The Opioid Crisis in America
The opioid crisis in particular is staggering in the number of lives it has claimed. Combating the crisis requires urgent, evidence-based approaches that addresses clinical, research, and education issues.
IRB
Making a Case for Interim HRPP Staffing
As much as we hate to admit it, many of us have been there…that moment when we suddenly realize “Oh no. I need to fill an HRPP position YESTERDAY. Help!”
Introducing Fireside Chats: Conversations On Burning Research Topics
Advarra is excited to introduce Fireside Chats, a series of virtual conversations discussing current issues in clinical trials. Each Fireside Chat brings together perspectives from across the research community, enabling real-time discussion of contemporary challenges and potential solutions to help make research altogether better.
Q&A – The New Normal: Considerations for Restarting Research
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider as we look to ramp up research in the COVID-19 pandemic’s “new normal.” In this blog our experts answer some of the most popular audience questions.
Patient Engagement and the IRB
Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. This approach is reflected in the founding of the Patient Centered Outcomes Research Institute (PCORI) as well as statements from the US Institute of Medicine and Food and Drug Administration (FDA) on the importance of including participant perspectives at every stage of the research process—from the design of studies through their implementation and the dissemination of research results.
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. The current pandemic offers a chance to consider strategies for facilitating adoption of such innovative designs.
Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions.
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the COVID-19 research impact in a recent webinar. We’ve addressed the most popular Q&A topics here.
Empowering Employees Starts with Building a Strong Culture
Now more than ever, people are seeking out employment at organizations that offer more than just standard benefits. They are
Differentiating “Public” and “Private” Internet Spaces in IRB Review
What is the difference between “public” and “private” internet spaces? This question has gained importance with the growing practice of using internet and social media platforms as a source of research data.
Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and regulatory issues and offering key regulatory guidance, he also provided hypothetical “case studies” to highlight challenging ethical and regulatory aspects of paying research participants. More than 1,000 clinical research professionals joined us for the webinar, which was followed by an engaging Q&A session. Below, Dr. Gelinas answers audience questions we weren’t able to address during the webinar. In the weeks ahead, we will publish part two of his responses, addressing additional questions from webinar attendees.