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Most Popular Blogs of 2017

As 2017 draws to a close, we invite you to take a look back at Schulman’s most popular blog posts from this year. To create this list, we used website data to determine the 2017 blogs with the largest readership audience. Revisit a favorite topic or discover something new from our blog. Have an idea […]

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Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know

On November 7, 2017, we announced that Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra. Our teams are excited to work with a like-minded organization and for the new opportunities this merger offers, and the overwhelmingly positive response we’ve received from the research community thus far reaffirms our confidence in […]

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Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know

On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for all NIH-funded research that collects or uses identifiable, sensitive information. Previously, CoCs were issued by NIH on request and only for research that involved information that, if disclosed, could have adverse consequences for subjects or […]

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“Significant Risk” and “Nonsignificant Risk” Determinations for Medical Devices

In medical device research, the determination of “significant risk” or “nonsignificant risk” can sometimes be confusing, especially for those new to device research. Unique to the device space, this risk determination is not the same as a “no more than minimal risk” determination. Let’s take a closer look at what significant risk (SR) and nonsignificant […]

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Compliance Corner – News Round Up

Whether you are settling into the new academic year or taking stock of 2017 before the winter holiday season takes over, this is often a good time of year to reflect on lessons learned and apply them forward. In that spirit, in this month’s news round up we’re looking at status updates for a couple […]

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IBC vs. IRB: What’s the Difference?

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring additional oversight by an institutional biosafety committee (IBC). In the clinical research community, we’re already familiar with IRBs, which also reviews risks. So what’s the difference between an IBC and an IRB?  While both committees […]

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Legally Authorized Representatives (LARs): Support for Decisionally Impaired Research Subjects

A potential research subject must provide his or her informed consent before enrolling in a clinical trial. But for adult subjects with impaired decision-making capacity, hindered perhaps by a neurodegenerative condition or an emergency situation, it might not be possible to obtain truly informed consent directly from the individual. In these cases, the IRB may […]

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Informed Consent and Individuals with Diminished Decision-Making Capacity

Researchers continue to chip away at the challenging field of neurological disease, seeking new treatments and potential cures for these conditions. This research is urgently needed: in the US, neurological diseases create nearly $800 billion annually in healthcare costs, and the economic, social and emotional costs of these conditions will continue to grow with our […]

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