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Compliance Corner – News Round Up

From the powerful computers we carry around in our pockets to self-driving cars and big data breakthroughs, it’s clear that what was once considered “future” is now everyday reality. This month, we’re interested in how we as humans are shaping our futures. The future is now—what are we doing about it? In the research world, […]

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Non-English Speaking Research Subjects: What’s in the Regs?

Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies. Sec. 907 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) directs FDA to “improve the inclusion of clinical trial data representing demographic subgroups,” and in 2016 the agency declared it The Year of […]

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Evaluating eConsent: Some Considerations from an IRB Perspective

At Schulman IRB we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective. We also now have federal guidance on how to implement eConsent in clinical research, making it a bit easier to implement […]

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Compliance Corner – News Round Up

This month we continue to contemplate big data as we look at two New England Journal of Medicine Perspective pieces. In Bridging the Data-Sharing Divide – Seeing the Devil in the Details, Not the Other Camp, Dr. Lisa Rosenbaum reflects on the differing views of data-sharing evidenced at a recent NEJM-sponsored summit, during which clinical […]

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Does This Study Require IBC Review?

One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s an exciting space that is full of promise, but because of the risks involved, it’s also a highly regulated space. As many clinical research professionals are new to gene therapy research, confusion is common regarding […]

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Upcoming Regulatory Deadlines: NIH Policy on sIRB Review, 21st Century Cures Act and Final Revisions to Common Rule

The past 12 months brought the research community some dramatic regulatory changes, including June’s NIH policy on the use of a single IRB for multi-site research, December’s passage of the 21st Century Cures Act, and most recently January’s final revisions to the Common Rule. With these new policies come compliance dates, and with so many […]

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NIH Policy for sIRB Review of Multicenter Research: Research Community Perspectives

With the effective date for NIH’s single IRB (sIRB) policy coming in January, many institutions are still grappling with what this policy means for their research programs. To gain a better understanding of the research community’s response to this new policy, Schulman IRB conducted an online survey of 260 institutional research leaders and administrators in […]

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Compliance Corner – News Round Up

We generally treasure our convenience tools – laptops, smart phones, baby monitors, home security systems – yet we are aware these tools can be hacked with deleterious effects. Now add to that list of hackable devices life-sustaining, health tools and medical devices, from pacemakers to insulin pumps. In FDA, Industry Fear Wave of Medical-Device Hacks, […]

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