Human Subjects Research

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

Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.

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

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.

We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:

The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:

Many studies do not accrue subjects at the site level, which contributes to a significant amount of waste of staff time and monetary resources. Read more:

If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.

Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors. Read more:

Advarra IRB experts discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. Read more:

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.