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
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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Draft Guidance ,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 HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...more
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
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Audits ,
Bayh-Dole Act ,
Biden Administration ,
Compliance ,
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Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Innovation Patent ,
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Inventors ,
Medical Records ,
National Security Agency (NSA) ,
NIST ,
OCR ,
OIG ,
Patents ,
Personal Data ,
Rescission ,
Research and Development ,
Settlement ,
Technology Sector ,
Universities
The HHS Office for Civil Rights (OCR) and other government agencies aren’t just worried that providers understand—and mitigate—the privacy and security risks of telehealth.
In fact, in 2022, the Government Accountability...more
2/9/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Cyber Threats ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
GAO ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
PHI ,
Privacy Laws ,
Risk Assessment ,
Risk Management ,
Risk Mitigation ,
Telehealth
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
12/22/2023
/ Bayh-Dole Act ,
Comment Period ,
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Inventions ,
Life Sciences ,
March-in-Rights ,
Medical Research ,
National Science Foundation ,
NIST ,
OIG ,
Patents ,
Scientific Research ,
Technology ,
U.S. Commerce Department ,
Universities ,
USPTO
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)
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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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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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
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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 ,
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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
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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
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
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
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
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
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
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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 Patient Privacy Volume 23, no 2 (February 2023)
When Micky Tripathi’s mom was recently transferred to a rehab facility to recover from a broken hip, the hospital, “right in front of me…printed off her record,...more
2/16/2023
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Data Privacy ,
Data Security ,
Data Storage ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Medical Records ,
Enforcement ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
ONC ,
PHI ,
Regulatory Agenda
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
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