Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more
4/1/2025
/ Compliance ,
Congressional Committees ,
Federal Funding ,
Government Agencies ,
Healthcare ,
Legislative Agendas ,
Regulatory Reform ,
Research and Development ,
Scientific Research ,
Transparency ,
Universities
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
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
5/24/2024
/ Audits ,
Compliance ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Fund Applications ,
Grants ,
HHS Office of Research Integrity (ORI) ,
Informed Consent ,
Labeling ,
Logos ,
National Institute of Health (NIH) ,
National Science Foundation ,
Noncompliance ,
Prescription Drugs ,
Professional Misconduct ,
Required Documentation ,
Scientific Research ,
Terms and Conditions
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
5/2/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Professional Misconduct ,
Research and Development ,
Scientific Research ,
The Common Rule
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
Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more
3/27/2024
/ Audits ,
Comment Period ,
Compliance ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Proposed Legislation ,
Research and Development ,
SACHRP ,
Scientific Research
The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...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. 12 (December 2023)
Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...more
11/27/2023
/ Audits ,
Compliance ,
Corporate Misconduct ,
Digital Health ,
Fraud ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Life Sciences ,
National Science Foundation ,
OIG ,
Research and Development ,
Scientific Research ,
Technology Sector
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
Report on Research Compliance Volume 20, Number 5. April 27, 2023 -
- NIH should conduct “site visits to foreign facilities that perform NIH-funded animal research” or require third-party verification to offer “reasonable...more
5/1/2023
/ Academic Misconduct ,
Compliance ,
Department of Health and Human Services (HHS) ,
False Statements ,
GAO ,
Grants ,
HHS Office of Research Integrity (ORI) ,
National Institute of Health (NIH) ,
OIG ,
Professional Misconduct ,
Scientific Research ,
Technology
Do you know what research misconduct is, and would you report it if you suspected it?
These deceptively simple questions reflect two pillars of research integrity: recognizing fabrication, falsification and plagiarism...more
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Hired under the Intergovernmental Personnel Act (IPA), staff referred to as IPAs assist the National Science Foundation (NSF) as temporary directors,...more
1/31/2023
/ Audits ,
Code of Conduct ,
Coronavirus/COVID-19 ,
False Advertising ,
False Reporting ,
GPS ,
Hiring & Firing ,
Investigations ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Repayment Options ,
Retirement ,
Scientific Research ,
Universities
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Since his arrest in August 2019, Feng “Franklin” Tao has published 16 “research articles” for the University of Kansas (KU), authored a book and began...more
1/31/2023
/ Appeals ,
China ,
Criminal Convictions ,
Criminal Investigations ,
Deceptive Intent ,
Department of Justice (DOJ) ,
Disclosure ,
False Statements ,
National Science Foundation ,
Research and Development ,
Scientific Research ,
Termination ,
Universities
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
11/28/2022
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Exports ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Life Sciences ,
National Institute of Health (NIH) ,
National Science Foundation ,
Research and Development ,
Scientific Research ,
The Common Rule
Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...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
The university in the eastern Ukrainian city of Severodonetsk was shelled Feb. 24—the first day Russian forces invaded. The attack destroyed most of the research enterprise of Volodymyr Dahl East Ukrainian National...more