On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
10/4/2022
/ 21st Century Cures Act ,
Clinical Trials ,
Consent ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
New Guidance ,
Notice of Proposed Rulemaking (NOPR) ,
Office for Human Research Protections (OHRP) ,
Recordkeeping Requirements ,
The Common Rule ,
Waivers
On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more
As part of the government’s broader efforts to combat foreign threats to U.S.-funded scientific research, the National Institutes of Health (NIH) and White House Office of Science and Technology Policy (OSTP) have announced...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
8/5/2020
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Physicians ,
Policy Updates ,
Public Health Service (PHS) ,
Reporting Requirements ,
Universities
Today, the Office for Human Research Protections (OHRP) will publish a notice in the Federal Register that its “Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018...more
On May 29, President Trump issued a proclamation, effective on June 1, 2020, to suspend and limit certain nonimmigrant Chinese nationals who seek to enter the United States with an F or J visa. This latest action by the Trump...more
6/9/2020
/ Best Practices ,
China ,
Enforcement Actions ,
Federal Funded Research and Development Centers (FFRDCs) ,
Foreign Nationals ,
Fraud ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
Presidential Proclamations ,
STEM ,
Students ,
Travel Restrictions ,
Trump Administration ,
Universities ,
Visas
The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more
4/10/2020
/ Clinical Trials ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Diversity ,
Drug & Alcohol Abuse ,
Ethics ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Institutional Review Board (IRB) ,
IRB ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP)
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more
3/12/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
National Institute of Health (NIH) ,
Policies and Procedures ,
Scientific Research ,
Universities