IRB Advisor – August 1, 2004
August 1, 2004
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As international research trials increase, new problems crop up
As the number of international research protocols increase, the problems faced by reviewing IRBs increase. International research is taking more and more IRB time, says Howard Guenther, PhD, MBA, associate vice chancellor for research and interim executive secretary of the Institutional Review Board at the University of Illinois at Urbana-Champaign. -
You can’t do emergency research in a vacuum
Emergency research may raise a number of issues for IRBs that either review such protocols or are asked to assess criteria for emergency room use of an investigational drug or device, experts say. -
Special Report: Regulations and Rules--Are We Heading in the Right Direction?
IRB Advisor asked IRB and human subjects protection experts from across the nation to discuss the state of human subjects protection regulations and how IRBs are interpreting federal requirements. This article, which is the last in the three-part series, will discuss investigator certification and training. -
On-line education is becoming standard
At institutions across the country, research administrators now are using Internet-based or local computer software modules to facilitate annual education in human subjects protections for investigators and IRB members. -
Bill for national trials registry on the table
A federally funded national clinical trials registry may soon be a reality if the American Medical Association (AMA) and several Democratic senators have their way. -
News Briefs
Senate passes BioShield; $5.6B slated for industry; FDA initiative seeks to speed up approvals; OHRP to require IRB registration.