Alerts: November 12, 2020

    Report on Research Compliance Volume 17, Number 12. November 19, 2020  | Author: Theresa Defino  | November 19, 2020 

    Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs,” which FDA said “offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit participation.” Additionally, the final guidance “provides recommendations on broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and recommendations on improving enrollment and retention of participants with rare diseases. The guidance notes that sponsors should consider early engagement with patient...

  19. '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...

  20. 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...

  21. 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...

  22. 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...

  23. 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...

  24. 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.”...

  25. 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...