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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.
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Disappointed by a funding gap in the federal support of stem cell research, the citizens of California have made the decision to directly involve the State in the research effort.
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Jay Wolfson, DrPH, JD, professor of health care law, finance, and policy at the Colleges of Public Health and Medicine at the University of South Florida in Tampa, offers this advice on how to counter not-for-profit lawsuits and avoid becoming a target for similar allegations.