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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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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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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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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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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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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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Community-based research requires a special type of review, and so should have its own type of review board, one that balances the responsibilities that IRBs have to individuals with an appreciation for the needs of the community in which research is conducted.
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A group of mental health professionals, trauma researchers, ethicists and IRB representatives have published a set of ethical guidelines for research with victims of disasters.
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In the days after the Sept. 11, 2001, terrorist attacks, New York City became a focal point for researchers interested in studying everything from post-traumatic stress disorder to physical complications among workers at the Ground Zero site.
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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.