IRB Advisor articles from July 2007

IRB Advisor archives from July 2007

You say UP, I say UE: What's the new government guidance all about?
July 1, 2007... You say UP, I say UE: What's the new government guidance all about? OHRP and FDA offer new language, definitions Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research...

FDA's guidance addresses adverse reporting of items.
July 1, 2007... FDA's guidance addresses adverse reporting of items Here's FDA advice in nutshell In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting...

Risks/benefits of a cancer trial from patient's view.
July 1, 2007... Risks/benefits of a cancer trial from patient's view IRBs should keep this difference in mind When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this...

Does your IRB need some help? Expert offers tips.
July 1, 2007... Does your IRB need some help? Expert offers tips Individuals are rarely the only problem For IRB offices to run smoothly, employees need to work well together and count on each other when the work overflows. So what should an IRB...

Sex abuse surveys don't harm participants.
July 1, 2007... Sex abuse surveys don't harm participants Abused subjects aren't more likely to be angered Anew study adds to the growing body of evidence that surveying people about past trauma doesn't put them at increased risk for harm. The...

Networks help physicians research practice-based care.
July 1, 2007... Networks help physicians research practice-based care Group has research network, IRB devoted to studies Primary care practice-based research networks (PBRNs) bring together physicians and clinicians in practices across the country to...

CE/CME objectives/questions.
July 1, 2007... CE/CME Objectives The CE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...