Reporting to the IRB: What NOT to Report
Despite clarification from FDA and OHRP, many of the “potential” unanticipated event reports IRBs receive are either submitted unnecessarily or don’t pertain to the aspects of research the IRB oversees.
Advarra
Making Sense of the New HUD Guidance
For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8, 2010 has been the go-to document for industry, FDA staff, clinicians/users, and IRBs to understand how to apply the regulations at 21 CFR 814.100, which govern the approval, use, and review of HUDs. Since then, amendments to the HUD program have been made by a variety of federal actions.
Should Social Media Be Part of Your Research Toolbox?
Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory and ethical considerations. Sponsors and investigators looking to incorporate social media into their research toolbox should devote themselves to understanding the details of particular social media platforms and work closely with their IRB to understand and apply the regulatory framework.
A Tale of Two Sites: The Power of Integrated Research Administration
Site timelines for studies can vary widely across the industry due to differences in internal efficiency. In this blog, James Riddle (Advarra VP of Institutional Services and Strategic Consulting) tells the tale of two sites, one with an integrated research administration, and one without.
Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light on what an IRB considers during its review.
What Is a Screening Consent?
Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. In this blog, we’ll take a look at a unique type of ICF known as the study-specific screening consent.
Quality Improvement Project vs Human Subject Research: What’s the Difference?
When does a quality improvement program cross over into research? How do the two categories inform one another in the context of human subjects protection? Advarra IRB Executive Chair Sarah Harnish clarifies the divisions on these two related, but separate categories.
The Future of Phase I Oncology Studies
Phase I studies in oncology pose challenges unlike any other early phase study. Most phase I studies begin with healthy volunteers, but because of the unique nature of the trial compounds, participants in oncology phase I studies are typically patients with cancer rather than healthy volunteers.
Meeting the Challenges of Investigator-Initiated Trials
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
Six Key GDPR Questions to Review
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.