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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.
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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.
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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.
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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.
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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?
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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.
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The clinical trial industry continues to experience major delays, leading to higher costs and a slow pipeline of products making it to market, experts say.
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There are a number of innovative practices IRBs can employ to improve their office's efficiency and work quality.
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When investigators interviewed 22 children in 1992, the IRB had questions, but the project was approved, leading to one of the few studies conducted in its area of interest.
