IRB Advisor – August 1, 2010
August 1, 2010
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OHRP move might increase trend of research sites using centralized IRBs
Research institutions increasingly are turning to central IRBs for multisite clinical trials, and this trend probably will accelerate due to recent news that federal regulators are encouraging the change, experts say. -
ASK2-4U: OHRP director explains shift on central IRBs
The Office for Human Research Protections (OHRP) in Washington, DC, is indicating to research institutions that the agency favors the use of centralized IRBs for multisite studies. -
OHRP correspondence on central IRBs
The Office for Human Research Protections (OHRP) in Washington, DC, recently published letters that explain the agency's revised stand on the use of central or external IRBs. -
Drama queens (and kings) help IRB training
Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent. -
What are four key areas to teach in informed consent?
Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent. -
Biobank uses opt-out approach to gathering blood samples
When Vanderbilt University Medical Center set about creating its BioVU biobank, it went in a different direction than most institutions. -
Survey shows QI projects do get some oversight
When the federal Office of Human Research Protections raised questions about a quality improvement (QI) initiative to reduce catheter infections in Michigan hospitals in 2007, it reignited a debate over the line between QI and human subjects research necessitating IRB review. -
Informed consent when the victim is a black male
Young black men are disproportionately more likely than other groups to be victims of violent crime. But when researchers set out to study this group, they encounter difficulty in recruiting and retaining subjects.