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  • Study Reveals Preferences for Simpler Research Language

    Boilerplate language for informed consent documents is simple, but not always easy for study participants to understand. The goal for IRBs is to help researchers simplify the words and scientific jargon they use to describe studies to participants, but it is unclear how this can be accomplished. One solution is the Consent Language Explicit And Reasonable Initiative.

  • IRB’s Re-Engineered Program Makes It More Responsive

    The revised Common Rule requires IRBs and research institutions to become more efficient and attentive. It also makes clear that an IRB cannot do all things for all stakeholders. The University of Texas Health San Antonio created a human research protection program office to handle institutional components of research protection work.

  • Real-Time IRB Process Reduces Turnaround by 71%

    The IRB of the Medical College of Wisconsin in Milwaukee experienced a protocol review turnaround time of 70.6 days, despite using a robust pre-review system. A real-time review process decreased turnaround to 20 days, a 71% reduction through 2018.

  • Appellate Court Affirms $6 Million Medical Negligence Arbitration Award

    The issue of liability in this case was unanimously decided by all three arbitrators in favor of the patient. The facts of the case leave little space to argue the nurse acted in conformity with the necessary standard of care, particularly because of the significance of the delayed medical intervention.

  • Severe Hypoxia During Delivery Results in Permanent Brain Damage, $15 Million Verdict

    This case presents a multitude of breaches of the standard of care that cumulatively gave rise to the liability and significant verdict in this matter. In the complaint, the patient alleged the physicians breached their duty of care on multiple factual bases, including by failing to disclose all the risks associated with VBAC, violating the hospital’s standard operating procedure, failing to monitor the fetal heart rate continuously, allowing the patient to ambulate, and failing to identify early signs of fetal hypoxia.

  • Causation Difficult for Plaintiff in ED Malpractice Claim

    Generally, plaintiff attorneys find some aspect of care that was arguably beneath the standard of care. Likewise, they can show the ED provider was acting in the scope of his or her employment. However, causation often is a difficult problem.

  • Patient Selection, Standardization Can Reduce Surgical Liability

    One-quarter of all malpractice claims in a recent closed claim study involved surgical allegations, second only to diagnosis-related allegations. The authors of the study said standardization and practice contribute to successful outcomes. Routine and rigor also are vitally important.

  • Fall Prevention Always Is a Concern; Innovative Products Help

    There has been progress in fall prevention, but there is much more room for improvement. Some organizations are finding success with innovative products that can help reduce falls.

  • Medical Record Retention Requires Good Policies, Strict Compliance

    Records retention is a critical issue for risk managers, as the loss of important patient records and other documents could compromise litigation defense and threaten ongoing care. Healthcare organizations must create clear records retention policies and follow them closely, experts say.

  • HHS, CMS Easing Some Abuse Rules, Will Reduce Compliance Burden

    The Department of Health and Human Services and the Centers for Medicare & Medicaid Services are trying to reduce regulatory burdens on healthcare organizations with rule changes that would protect some activities from anti-kickback allegations. The changes are intended to promote value-based care.