IRB Advisor – July 1, 2007
July 1, 2007
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You say UP, I say UE: What's the new government guidance all about?
Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research Protections (OHRP) of Rockville, MD, and the draft guidance from the Food and Drug Administration (FDA), their duties in handling these issues should be clear, right? -
FDA's guidance addresses adverse reporting of items
In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection." -
Risks/benefits of a cancer trial from patient's view
When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this particular population, or else they'll err by being too cautious, an expert suggests. -
Does your IRB need some help? Expert offers tips
For IRB offices to run smoothly, employees need to work well together and count on each other when the work overflows. -
Sex abuse surveys don't harm participants
Anew study adds to the growing body of evidence that surveying people about past trauma doesn't put them at increased risk for harm. -
Networks help physicians research practice-based care
Primary care practice-based research networks (PBRNs) bring together physicians and clinicians in practices across the country to research how patients are treated in a primary care setting.