IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

March 10, 2020

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?

March 4, 2020

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

February 19, 2020

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

February 5, 2020

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

January 20, 2020

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

January 8, 2020

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

December 18, 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

December 11, 2019

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

December 4, 2019

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

November 20, 2019

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…