IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider
In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.
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.
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…
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements…
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…
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…
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.
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations,…
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…