Report on Research Compliance 17, no. 7 (July 2020) -
NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more
6/29/2020
/ Audits ,
Compliance ,
Coronavirus/COVID-19 ,
Export Controls ,
FDA Approval ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Research and Development ,
Universities ,
Virus Testing
Report on Research Compliance 17, no. 7 (July 2020):
In the first six months of this year, NIH removed 24 individuals from its peer review panels, and at least 14 researchers lost their status as principal investigators...more
6/26/2020
/ Bullying ,
Compliance ,
Funding Opportunities ,
Hostile Environment ,
Medical Research ,
National Institute of Health (NIH) ,
Peer Review ,
Policies and Procedures ,
Private Investigators ,
Retaliation ,
Sexual Harassment ,
Working Groups
Report on Research Compliance 17, no. 6 (June 2020) -
A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more
5/26/2020
/ Audits ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Reporting ,
Federal Grants ,
Fraud ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
IP License ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Patents ,
Professors ,
Repayment Options ,
Settlement ,
Tax Fraud ,
U.S. Attorney ,
Universities ,
Veterinarians
Report on Research Compliance 17, no. 6 (June 2020) -
With the recent appointment of an HHS leader as its permanent director and a former Johns Hopkins misconduct official to another key post, the HHS Office of Research...more
5/22/2020
/ Academic Misconduct ,
Administrative Appointments ,
Compliance ,
Department of Health and Human Services (HHS) ,
Electronically Stored Information ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
Regulatory Oversight ,
Request For Information ,
Research and Development ,
Scientific Research ,
Sequestration
Report on Research Compliance 17, no. 5 (May 2020)
- Cybercriminals are “sending malicious phishing emails that appear to be from trusted federal agencies,” such as HHS, in order to “steal sensitive data,” warned Michael...more
4/29/2020
/ Academic Misconduct ,
Allowable Expenses ,
Collusion ,
Compliance ,
Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Electronically Stored Information ,
Evidence ,
Foreign Affiliates ,
Government Investigations ,
HHS Office of Research Integrity (ORI) ,
Internal Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
OIG ,
Peer Review ,
Phishing Scams ,
Repayment Options ,
Termination ,
University Studies
Report on Research Compliance 17, no. 5 (May 2020) -
Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design and recruitment methods,...more
Report on Research Compliance 17, no. 4 (April 2020)
The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more
4/1/2020
/ Audits ,
Clinical Trials ,
Compliance ,
Conflicts of Interest ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
NASA ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Professors ,
Reporting Requirements ,
Sexual Harassment ,
Warning Letters ,
Wrongful Termination
Report on Research Compliance 17, no. 4 (April 2020) -
“In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for...more
3/30/2020
/ Business Continuity Plans ,
Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Extensions ,
Federal Grants ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
Office Closures ,
Pharmaceutical Industry ,
Universities
Report on Research Compliance 17, no. 3 (February 20, 2020) -
Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more
2/24/2020
/ Acting Directors ,
Actual Costs ,
Allowable Expenses ,
Arrest ,
Audits ,
China ,
Compliance ,
Criminal Investigations ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Espionage ,
False Claims Act (FCA) ,
False Statements ,
FBI ,
Federal Contractors ,
Federal Funding ,
Federal Grants ,
Fraud ,
Harvard University ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
National Science Board (NSB) ,
National Science Foundation ,
OSTP ,
Policies and Procedures ,
Presidential Nominations ,
Reimbursements ,
Scientific Research ,
Smuggling ,
Theft ,
Universities ,
Visa Fraud
Report on Research Compliance 17, no. 3 (February 20, 2020) -
Institutions with federal research dollars, particularly from the National Science Foundation (NSF), know they may be subject to an audit by the funding...more
Report on Research Compliance 17, no. 2 (January 23, 2020) -
- More than two years after Ozgur Tataroglu’s paper was retracted, the HHS Office of Research Integrity found that it and two grant applications contained...more
1/29/2020
/ Audits ,
Compliance ,
Cross-Border ,
Embezzlement ,
Enforcement Actions ,
False Reporting ,
Federal Grants ,
Global Code of Ethics ,
Global Health Issues ,
HHS Office of Research Integrity (ORI) ,
Integrity Policies ,
Life Sciences ,
Medical Research ,
Medical School ,
National Science Foundation ,
OIG ,
Professors ,
Research Funding ,
Research Papers ,
Retracted Documents ,
Scientific Research ,
State Universities ,
Supervision ,
Suspensions & Debarments
Report on Research Compliance 17, no. 2 (January 23, 2020) -
Acting with “deliberate ignorance” and “reckless disregard” are not words that any institution wants to hear associated with its name. But these are at the heart...more
1/28/2020
/ China ,
Civil Monetary Penalty ,
Compliance ,
Department of Justice (DOJ) ,
Failure To Disclose ,
False Claims Act (FCA) ,
Federal Funding ,
Federal Grants ,
Foreign Investment ,
Foreign Workers ,
Government Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Omissions ,
Research Funding ,
Restitution ,
Settlement
Report on Research Compliance 17, no. 1 (January 2020) -
? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more
12/20/2019
/ Clinical Trials ,
Criminal Conspiracy ,
Criminal Convictions ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Diversity ,
Drug & Alcohol Abuse ,
Ethics ,
FCOI ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Fraud ,
GAO ,
Healthcare Fraud ,
Institutional Review Board (IRB) ,
IRB ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
NIAAA ,
NIDA ,
Office for Human Research Protections (OHRP) ,
OMB ,
Opioid ,
OSTP ,
Public Citizen ,
Public Comment ,
Request For Information ,
Sexual Harassment ,
USAspending.gov
Report on Research Compliance 17, no. 1 (January 2020) -
Ah, those pesky residents. If you’re a teaching hospital, you can’t live without them, right? But sometimes living with them is mighty costly, as the University of...more
12/19/2019
/ Administrative Appeals ,
Civil Monetary Penalty ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
Laptop Computers ,
Medical Research ,
Medical Residents ,
OCR ,
PHI ,
Settlement ,
Teaching Hospitals
Report on Research Compliance 16, no. 12 (December 2019) -
An independent federal office should be established to address “substantiated claims of sexual misconduct,” investigators should disclose related findings against...more
11/21/2019
/ #MeToo ,
Bioengineering ,
Biotechnology ,
Diversity ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Life Sciences ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
Research Assistants ,
Scientific Research ,
Sexual Harassment ,
STEM ,
Title XI