When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more
5/28/2025
/ Biden Administration ,
Compliance ,
Department of Health and Human Services (HHS) ,
Employees ,
Enforcement ,
Federal Funding ,
Government Agencies ,
Hiring & Firing ,
National Institute of Health (NIH) ,
OCR ,
Office for Human Research Protections (OHRP) ,
Regulatory Oversight ,
Trump Administration
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) ,
Popular ,
Regulatory Oversight ,
Regulatory Reform ,
Research and Development ,
SACHRP
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
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
1/27/2025
/ Academic Misconduct ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Research Funding ,
Scientific Research ,
Settlement ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers
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
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
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
11/4/2024
/ Compliance ,
Corrective Action Plans (CAPs) ,
Cybersecurity ,
Disclosure Requirements ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Reporting ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Harassment ,
Healthcare ,
HHS Office of Research Integrity (ORI) ,
Information Sharing ,
Investigations ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Policies and Procedures ,
SACHRP ,
Scientific Research ,
Settlement ,
Sexual Harassment ,
Statutory Requirements ,
Warning Letters
Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
6/10/2024
/ Clawbacks ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Justice (DOJ) ,
Disclosure ,
False Claims Act (FCA) ,
Healthcare ,
National Institute of Health (NIH) ,
Regulatory Requirements ,
Settlement ,
Universities
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
5/24/2024
/ Audits ,
Compliance ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Fund Applications ,
Grants ,
HHS Office of Research Integrity (ORI) ,
Informed Consent ,
Labeling ,
Logos ,
National Institute of Health (NIH) ,
National Science Foundation ,
Noncompliance ,
Prescription Drugs ,
Professional Misconduct ,
Required Documentation ,
Scientific Research ,
Terms and Conditions
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
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
1/30/2024
/ AAMC ,
Cancer ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OSTP ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Requirements ,
Scientific Research ,
Technology
Report on Research Compliance 20, no. 12 (December 2023)
In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
11/27/2023
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Disclosure ,
Extensions ,
Food and Drug Administration (FDA) ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
NPRM ,
Proposed Regulation ,
Regulatory Requirements ,
Rulemaking Process ,
Scientific Research ,
Universities
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
A criminology professor at Florida State University (FSU), dogged by accusations of research misconduct and the subject of multiple probes, was terminated last month, according to a letter published by Retraction Watch. Hired...more
8/30/2023
/ AAMC ,
Artificial Intelligence ,
Audits ,
Department of Health and Human Services (HHS) ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Negligence ,
Office for Human Research Protections (OHRP) ,
OIG ,
Professional Misconduct ,
Validation and Re-Validation Requirements
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
Report on Research Compliance Volume 20, Number 5. April 27, 2023 -
- NIH should conduct “site visits to foreign facilities that perform NIH-funded animal research” or require third-party verification to offer “reasonable...more
5/1/2023
/ Academic Misconduct ,
Compliance ,
Department of Health and Human Services (HHS) ,
False Statements ,
GAO ,
Grants ,
HHS Office of Research Integrity (ORI) ,
National Institute of Health (NIH) ,
OIG ,
Professional Misconduct ,
Scientific Research ,
Technology
During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food...more
3/29/2023
/ Audits ,
Federal Register ,
Food and Drug Administration (FDA) ,
GAO ,
Genetic Testing ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
IRIS ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP) ,
SACHRP
Report on Research Compliance Volume 20, Number 3. February 23, 2023 -
To those who say whistleblowers are only interested in the money a settlement can bring, meet Devin English. An assistant professor in the Department of...more
2/27/2023
/ Bonuses ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Grants ,
Individual Accountability ,
Luxury Goods ,
National Institute of Health (NIH) ,
Settlement ,
Transparency ,
Whistleblower Awards ,
Whistleblowers
Report on Research Compliance Volume 20, Number 3. February 23, 2023 -
The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more
2/27/2023
/ Audits ,
Build America Investment Initiative ,
Buy American Act ,
Compliance ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
GAO ,
Hackers ,
Health Technology ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Infrastructure ,
National Institute of Health (NIH) ,
National Science Foundation ,
OCR ,
OIG ,
OMB ,
PHI ,
Proposed Rules ,
Repayment Options ,
Request For Information ,
Uniformity
Report on Research Compliance Volume 20, Number 2. (January 2023)
-Hired under the Intergovernmental Personnel Act (IPA), staff referred to as IPAs assist the National Science Foundation (NSF) as temporary directors,...more
1/31/2023
/ Audits ,
Code of Conduct ,
Coronavirus/COVID-19 ,
False Advertising ,
False Reporting ,
GPS ,
Hiring & Firing ,
Investigations ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Repayment Options ,
Retirement ,
Scientific Research ,
Universities
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more
12/28/2022
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hiring & Firing ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
Notice of Non-Compliance ,
Office for Human Research Protections (OHRP) ,
Technology ,
The Common Rule
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
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...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