When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more
5/9/2025
/ Budget Cuts ,
Compliance ,
Department of Energy (DOE) ,
Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Employees ,
Enforcement ,
Government Agencies ,
Grants ,
Institutional Review Board (IRB) ,
Investigations ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Regulatory Oversight ,
Regulatory Reform ,
Research and Development ,
SACHRP
Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more
4/1/2025
/ Compliance ,
Congressional Committees ,
Federal Funding ,
Government Agencies ,
Healthcare ,
Legislative Agendas ,
Regulatory Reform ,
Research and Development ,
Scientific Research ,
Transparency ,
Universities
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
3/3/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Diversity ,
Diversity and Inclusion Standards (D&I) ,
Executive Orders ,
Federal Contractors ,
Federal Funding ,
Grants ,
Healthcare ,
Legislative Agendas ,
Mental Health ,
National Institute of Health (NIH) ,
New Legislation ,
New Regulations ,
OMB ,
Regulatory Agenda ,
Research and Development ,
Restraining Orders ,
Secretary of HHS ,
Trump Administration
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
1/7/2025
/ Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Healthcare ,
Institutional Review Board (IRB) ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Policies and Procedures ,
Regulatory Requirements ,
Research and Development ,
Research Funding ,
SACHRP ,
Scientific Research ,
Secretary of HHS
Note to research compliance officials still digesting news of Pennsylvania State’s recent $1.25 million settlement over False Claims Act (FCA) allegations related to cybersecurity and the government’s recent intervention in a...more
12/9/2024
/ Cloud Service Providers (CSPs) ,
Compliance ,
Cybersecurity ,
Data Security ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
DFARS ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Government Seals ,
NIST ,
Noncompliance ,
Penn State ,
Research and Development ,
Settlement ,
Whistleblowers
In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more
11/4/2024
/ China ,
Compliance ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
Disclosure ,
Failure To Disclose ,
False Claims Act (FCA) ,
Interference Claims ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Research and Development ,
Scientific Research
Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more
10/1/2024
/ Academic Misconduct ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
New Regulations ,
NPRM ,
Policies and Procedures ,
Regulatory Requirements ,
Research and Development
Sheila Garrity, director of the HHS Office of Research Integrity (ORI), recently spoke to RRC about the agency‘s new rule revising research misconduct regulations, which has a compliance date of Jan. 1, 2026 (see related...more
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
Report on Research Compliance 21, no. 9 (September, 2024) -
Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
9/5/2024
/ Academic Misconduct ,
Artificial Intelligence ,
Audits ,
Biopharmaceutical ,
China ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Institutional Review Board (IRB) ,
Life Sciences ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Reporting Requirements ,
Research and Development
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
8/6/2024
/ Antitrust Division ,
Chief Compliance Officers ,
Chief Ethics and Compliance Officers (CECO) ,
Code of Federal Regulations (CFR) ,
Compliance ,
Coronavirus/COVID-19 ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Ethics ,
False Statements ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
National Science Foundation ,
Office of Laboratory Animal Welfare (OLAW) ,
OIG ,
Pharmaceutical Industry ,
Research and Development ,
Settlement Agreements ,
Technology Sector ,
Vaccinations ,
Warning Letters ,
Wire Fraud
“I am writing with good news!!! Yesterday, the 10th Circuit overturned Franklin’s only remaining conviction and ordered the trial judge to enter a verdict of NOT GUILTY!!! After five long and difficult years, Franklin has...more
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
5/24/2024
/ Auditors ,
Audits ,
Compliance ,
Department of Health and Human Services (HHS) ,
Educational Institutions ,
FCOI ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Policies and Procedures ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements ,
Reporting Requirements ,
Research and Development ,
Research Funding ,
Scientific Research
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
5/2/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Professional Misconduct ,
Research and Development ,
Scientific Research ,
The Common Rule
In December 2022, Julie Kaneshiro—then deputy director of the HHS Office for Human Research Protections (OHRP)—disclosed that the agency had 32 positions but that only 20 were filled, leaving 12 vacant or “on hold,” due to...more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
3/27/2024
/ Clinical Trials ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Statements ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Investigations ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Popular ,
Research and Development ,
Scientific Research ,
Wire Fraud
Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more
3/27/2024
/ Audits ,
Comment Period ,
Compliance ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Proposed Legislation ,
Research and Development ,
SACHRP ,
Scientific Research
The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more
2/26/2024
/ Auditors ,
Audits ,
Bayh-Dole Act ,
Biden Administration ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Innovation Patent ,
Inventions ,
Inventors ,
Medical Records ,
National Security Agency (NSA) ,
NIST ,
OCR ,
OIG ,
Patents ,
Personal Data ,
Rescission ,
Research and Development ,
Settlement ,
Technology Sector ,
Universities
Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more
At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more
12/22/2023
/ Algorithms ,
Artificial Intelligence ,
Bots ,
Chief Information Security Officer (CISO) ,
Compliance ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Institutional Review Board (IRB) ,
Medical Research ,
Privacy Laws ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development ,
Risk Management ,
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 20, no. 11 (November, 2023)
City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more
10/26/2023
/ Animal Testing ,
Clinical Trials ,
Compliance ,
Conflicts of Interest ,
False Statements ,
FCOI ,
Fraud ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
Professional Misconduct ,
Regulatory Requirements ,
Research and Development ,
Research Funding ,
SACHRP ,
Scientific Research ,
Universities
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, no 8 (August 2023)
With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more
8/1/2023
/ Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Financial Fraud ,
Fines ,
Fraud ,
Fraud and Abuse ,
Grants ,
Health Care Providers ,
Healthcare ,
Information Blocking Rules ,
Medical Research ,
OIG ,
Penalties ,
Research and Development