In the end, the final termination letter arrived in the mail on July 18.
For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more
7/28/2025
/ Department of Health and Human Services (HHS) ,
Employment Litigation ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Hiring & Firing ,
Human Resources Professionals ,
Office for Human Research Protections (OHRP) ,
Regulatory Agencies ,
Regulatory Requirements ,
Termination
Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more
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
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
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
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
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
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)
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
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
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
8/30/2023
/ 21st Century Cures Act ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Informed Consent ,
Institutional Review Board (IRB) ,
Office for Human Research Protections (OHRP) ,
Proposed Rules ,
Reimbursements ,
Rulemaking Process ,
SACHRP
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
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 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
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 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. 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. 4 (April, 2022) -
A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
3/28/2022
/ Cancer ,
Clinical Trials ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Determination Letter ,
Food and Drug Administration (FDA) ,
Foreign Students ,
HHS Office of Research Integrity (ORI) ,
Institutional Review Board (IRB) ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
OIG ,
Plea Agreements ,
Research Assistants ,
Tuition ,
Universities ,
Wire Fraud
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. 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. 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. 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 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