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A study by Canadian researchers shows that many published breast cancer studies are biased to show a positive outcome.
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In order to protect human subjects and the integrity of research, everyone involved should adhere to ethics guidelines and must adhere to ethics and compliance standards.
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Informed consent documents remain long and complex, despite successful efforts in recent years to improve their readability, an expert reports.
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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investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.
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The University of California at Berkeleys Consent Builder application relies on the simplified language and template structure previously developed by the institutions IRB office.
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Sometimes an IRB director will notice that board members lack interest in evaluation processes. Any attempt to assess how each member is doing might be shuffled to the back burner of the schedules of very busy people.
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A new research ethics program seeks to repair problems when investigators misbehave or are in noncompliance.