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
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 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
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
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
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
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
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
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 19, no. 2 (January 27, 2022) -
The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
1/28/2022
/ Clinical Trials ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Informed Consent ,
Money Laundering ,
Pediatrics ,
Physicians
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. 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. 8 (August, 2021) -
“As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more
7/26/2021
/ Audits ,
Best Practices ,
Clinical Trials ,
Compliance ,
Consent ,
Data Privacy ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research Funding ,
The Common Rule ,
Universities
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 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. 11 (November 2020) -
As the pandemic continues to grip the United States, bringing more illness and death to minorities in particular, and the nation reflects on a summer of unrest over...more
Report on Research Compliance 17, no. 11 (November 2020)
- In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
10/24/2020
/ AAMC ,
Biomedical Companies ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Criminal Convictions ,
Cybersecurity ,
Data Management ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Funding ,
Fraud ,
Institutional Review Board (IRB) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
Office for Human Research Protections (OHRP) ,
Professors ,
Public Health Emergency ,
Scientific Research ,
Universities
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. 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