Informed Consent

Is GDPR Coming to the US? CCPA and Its Impact on Research

Remember on the older The Price Is Right game shows with Bob Barker, when the announcer would describe to the contestant they could win “a brand-new car!” and then proceed to describe the car? Part of the description was always that the car had “and California emissions.” Why was that? What was so special about California? Turns out the state of California had different, more restrictive, pollution rules from the rest of the country; and if you wanted to sell cars in California you had to meet the California standards. It was difficult for car manufacturers to produce cars separate just for California, so eventually the country normalized on one standard, which looked a lot like the original California emissions standard.

Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution

In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology research has influenced agility in clinical trial design, particularly during the COVID-19 pandemic. Panelists talked about how the COVID-19 pandemic has impacted oncology research and propelled the field’s groundbreaking contributions to research. They also explored ways the pandemic response has shaped the future of oncology research—and research in general.

Getting “Engaged” in the Time of COVID

When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.

IRB Review of Virtual Trial Technologies

Our webinar proved so popular, we thought a deeper dive would be appropriate. In this post we explore some key issues IRBs face when reviewing research involving virtual trial technology.

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.

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.

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