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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investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.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 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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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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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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Informed consent documents remain long and complex, despite successful efforts in recent years to improve their readability, an expert reports.
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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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A study by Canadian researchers shows that many published breast cancer studies are biased to show a positive outcome.
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Low-income cancer patients, including those who are on Medicare, are far less likely to participate in clinical trials than higher-income patients, according to a study in the Journal of Clinical Oncology.
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When an IRB initiates electronic metrics collection and analyses as part of its quality improvement process, there will be obstacles to overcome.
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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.
