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Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.
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When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.
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For more than 30 years, the National Surgical Adjuvant Breast and Bowel Project has collected copies of every consent form signed by the more than 130,000 patients enrolled in its clinical cooperative group trials.
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Using the National Cancer Institute's Central IRB (CIRB) saved affiliated institutions money, staff time and time spent on review, according to a recent study of the costs and benefits associated with the CIRB.
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Large compensation to subjects for their participation in a study is considered a red flag by many IRBs, who worry that it could provide undue inducement to join a study without considering its risks.
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While passive consent may not be the preferred way of obtaining parental permission to survey underage students, researchers say there will continue to be some situations in which it's the best and perhaps only practical choice.
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When researchers want to survey underage students in school settings, it's obviously necessary to get permission from the children's parents. But exactly how that permission is best obtained has been a matter of debate.
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Researchers at Temple University in Philadelphia, PA, have developed a novel approach to assessing the potential social risks to participants in a research study before the study commences.
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Nationwide, research institutions are cutting costs in response to the economic downturn. Funding for education and training has been one area hit fairly hard, and this made it a challenge for IRB offices to meet their educational demands.
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In this question-and-answer session, Mark Schreiner, MD, chair of the Committees for the Protection of Human Subjects (IRB) at the Children's Hospital of Philadelphia (CHOP) and an associate professor of anesthesia in pediatrics at the University of Pennsylvania in Philadelphia, PA, discusses the issue of informed consent in cluster-randomized clinical trials.
