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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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Planning Gene Therapy Research? Plan for IBC Review

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]

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eConsent in Clinical Research: Trends and Questions

As everyone familiar with eConsent is aware, FDA and OHRP released a Q&A-style guidance on electronic consent in clinical research last December. Using that guidance as a springboard, some Schulman colleagues and I met with several dozen research professionals to discuss the topic in Boston this past February. We discussed key challenges of implementing eConsent […]

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Compliance Corner – News Round Up

Considering Technology, Privacy and Its Impact on Health Technological advancements have made it possible for us to communicate and collaborate in incredible new ways. This same technology has also brought us new ethical challenges in what and how we share with each other. This month, we look at three recent developments in the realm of […]

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