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
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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. 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
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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 Patient Privacy 23, no. 11 (November, 2023)
Tim DiBona clearly remembers Christmas Eve 2018 when the staff of his small firm—Doctors’ Management Service (DMS)—arrived at their West Bridgewater, Mass., office to...more
11/10/2023
/ Compliance ,
Corrective Action Plans (CAPs) ,
Cyber Attacks ,
Cyber Incident Reporting ,
Cybersecurity ,
Data Breach ,
Data Management ,
Data Protection ,
Data Recovery ,
Electronic Protected Health Information (ePHI) ,
Fines ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Popular ,
Ransomware ,
Risk Management
Report on Research Compliance 20, no. 11 (November, 2023)
It wasn't just China.
China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more
10/26/2023
/ China ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure ,
Educational Institutions ,
Failure To Disclose ,
False Claims Act (FCA) ,
Foreign Entities ,
Government Investigations ,
Investigations ,
Medical Research ,
National Science Foundation ,
OIG ,
Penalties ,
Popular ,
Research Funding ,
Settlement ,
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
Report on Patient Privacy 23, no. 10 (October, 2023)
By 2016, it should have been clear to HIPAA covered entities that a security risk analysis—and corresponding risk management plan—were compliance basics. Yet, a new...more
10/6/2023
/ Compliance ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Disclosure Requirements ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Privacy Laws ,
Risk Assessment ,
Risk Management
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
Start with a records request. Add a seven months’ wait. Stir in the chaos of the pandemic, with most employees working from home. Blend in a perhaps-neglected post office box. Bake for two-and-a-half years....more
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
Report on Patient Privacy Volume 23, no 8 (August 2023)
The allegation was shocking and, if true, would devastate the orthopedic surgeon’s reputation.
An online commenter accused him of operating on the wrong arm or...more
8/17/2023
/ Cybersecurity ,
Health Care Providers ,
Healthcare ,
Internet ,
OCR ,
Online Commentary ,
Online Reputation ,
Online Reviews ,
Privacy Concerns ,
Reputation Management ,
Reputational Injury ,
Retaliation ,
Slander
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
Report on Patient Privacy Volume 23, no 7 (July 2023)
In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more
7/17/2023
/ Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Privacy Rule ,
HIPAA Violations ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OCR ,
Penalties ,
Proposed Regulation ,
Regulatory 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
One university lost 14 awards; another, four. An investigator was suspended governmentwide. A public institution paid back more than $850,000, while two others returned nearly a million dollars....more
6/23/2023
/ Academic Misconduct ,
China ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure ,
Educational Institutions ,
False Claims Act (FCA) ,
Foreign Subsidiaries ,
Investigations ,
National Science Foundation ,
OIG ,
Reporting Requirements ,
Research Funding ,
Suspensions ,
Universities
Five Years After ‘a Singular Human Error,’ Two Breach Notices, Revenue Firm Settles With OCR -
As far as settlements for alleged HIPAA violations go, a recent agreement announced by the HHS Office for Civil Rights (OCR)...more
6/9/2023
/ Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
File Transfer Protocols (FTP) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Violations ,
OCR ,
PHI ,
Risk Assessment ,
Settlement ,
State Data Breach Notification Statutes ,
Subcontractors
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
HIPAA covered entities (CEs) longing for the opportunity to dispense with what some would call the more nettlesome aspects of notices of privacy practices (NPPs) will just have to be patient. For how long, no one is saying....more
5/12/2023
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Proposed Amendments ,
Proposed Rules ,
Reproductive Healthcare Issues
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
Do you know what research misconduct is, and would you report it if you suspected it?
These deceptively simple questions reflect two pillars of research integrity: recognizing fabrication, falsification and plagiarism...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
A legal fight with People for the Ethical Treatment of Animals (PETA) over the release of documents—including the names of institutional animal care and use committee (IACUC) members—has already cost the University of...more
In some respects, assuring compliance with HIPAA has always been a challenge because many health care providers, particularly physicians, pride themselves on maintaining patient confidentiality—even when they aren’t. Nurses,...more
3/10/2023
/ Data Privacy ,
Data Protection ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Workers ,
Personally Identifiable Information ,
Policies and Procedures ,
Remote Working ,
Risk Management