IRB Advisor – August 1, 2015
August 1, 2015
View Issues
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Informed consent flexibility on fed side results in creative IC
In recent years, IRBs have witnessed federal regulators becoming more flexible in applying regulations regarding informed consent — a shift resulting in more creative and practical IC methods, including electronic, short form, and video consent.
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Strategies for providing IC to very large subject pools
Newborn blood-sample screening has been going on for decades, but ethical considerations have evolved in recent years, and this is changing research informed consent.
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VoICE Project fills education gap in informed consent process
Research institutions should make certain the responsibility for a successful informed consent process is primarily that of the researcher and not the potential participant.
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Here’s a short version of the criteria for approval
Title 45, part 46.111 of the U.S. Department of Health and Human Services’ Protection of Human Subjects, revised in 2009, contains a very short, but important list of criteria for IRB approval of research.
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Using QI to improve electronic and other systems or processes
Many IRBs have had quality improvement processes and electronic IRB systems in place for a number of years now, but are they working optimally?
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Overhauling processes is a major HRPP challenge
IRBs have accumulated a lot of responsibilities and processes over the years, and some of it is not necessary or not really part of the IRB’s role, experts say.
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Big data is at every IRB’s fingertips — but can you use it?
Research institutions increasingly are investing in electronic systems that have the capability of collecting and storing big data.