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Recruiting patients for Phase I oncology studies which are unlikely to provide therapeutic benefit to participants and which carry the risk of significant side effects raises unique issues in informed consent.
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As institutions continue to weather the economic downturn, the toll on IRB offices is showing. The trends of previous years fewer raises, more job cuts, increasing workloads continued in 2010, according to responses to IRB Advisor's annual Salary Survey.
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The software demands of smaller IRBs and larger ones can be very different, and its hard to meet everybodys needs with a single program. So Third Sky Inc. doesnt try.
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Four times a year, staff and board members from IRBs around the St. Louis area get together to talk about the issues that concern them, in an effort to learn from each other and to jointly sponsor educational programs.
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The latest round in the ongoing debate between IRBs and social and behavioral researchers about the scope and effectiveness of IRB review has come in the form of a white paper, Improving the System for Protecting Human Subjects: Counteracting IRB Mission Creep, released late last year by the Center for Advanced Study at the University of Illinois at Urbana-Champaign.
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The University of Southern Californias Office for the Protection of Research Subjects provides tips on how to identify human research studies in its booklet, Is Your Project Human Subjects Research? A Guide for Investigators.
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Mission creep among IRB work occurs when research institutions and IRBs permit fear of missing something to rule their decisions, an expert says.
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The problem of how to handle quality improvement (QI) projects resulted in a research project that explored the intersection between research and quality improvement and ethical oversight.
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A well-organized record keeping system is essential to IRB functions. IRB and research offices might improve their office documentation and efficiency by following a best practice model established by a large research institution.
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A trial studying antipsychotic drugs provides best practices for handling ethical issues involving decisionally impaired persons. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study was an 18-month study in which it was anticipated that some participants would lose decision-making capacity during the course of the study.
