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
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Draft Guidance ,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
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Draft Guidance ,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
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
/ Auditors ,
Audits ,
Bayh-Dole Act ,
Biden Administration ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Innovation Patent ,
Inventions ,
Inventors ,
Medical Records ,
National Security Agency (NSA) ,
NIST ,
OCR ,
OIG ,
Patents ,
Personal Data ,
Rescission ,
Research and Development ,
Settlement ,
Technology Sector ,
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
/ Audits ,
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
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
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
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 -
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
Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more
12/28/2022
/ Audits ,
Department of Health and Human Services (HHS) ,
False Reporting ,
False Statements ,
Falsified Documents ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
Medical Research ,
National Science Foundation ,
OIG ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Retracted Documents ,
Settlement Agreements ,
Universities
Report on Research Compliance 19, no.8 (August, 2022)
- An audit of San Francisco State University (SFSU) by the National Science Foundation (NSF) Office of Inspector General (OIG) that tested more than $1.9 million of...more
Report on Research Compliance 19, no. 7 (July, 2022)
- Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more
6/28/2022
/ Animal Testing ,
Audits ,
Department of Health and Human Services (HHS) ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Research and Development ,
Research Funding ,
Scientific Research ,
Universities
Report on Research Compliance 19 no. 6 (June, 2022)
- Auditors for the National Science Foundation (NSF) Office of Inspector General (OIG) questioned $35,316 of costs claimed by the University of Idaho (UI) among $42.7...more
6/2/2022
/ Audits ,
Criminal Conspiracy ,
Criminal Convictions ,
Federal Funding ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Research Funding ,
Scientific Research ,
Trade Secrets ,
Universities
Report on Research Compliance 19, no. 3 (March, 2022) -
Government auditors know they have something of a thankless job. Their role is to be perhaps hypercritical: Was that computer bought near the end of the award really...more
Report on Patient Privacy 22, no. 2 (February, 2022) -
The new national health information network calls for a number of privacy and security safeguards and standards that, in some instances, exceed what HIPAA covered...more
2/14/2022
/ Audits ,
Business Associates ,
Certifications ,
Covered Entities ,
Cyber Incident Reporting ,
Cyber Insurance ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Apps ,
Notification Requirements ,
PHI ,
Popular
Report on Research Compliance 18, no. 11 (November, 2021) -
A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...more
11/1/2021
/ Audits ,
Coronavirus/COVID-19 ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Espionage ,
False Claims Act (FCA) ,
False Statements ,
Falsified Documents ,
Fraud ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Medical Research ,
National Science Foundation ,
OIG ,
OMB ,
Probation ,
Professors ,
Research and Development ,
Research Funding ,
Restitution ,
Settlement Agreements ,
Tenure ,
Universities
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
Issue a final rule revising the privacy regulation and write guidance on the information blocking rule. Formalize the fledgling audit program required by Congress more than 10 years ago. Engage with providers and other...more
8/13/2021
/ 21st Century Cures Act ,
Audits ,
Biden Administration ,
Business Associates ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Violations ,
Information Blocking Rules ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Ransomware
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. 5 (May 2021) -
Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced...more
4/26/2021
/ Audits ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Department of Justice (DOJ) ,
Failure to Report ,
False Statements ,
Federal Budget ,
Federal Funding ,
J-1 Visas ,
Medical Research ,
Medical School ,
National Science Foundation ,
OIG ,
Physicians ,
Teaching Hospitals ,
Universities ,
Visa Fraud ,
Wire Fraud
Report on Research Compliance 18, no. 3 (March 2021) -
◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct...more
2/24/2021
/ Audits ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
False Statements ,
Guilty Pleas ,
HHS Office of Research Integrity (ORI) ,
Hospitals ,
Investigations ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
OIG ,
Scientific Research ,
Universities ,
Wire Fraud
Report on Research Compliance 18, no. 2 (February 2021) -
A National Science Foundation (NSF) Office of Inspector General (OIG) audit of five Established Program to Stimulate Competitive Research (EPSCoR) awards to the...more
1/26/2021
/ Allowable Expenses ,
Audits ,
Compliance ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Falsified Documents ,
Guilty Pleas ,
Healthcare Fraud ,
HHS Office of Research Integrity (ORI) ,
Medical Records ,
National Science Foundation ,
OIG ,
Physicians ,
Research Funding ,
Scientific Research ,
Wire Fraud
Report on Research Compliance 17, no. 9 (August 20, 2020)
- The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more
8/24/2020
/ Allowable Expenses ,
Audits ,
Compliance ,
Federal Grants ,
HHS Office of Research Integrity (ORI) ,
Infectious Diseases ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
National Science Foundation ,
New Guidance ,
OIG ,
OMB ,
Pharmaceutical Industry ,
Plagiarism ,
Professors ,
Retirement ,
Scientific Research ,
Suspensions & Debarments ,
Trade Associations ,
Universities