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What is the FDAs most important focus these days with regard to the clinical trial industry?
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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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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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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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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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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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An effective compliance oversight process can nip noncompliance problems in the bud acting quickly to handle small problems before they get bigger, even preventing future noncompliance from occurring.
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New ethics guidelines rolled out by the National Institutes of Health (NIH), aimed at repairing a damaged public image, angered employees and could create internal problems for the organization.
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Two-thirds of Americans believe that clinical research is safe for people who participate in them, according to a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) and Opinion Dynamics Corp. (ODC).
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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.