IRB Advisor
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IRB creates user-friendly chart review application
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QI projects aim to prevent problems, improve processes
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Staffing, collaborations top IRB issues
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QI review finds problem with IRB's IC form
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Study: Not all published trial data is complete
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Observation index ensures efficient audit
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Try this 30-second QI solution for IC
Informed consent templates are useful when an IRB office starts a new process or when there are new employees or new investigators submitting applications, but an experienced office can improve IC review quality by weaning its staff off of templates, an expert suggests. -
Translation services may improve trial enrollment
Non-English speakers often are under-represented in clinical trials because of the language barrier and the lack of resources to provide clear and up-to-date translations of informed consent. This leads to questions of equity, an expert notes. -
More subjects enrolled than previously
Recruiting patients in many areas of clinical trial research is a very slow process, contributing to delays in getting new treatments through the research pipeline. -
Essentials document defines protocol ethics
Developing a sound, ethical protocol is the top goal for any researcher or IRB. But the basic ethical elements and the considerations behind an investigator's choices may not always be clear, often resulting in back-and-forth discussions between investigators and IRBs reviewing the protocol. A group from Harvard University collaborated with other research stakeholders to develop an ethics reference tool for investigators.