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IRBs that desire to improve their informed consent (IC) forms might learn a great deal from questions and comments from people reviewing these forms.
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While emphasis often is put on the linguistic challenges of consent creating a document that correctly outlines the details of the study in multiple languages there are cultural translation issues as well. What one culture means by "consent," "risk," or even "research" may be very different from how another culture interprets those concepts.
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Nearly 47 million Americans lack health insurance, leaving them without regular access to health care and making them a potentially vulnerable population in health care research.
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IRB offices no longer can use the trial-by-fire method of new board member training.
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How IRBs should handle incidental findings is becoming such a notable issue among IRB professionals that there was a recent conference devoted to the topic.
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Fledgling student investigators at universities can find human subjects protection regulations complicated and overwhelming and the IRB bureaucracy intimidating and scary.
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The recommendations of the American Psychological Association's Task Force on IRBs and Psychological Science focus on giving IRBs and psychological researchers a better understanding of each other's methods and motivations, as well as generating more useful data about how the two groups interact.
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Studies involving terrorism or disaster victims should receive extra attention and concern from the IRB, but not always for the reasons IRB members suspect, an expert says.
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A special task force of the American Psychological Association studying the tensions between IRBs and psychology researchers has released a list of recommendations on how to address those tensions.
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Senate passes BioShield; $5.6B slated for industry; FDA initiative seeks to speed up approvals; OHRP to require IRB registration.
