Compliance
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PowerPoint Is Not Enough: How to Improve Safety Education and Training
Safety education requires more than a dull presentation and a few slides. Risk managers should seek effective methods.
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EHRs Are Still a Work in Progress
Recent research may not tell the whole story about electronic health records (EHRs) and patient safety. Hospitals must be vigilant in weighing the benefits of using clinical decision support tools in EHRs against the potential downsides of overly tying doctors to their computers with an abundance of manual, perceived non-value-added tasks.
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EHRs Still Not Improving Safety After Years of Promise
Recent research indicates electronic health records still are not improving patient safety, despite years of efforts to make them more effective in preventing errors and boosting adherence to best practices.
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Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials
The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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Court Rejects Challenge to Federal Price Transparency Rule
Plaintiffs announced intention to appeal decision.
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Small IRB Copes with COVID-19 Pandemic Under Limited Budget
Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.