Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
6/10/2024
/ Clawbacks ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Justice (DOJ) ,
Disclosure ,
False Claims Act (FCA) ,
Healthcare ,
National Institute of Health (NIH) ,
Regulatory Requirements ,
Settlement ,
Universities
The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more
2/26/2024
/ Auditors ,
Audits ,
Bayh-Dole Act ,
Biden Administration ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Innovation Patent ,
Inventions ,
Inventors ,
Medical Records ,
National Security Agency (NSA) ,
NIST ,
OCR ,
OIG ,
Patents ,
Personal Data ,
Rescission ,
Research and Development ,
Settlement ,
Technology Sector ,
Universities
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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
Report on Research Compliance Volume 20, no. 10 (October, 2023)
Please don’t send uncorrected transcripts of interviews conducted via Zoom or other means to the National Science Foundation (NSF) Office of Inspector General...more
9/26/2023
/ Best Practices ,
Compliance ,
Documentation ,
Ethics ,
HHS Office of Research Integrity (ORI) ,
Internal Investigations ,
Investigations ,
National Science Foundation ,
OIG ,
Reporting Requirements ,
Research and Development ,
Universities ,
Zoom®
One university lost 14 awards; another, four. An investigator was suspended governmentwide. A public institution paid back more than $850,000, while two others returned nearly a million dollars....more
6/23/2023
/ Academic Misconduct ,
China ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure ,
Educational Institutions ,
False Claims Act (FCA) ,
Foreign Subsidiaries ,
Investigations ,
National Science Foundation ,
OIG ,
Reporting Requirements ,
Research Funding ,
Suspensions ,
Universities
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
A legal fight with People for the Ethical Treatment of Animals (PETA) over the release of documents—including the names of institutional animal care and use committee (IACUC) members—has already cost the University of...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
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
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 19, no.8 (August, 2022) -
The most recent semiannual report (SAR) to Congress issued by the National Science Foundation (NSF) Office of Inspector General (OIG) details five misconduct...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. 6 (June, 2022)
- Auditors for the National Science Foundation (NSF) Office of Inspector General (OIG) questioned $35,316 of costs claimed by the University of Idaho (UI) among $42.7...more
6/2/2022
/ Audits ,
Criminal Conspiracy ,
Criminal Convictions ,
Federal Funding ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Research Funding ,
Scientific Research ,
Trade Secrets ,
Universities
Report on Research Compliance 19, no. 5 (May, 2022) -
Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS...more
4/25/2022
/ APHIS ,
Clinical Trials ,
Corrective Action Plans (CAPs) ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Determination Letter ,
Embezzlement ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
Noncompliance ,
Office for Human Research Protections (OHRP) ,
OIG ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 19, no. 5 (May, 2022) -
In an address at George Mason University in February, U.S. Assistant Attorney General Matthew Olsen said the government had “heard concerns from the civil rights...more
4/22/2022
/ Conflicts of Interest ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Failure To Disclose ,
Failure-to-File ,
False Statements ,
Indictments ,
Jury Verdicts ,
Lack of Evidence ,
National Institute of Health (NIH) ,
Research Funding ,
Universities ,
Wire Fraud
Report on Research Compliance 19, no. 4 (April, 2022) -
A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
3/28/2022
/ Cancer ,
Clinical Trials ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Determination Letter ,
Food and Drug Administration (FDA) ,
Foreign Students ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Plea Agreements ,
Research Assistants ,
Tuition ,
Universities ,
Wire Fraud
Report on Research Compliance 19, no. 4 (April, 2022) -
Terry Magnuson, the long-time research vice chancellor at the University of North Carolina (UNC) at Chapel Hill, described his three instances of plagiarism inserted...more
Report on Research Compliance 19, no. 3 (March, 2022) -
Since the start of the year, the Animal and Plant Health Inspection Service (APHIS) has issued notices of alleged violations of the Animal Welfare Act (AWA) to one...more
2/28/2022
/ America Competes Act ,
APHIS ,
Bribery ,
Criminal Conspiracy ,
Data Management ,
Data Privacy ,
Data-Sharing ,
Indictments ,
National Institute of Health (NIH) ,
National Security ,
Notice of Violation ,
OSTP ,
Presidential Memorandum ,
Research and Development ,
Small Business ,
Universities
Report on Research Compliance 19, no. 3 (March, 2022) -
Government auditors know they have something of a thankless job. Their role is to be perhaps hypercritical: Was that computer bought near the end of the award really...more