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Reliance Teams Strengthen Relationships with Central IRB
IRBs and research institutions continue to hammer out processes and best practices related to the revised Common Rule. As one IRB found, this process requires a team effort. When collaborative IRB requests began to increase, the Augusta (GA) University IRB office formed a reliance team. The IRB also designated one team member, a reliance coordinator, to handle issues related to reliance agreements. A recent study revealed the reliance team helps IRB offices with collaboration and reviewing reliance agreements to ensure the research is in accordance with local policies. The team also can help investigators navigate through reliance process. -
IRB Staff Training Program Improves Consistency and Work Group Efficiency
When an IRB office aimed to improve its staff training and work efficiency, the solution was to create a new program, called the IRB Staff Training and Onboarding Program. The process began with the IRB’s internal staff training and member work group and leaders identifying ways to improve training and onboarding of new IRB staff. -
Pfizer and Moderna Begin COVID-19 Vaccine Trials in Younger Children
Both Pfizer-BioNTech and Moderna announced in March they had begun clinical trials of their COVID-19 vaccines in children younger than age 12 years. Although public reaction was mixed, researchers and bioethicists now say the timetable for a pediatric vaccine and for the United States to possibly reach herd immunity is early 2022. -
Lawmakers Approve Workplace Violence Prevention Measure
Legislation would require extra measures to maintain safe healthcare environments.
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White Adults, Women Overrepresented in U.S. Vaccine Trials
Investigators uncover reporting gaps, lack of proper representation for older adults, minority groups.
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Patient’s Notice of Claim Not Time-Barred for Filing Two Years After Injury
This case is important to learn how time restraints are applied in medical malpractice suits. All states use specific statutes of limitations, and some states enacted additional time requirements to prevent a patient from waiting too little or too long before notifying the medical provider of intention to file suit. -
Punitive Damages Award Upheld for Wrongful Death Action Alleging Mere Negligence
This case demonstrates the need to fully inform patients of their treatment options — especially in non-emergency situations — and to carefully monitor patients during the relevant times, particularly during and after surgery, and to investigate abnormal conditions appearing after the surgery. A well-considered and documented informed consent can be as important to the patient’s safety from harm — and the physician’s protection from litigation — as making the correct diagnoses, prescribing the appropriate medications, or skillfully performing the correct procedures. -
Analysis: Few EMTALA Violations for Vascular-Related Issues
Few EMTALA violations involve vascular-related issues, according to the authors of a recent analysis. Of 7,001 patients with an EMTALA violation from 2011 to 2018, only 1.4% were vascular-related. Cases included cerebrovascular, ruptured aortic aneurisms, aortic dissections, vascular trauma, peripheral arterial disease, venous thromboembolism, dialysis access, and bowel ischemia. -
Specialty Pharmacists Play Important Role in Patient Safety
Specialty pharmacists can be influential with encouraging other pharmacists to improve patient safety. Those at a health system level work with many pharmacy departments. -
Proactive Programs Needed to Address Vaccine Resistance
Even as millions of Americans continue to receive the COVID-19 vaccine, some healthcare organizations still struggle with a worrying number of employees who will not accept the vaccines. Physicians and other leaders should address concerned employees and correct misinformation.