Research Ethics

What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

Participant compensation is often a complicated matter. This blog will shed light on what an IRB considers during its review.

Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.

Quality improvement and human subjects research often intersect. Executive IRB Chair Sara Harnish discusses questions to differentiate the two.

Oncology drugs in phase I trials are usually conducted on patients with cancer due to their inherent risk. Advarra IRB member Ran Goldman expands:

How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.

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.

Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?

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