Are “Virtual Trials” Mainstream Yet?
While some completely virtual trials are taking place, the real trend involves bringing virtual trial components to traditional study designs to improve study efficiency and reduce participant burden.
IRB
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”).
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.
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.
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.