Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light on what an IRB considers during its review.
IRB
What Is a Screening Consent?
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.
Quality Improvement Project vs Human Subject Research: What’s the Difference?
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.
The Future of Phase I Oncology Studies
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.
Meeting the Challenges of Investigator-Initiated Trials
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.
The Challenge of Unproven Regenerative Stem Cell Therapies
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.
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
Quorum/Kinetiq Acquisition & Integration:
What You Need to Know
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.
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
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.
Informed Consent Changes in the Revised Common Rule
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the
Do I Need to Comply With the Revised Common Rule?
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete. SOPs have been harmonized; staff