Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more
Featuring Francis Collins, M.D., Ph.D., Senior Advisor to President Biden and Former Director of the National Institutes of Health, and Joni Rutter, Ph.D., NCATS Director, Plus a Panel of Health Care Leaders From Pfizer,...more
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more
Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more
Report on Research Compliance 19, no.8 (August, 2022) - An audit of San Francisco State University (SFSU) by the National Science Foundation (NSF) Office of Inspector General (OIG) that tested more than $1.9 million of...more
Report on Research Compliance 19, no. 7 (July, 2022) - Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more
Report on Research Compliance 18, no. 9 (September, 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...more
When Anming Hu, an engineering professor at the University of Tennessee, Knoxville (“UTK”) was indicted in February 2020 on charges related to his alleged failure to disclose ties to a state-run Chinese university, the case...more
Report on Research Compliance 18, no. 7 (July 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...more
This month, two congressional Republican lawmakers introduced a bill to legalize marijuana at the federal level, as well as to protect banks that service state-legal cannabis businesses and to ensure that military veterans...more
Key Points - Notice reflects NIH’s continued concerns regarding foreign influence and imposes significant new compliance obligations on both grantees and individual researchers. - Obligates grantees to provide NIH...more
Report on Research Compliance 18, no. 4 (April 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...more
Report on Research Compliance 18, no. 3 (March 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...more
Report on Research Compliance 18, no. 1 (January 2021) - The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be...more
Report on Research Compliance 17, no. 11 (November 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...more
Report on Research Compliance 17, no. 9 (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...more
Federal authorities have recently described the threat of economic espionage from foreign entities as one of the greatest threats to the economic vitality of the United States, and this has led to an increase in...more
Report on Research Compliance 17, no. 8 (August 2020) - Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...more
The National Institutes of Health recently opened its data platform for user feedback of its “All of Us Researcher Workbench.” Researchers are now able to use the initial datasets obtained from nearly 350,000 participants in...more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more