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Behavioral surveys of adolescents always are a delicate proposition, requiring consent from parents as well as assent from the child and asking both to consider the possible implications of participation.
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As IRBs move to improve the quality of human subjects protection in international research, they should pursue a model of informed consent that begins long before an individual signs a consent document and continues afterward.
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Public trust in clinical trial research was damaged in the past year because of conflicts of interest issues that arose with the NIH and by front-page media reports about drugs that had been studied and approved, yet were found later to result in deaths among some people who used them.
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Obtaining informed consent from people with schizophrenia is a process fraught with difficulty, as the condition can impair a potential research subjects ability to recall the consent information he or she is given.
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Research into the intricacies of the human genome has opened up a new era for biologic and biomedical research. Investigators are poised to explore the almost unlimited potential to diagnose, treat and possibly cure and prevent many diseases once thought untreatable.
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What is the FDAs most important focus these days with regard to the clinical trial industry?
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The U.S. Environmental Protection Agency (EPA) has decided to delay the start of a controversial effort to study the effect of pesticides on children after some agency officials raised concerns about its recruitment procedures.
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Although IRBs are often charged with giving special consideration to research involving subjects deemed to be particularly vulnerable to exploitation, there is no standard definition of what this term means, and no guidance governing what additional protective measures it should prompt.
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A pilot program of a web-based system for reporting adverse events in clinical trials already has shown itself to be a timesaver for study staff at the Dana Farber/Harvard Cancer Center.
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From a renewed push for a mandatory clinical trials registry to a new secretary of Health and Human Services, the political landscape promises to keep IRBs and others involved in protecting human research subjects busy.
