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.
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.
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.
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
