IRB Advisor – February 1, 2005
February 1, 2005
View Archives Issues
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Vioxx, NIH crises lead to questions about drug safety and IRBs’ role
The revelation that Mercks popular painkiller rofecoxib (Vioxx), as well as other drugs in the COX-2 inhibitor class, pose an increased risk of heart attack and stroke in patients who take them has led many in the research community to question whether the instiutional review boards at the sites where the drug was tested failed in their mission. -
2005 issues: Stem cell research, noncompliance
The work of IRBs will not get easier this year, if predictions from panelists at the fall Public Responsibility in Medicine & Research (PRIM&R) conference are on point. Some issues are old hat informed consent, conflict of interest and others will arise out of the new frontier of stem cell research. -
IRB application helps educate researchers
A new computerized tool developed at Vanderbilt University in Nashville, TN, provides investigators with information about IRB policies and human subject research regulations at a critical point in the research process when theyre filling out their IRB applications. -
New web site centralizes multicenter submissions
Developers of a new web site for researchers and IRB administrators hope it will help streamline review of multisite research by centralizing protocol creation and enhancing communication among research sites. -
Newborn subjects, vulnerable families
After sometimes traumatic deliveries, mothers are exhausted, and perhaps on medication. Fathers are frantic with worry about both mother and baby. Some question whether its even possible to get true informed consent for research under those circumstances.