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Evaluating research risk requires understanding a variety of potential harms and their nuanced impact. IRBs might find it useful to have a matrix to help explore each potential harm.
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Even as multicenter studies with central IRB reviews gain traction, some IRBs are still hesitant to join in. However, coordinating a multisite study among several IRBs within the same university system can be a time and paperwork hassle for both principal investigators and IRBs and could make previously reluctant IRBs consider a new central reliance agreement.
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The Presidential Commission for the Study of Bioethical Issues May 2014 report, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, includes recommendations for institutions and individuals engaged in neuroscience research.
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Technology advances have driven increased interest in molecular studies involving tissue analyses. As a result, biotech firms increasingly are asking scientists to sell human tissues for study by outside enterprises.
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The IRB at Grand Valley State University in Allendale, MI, uses a matrix that clarifies how IRB members and staff might describe various potential harms at four levels, from no more than minimal risk to high risk.
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It's the little details that matter in the informed consent process.
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IRB professionals responding to IRB Advisor's 2008 Salary Survey continue to report modest salary increases and larger staffs over the previous year. But they worry that raises aren't keeping up with increasing workloads and that they and their staffs are burning out.
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A series of two-day regional conferences will be held next year focusing on Food and Drug Administration clinical trails requirements, regulations and compliance issues.
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One strategy that helped a Lexington, KY, university research institution achieve full accreditation was its development of IRB approval checklists.
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Honest broker systems which process data and specimens for research by removing identifiers that otherwise would compromise patient privacy have been touted as a smart way to encourage research while still protecting patient privacy as required by the Health Insurance Portability and Accountability Act (HIPAA).