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IRB Advisor – May 1, 2006
May 1, 2006
View Issues
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Clinical trial problems in England raise ethical questions in US
Three weeks after a phase I clinical trial ended terribly wrong, four of the six London, England, volunteers remained hospitalized, and one patient remained in critical condition. No one could have predicted such an outcome for the first trial for a drug to treat cancer and autoimmune diseases. -
Research is changing IRB views about PTSD studies
In the past, IRBs considering protocols that sought to survey or interview trauma victims had to essentially follow their gut when pondering the question: Would answering questions harm participants by causing them to relive their painful experiences? -
Consent, confidentiality key in PTSD research
While recent studies have shown that interviews with trauma victims may not cause serious harm, and in fact can be beneficial, there still are serious issues surrounding asking people about such sensitive, personal experiences. -
Spotlight On Compliance: The FDA launches guidance initiative
To keep IRBs informed on current FDA thinking, the agency has created the Good Guidance Practices (GGPs) program. This is a process whereby dated and obsolete guidance is replaced by new information sheets on a variety of topics, along with the opportunity to comment. -
Liaison efforts can improve compliance
Compliance in research oversight has become a more prevalent concept in recent years, and this has led IRBs and research institutions to search for new ways to improve compliance communication and policies. -
Guest Column: Different disciplines, similar challenges
On the surface, it seems that individuals who oversee biomedical research face challenges that are very different from those encountered by their peers in behavioral and social science research.