IRB Advisor – January 1, 2007
January 1, 2007
View Issues
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Improve SAE reporting via electronic submission
One of the bigger headaches for IRBs is having to sift through hundreds or thousands of unanticipated problems submissions when most of these should never have been reported. -
When to inform about subjects' threats is unclear
Public health researchers studying sensitive issues suicide, domestic violence, drug use sometimes find themselves dealing with more than just the survey questions at hand. -
Virtual reality helps students with informed consent
Students who did practice sessions with a virtual reality "human subject" learned better informed consent skills than did those who only studied consent rules from written material, according to a recent study. -
Review process for unforseen problems is simple
The two-part process of electronic submission of unanticipated problems at Washington University School of Medicine in St. Louis, MO, requires investigators and clinical trial staff to enter information about the events after passing the chief screening criteria, and then it requires a reviewer to look at what has been submitted. -
IRB streamlines process to improve IRB response time
Intermountain Health Care Urban South Region of Provo, UT, revamped its IRB process with a goal of reducing its lengthy response time and to improve quality in IRB submissions. -
Think far beyond ethical requirements set, expert says
One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what they're required to do and sometimes neglect to address the bigger picture, an ethics expert says.