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
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Draft Guidance ,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
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The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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)
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 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®
Report on Research Compliance Volume 20, no. 10 (October, 2023)
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more
9/26/2023
/ Build America Investment Initiative ,
Compliance ,
Department of Health and Human Services (HHS) ,
Ethics ,
Falsified Documents ,
Federal Funding ,
Guidance Update ,
HHS Office of Research Integrity (ORI) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Investigations ,
Office for Human Research Protections (OHRP) ,
OMB ,
Research and Development ,
Research Funding ,
SACHRP ,
Willful Misconduct
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
During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food...more
3/29/2023
/ Audits ,
Federal Register ,
Food and Drug Administration (FDA) ,
GAO ,
Genetic Testing ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
IRIS ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
SACHRP
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
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
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. 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. 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. 2 (January 27, 2022) -
While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more
1/31/2022
/ APHIS ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Failure to Report ,
False Statements ,
Federal Grants ,
Food and Drug Administration (FDA) ,
HHS Office of Research Integrity (ORI) ,
Medical Centers ,
Medical Research ,
Research Funding ,
Scientific Research ,
Sexual Harassment ,
Universities
Report on Research Compliance 18, no. 11 (November, 2021) -
A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...more
11/1/2021
/ Audits ,
Coronavirus/COVID-19 ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Espionage ,
False Claims Act (FCA) ,
False Statements ,
Falsified Documents ,
Fraud ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Settlement Agreements ,
Tenure ,
Universities
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
8/30/2021
/ Animal Testing ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Draft Guidance ,
False Claims Act (FCA) ,
Federal Funding ,
Federal Grants ,
Hackers ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Indictments ,
Malware ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
OMB ,
Phishing Scams ,
Public Comment ,
Research and Development ,
Research Funding ,
Scientific Research ,
Universities ,
Voluntary Disclosure
Report on Research Compliance 18, no. 6 (June 2021) -
Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
5/24/2021
/ Compliance ,
Criminal Conspiracy ,
Data Transfers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Environmental Protection Agency (EPA) ,
FDA Warning Letters ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Health Care Providers ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
National Institute of Health (NIH) ,
National Science Foundation ,
Noncompliance ,
OIG ,
OSTP ,
Pharmaceutical Industry ,
Reporting Requirements ,
Restitution ,
Scientific Research ,
Trade Secrets ,
Universities
Report on Research Compliance 18, no. 5 (May 2021) -
For the first time since 2012, the HHS Office of Research Integrity (ORI) issued an annual report, but for those used to previous updates or looking for useful details,...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
2/24/2021
/ Audits ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
False Statements ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Scientific Research ,
Universities ,
Wire Fraud
Report on Research Compliance 18, no. 2 (February 2021) -
A National Science Foundation (NSF) Office of Inspector General (OIG) audit of five Established Program to Stimulate Competitive Research (EPSCoR) awards to the...more
1/26/2021
/ Allowable Expenses ,
Audits ,
Compliance ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Falsified Documents ,
Guilty Pleas ,
Healthcare Fraud ,
HHS Office of Research Integrity (ORI) ,
Medical Records ,
National Science Foundation ,
OIG ,
Physicians ,
Research Funding ,
Scientific Research ,
Wire Fraud