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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.
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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.
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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.
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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.
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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.
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IRB processes are so varied from hospital to hospital that they can unnecessarily impede multicenter trials, according to a survey that looked at the responses of 68 hospitals to one study.
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The FDA announced in early November that it was strengthening its safety program for marketed drugs. Lester M. Crawford, DVM, PhD, acting FDA commissioner, says that he has authorized the Center for Drug Evaluation and Research (CDER) to take the following measures.
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The Belmont Report has withstood the test of time as a framework for ethical decision making about human subjects research, experts in research ethics say.
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In this Q&A, Bernard Schwetz, DVM, PHD, director of the Office of Human Research Protections (OHRP), discusses the Belmont Reports successes and challenges as the 25th anniversary of its launching has passed.
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The St. Louis-based genomic medicine development company GenoMed is taking a novel approach to testing its hypothesis that inflammation-reducing heart medications can be effective in treating severe complications of influenza.
