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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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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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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.
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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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IRBs often struggle with determining risks of social and behavioral research studies. Its easy to be both too cautious and too complacent.
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There are no industry standards for handling incidental findings (IFs) in research.
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As technology in genetic and genomic research expands, most if not all IRBs will face the issue of incidental findings, including how to manage them, and whether researchers have a duty to report them to study participants, experts say.
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The Cincinnati Childrens Hospital Medical Center IRB and a special task force developed guidance and a template for improving and simplifying informed consent forms.
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The exponential increase in smartphones and social networking sites has led to concerns from some patients regarding the possible unlawful distribution of images outside the realms of their care.
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An IRB member and human research protection expert learned firsthand how complicated informed consent (IC) forms could be when her granddaughter was seriously ill.
