Most Popular Blogs of 2019
As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.
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Reporting to the IRB: What NOT to Report
Despite clarification from FDA and OHRP, many of the “potential” unanticipated event reports IRBs receive are either submitted unnecessarily or don’t pertain to the aspects of research the IRB oversees.
Should Social Media Be Part of Your Research Toolbox?
Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory and ethical considerations. Sponsors and investigators looking to incorporate social media into their research toolbox should devote themselves to understanding the details of particular social media platforms and work closely with their IRB to understand and apply the regulatory framework.
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.
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.
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.
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.
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