In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.
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.
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.
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”).
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.
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.
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.
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.
Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light on what an IRB considers during its review.
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.
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.
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.
