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
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. 1 (January, 2022) -
Although a continuing resolution is now in place that funds the federal government through Feb. 18, committees are still working on bills that could contain...more
12/29/2021
/ APHIS ,
Consolidated Appropriations Act (CAA) ,
Continuing Resolution ,
Data-Sharing ,
False Statements ,
Federal Funding ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Proposed Rules ,
Request For Information ,
Research Funding ,
Universities ,
Wire Fraud
Report on Research Compliance 18, no. 10 (October, 2021) -
An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more
9/28/2021
/ Audits ,
Clinical Trials ,
Compliance ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Statements ,
Form 990 ,
Grants ,
Guilty Pleas ,
Health Care Providers ,
Indictments ,
Institutional Review Board (IRB) ,
IRS ,
Mail Fraud ,
Massachusetts Institutie of Technology (MIT) ,
Medical Records ,
Medical Research ,
Money Laundering ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
OIG ,
Plea Agreements ,
Policies and Procedures ,
Research Funding ,
Restitution ,
Risk Assessment ,
Sexual Harassment ,
Third-Party Risk ,
Wire Fraud
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. 9 (September, 2021) -
To his supporters and colleagues, Song Guo Zheng, MD, PhD, was the most productive worker they’ve seen in 50 years, publishing nearly 300 papers, a man who lived...more
8/27/2021
/ China ,
Conflicts of Interest ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Failure To Disclose ,
False Statements ,
Federal Funding ,
Guilty Pleas ,
National Institute of Health (NIH) ,
Penn State ,
Prison ,
Scientific Research ,
Universities
Report on Research Compliance 18, no. 8 (August, 2021) -
“As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more
7/26/2021
/ Audits ,
Best Practices ,
Clinical Trials ,
Compliance ,
Consent ,
Data Privacy ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research Funding ,
The Common Rule ,
Universities
Report on Research Compliance 18, no. 8 (August, 2021) -
NIH is continuing to face pushback and questionable actions by institutions grappling with agency-funded “superstar” principal investigators (PIs) who sexually...more
7/23/2021
/ Employee Misconduct ,
Graduate Students ,
Investigations ,
National Institute of Health (NIH) ,
Non-Disclosure Agreement ,
OCR ,
Peer Review ,
Proposed Regulation ,
Sanctions ,
Scientific Research ,
Sexual Harassment ,
Title IX
Report on Research Compliance 18, no. 7 (July 2021) -
In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
6/28/2021
/ Auditors ,
Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Data Rights ,
Data Sets ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Failure To Disclose ,
False Statements ,
FBI ,
Food and Drug Administration (FDA) ,
Foreign Investment ,
Funding ,
Guilty Pleas ,
Hospitals ,
Medical Records ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
OMB ,
Pharmaceutical Industry ,
Plea Agreements ,
Research and Development ,
Scientific Research ,
Universities
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. 6 (June 2021) -
Nearly four years after noticing spending “irregularities” by a principal investigator (PI), the University of Nevada Las Vegas (UNLV) entered into a settlement...more
5/21/2021
/ Civil Monetary Penalty ,
Conflicts of Interest ,
Department of Health and Human Services (HHS) ,
FCOI ,
Fringe Benefits ,
HRSA ,
National Institute of Health (NIH) ,
OIG ,
Risk Assessment ,
Self-Disclosure Requirements ,
Settlement Agreements
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. 4 (April 2021) -
A new report by the National Academies of Sciences, Engineering, and Medicine examining the impact of the COVID-19 pandemic found “intensified complications related...more
3/30/2021
/ Conflicts of Interest ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
HRSA ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
National Security ,
Office for Human Research Protections (OHRP) ,
OIG ,
Presidential Memorandum ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 18, no. 4 (April 2021) -
Following social injustice protests over police brutality against Black people and the health disparities accelerated by the COVID-19 pandemic, an advisory committee...more
3/29/2021
/ Coronavirus/COVID-19 ,
Disparate Treatment ,
Diversity and Inclusion Standards (D&I) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Minorities ,
National Institute of Health (NIH) ,
Physicians ,
Race Discrimination ,
Request For Information ,
Social Justice Issues
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. 1 (January 2021) -
The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be...more
12/30/2020
/ Colleges ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
False Statements ,
GAO ,
Grants ,
Guilty Pleas ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Professors ,
Regulatory Requirements ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 18, no. 1 (January 2021) -
As the pandemic continues to not only drag on but intensify, the toll on institutions and staff is becoming more evident. To get a sense of what was happening, and...more
12/29/2020
/ Biomedical Companies ,
Business Expenses ,
Career Development ,
Coronavirus/COVID-19 ,
Health and Safety ,
Infectious Diseases ,
Laboratories ,
Medical Research ,
Mentors ,
National Institute of Health (NIH) ,
Research and Development
Report on Research Compliance 17, no. 12 (December 2020) -
Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
11/25/2020
/ Clinical Trials ,
Comment Period ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Communications ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Health Care Providers ,
Health Technology ,
HHS Office of Research Integrity (ORI) ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Intent to Defraud ,
Medical Records ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Office of Laboratory Animal Welfare (OLAW) ,
Pediatrics ,
Pharmaceutical Industry ,
Physicians ,
Public Comment ,
Public Health ,
Research and Development ,
Telehealth ,
Veterinarians ,
Wire Fraud