Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
1/27/2025
/ Academic Misconduct ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Research Funding ,
Scientific Research ,
Settlement ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
1/7/2025
/ Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Healthcare ,
Institutional Review Board (IRB) ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Policies and Procedures ,
Regulatory Requirements ,
Research and Development ,
Research Funding ,
SACHRP ,
Scientific Research ,
Secretary of HHS
In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more
11/4/2024
/ China ,
Compliance ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
Disclosure ,
Failure To Disclose ,
False Claims Act (FCA) ,
Interference Claims ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Research and Development ,
Scientific Research
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
11/4/2024
/ Compliance ,
Corrective Action Plans (CAPs) ,
Cybersecurity ,
Disclosure Requirements ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Reporting ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Harassment ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Information Sharing ,
Investigations ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Policies and Procedures ,
SACHRP ,
Scientific Research ,
Settlement ,
Sexual Harassment ,
Statutory Requirements ,
Warning Letters
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
5/24/2024
/ Auditors ,
Audits ,
Compliance ,
Department of Health and Human Services (HHS) ,
Educational Institutions ,
FCOI ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Policies and Procedures ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements ,
Reporting Requirements ,
Research and Development ,
Research Funding ,
Scientific Research
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
3/27/2024
/ Clinical Trials ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Statements ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Investigations ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Popular ,
Research and Development ,
Scientific Research ,
Wire Fraud
Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...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
1/30/2024
/ AAMC ,
Cancer ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OSTP ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Requirements ,
Scientific Research ,
Technology
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
12/22/2023
/ Bayh-Dole Act ,
Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Falsified Documents ,
Fraud ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Inventions ,
Life Sciences ,
March-In Rights ,
Medical Research ,
National Science Foundation ,
NIST ,
OIG ,
Patents ,
Scientific Research ,
Technology ,
U.S. Commerce Department ,
Universities ,
USPTO
At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more
12/22/2023
/ Algorithms ,
Artificial Intelligence ,
Bots ,
Chief Information Security Officer (CISO) ,
Compliance ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Institutional Review Board (IRB) ,
Medical Research ,
Privacy Laws ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development ,
Risk Management ,
Scientific Research ,
Universities
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
11/27/2023
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Disclosure ,
Extensions ,
Food and Drug Administration (FDA) ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
NPRM ,
Proposed Regulation ,
Regulatory Requirements ,
Rulemaking Process ,
Scientific Research ,
Universities
Report on Research Compliance 20, no. 11 (November, 2023)
It wasn't just China.
China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more
10/26/2023
/ China ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure ,
Educational Institutions ,
Failure To Disclose ,
False Claims Act (FCA) ,
Foreign Entities ,
Government Investigations ,
Investigations ,
Medical Research ,
National Science Foundation ,
OIG ,
Penalties ,
Popular ,
Research Funding ,
Settlement ,
Universities
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
10/26/2023
/ Animal Testing ,
Clinical Trials ,
Compliance ,
Conflicts of Interest ,
False Statements ,
FCOI ,
Fraud ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Professional Misconduct ,
Regulatory Requirements ,
Research and Development ,
Research Funding ,
SACHRP ,
Scientific Research ,
Universities
A criminology professor at Florida State University (FSU), dogged by accusations of research misconduct and the subject of multiple probes, was terminated last month, according to a letter published by Retraction Watch. Hired...more
8/30/2023
/ AAMC ,
Artificial Intelligence ,
Audits ,
Department of Health and Human Services (HHS) ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Negligence ,
Office for Human Research Protections (OHRP) ,
OIG ,
Professional Misconduct ,
Validation and Re-Validation Requirements
Report on Research Compliance Volume 20, no 8 (August 2023)
With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more
8/1/2023
/ Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Financial Fraud ,
Fines ,
Fraud ,
Fraud and Abuse ,
Grants ,
Health Care Providers ,
Healthcare ,
Information Blocking Rules ,
Medical Research ,
OIG ,
Penalties ,
Research and Development
After reviewing recommendations from its Office of Inspector General (OIG), the National Science Foundation (NSF) required Yale University to repay $172,213 of the $251,973 auditors flagged in a 2020 report. According to a...more
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more
12/28/2022
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hiring & Firing ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Notice of Non-Compliance ,
Office for Human Research Protections (OHRP) ,
Technology ,
The Common Rule
Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more
12/28/2022
/ Audits ,
Department of Health and Human Services (HHS) ,
False Reporting ,
False Statements ,
Falsified Documents ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Medical Research ,
National Science Foundation ,
OIG ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Retracted Documents ,
Settlement Agreements ,
Universities
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
8/30/2022
/ Corrective Actions ,
Department of Health and Human Services (HHS) ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
NIST ,
Office for Human Research Protections (OHRP) ,
OIG ,
OSTP ,
Policies and Procedures ,
Research and Development ,
Scientific Research ,
Suspensions & Debarments ,
Universities
Report on Research Compliance Volume 19, Number 9 (September, 2022) -
Nina F. Schor, M.D., had been in her job as acting deputy director of NIH’s intramural research program (IRP) for 15 days when she received an email...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
6/28/2022
/ Animal Testing ,
Audits ,
Department of Health and Human Services (HHS) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research and Development ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 19, no. 7 (July, 2022) -
NIH’s highest ranking external advisory committee had just heard a spirited, hour-long explanation about the agency’s Advanced Research Project Agency for Health...more