At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more
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
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Since his arrest in August 2019, Feng “Franklin” Tao has published 16 “research articles” for the University of Kansas (KU), authored a book and began...more
1/31/2023
/ Appeals ,
China ,
Criminal Convictions ,
Criminal Investigations ,
Deceptive Intent ,
Department of Justice (DOJ) ,
Disclosure ,
False Statements ,
National Science Foundation ,
Research and Development ,
Scientific Research ,
Termination ,
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
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 19, no. 10 (October, 2022)
- Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more
9/28/2022
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Falsified Documents ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Massachusetts Institutie of Technology (MIT) ,
National Institute of Health (NIH) ,
National Science Foundation ,
New Guidance ,
OSTP ,
Real World Evidence ,
Research and Development ,
Research Funding ,
Tuition
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. 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. 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. 3 (March, 2022) -
Government auditors know they have something of a thankless job. Their role is to be perhaps hypercritical: Was that computer bought near the end of the award really...more
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. 11 (November, 2021) -
If a timeline announced by the White House is met, universities and others should receive guidance later this month on securing the research enterprise as the...more
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. 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. 2 (February 2021) -
“I don’t want to be on the front page of the paper with my best researcher being dragged off in handcuffs. It doesn’t look good for our university,” a senior...more
1/25/2021
/ Collaboration ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Statements ,
Federal Funding ,
Federal Grants ,
Foreign Entities ,
Government Agencies ,
Guilty Pleas ,
National Security ,
Research and Development ,
Risk Management ,
Risk Mitigation ,
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. 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. 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. 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