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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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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

Update: On October 7, 2017, the US Department of Health and Human Services (HHS) submitted a proposal to the White House Office of Management and Budget (OMB) to delay implementation of the final revised Common Rule by 1 year (to January 2019).  As of October 13, 2017, this proposal is under review with OMB, and […]

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