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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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Compliance Corner – News Round Up

In the US, we often treat this time of year as “back to work” time. Whether you’re returning to a new academic year or just returning to work after the lovely distractions of summer, this is a season of organization and preparation. With that in mind, we’ve put together some helpful lists related to current […]

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If I’d Known You Were Coming, I’d Have Translated the Consent: Short Form Consents and the Unexpected Non-English Speaking Participant

For research sites in communities with large populations of non-English speakers, it may be standard operating procedure to obtain a translated version(s) of the study’s informed consent document at the beginning of a study—that way, when a non-English speaking potential study participant shows interest in the study, researchers can help the potential participant learn more […]

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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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