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.
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.
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.
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
On March 5, 2019, Advarra announced its acquisition of Quorum Review IRB and Kinetiq, the research and technology consulting division of Quorum. We’ve assembled this FAQ to address some of the most commonly asked questions about the acquisition and integration.
The bad news is we cancelled our webinar on the revised Common Rule. The good news? We cancelled it because it seems the revised Common Rule implementation and transition have actually been relatively smooth.
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of
The Advarra team is proud to announce that all major integration activities are now complete. SOPs have been harmonized; staff
When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated.
