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A pilot program of a web-based system for reporting adverse events in clinical trials already has shown itself to be a timesaver for study staff at the Dana Farber/Harvard Cancer Center.
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Although IRBs are often charged with giving special consideration to research involving subjects deemed to be particularly vulnerable to exploitation, there is no standard definition of what this term means, and no guidance governing what additional protective measures it should prompt.
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The U.S. Environmental Protection Agency (EPA) has decided to delay the start of a controversial effort to study the effect of pesticides on children after some agency officials raised concerns about its recruitment procedures.
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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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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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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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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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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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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 Belmont Report has withstood the test of time as a framework for ethical decision making about human subjects research, experts in research ethics say.
