Research Compliance
Special Considerations for Pediatric Trials
In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.
Revised Common Rule Compliance Now in Full Effect—and What That Means
The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.
Beyond the Regulations: More Considerations for Emergency Research
Go beyond the regulatory requirements and examine three key actions research organizations must consider before conducting planned emergency research.
Reporting to the IRB: What NOT to Report
Reportable events can be tricky: according to the regulations, not every unanticipated event should be submitted to the IRB.
Making Sense of the New HUD Guidance
Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.
Should Social Media Be Part of Your Research Toolbox?
Social media has emerged as a valuable tool for diverse stakeholders across the research community. Learn about the risks and benefits in this article.
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.
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?