Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Hosted Payload Episode 9: Danielle Pineres/First Man
[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1
What to Do When Your University, FBI, or DOJ Knocks on Your Door: Responding to University, Criminal, and Civil Investigations
Chien-Shiung Wu - The First Lady of Physics (Women's History Month)
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more
The Trump Administration’s first two months have been marked by a flurry of actions impacting federal grant recipients, federal contractors, and academic and scientific researchers. These unprecedented measures, including...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more
On Friday, February 7, the National Institutes of Health (“NIH”) issued Policy Statement Supplemental Guidance affecting budgets both for active grants and for future grants, which was set to take effect on Monday, February...more
The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more
On January 27, the Acting Director of the Office of Management & Budget issued a new Memorandum (M-25-13) that presages significant disruption—if not outright cancellation—of many federal assistance awards. ...more
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
PFAS are everywhere—even when they’re not. A recent study published in Proceedings of the National Academy of Sciences is garnering significant media attention for suggesting that a crisis exists because of...more
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
Introduction: Three Key Components of Storm Damage Claims - Professional meteorology, as it relates to insurance claims handling and the litigation process, is becoming increasingly recognized, and the employment of...more
After three years and lots of back-and-forth, the FDA finally greenlit the Multidisciplinary Association for Psychedelic Studies’ (MAPS) Phase 2 study of smoked cannabis in veterans for the treatment of PTSD (MJP2). ...more
On December 10, 2024, the U.S. Fish and Wildlife Service (USFWS) proposed to list the monarch butterfly (Danaus plexippus) as threatened under the federal Endangered Species Act (ESA). A proposed critical habitat designation...more
COP29 is upon us (Perfidy, thy name is the UNIPCC) being held in the greenwashing Republic of Azerbaijan. And ironically, there are dire warnings from some quarters about the methods “anti-science” Donald Trump will deploy to...more
A return to the presidency by Donald Trump has raised questions about the future of the U.S. Environmental Protection Agency (EPA) and the broader landscape of environmental policy in the United States. Given Trump’s past...more
In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
What consumers can do to reduce environmental health threats all around us - It’s a paradox of modern life: We want more and more stuff, and we want to get all of it faster, cheaper, more conveniently. And yet, does our...more
In recent years, federal and state governments have taken action to make marijuana research easier. These actions are a step in the right direction, and researchers operating in the marijuana space must be aware of the...more