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
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
Report on Research Compliance 21, no. 9 (September, 2024) -
How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...more
9/5/2024
/ Academic Misconduct ,
Compliance ,
False Claims Act (FCA) ,
False Reporting ,
Fraud ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Medical Records ,
National Science Foundation ,
OIG ,
Research and Development ,
Settlement
Report on Research Compliance 21, no. 9 (September, 2024) -
Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
9/5/2024
/ Academic Misconduct ,
Artificial Intelligence ,
Audits ,
Biopharmaceutical ,
China ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Institutional Review Board (IRB) ,
Life Sciences ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Reporting Requirements ,
Research and Development
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
8/6/2024
/ Antitrust Division ,
Chief Compliance Officers ,
Chief Ethics and Compliance Officers (CECO) ,
Code of Federal Regulations (CFR) ,
Compliance ,
Coronavirus/COVID-19 ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Ethics ,
False Statements ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
National Science Foundation ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
Pharmaceutical Industry ,
Research and Development ,
Settlement Agreements ,
Technology Sector ,
Vaccinations ,
Warning Letters ,
Wire Fraud
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
5/2/2024
/ 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
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
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)
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 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®
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
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
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
Report on Research Compliance Volume 20, Number 3. February 23, 2023 -
The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more
2/27/2023
/ Audits ,
Build America Investment Initiative ,
Buy American Act ,
Compliance ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
GAO ,
Hackers ,
Health Technology ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Infrastructure ,
National Institute of Health (NIH) ,
National Science Foundation ,
OCR ,
OIG ,
OMB ,
PHI ,
Proposed Rules ,
Repayment Options ,
Request For Information ,
Uniformity
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
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 19, no. 10 (October, 2022) -
What is a malign foreign government talent recruitment program and why does it matter?
This is a term with which research compliance officials managing federal...more
9/27/2022
/ Annual Reports ,
Disclosure Requirements ,
Educational Institutions ,
Gifts ,
National Science Foundation ,
National Security ,
New Legislation ,
OIG ,
OSTP ,
Recruitment Policies ,
Research and Development ,
Research Funding ,
Risk Assessment ,
Semiconductors ,
Training Requirements
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