IRB Advisor – June 1, 2006
June 1, 2006
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Creative suggestions for getting consent from decisionally impaired
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. -
IRB puts its imprint on recruitment registry
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. -
QI program identifies deficiencies, educates
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. -
Electronic system improves IRB record management
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. -
IRB can now move huge data files with technology
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. -
New journal focuses on research ethics
A new journal about research ethics includes articles in June 2006, that discuss how the ethics review process has gone wrong for qualitative research, including ethnography. -
News Briefs
UK clinical trial disaster: Five subjects sent home; NIH launches MedlinePlus Magazine for public; GAO: Improve post-approval drug oversight