Hospital Management
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Earning the Trust of Research Subjects
Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.
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Research Program Closely Monitors ClinicalTrials.gov Compliance
Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.
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FDA Unveils Real-World Data Initiative
The FDA recently opened a promising path to capture real-world data and evidence to complement traditional clinical trials and open new avenues of research.
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Right to Try Off to a Cautious Start
While the federal Right to Try law enacted last year essentially bypassed IRB oversight of patients seeking investigational drugs, research ethics panels and their institutions can codify a requirement for local oversight into their policies and procedures.
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Study Sheds Light on Improving Informed Consent Readability
A small study about improving readability of informed consent examines how investigators and IRBs can make research understandable to people with very limited reading skills.
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Low Health Literacy Is Major Barrier to Research Participation
Researchers may design an informed consent form at a fifth-grade reading level, but even that is too high, according to experts.
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Court Denies New Trial After Jury Exempts Doctor in Retained Object Case
Lessons from this case reveal the importance of proving or disproving causation, a critical element in any medical malpractice case.
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Obstetrician Liable For $1.75 Million Due to Permanent Brain Injuries to Infant During Delivery
This case focused on the use, or misuse, of a medical device: the vacuum extractor.
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Developing a Culture of Healthcare Safety Requires Multifaceted Approach
Improving the safety culture of a hospital or health system will require tackling challenges on several levels of the organizational structure.
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Electronic Discovery Can Be Costly, Time-Consuming
Discovery requests for electronic data can be especially burdensome in healthcare because of the vast amount of data involved.