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IRBs and human research protection staff engage in important, sometimes life-protecting work. Their purpose and goals are on high ethical and moral ground. So its easy to forget that its also an enterprise with clients or customers to satisfy.
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It is a natural electronic data evolution: First, IRBs began using electronic data systems; then these morphed into full electronic submission, and now IRBs are collecting valuable electronic, real-time data that can be mined very quickly for process and quality improvement purposes. Metrics are key to this transition.
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A new study has found that while nine out of 10 clinical trials worldwide meet enrollment goals, reaching those goals could mean doubling original timelines.
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To better clarify the IRBs position in investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.
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A female doctor claimed to have suffered years of gender discrimination from a hospital's chief of surgery.
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An orthopedic surgeon who reportedly performed as many operations in two days as the typical orthopedic surgeon averages in one month is facing multiple malpractice lawsuits, as are the surgery center and hospitals where he operated.
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Consumer Reports has rated U.S. hospitals on how patients fare during and after surgery.
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