Reporting to the IRB: Unanticipated Device Effects (UADEs) in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting requirements? In this blog, Advarra addresses some frustrating gray areas.
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter. This blog will shed light on what an IRB considers during its review.
What Is a Screening Consent?
Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.
Quality Improvement Project vs Human Subject Research: What’s the Difference?
Quality improvement and human subjects research often intersect. Executive IRB Chair Sara Harnish discusses questions to differentiate the two.
The Future of Phase I Oncology Studies
Oncology drugs in phase I trials are usually conducted on patients with cancer due to their inherent risk. Advarra IRB member Ran Goldman expands:
Meeting the Challenges of Investigator-Initiated Trials
How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.
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.
Six Key GDPR Questions to Review
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
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.