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[Editor's note: Valerie Bonham, JD, executive director of the Presidential Commission for the Study of Bioethical Issues, answers these two questions about the new International Research Panel formed this year by President Barack Obama.]
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When consultant Jeffrey Cooper talks to IRBs about using the flexibility of federal regulations to change their procedures, he can see that the message doesn't always get through.
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Five years ago, a panel of researchers and others involved in social and behavioral sciences convened to explore concerns about the scope and effectiveness of IRB review.
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How do you bridge the gap between an IRB that believes all of the work you do is subject to oversight and a faculty that thinks none of it is?
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When a researcher breaches a cultural divide to study a group of people, he or she needs more than a translator to convert documents from one language to another.
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As a research institution's human subjects research increases, so must an IRB's work. In some cases this means expanding to handling multicenter protocols, which bring may result in new challenges.
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A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions.
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The Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA, has developed a formal process for investigators who wish to appeal an IRB determination.
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IRB application submissions often lack consistency, have omissions and errors, and other problems that IRBs should teach investigators to anticipate and correct before filing their application. Among these mistakes are policy errors, data security concerns, and other procedural problems.
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First-in-human clinical trials raise difficult ethical issues for researchers and IRBs because of the uncertainty that accompanies them. Did the preclinical studies that preceded them provide enough information about effectiveness and risks and benefits to proceed with human volunteers?
