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Blog

Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

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

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2 min. read
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Blog

How Centralized IBC Review Can Benefit Gene Therapy Research

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

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4 min. read
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Blog

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.

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5 min. read
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Blog

What Is a Screening Consent?

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

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3 min. read
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Blog

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.

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3 min. read
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Blog

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:

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4 min. read
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Blog

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.

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6 min. read
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Blog

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.

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7 min. read
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Blog

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?

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5 min. read
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Blog

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.

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4 min. read
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