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IRBs often are involved with studies that involve sites in other states, which raise a host of concerns and complications.
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An anonymous survey of investigators, research administrators, and project managers found that principal investigators and co-investigators tend have a less favorable impression of IRBs and IRB staff than do the research assistants and project managers.
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IRB policies and forms often need to be updated and revised as human subjects research rules and regulations evolve.
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When research officials at the University of Virginia of Charlottesville, VA, began to ask what happens to a study once it's approved by the IRB, the answer became a new program: a post-IRB approval compliance monitoring and education program.
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A new consortium of research institutions is seeking to transform the process of translational research, in hopes of progressing more efficiently from scientific breakthrough to patient treatment.
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When research calls for recruiting patients with Alzheimer's disease and other forms of dementia, it's often hard to know whether patients would want to participate had they been able to make the decision themselves.
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In this digital age, a breach of personal data about clients or customers is the nightmare scenario for any business, conjuring specters of identity theft and public relations woes.
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The controversy of the past few years over possible suicidality associated with various drugs pointed out the importance of tracking suicidal thoughts or behavior in subjects involved in clinical trials.
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Giving children a chance to assent to their own participation in research is an important goal of the pediatric research community. Done properly, it can empower young patients, help them develop their decision-making skills, and prompt them to take their participation more seriously.
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An Institute of Medicine (IOM) committee studying the effects of the HIPAA Privacy Rule has painstakingly documented the strain it is putting on research.