10 Tips for Writing Compliant Participant Materials
Learn how to craft compliant participant materials with tips on regulations, language to avoid, and effective phone screening scripts.
IRB
Research in Pediatric Populations
Learn about the unique challenges of pediatric clinical trials, including federal regulations, minimal risk, and parental permissions.
6 Tips for Submitting a Research Study for Expedited Review
Learn the essentials of expedited IRB review, including minimal risk criteria, eligible study procedures, and regulatory distinctions.
Key Biosafety Considerations for Coronavirus Research
The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has led to a surge of interest in coronavirus research and concern about the risks associated with coronaviruses. In this blog we introduce coronaviruses and cover strategies for developing medical countermeasures to combat the recent outbreak.
Revised Common Rule Compliance Now in Full Effect—and What That Means
After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).
What Level of Review Does Your Study Need?
Discover the criteria for IRB review, including fully convened, designated member reviews, or exemption, with tips for better study planning.
Beyond the Regulations: More Considerations for Emergency Research
In this blog post we go beyond the regulatory requirements and examine three other key actions that research organizations may want to consider before conducting planned emergency research at their facilities.
Most Popular Blogs of 2019
As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.
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.
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.
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.