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. 6 (June, 2022) -
When Terry Magnuson resigned in April as research vice chancellor at the University of North Carolina (UNC) at Chapel Hill after admitting to three instances of...more
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. 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 19, no. 1 (January, 2022) -
During the second half of fiscal year 2021, which ended Sept. 30, the National Science Foundation (NSF) collected more than $2.5 million from six universities and...more
12/28/2021
/ Criminal Prosecution ,
Federal Funding ,
Guilty Pleas ,
Investigations ,
Medical Research ,
Misallocation of Funds ,
Mismanagement ,
National Science Foundation ,
OIG ,
Research Funding ,
Scientific Research ,
Settlement Agreements ,
Suspensions & Debarments ,
Universities
Report on Research Compliance 18, no. 12 (December, 2021) -
A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...more
12/3/2021
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Electronic Reporting ,
Food and Drug Administration (FDA) ,
Medical Research ,
National Science Foundation ,
Noncompliance ,
Office for Human Research Protections (OHRP) ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
Presidential Nominations ,
SACHRP ,
Scientific Research
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. 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. 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. 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. 7 (July 2021) -
Elisabeth Bik will not be silenced.
While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more
Report on Research Compliance 18, no. 5 (May 2021) -
Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced...more
4/26/2021
/ Audits ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Department of Justice (DOJ) ,
Failure to Report ,
False Statements ,
Federal Budget ,
Federal Funding ,
J-1 Visas ,
Medical Research ,
Medical School ,
National Science Foundation ,
OIG ,
Physicians ,
Teaching Hospitals ,
Universities ,
Visa Fraud ,
Wire Fraud
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. 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
Report on Research Compliance 17, no. 11 (November 2020) -
As the pandemic continues to grip the United States, bringing more illness and death to minorities in particular, and the nation reflects on a summer of unrest over...more
Report on Research Compliance 17, no. 11 (November 2020)
- In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
10/24/2020
/ AAMC ,
Biomedical Companies ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Criminal Convictions ,
Cybersecurity ,
Data Management ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Funding ,
Fraud ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Professors ,
Public Health Emergency ,
Scientific Research ,
Universities
Report on Research Compliance 17, no. 10 (October 2020) -
When Kris Wolff, director of the Office of Sponsored Programs at Fordham University, came down with COVID-19, she didn’t hide it from her staff. “I was really open...more
Report on Research Compliance 17, no. 9 (August 20, 2020)
- The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more
8/24/2020
/ Allowable Expenses ,
Audits ,
Compliance ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Infectious Diseases ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
New Guidance ,
OIG ,
OMB ,
Pharmaceutical Industry ,
Plagiarism ,
Professors ,
Retirement ,
Scientific Research ,
Suspensions & Debarments ,
Trade Associations ,
Universities
Report on Research Compliance 17, no. 9 (August 20, 2020) -
As part of its recent settlement with the Department of Justice regarding allegations of False Claims Act (FCA) violations, Lehigh University of Pennsylvania is...more
8/20/2020
/ Audits ,
Compliance ,
Conflicts Committee ,
Employee Handbooks ,
Employee Training ,
False Claims Act (FCA) ,
Federal Grants ,
IRB ,
Medical Research ,
Office of Research and Sponsored Programs (ORSP) ,
Oversight Duties ,
Policies and Procedures ,
Scientific Research ,
Sham Transactions ,
Universities
Report on Research Compliance 17, no. 8 (August 2020) -
Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...more
7/27/2020
/ Animal Health ,
Compliance ,
Deportation ,
F-1 Visa ,
False Claims Act (FCA) ,
Foreign Students ,
Harvard University ,
Immigration and Customs Enforcement (ICE) ,
M-1 Visa ,
Medical Devices ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Office of Laboratory Animal Welfare (OLAW) ,
Remote Learning ,
Reversal ,
SACHRP ,
Scientific Research ,
Universities ,
Veterinarians