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
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
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
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
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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins...more
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
Readers of this newsletter know we’re big fans of high-quality medical research. Well-designed, statistically robust studies have saved lives, changed medical practice, and made the world a better place....more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
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
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more
Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more