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A new technology solution can help research institutions with a nagging logistical problem ever-larger files that must be routed within an institution or to external partners.
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A well-run human research quality improvement (QI) program can be an IRB's best friend, working with investigators to help them prevent common mistakes and to communicate better with the IRB, while avoiding the back-and-forth questioning that can drag out the review process.
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Thanks to a volunteer recruitment registry at Vanderbilt University, potential research subjects even those not currently being treated at the university's medical center or by affiliated doctors can make their names and health information available for future use.
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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.
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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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One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what theyre required to do and sometimes neglect to address the bigger picture, an ethics expert says.
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As IRBs deal with the privacy provisions of HIPAA, they often must decide whether researchers are allowed to waive individual authorization for use of patients data.
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Add one more discipline to the list of those that have issues with IRB review: Oral historians, who maintain that they should not be required to seek review for their interviews with participants.
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The NIH has created a framework and benchmarks program for evaluating research ethics. Christine Grady, PhD, RN, head of the section on human subjects research in the department of clinical bioethics at NIH, provides these insights into the seven principles outlined in the framework:
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Guidelines and regulations related to research ethics often are conflicting and difficult to follow, so IRBs are left with a multitude of ways to interpret human subjects research issues that arise during the protocol review process.