IRB Advisor – September 1, 2005
September 1, 2005
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Surveying teens about sex: Full disclosure, confidentiality key
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. -
Here or abroad, informed consent is still a process
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. -
Cues prove helpful to schizophrenia patients
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. -
Advisory board tackles life sciences issues
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. -
Ethical practice starts when study is designed
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. -
FDA senior advisor discusses GCP goals
What is the FDAs most important focus these days with regard to the clinical trial industry?