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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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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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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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As IRB offices gear up for a busy academic research year, its a good idea to dust off IRB templates, checklists, and other tools to revise, improve, and adapt to technology and other changes.
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For many years, the IRB office at Childrens Hospital Los Angeles (CHLA) followed a process that was standard at most institutions: long, regularly scheduled meetings organized to review an ever-increasing number of protocols.
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Over the past decade, several large-scale disasters have tested emergency response teams and healthcare providers. They've also tested the research community's ability to quickly, efficiently and ethically dispatch investigators to do vital research that could help prevent and respond to future disasters.
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Haverford College of Haverford, PA, has spent more than a year dealing with a problem that IRBs do everything they can to avoid: a research noncompliance investigation requested by the Office for Human Research Protections (OHRP).
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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).
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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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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.
